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Cleaning Handbook

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Cleaning
Handbook
Tetra Pak Processing Solutions

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1. INTRODUCTION.......................................................................................4
1.1 CIP Validation Procedure..................................................................................5
1.2 Glossary & Definitions .......................................................................................5
2. HYGIENIC DESIGN OF LINES AND COMPONENTS .............................6
2.1 Introduction.........................................................................................................6
2.2 Hygienic Design Prerequisites ...........................................................................6
2.3 Hygienic design....................................................................................................9
2.4 Hygienic Risk Assessment ................................................................................25
2.5 Hygienic Design Checklist Machines and Peripheral Equipment.............26
2.6 Hygienic Design Checklist Process Lines & Plants.....................................27
3. CIP TECHNOLOGY ................................................................................29
3.1 Different Types of Soil ......................................................................................29
3.2 Water Chemistry and Quality .........................................................................31
3.3 CIP Theory ........................................................................................................33
3.4 Detergent Chemistry.........................................................................................35
Alkalis ...................................................................................................................36
Acids .....................................................................................................................37
Surfactants (wetting agents)..................................................................................37
Sequestering Agents (chelating agents) ................................................................38
Oxidation Agents ..................................................................................................39
Overview of Some Cleaners and Disinfectants ....................................................40
3.5 Detergent Concentration ..................................................................................43
Dosing of Cleaning Agents...................................................................................44
3.6 Cleaning Temperature......................................................................................46
3.7 Cleaning Time ...................................................................................................48
3.8 Cleaning Flow....................................................................................................49
3.9 CIP Sequences for Certain Products...............................................................57
Full CIP Sequences for Various Applications ......................................................57

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Aseptic Intermediate Cleaning..............................................................................60


3.10 CIP of Specific Components in a Processing Line .......................................61
Separators..............................................................................................................61
Homogenisers .......................................................................................................61
Tank Cleaning.......................................................................................................62
3.11 Control of Cleaning Result.............................................................................65
3.12 Disinfection/Sterilisation of Equipment........................................................66
Sterilisation ...........................................................................................................66
Disinfection...........................................................................................................66
3.13 Guidelines for Determining Cleaning Intervals for Sterilisers...................67
3.14 CIP Systems.....................................................................................................68
Design of CIP Systems .........................................................................................69
Centralised CIP .....................................................................................................70
FURTHER CIP READING...........................................................................72
Appendix..................................................................................................................73
Extract from the EHEDG Glossary.......................................................................73

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1. Introduction
Cleaning, in this context, is the removal of deposited soil from processing equipment
surfaces, and is an essential operation in food processing. The main reasons for
cleaning are to satisfy food safety and regulatory standards, and to increase shelf-life
and reduce spoilage rates. It is also compulsory for suppliers of food processing
equipment to guarantee that the equipment can be cleaned. The purpose of cleaning is
to ensure that processing equipment is physically clean, i.e. all visible soil is
removed.
The principle of cleaning is very easy: the forces that bind the soil to the surface of
the equipment have to be overcome. This is achieved by mechanical and/or chemical
effects, together with an increase in temperature. A term often used in cleaning is the
Zinner circle, which defines the four main parameters governing the cleaning process:
cleaning temperature, cleaning flow, detergent concentration and cleaning time.
These are all closely related.
Designing and implementing cleaning procedures are both extremely important, but
before all else processing equipment must be designed for hygiene. It must be
possible to clean the equipment. A badly designed valve or processing unit will
endanger good hygiene and can not be properly cleaned. Hygienic design is the basis
for a good cleaning result, preventing the consumers health being put at risk due to
hazards that can affect food safety and the quality of processed or packaged food.
The aim of this document is to provide guidelines in hygienic design when integrating
process equipment into a process line, and to provide a general overview of the
importance of hygienic design. Furthermore, the document also describes the
cleaning-in-place (CIP) state of the art. It briefly describes some of the different
detergents used and the parameters of the Zinner circle. In the last section of Chapter
3 various CIP systems are described.
The target groups for this Cleaning Handbook are pre-project leaders, field service
engineers, designers, process engineers, development engineers and staff from market
companies. However, all those who need to know more about CIP should hopefully
find this a useful introduction.

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1.1 CIP Validation Procedure


A CIP validation procedure has been developed at Tetra Pak Processing Systems,
which is owned by Tetra Pak Dairy & Beverage (document FCDPM 0706-001). The
objective of this CIP validation procedure is to verify the effectiveness of the cleaning
procedures in Tetra Paks processing equipment. The layout of the document is
presented in Fig. 1. The following issues are discussed:

Design qualification
In-house validation
Installation qualification
Operational qualification and
Performance qualification

For a more detailed description the reader is referred to the CIP validation document.
The document also describes a method of assessing cleanliness. It is based on a
method of determining the value of ATP on the cleaned surface. A limit is suggested
defining clean processing equipment.

Fig. 1. The five steps in the CIP validation procedure.

1.2 Glossary & Definitions


The European Hygienic Engineering & Design Group (EHEDG) is an association
working in the field of hygiene. They have developed a glossary including some of
the most frequently used terms, phrases and expressions in cleaning and hygiene. The
EHEDG Glossary is given in the appendix.

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2. Hygienic Design of Lines and Components


2.1 Introduction
Within Europe, the essential requirements of the Machinery Directive, 98/37/EC,
should be met in respect of both safety risks to the operator of the equipment and
hygiene risks (Annex 1, paragraph 2.1) to the food (i.e., the product processed by the
equipment). The hygienic requirements of the directive can be met by using the Cstandard EN 1672-2:2005. The principles for performing a Hygienic Risk Assessment
can also be also found in the same standard; see also Tetra Pak Corporate Standard B
2153.05.
Hygienic requirements in the USA are to be found in Food & Drug Administration
legislation, FDA CFR Title 21 Food and Drugs, in the Grade A Pasteurized Milk
Ordinance (PMO) and the USDA Guidelines for the Sanitary Fabrication of Dairy
Equipment. Equipment exported to the USA must have a TPV approval according to
the 3A-SSI standard. Lubricants must have an NSF class H1 approval.
Other countries have similar legislation, often corresponding to, or referring to, EU or
US legislation and standards. However, questions concerning local legal demands and
standards must be checked by each Tetra Pak market company.

2.2 Hygienic Design Prerequisites


The single most important issue in engineering is to consider food safety, i.e. a
hygienic design. A design method that eliminates risks to both hygiene and safety
should be adopted. If this is not possible, then options safeguarding both hygiene and
safety should be employed. If this is not possible, either hygiene or safety should be
safeguarded. Where no design or safeguarding options to adequately control both
hygiene and safety risks are possible on the engineering level, one of the risks, or
both, must be dealt with by other safety measures, including instructions to the user.
The following affect the design and must be considered:;
- Type of product
- Materials in contact with food
- Utilities in contact with food
- Environment
Type of product
The following are presented for guidance and as examples of the range and type of
factors that must be considered regarding the process line and the
components/equipment in question when undertaking a risk assessment.
a) The intended use of the equipment: Will the equipment be used for one specific
purpose only, for which the hygienic demands are readily identifiable, or could the

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equipment be used for a wide range of products in many industries (e.g. a pump)?
Components are normally tested using water, or liquids with a similar viscosity. The
component may therefore not be suitable for soups, sauces, or similar products.
b) The type of product to be processed by the equipment: Will the product be
contaminated (e.g. a raw material), or will it be pasteurised or aseptic? Are additives
used? A product recipe may call for additives such as starch or stabilisers, or others to
increase the fat or protein content, etc. This can cause problems during cleaning and
may affect the choice of components and the flow engineering, etc., and must also be
considered.
c) The degree of further processing: Will the product processed by the equipment
subsequently undergo a further process which acts as a hazard elimination step (e.g.
heat treatment), or is the process for which the equipment is intended the final
process? The method used for heat treatment, as well as the time/temperature
combination differs depending on the type of product and its properties: such as
viscosity, homogeneity, content of fibres or particles, whole berries, etc.
d) Specific application of the product:
1. Is the product to be used by the consumer immediately after processing, or
does the product have a shelf-life during which the food safety hazard could
increase (e.g. microbial growth)? Use of hygienic zoning must be considered
for ESL products, incubation areas, etc.
2. Will the product be used by a specific consumer group to whom the hazard
may present a more serious risk (e.g. babies, the elderly or the infirm)? It may
be necessary to fulfil specific demands, such as high quality welds,
differentiation of production lines due to allergens in a product, etc.
e) The degree of cleaning, disinfection, pasteurization, sterilization and/or inspection:
Is the equipment to be cleaned, disinfected, pasteurized, sterilized and/or inspected
after every batch, routinely during the day, every day, or every week, etc.?
f) The use of the equipment: Is the equipment likely to be well maintained or used
infrequently? Is it designed for high or continuous use, and is misuse foreseeable?
This will affect the use of aseptic and non-aseptic equipment, as well as necessary
barriers such as steam, sterile air, nitrogen, etc.

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Materials in contact with food


The following are presented for guidance and as examples of the type of factors
regarding materials in contact with food that must be considered for the process line
and the components/equipment to be used in the various stages in risk assessment.
Under the intended conditions of use, the materials in contact with food shall be:
corrosion resistant
non-toxic
inert to the product, i.e. they must
- not absorb material (except when technically or functionally unavoidable)
- not transfer undesirable odours or colours, or taint the food;
- not contribute to the contamination of food, or have any adverse influence on
the food.
Detailed legal demands and directives are enforced for plastic, rubber, ceramics, etc.
within the EU and the USA, as well as in several other countries, such as Japan. Glass
should be avoided in equipment that comes into contact with food, and if used it must
be splinter free, and it must be impossible for it to get into the food product. When
necessary, filters are to be installed in the production line to avoid contamination
from sacks, etc.
Lubricants used in food production equipment must be of Food Grade, NSF
approved, class H1. In the USA 10 mg/l is allowed in the product and in the EU the
product must contain no oil.
It is important to take into account the legal demands included in the design criteria in
the purchase documentation sent to the suppliers.
Utilities in contact with food
The following examples of utilities are presented for guidance and as examples of the
type of factors that must be considered regarding the process line and the
components/equipment to be used.
Steam must be of a specific quality when used in contact with food. Culinary or clean
steam must be used as steam normally contains additives to prevent calcium deposits
in the steam-generating system. These additives are toxic and must not come into
contact with food.
Water must be of a special quality when used in contact with food. Potable water
according to the WHO recommendation must be used. Furthermore, Tetra Pak places
specific demands on water quality, for technical reasons, to ensure correct
functionality and to avoid corrosion of components/equipment. The water quality is
naturally also of the utmost importance for the results of cleaning, for example, in
avoiding re-contamination.
Compressed air must be of a specific quality: dry, clean and oil free, when used in
contact with food, for example in ice cream freezers. Additional active carbon filters,

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or corresponding equipment must be used when compressed air is used as sterile air
in aseptic applications.
Ventilation: the flow, temperature and humidity of incoming air must be controlled.
Zoning may have to be considered to avoid contamination being spread from a lower
zone to a higher one. Special HEPA filters then have to be installed to remove
particles.
It is important to address the legal demands included in
the design criteria in the purchase documentation sent
to the suppliers.

2.3 Hygienic design


General requirements
Materials must be suitable for the intended use. Surfaces of materials and coatings
shall be durable and cleanable and, where required, capable of being disinfected,
unflawed, resistant to cracking, chipping, flaking and abrasion, and undesirable
matter must not be able to penetrate the surface under the intended use.
Surfaces
1. The surface finish shall be suitable for the intended use.
2. Surfaces shall be cleanable and, where required, it must be possible to
disinfect them. For this purpose they must be smooth, unflawed or sealed. The
surface design and finish shall be such that the product is prevented, as far as
possible, from becoming accidentally separated from the food contact area
and from returning to it, if that return could cause a hazard associated with the
processed food.
3. Surfaces shall have a finish such that no product particle can become trapped
in small crevices, thus becoming difficult to dislodge and so introduce a
contamination hazard.
The above requirements also apply to dismountable parts, which are removable for
cleaning.
NOTE: Guidance for measurement of surface finish
(roughness specification Rz and/or Ra) can be found in
EN ISO 4288. Additional requirements for surface
finish can be found in some equipment-specific type C
standards.

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Joints
Permanent joints

Joints shall be sealed and hygienic. Recesses, gaps, crevices, protruding ledges, inside
shoulders and dead spaces shall be avoided. If technically impossible, adequate
design solutions (e.g. cleaning or disinfection instructions, etc.) are to be given.

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Dismountable joints

Dismountable joints shall exhibit a true and hygienic fit. Gasket compression is to be
limited by a mechanical stop.
Fasteners
Fasteners such as screws, bolts, rivets, etc., shall be avoided. If technically
impossible, adequate solutions (e.g. cleaning or disinfection instructions, etc.) shall be
given.

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Drainage

a) not drainable
1 concentric reducer
2 centric reducer
The equipment should preferably be self-draining; if this is not possible, it must be
easy to remove the residual liquid by other means.
Note: In our applications piping should normally remain filled with water to prevent
contamination and to avoid pitting corrosion which may occur when droplets
evaporate.

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Internal angles and corners

Internal angles and corners shall be constructed such that they can be cleaned
effectively and, where required, can be disinfected. Internal angles and corners are to
comply with the technical requirements given in equipment-specific C standards.

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Dead spaces

Dead spaces are to be avoided unless technically impossible in the design,


construction or installation of the equipment. Unavoidable dead spaces shall be
constructed in such a way that they are drainable/cleanable and can be disinfected,
when required.

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Bearings and shaft entry points

Bearings shall either be located outside the food area, except where this is technically
unavoidable, or designed for and lubricated with food grade lubricant, cleanable and
where required capable of being disinfected.
Shaft seals and moving shafts in the food area shall be self- (or product-) lubricated,
or should be designed for and lubricated with food grade lubricant, cleanable and,
where required, capable of being disinfected.
Note: Requirements for equipment used in aseptic
processing can be found in specific C standards.

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Instrumentation and sampling devices

Instrumentation and sampling devices shall comply with the relevant design
parameters.
Panels, covers, doors
These parts shall be so designed such that they have no adverse influence (e.g.
entrance and/or accumulation of soil) and shall be cleanable and, where required,
capable of being disinfected.
Control devices
If there is no manual contact with the food, items or areas of equipment that are
handled for control reasons by the operator, shall be considered as non-food areas. In
the case of manual contact with the food, where cross-contamination can occur, these
areas or items are to be covered by the definition of a food area.

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Splash area

Splash areas are to be designed and constructed following the same principles as
those applicable to the food area. As the product does not return to the food area, the
technical design criteria may be less stringent than in the food area in areas such as
the following, provided that there is no adverse effect on the food:
technical requirements for surface finish may allow for higher Rz and/or Ra
values;
internal angles and corners may be of smaller radius, provided they are still
cleanable and, where required, capable of being disinfected
bearings, seals, moving shafts, etc., located in a splash area, may be lubricated
by non-food grade lubricants, provided there is no adverse influence on the
food.
Non-food areas
In addition to the general requirements, exposed surfaces in the non-food area are to
be made of corrosion-resistant material or material that is treated (coated or painted)
so as to be corrosion resistant. These surfaces shall be cleanable and, where required,
capable of being disinfected, and shall not contaminate or have any adverse influence
on the food.
Equipment shall be designed and constructed in such a manner as to prevent the
retention of moisture, ingress and harbourage of vermin, and accumulation of soil,
and to facilitate inspection, servicing, maintenance, cleaning and, where required,
disinfection. Tubular framing shall be completely closed or effectively sealed.

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Welding
The best welding method for hygienic welds is TIG, as this has the best performance
when welding thin-walled stainless steel tubes. Orbital welding with inert gas ensures
high repeatability, resulting in welds of high quality.
Weld defects, such as cracks, porosity, etc., must be avoided to prevent the build-up
of residues, minimising the risk of microbiological contamination to the lowest
possible level.
The settings on the welding equipment (current, gas, etc.) are important, as well as
preparation of the tubes. Misalignment, gaps, etc., should be avoided.

Steel quality: SS-2333, AISI 304 L Welding 2-pulse, O2 content shown in ppm
It is important to visually inspect and check all welds. A fibroscope can be used to
inspect welds inside tubes. Concavity, convexity, penetration, cracks, cavities, arc
strikes and weld bead meandering must be considered in order to ensure a hygienic
weld. It is also important to inspect the colour of the weld area as discolouration

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indicates the use of incorrect current or too high an oxygen content. Poor welds must
be cut out and replaced by an approved weld.
Hygienic zoning
Zoning is understood as the physical segregation of different unit operations or
activities including the use of physical barriers in regards to the hygiene level. Zoning
is also used to control the movement of personnel, equipment and materials, as well
as the circulation of ambient air.
Preventing the contamination of a product involves protecting the product, not only in
the vicinity of, for example, a filling line, but also in the entire process area, or zone.
Therefore, zones are defined according to the level of cleanliness and hygienic
classification, to protect different types of products from, for example, various vectors
carrying microorganisms (cross-contamination), pests and odours originating from
the factory environment and its surroundings.
Hygienic zones are normally defined in two or three levels of hygiene, such as the
Basic Hygiene Zone, Medium Hygiene Zone and High Hygiene Zone.
Basic hygienic zones require Good Manufacturing Practice (GMP) and can be used
to separate the area from outside areas. Typical basic hygiene zones are in the
warehouse or incoming material reception areas. The milk reception area is also a
basic hygiene zone. Personnel in this zone are not required to wear special clothing,
but their clothing must be clean at all times. There should be no open product
handling in this area.
Medium hygiene zones also require GMP. Examples are process areas where
products are made for consumer groups that are not especially sensitive, or products
in which no further microbiological growth is possible in the final product. Areas in
which closed equipment with much higher internal hygienic requirements is operated
(e.g. most of Tetra Pak Processing and Filling equipment), are often defined as
medium hygienic zones. Personnel clothing must be clean, and white coats and
protective headwear (hairnets) must be worn. Changing of shoes for operators or shoe
covers for visitors may be recommended, but are rarely essential. Filtered and
conditioned air at an overpressure is recommended for certain applications.
High hygiene zones are those in which processed products are exposed and are
vulnerable to recontamination. This classification is typical for open processes or
operations in which the highest level of hygienic precautions must be adopted. This
zone should be limited in size, and the layout should be as simple as possible.
Supplementary equipment such as fans, pumps, power supplies, etc., should be placed
outside the area. Special rules are applied in such zones, for example, restricted
movement of personnel and materials. Protective clothing, changing of shoes, etc., is

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essential before entering. Filtered (HEPA filter) and conditioned air at an


overpressure is essential to minimise possible sources of contamination. Dry or
controlled wet cleaning procedures are normally required for such areas. High
hygiene zones are never subject to wet cleaning.

Note: Zoning should be used as a preventive measure,


as part of the total hygiene concept. Zoning alone does
not prevent contamination if the surfaces in contact
with, or very close to, the product are not properly
cleaned and maintained.

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Flow systems
It is of the utmost importance to avoid the mixing of cleaning solution and product, or
heat-treated and non-heat-treated product. In order to avoid this, different flow
solutions can be used, such as swing bend plates, mix-proof valves or separation by
valves and a drainable pipes. The three examples below show recommended flow
solutions.
Examples of mix-proof arrangements
Valve arrangements for tanks - Filling and emptying from the bottom of the
tank
When filling and emptying a tank with a single bottom connection, a valve
arrangement such as that shown in Fig. 2 can be used.

Fig. 2. Valve arrangement


V1 = Change-over valve, 3 gates for connection of CIP pressure
V2 = Stop valve
V3 = Change-over valve, 4 gates to separate tank cleaning, pipe cleaning
V4 = Change over valve, 3 gates for connection of CIP return
V5 = Change-over valve, 3 gates for bypass during pipe cleaning
V6 = Change-over valve, 3 gates for bypass during pipe cleaning

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Cleaning of tank with mix-proof valves

Fig. 3. Cleaning of tank with mix-proof valves.


Cleaning of inlet/outlet backwards with pressure
Note: It is possible to clean the inlet or outlet line with product in the
tank.

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Common tank bottom inlet/outlet LKB/SBP

Fig. 4. Common tank bottom inlet/outlet LKB/SBP.

Application
This design shows the arrangement of the connection of a tank to CIP and
production using a swing bend panel.
Functions during production
When running the transport to the tank the swing bend must be in the horizontal
position, as shown on the diagram.
Cleaning the tank
When cleaning the tank the swing bend must be in the vertical position. CIP return
is on the right side of the swing bend panel. The valve in the bottom of the tank is to
be flipped without pressure during certain steps in the CIP sequence.
Cleaning the inlet/outlet pipe
When cleaning the inlet/outlet pipe the swing bend must be in the vertical position.
CIP return is on the left side of the swing bend panel.

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Instruction handbook
An instruction handbook shall be provided by the manufacturer, which must meet
several requirements including the requirement set out in EN ISO 12100-2:2003.
Specific information related to the hygienic design is to be provided, in particular:

Space required for operation and maintenance, for example, measures to be


taken when installing equipment. Care shall be taken to ensure that there is
adequate access for servicing the equipment and for cleaning service systems
and their adjacent areas, so that the required level of hygiene can be
maintained.
Acceptable environmental operating conditions and, where required,
measures to be taken to ensure that the food is not adversely influenced by,
for example, air currents, dust or liquids derived from leakage, condensation
or aerosols.
Dismantling (if necessary), cleaning, disinfection, rinsing and inspection for
control of cleanliness. The method and frequency of cleaning various
surfaces, including dismountable parts, are, however, dependent on the food
product being processed and the associated/relevant hazard(s).
Recommended cleaning and disinfecting agents and instructions for
dismantling (if necessary), cleaning, disinfection, rinsing and inspection to
ensure cleanliness.
The method and frequency of cleaning various surfaces, including
dismountable parts, are dependent on the food product being processed and
the associated/relevant hazard(s).
A scheme describing the measures required to ensure that the necessary level
of hygiene of food equipment is maintained within specified intervals.
If food grade lubricants are required, this must be specified.

2.4 Hygienic Risk Assessment


Performing a hygienic risk assessment of the design will indicate the relative
significance and the need for higher levels of protection (i.e. safeguarding). Hazards
are to be eliminated, or the associated risks reduced by ensuring that the equipment
is properly designed and constructed, and capable of being properly installed,
operated, cleaned and maintained. The hygiene requirements of the different parts of
the equipment depend on their function, the type of food to be processed, and the
nature of the hazards to the food. The primary objective of applying design and
construction criteria is to eliminate or reduce the risks to an acceptable level.
The mandatory hygiene risk assessment at Tetra Pak follows the methodology
described in Tetra Pak Corporate Standard, document No. KA 2153.05, which is
based on the methodology described in EN 1672-2:2005.

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2.5 Hygienic Design Checklist Machines and Peripheral


Equipment
CE marking
- hygienic design, possible to clean (MD 98/37/EC, Annex 1, paragraph 2.1)
- HRA performed according to EN 1672-2:2005
- withstand product pressure/volume (PED 97/23/EC)
Suitable materials for product contact surfaces
- stainless steel (and other metals): quality suitable for the food to be processed
- elastomers and plastics: quality suitable for the food to be processed
- appropriate surface finish (USA & EHEDG 0.8 m)
Lubricants
- NSF-approved food grade lubricant: zero content in food in the EU, in USA <
0.1 mg/l is permissible
Joints
- permanent joints shall be sealed; crevices, inside shoulders, dead spaces, etc.
are to be avoided
- dismountable joints shall exhibit a true and hygienic fit
Drainage
- the equipment should preferably be self-draining
Internal angles and corners
- shall be cleanable and, where required, capable of being disinfected, Rmin =
3 mm
Dead ends
- shall be avoided unless technically impossible in the design, max
recommended length 1.5 x diameter
- if unavoidable, they shall be drainable/cleanable and capable of being
disinfected
Fasteners
- screws, bolts, rivet, etc., shall be avoided
Hygienic welds
- approved certified welder
- suitable welding method with correct parameter settings
- orbital welding preferred: tungsten electrodes and inert gas, recommended O2
level 40 50 ppm
- pipe alignment

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inspection and approval of welds (use appropriate method; visual, video


scope, X-ray, etc.)

Bearing and shaft entry points


- preferably located outside the food area, unless technically unavoidable
- shaft seals and moving shafts in the food area shall be self- (or product-)
lubricated
- if technically impossible, they must be lubricated with food grade lubricant
- shall be cleanable and, where required, capable of being disinfected
Panels, covers, doors
- must be designed to avoid any adverse effects, to be cleanable and, where
required, capable of being disinfected
- control devices can normally be considered as non-food areas
Splash area
- designed and constructed following the same principles as for the food area
Non-food area
- corrosion-resistant material or material that is inert (i.e. has no influence on
food) and cleanable

2.6 Hygienic Design Checklist Process Lines & Plants


CE marking
- hygienic design, possible to clean (MD 98/37/EC, Annex 1, paragraph 2.1)
- HRA performed according to EN 1672-2:2005 or EN ISO 14159:2002
- withstand product pressure/volume (PED 97/23/EC)
Suitable materials for surfaces in contact with food
- stainless steel (and other metals): quality suitable for the food to be processed
- elastomers and plastics: quality suitable for the food to be processed, EU reg.
1935/2004 or FDA
- correct surface finish (USA & EHEDG 0.8 m)
Lubricants
- NSF-approved food grade lubricant is to be used; in EU no presence in food,
in USA < 0.1 mg/l
Suitable components for the food to be processed
- material approved for food contact
- temperature resistance (process, hot water sterilisation, steam or other)
- hygienic connection not causing dead ends or misalignment
- installation direction not causing dead ends
- need for steam barrier or hot condensate (correct temp. & flow)
- T-pipes, correct CIP flow
- drainable, no product residues in pockets
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positive pumps cleanable (by-pass valve)


masking of feedback signals, forced control, etc. (control system must not
affect hygienic design)
instrumentation and sampling devices must comply with the relevant design
parameters

Hygienic welds
- approved certified welder
- suitable welding method with correct parameter settings
- orbital welding preferred: tungsten electrodes and inert gas, recommended O2
level 40 50 ppm
- pipe alignment
- inspection and approval of welds (visual, videoscope)
Cleaning circuits
- number of objects -fouling of cleaning solution
- number of circulations (reuse) before reject
- flow rate of cleaning solution >1.5 m/s
- no mixing of product and cleaning solution possible, drainability
- no simultaneous upper and lower flip on Unique valves
Pipe support
- pipe slope rec. 3%
- expansion aid used to avoid risk of tension
- valve clusters not used to support pipes, risk of tension intercrystalline
corrosion
Positioning/layout
- building and other premises acc. to Codex principles
- hygiene zones with transfer barriers (air pressure, air filter quality, PPE, etc.)
- possible to inspect and maintain equipment
- possible to clean equipment externally (non-food area)
- insulation properly mounted and suitably sealed
Utilities
- culinary steam quality in food contact
- potable water quality in food contact and for cleaning purposes
- sanitary compressed air in food contact (filter quality, oil- and condensationfree)
- air used for ventilation (zoning, filter quality)

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3. CIP Technology
The result of cleaning depends on a range of factors, including the type of product
being processed, the quality of the raw material/product, the configuration of the
equipment, running time before CIP, type of cleaning solution, detergent
concentration, water quality, cleaning time, cleaning temperature, and flow rate of
CIP solutions.
Factor

Consequences

High quality of raw product


Type and configuration of equipment
Type of product
Running time before cleaning
Type of detergent

Improved protein stability


Running time restriction
Type of soil (mineral/fat/protein)
Thickness of soil layer
Alkali, acid and additives

Detergent concentration
Water quality
Cleaning time
Cleaning temperature
Flow rate

Cleaning result

3.1 Different Types of Soil


It is important to know the composition of the soil when designing a CIP sequence.
The composition of soil will vary depending on the type of product being processed.
Simply changing the fat content of milk can result in a change in the composition of
the soil, which makes it more difficult to remove. Tetra Pak process equipment is
used for different food applications, ranging from juices to prepared food such as
rice pudding and Bchamel sauce. Table 1 shows a schematic overview of the
different types of soil that need to be removed from equipment surfaces during CIP.

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Table 1. Different types of soil (according to Guthrie, 1972). From the Handbook of
Hygiene Control in the Food Industry (Ed. Lelieveld, H. L. M., Mostert, M. A. &
Holah, J., CRC Press, 2005)
Type of soil
Solubility
Ease of removal
Low/medium
High
pasteurisation
pasteurisation/UHT
Sugar
Soluble in water
Easy
Caramelisation,
more difficult to
clean
Fat
Not soluble in
Difficult
Film formation,
water, soluble in
more difficult to
alkali
clean
Protein
Not soluble in
Very difficult
Very difficult
water, soluble in
alkali, slightly
soluble in acid
Mineral salts
Solubility in water Varies
Varies
varies, most salts
soluble in acid
Starch
Soluble in water
Easy to moderate
Glue-like
and alkali
formation, difficult
to remove
Two examples are given below of the fouling that can be found in Tetra Pak
processing equipment, originating from milk production and tomato paste
production. Both products represent typical soil situations, but also serve to
illustrate the differences in the CIP cycles.
Milk fouling
During the processing of milk, either pasteurised or UHT milk, the heating
equipment is fouled. There are two main types of fouling (see Table 2). Lowtemperature pasteurisation (maximum temperature 72-75 C) creates a kind of
fouling with a high content of protein, mainly -lactoglobulin. This type of fouling
is denoted type A, and is dominant in the temperature range 70 to 105 C. During
the production of UHT milk, another type of fouling besides type A fouling,
denoted type B, arises. Type B fouling is created in the high-temperature range
starting at 110 C. This type of fouling contains a higher level of minerals than type
A fouling, mainly calcium phosphate.
Table 2. Composition of soil in dairy applications.
Type of fouling
(Type A)
%
Protein
Minerals (calcium phosphate)
Fat

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50-60
30-50
4-8

(Type B)
%
15-20
70-80
4-8

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Tomato paste fouling


When cleaning a protein deposit, e.g. milk fouling, the detergent solution will cause
swelling of the soil. Deposits resulting from the processing of tomato paste are
cohesive, and can be removed in large chunks by hydration of the depositsubstrate
interface. Fouling deposits form as a result of both adhesion of material to the
equipment surface and cohesion between elements of the material.

3.2 Water Chemistry and Quality


Two main issues are of importance regarding water quality, namely microbiological
status and water hardness. The microbiological status is the more important one in
food processing. The other issue, water hardness, concerns the amount of metal ions
in the water. Water hardness and inadequate pre-rinsing are two major factors
causing failure in CIP operations, apart from inadequate flow rates. Calcium and
magnesium ions are considered in the context of water hardness, but other
polyvalent cations may also be of importance. The European standard for water
hardness is German degrees (dH).
Three problems causing failure of CIP:
water hardness
inadequate pre-rinsing
too low flow rate (Sect. 3.8)
Water hardness can be discussed in terms of carbonate hardness (temporary
hardness) or non-carbonate hardness (permanent hardness). The salts causing
permanent hardness are Ca and Mg sulphates or chlorides. Temporary hardness is
remedied by heating the water. The total water hardness is defined as the sum of the
calcium and magnesium concentrations, expressed as equivalent calcium carbonate,
according to:
mg equivalent CaCO3/l = 2.4797 [Ca, mg/l] + 4.118 [Mg, mg/l]

When referring to water hardness, it is essential to


make it clear whether one is referring to temporary,
permanent or total hardness.
In Table 3 the limits for different degrees of hardness are given in terms of the
concentration in mg/l (ppm), German degrees and milliequivalent/l. Several units
are used to express water hardness, and Table 4 gives the conversion factors for
those most frequently used.

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Table 3. Water hardness according to The Orange Book.


Hardness
CaCO3
German
mg/l (ppm)
dH

Milliequivalent/l
meq/l

Very soft
Soft
Moderately hard
Hard
Very hard

1
1-2
2-4
4-8
>8

<50
50-100
100-200
200-400
>400

2.8
2.8-5.6
5.6-11
11-22
>22

Table 4. Conversion table for water hardness units (The Orange Book).
= 17.9 mg CaCO3 / l
1 dH
1 meq/l
= 50.0 mg CaCO3 / l
= 10.0 mg CaCO3 / l
1 f
= 14.3 mg CaCO3 / l
1 Clark
1 grain/US gal
= 17.1 mg CaCO3 / l
Water quality can vary depending not only on the source, but also the time of day.
Some naturally soft water can cause corrosion due to its acidic pH. Mineral salts
make water more basic (pH above 7) and corrosion increases, leading to a high risk
of damage to pipelines, heat exchangers and boilers.
Table 5. Water quality recommendations for minimum corrosion (ppm or mg/l).
Hardness
4 7 dH
Alkalinity
> 0.6 meq/l
Chloride ions
< 30 ppm ClChlorine
< 0.2 ppm Cl2
pH
7.0 8.5
Sulphate ions
< 100 ppm
Aluminium
< 0.1 ppm
Iron
< 0.2 ppm
Manganese
< 0.05 ppm
KMnO4 consumption
< 20
Aggressive carbon acid
0 ppm CO2

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3.3 CIP Theory


Cleaning of processing equipment is a necessity for all food producers. CIP should
be planned in such way that it intrudes as little as possible on production time. In
order to reduce CIP times it is important to consider the process as a whole.
Cleaning is not an isolated event, and product recovery preceding CIP can be
performed in an intelligent way. In many UHT applications, production starts
immediately after cleaning, and thus the sterilisation of the process equipment must
also be considered as part of the cleaning cycle.
The factors influencing the cleaning of processing plants are mechanical design,
process design and cleaning process. The interrelationships between these is
illustrated in the figure below (Fig. 5). It can be seen how the process design is
related to the cleaning process through the type and amount of fouling on the
equipment surface. The type of detergent and concentration must be chosen so as to
be appropriate for the type of fouling. The mechanical design then governs both the
process design and the cleaning process. Designing and managing cleaning
processes is extremely important, but before all else processing equipment must
be designed for hygiene.
Mechanical design
- materials, surface finish
- equipment design and installation
- geometry

Process design
- quantity and type of
soiling
- age/moisture of soiling
- composition of soiling

Cleaning process
- detergent type and concentration
- temperature
- flow rate
- water hardness

Fig. 5. The relations between the factors affecting the cleaning of a food processing
plant.

Designing and managing cleaning processes is


extremely important, but before all else processing
equipment must be designed for hygiene.

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The cleaning steps after pre-rinsing can be described in the following steps, which
are illustrated schematically in Fig. 6.
1. The cleaning solution is transported to the fouling layer by the fluid flow
(turbulence).
2. The detergent reacts with the surface of the fouling layer and the chemicals
start to penetrate the layer. Proteinaceous fouling starts to swell.
3. The dissolved fouling layer is then transferred to the bulk solution. It is
possible to prevent the soil from aggregating and re-attaching to the fouling
layer by using additives.

Rinsing water

Alkaline cleaning solution

Alkaline cleaning solution

Alkaline cleaning solution

Fig. 6. Illustration of the cleaning mechanism.


(from Jeurnink and Brinkman)
.

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Fig. 7 illustrates Zinners circle consisting of the four main process parameters that
can be controlled during CIP: the concentration of the cleaning agent, temperature,
time and flow. Zinners circle is surrounded by a circle representing the production
time. A longer production time usually results in a longer cleaning period. This in
turn may result in a longer down time. Therefore, production time must be
considered as well as the specific product being processed.

Time

Concentration

Flow

Temperature

Fig. 7. The parameters that affect the cleaning result.


It is important to know which of these four parameters is the most important. In
order to reduce costs and energy consumption it is important to optimise the CIP
sequence. The cost of the energy required to heat the CIP solutions, the energy
needed to pump the CIP solutions and the price of the CIP solutions should thus be
compared. In the broader perspective CIP must be included in the total production
scenario.
In the following sections the different aspects of cleaning will be considered in
more detail, starting with the chemistry of cleaning.

3.4 Detergent Chemistry


Many dairy producers today use lye (sodium hydroxide solution) and an acid as
cleaning agents. This is sufficient for many applications and results in adequate
cleaning. Commercial manufacturers offer a range of detergents for different
applications and products. Various components are added to the alkaline or acid
solutions, such as wetting agents and complex-forming agents. Cleaning
components are usually described as alkalis, complex phosphates, surfactants,

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chelating agents and acids, and it is important to choose the most suitable
component or components based on:
the kind of fouling to be removed
the detergent
the concentration, temperature and contact time
the quality of the water
The function and effectiveness of various detergent compounds are summarised in
Table 6, on a scale from 1 to 5, where 5 indicates excellent functionality.
Table 6. The effectiveness of various cleaning compounds (from the Handbook of
Hygiene Control in the Food Industry, Ed. Lelieveld, H. L. M., Mostert, M. A. &
Holah, J., CRC Press, 2005)
Cleaning
Strong Mild Polyphosphates Weak Strong Surfactants
function
alkalis alkalis (sequestering
acids acids
agents)
Chelation
1
2
5
1
1
1
Saponification
5
4
4
4
4
2
Wetting
2
3
2
2
1
5
Peptising
5
4
2
3
4
1
Emulsification
2
3
3
1
1
5
Dispersion
3
4
2
4
1
4
Rinsing
4
4
3
2
1
5
Corrosion
5
3
1
3
5
1

Alkalis
If the fouling consists of proteins an alkali is the best cleaning agent. The most
frequently used alkali detergents are sodium hydroxide (NaOH), potassium
hydroxide (KOH) and sodium carbonate (Na2CO3). Alkalis cause the proteins to
swell, facilitating their removal. In order to reduce the cleaning time the pH of alkali
solutions should be between 12 and 13 (Table 7).
Fat is also removed by alkali. At high temperatures fat is saponified, i.e. soap is
formed. Soaps also lower the surface tension of solutions thus improving the
emulsification of fat and the wetting effect.

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Sodium hydroxide (NaOH) has excellent detergent properties but corrodes


aluminium, galvanised metal and tin. Its rinsing and wetting properties are poor, and
divalent metal ions (Ca2+ and Mg2+) are precipitated in alkaline solutions. If hard
water is used for rinsing and/or preparation of the cleaning solutions, this will add to
the mineral-based fouling of the equipment.
Table 7. pH as a function of concentration for two alkali detergents.
Concentration 0.25
0.5
1.0
2.0
NaOH
12.5
12.8
13.0
13.3
Na2CO3
11.3
11.4
11.6
11.7

The use of NaOH with hard water will add to the


mineral-based fouling of the processing equipment.

Acids
The hydrogen ion (H+) in acids reacts with the fouling causing it to break down and
dissolve. The most frequently used inorganic acids are nitric acid (HNO3) and
phosphoric acid (H3PO4). The former is most frequently used in Europe, while the
latter is the first choice in the USA. Nitric acid is a stronger acid, having a higher
coefficient of dissociation than phosphoric acid, and is thus more efficient, but it is
also more corrosive to stainless steel. Among the organic acids, acetic acid, lactic
acid, citric acid and gluconic acid are the most frequently used. These acids are
weaker than, and not as corrosive as, nitric acid but expensive compared with the
above mentioned inorganic acids. Hydrochloric acid (HCl) must not be used due to
its corrosive properties on stainless steel. However, chlorine detergents are
commonly used in membrane cleaning applications due to their high oxidising
capability.
In many applications alkali CIP is followed by acid CIP. However, inorganic acids
have strong dissolving effects on protein fouling and can thus be used before alkali
CIP in order to facilitate cleaning with an alkali detergent. Due to the passivating
effect of acids on stainless steel, acid detergents are used after alkali CIP. In the
cleaning of UHT milk processing equipment, especially in high-temperature parts of
the steriliser, minerals and the white deposit called milk stone are removed by acid
cleaners.
Surfactants (wetting agents)
Surfactants, also called wetting agents, can be added to detergents to lower their
surface tension, enabling them to wet the surface of equipment more effectively,

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thus making cleaning more efficient. They also prevent re-deposition of fouling
material on the surface through electrostatic interactions or steric hindrance.
As can be seen in Table 6, the function of these compounds in CIP detergents is to
improve the physical dispersion, emulsification, foaming and wetting of the fouling
layer. Surfactants may be ionic or non-ionic. The ionic surfactants are divided into
three sub-classes: anionic (negatively charged in water), cationic (positively charged
in water) and amphoteric (charge is pH dependent). Amphoteric surfactants are
cationic under acidic conditions and anionic under alkaline conditions. The active
components in these substances are tensides, which means they have a hydrophilic
part (from the Greek for water-loving) and a hydrophobic part (from the Greek
water-rejecting). This enables them to act as a binder between the hydrophilic water
and the hydrophobic fat.
Ionic surfactants
Anionic wetting agents can be classified into five groups: sulphated alcohols,
sulphated hydrocarbons, aryl alkyl polyether sulphates, sulphonated amides and
alkyl aryl sulphonates, which have good to excellent detergency. Both the removed
foulant and the equipment surface become negatively charged, thus preventing redeposition. However, in the presence of Ca2+ or Mg2+ ions the effect will be the
opposite, and therefore sequestering agents should be added to these detergent
solutions.
Cationic wetting agents consist of quaternary ammonium compounds. This group of
wetting agents exhibits lower cleaning efficiency than anionic and non-ionic wetting
agents, and is not used for the cleaning of food processing equipment.
Amphoteric wetting agents act by loosening and softening protein- and
carbohydrate-rich soil, and are widely used in the food processing industry.
Non-ionic surfactants
These surfactants are best employed when removing soil consisting of oil, and are
affected little by water hardness. The working principle is to sterically prevent the
removed soil from returning to the equipment surface or aggregating in the bulk
solution.
Sequestering Agents (chelating agents)
The function of sequestering agents is to bind to calcium and magnesium ions in
order to soften water. The ions are bound so securely that they can no longer react to
form so-called milk stone or calcium soaps. Common sequestering agents are
orthophosphate, orthosilicate and phosphates. It is important to bear in mind that the
waste water evacuated to the drain contains phosphates, which can be an
environmental problem.
Complex-forming agents form a sub-group of sequestering agents. The difference
between them is that sequestering agents act on a micro-crystalline level, unlike
complex-forming agents. Complex-forming agents can only bind one metal ion per
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molecule in contrast to sequestering agents, which can bind to a number of metal


ions. The most common complex-forming agents are EDTA (ethylene diamine tetra
acetic acid), NTA (nitrilo-tri acetic acid), IDS (imido-disuccinic acid) and
gluconate.
Oxidation Agents
Formulated alkaline detergents produced by detergent manufacturers can contain
oxidation agents to boost their cleaning effects. Examples of such substances are
oxygen-releasing agents, active chlorine or active-chlorine carriers. These may be in
a liquid form, such as sodium hypochlorite, hydrogen peroxide or potassium
hypochlorite, or in powder form, such as sodium perborate or sodium percarbonate.
They are added in a stabilised form, and active oxygen is cleaved off over a certain
period of time. They create new sites for detergents to act.

Summary of the different detergents used in food


equipment cleaning:
Alkalis
- NaOH
- KOH
- Na2CO3
Acids
- HNO3
- H3PO4
Wetting agents
- Ionic (anionic, cationic and amphoteric)
- Non-ionic
Sequestering agents
- EDTA
- NTA
- IDS
- Gluconate
Oxidation agents
- Sodium hypochlorite
- Hydrogen peroxide
- Potassium hypochlorite
- Sodium perborate

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Overview of Some Cleaners and Disinfectants


Below follows an overview of acid descalers and cleaners, neutral cleaners, alkaline
cleaners and disinfectants.
Table 8. Acid descalers and cleaners (from the Handbook of Hygiene Control in the
Food Industry).
Ingredient
Inorganic acids

Substance
Nitric acid

Function
Owing to its oxidising properties at high concentrations
nitric acid cannot be used in complex formulations, e.g.
with surfactants. Its use is limited to descalers for
removing inorganic residues such as water scale and milk
stone from surfaces.

Phosphoric acid
Sulphonic acids
Sulphuric acid

These acids can be combined with surfactants, defoamers


and other components in cleaning agents, and may be used
in formulations designed to simultaneously remove
inorganic and organic residues from food contact surfaces .

Organic acids

Formic acid
Citric acid
Lactic acid
Gluconic acid
Sulphamic acid

See phosphoric acid

Inhibitors

Phosphonic acids

Protect materials against chemical attack.

Surfactants

Non-ionic and
anionic surfactants

Improve cleaning efficacy regarding organic soil; enhance


scale-removing properties and are the choice for removing
fat residues.

Defoamers

Hydrophobic
non-ionic
substances
Hydrotrophic
substances

Suppress foam arising from formula components and/or


removed soil.

Stabilisers

Stabilise liquid formulations at high and/or low


temperatures.

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Table 9. Neutral cleaners (from the Handbook of Hygiene Control in the Food
Industry).
Ingredient
Builders

Substance
Phosphates
Phosphonates
Citrates

Function
Enhance soil-removal and suspension properties as well as
the effects of surfactants.

Surfactants

Non-ionic and
anionic surfactants

Allow soil penetration and emulsification, and provide


better surface wetting.

Defoamers

Hydrophobic nonionic substances

Suppress foam arising from formula components and/or


removed soil.

Enzymes

Proteases

Improve protein removal at around neutral pH from


sensitive surfaces.

Lipases

Improve fat removal without using surfactants.

Specific enzymes

Improve removal of recalcitrant substances from surfaces


without using aggressive chemicals.

Hydrotrophic
substances

Stabilise liquid formulations at high and/or low


temperatures.

Stabilisers

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Table 10. Alkaline cleaners (from the Handbook of Hygiene Control in the Food
Industry).
Ingredient
Bases

Substance
Sodium hydroxide
Potassium hydroxide

Function
Solve, peptise, soften or decompose organic soil.

Chelates

EDTA
NTA
IDS
Gluconate

Chelates not only reduce the negative effect of water


hardness on cleaning efficacy and provide scale
prevention, they can also remove fresh, thin layers of
inorganic deposits, attack inorganic soil and help in
removing organic soil when combined with inorganic
scale.

Builders

Phosphates
Phosphonates
Citrates
Silicates

By chemical nature most of the builders are chelates. They


enhance soil-removal and suspension properties as well as
the effects of surfactants.

Surfactants

Non-ionic and
anionic

Improve soil penetration and emulsification, as well as


surface wetting.

Defoamers

Hydrophobic nonionic substances

Suppress foam arising from formula components and/or


removed soil.

Sequestering
agents

Polyphosphates
Phosphonates

Prevent scaling, especially in rinsing stages.

Corrosion
inhibitors

Silicates

Protection of soft metals against chemical attack.

Oxidising
cleaning
boosters

Hypochlorites

Assist in removal of recalcitrant and insoluble soil. They


can break down larger molecules into smaller fractions by
means of oxidation, or render soil soluble by introducing
functional groups.

Stabilisers

Hydrotrophic
substances

Stabilise liquid formulations at high and/or low


temperatures.

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Table 11. Disinfectants (from the Handbook of Hygiene Control in the Food
Industry).
Ingredient
Disinfectants

Substance
Hypochlorites
Peroxides
Quaternary
ammonium
compounds
Ampholytes

Function
To kill microorganisms by complex reactions on either the
outside or inside of the microbial cell.

pH-regulators,
buffers

Bases
Acids
Salts

To provide optimum pH for the active biocide, stabilise the


pH during application, e.g. to reduce the risk of corrosion
with oxidising disinfectants, or to provide product stability
in solution or in concentrated form.

Surfactants

Non-ionic and
anionic surfactants

To improve wetting, enhance biocidal efficacy and enable


foam applications.

Defoamers

Hydrophobic nonionic substances


Hydrotrophic
substances

To control foaming during cleaning

Stabilisers

To stabilise liquid formulations at high and/or low


temperatures.

3.5 Detergent Concentration


When cleaning fails the natural reaction is to increase the concentration of the
detergent. However, this may be counterproductive. A number of investigations into
milk fouling in the pasteurisation temperature range have indicated an optimum
NaOH concentration in the range 0.5-1% (w/w) (see Fig. 8). This can be explained
by the fact that an increase in the NaOH concentration does not increase the
cleaning rate, but instead results in a glassy surface on the soil, preventing the
cleaning solution from penetrating it.
The cleaning procedures used in the dairy industry involve a higher lye
concentration than that mentioned above (0.5-1%). The reason for this is that these
plants are more heavily soiled and lye is consumed during cleaning.
However, it is important to bear in mind that increasing the detergent concentration
may not solve cleaning problems. Many investigations have shown that there is an
optimum detergent concentration and that increasing it will lead to less effective
cleaning. The optimal concentration varies depending on the type of detergent, e.g.
pure NaOH, NaOH with additives or formulated detergents from a detergent
supplier.

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0,2

0,4

0,6

0,8

Lye concentration / %

Fig. 8. A number of investigations of milk fouling in the pasteurisation temperature


range have indicated an optimum in NaOH concentration in the range 0.5-1%
(w/w). The optimal concentration varies with the type of detergent.

The solution might not be to increase the detergent


concentration when encountering cleaning problems.
Consider other cleaning parameters, such as flow rate,
temperature and cleaning time.

Dosing of Cleaning Agents


The goal is to obtain an even distribution of the cleaning agent throughout the whole
equipment. Cleaning agents can be dosed directly or in-line. The advantage of using
in-line dosing is that the correct detergent concentration will be obtained for that
particular piece of equipment or plant. To obtain the best effect with in-line dosing,
both the flow and the dosing frequency should be high, making the distribution
more even.
The principle of in-line dosing is shown in Fig. 9. Three cases are shown.

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Fig. 9. The principle of in-line dosing. (From the Handbook of Hygiene Control in
the Food Industry.) Top left: high flow velocity and low dosing frequency, resulting
in a poor distribution of the detergent. Top right: changing the dosing volume will
not result in a better distribution. Bottom: the best alternative is to maintain a high
flow velocity and increase the dosing frequency.
When using in-line dosing high demands are placed on measuring and controlling
the detergent concentration. This is normally achieved by measuring the
conductivity in-line. Table 12 gives the conductivity for various solutions at 20 C.
It is important to remember that the conductivity is strongly dependent on
temperature, as is shown in Fig. 10. The conductivity sensors used today are
temperature calibrated.
Table 12. Conductivity of different solutions at 20 C (from the Handbook of
Hygiene Control in the Food Industry).
Solution
Conductivity @ 20 C (mS/cm)
Tap water, soft
Tap water, hard
Tap water, saline
Brackish water
NaOH 1 % w/w
NaOH 2 % w/w
NaOH 3 % w/w

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0.18
0.46
0.75
2
47.5
90.0
127.0

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350
1.0% w/w NaOH
300

2.0% w/w NaOH

Conductivity (mS/cm)

3.0% w/w NaOH


250
200
150
100
50
0
10

20

30

40

50

60

70

80

90

Temperature (C)

Fig. 10. Conductivity vs. temperature for three NaOH concentrations (from the
Handbook of Hygiene Control in the Food Industry).

3.6 Cleaning Temperature


Chemical reactions generally proceed faster at higher temperatures. This is also the
case when cleaning solutions react with foulants. It is generally said that the
effectiveness of an alkali solution will double for every 8 C increase in
temperature. This has been demonstrated for the removal of proteinaceous deposits
at cleaning temperatures up to 80 C, but is probably also true for higher
temperatures. It can clearly be seen in Fig. 11 that increasing the cleaning
temperature when removing protein fouling from a pasteuriser increases the
cleaning rate.
It is important to remember that the production temperature must not be exceeded
when cleaning the processing equipment, especially when removing proteinaceous
foulants. If this temperature is exceeded, the proteins may be denatured, making the
deposit more difficult to remove.

Guideline
Do not exceed the production temperature during CIP
since proteins may be denatured, making the deposit
more difficult to remove.

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Time to clean / a.u.

Document owner

60

70

80

90

Temperature / C

Fig. 11. The influence of temperature on cleaning time.

Table 13 gives some general guidelines for choosing CIP temperatures for some
typical cleaning objects in a dairy process line.
Table 13. Suitable cleaning temperatures for the cleaning of equipment in the dairy
industry (from the Handbook of Hygiene Control in the Food Industry).
Type of
Temperature
Equipment to be cleaned
detergent
(C)
HNO3

NaOH

60-65

Tanks, pipes, milk pasteurisers

80-85

UHT plants

60-80

Milk collection tankers, milk tanks, cream tanks,


quarg and yoghurt tanks, filling machines

70-90

Milk pasteurisers

90-130

UHT plants, sterilisers for puddings and desserts

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3.7 Cleaning Time


Cleaning time is the most interesting parameter from the production perspective.
The cleaning time places the focus on the fact that cleaning is to a large extent an
optimisation issue. The milk producer does not want to clean longer than necessary,
but the soil must be removed to ensure food safety. The cleaning time is correlated
to the specific equipment to be cleaned, thus it is of vital importance to characterise
every piece of equipment when optimising the CIP sequence in order to identify the
equipment that requires the longest cleaning time.
Another factor that must be taken into consideration when designing CIP sequences
is the length of production time preceding cleaning, which is illustrated in Fig. 7. A
longer production time will probably result in the need for a longer cleaning period.
The third factor that affects the cleaning time is the type of product that has been
processed, chocolate milk being harder to remove than normal milk, for example.
Several steps are included in the cleaning process that do not involve the use of
cleaning solutions, such as pre-rinsing, inter-rinsing and final rinsing. The cleaning
steps involving detergent require enough time for the solutions to dissolve the soil,
swell it, saponificate it, disperse it and finally remove it. The detergent must be in
contact with the foulant long enough to ensure that it is completely removed from
the surface of the equipment.

Cleaning time depends on:


- the kind of equipment to be cleaned
- the production period prior to cleaning
- type of product being processed

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3.8 Cleaning Flow


The last parameter in Zinners circle, but perhaps the most important, is the flow. If
the flow is too low, the efficiency of the other three parameters, detergent
concentration, cleaning time and temperature, might decrease. Approximately 50%
of all CIP-related problems are due to inadequate flow. The flow must be sufficient
to ensure the satisfactory transport of detergent solution to the soiled surface. The
soiled surface is also exposed to shear forces (mechanical forces) through the fluid
flow, resulting in the removal of soil, which is then transported into the bulk
solution.
The role of the flow in CIP is:
- to transfer the detergent solution to the
deposited soil and
- to remove the dissolved soil.
In the CIP literature it is normally stated that the velocity in a pipe flow must exceed
1.5 m/s to obtain good cleaning results. For plate heat exchangers the CIP flow is
normally 0.3-1.0 m/s. Table 14 gives the volume flows recommended for a range of
pipe diameters to ensure a minimum CIP flow of 1.5 m/s. A common
recommendation for cleaning of tubular heat exchangers is to use a CIP flow 1.5 to
2 times higher than that during production.

Table 14. Recommended pumping capacities to ensure a flow of 1.5 m/s during
CIP.
Pipe outer diameter
Pipe inner diameter
Volume flow
mm / inches
mm
l/h
38 /1.5
35.6
5 400
51 / 2
48.6
10 000
63.5 / 2.5
60.3
15 400
76 / 3
72.8
22 500

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Flow velocity in pipe flow:

Volume flow (m3 / s)


Area (m 2 )

where the volume flow and area are calculated from:

Volume flow (m 3 / s ) =

Volume flow (l / h)
3.6 10 6

Area (m 2 ) =

(d i.d . (m) )2
4

Figure 12 illustrates how the flow velocity in a pipe varies as a function of


volumetric flow for a range of pipe diameters. It is important to bear this in mind
when designing a process plant, so that pumps have the correct capacity to cope
with pipe expansions and contractions. However, in some objects/components the
flow does not reach this level, resulting in zones of low wall shear stress. The result
of cleaning may be good despite this, due to the fact that the turbulence is high,
ensuring that fresh detergent solution reaches the soil layer. However, a practical
implication is that the CIP sequence takes longer than if a higher flow velocity had
been used.

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Velocity
v m/s

25 mm

38 mm

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51 (83)

51 mm

3.0

2.5

63.5 mm

2.0
76 mm
1.5
89 mm

1.0

0.5

5000 10000 15000 20000 25000 30000 35000


Flow rate Q l/h

Fig. 12. Illustration of the variation of fluid velocity in pipes with the volumetric
flow rate for six different pipe diameters.

In Fig. 13 the Zinner circle is shown for three different cleaning situations: fully
developed pipe flow, a dead end with poor fluid exchange, and zones with swirling
flow. These examples should be regarded as guidelines, and not as exact ratios for
the different cases. In the first case, with a fully developed pipe flow, all four
cleaning parameters work well together to remove the soil from the surface. The
contact time of the detergent solution will be long enough to weaken the chemical
bonds between the soil and surface, and the soil will be removed by the flow. In Fig.
13b the principle of cleaning a dead end is shown. In this situation the cleaning time
must be prolonged to ensure that the detergent solution reaches the soiled surface,
and removes the dissolved soil. The lack of mechanical energy makes the removal
of the soil much more difficult, and increasing the detergent concentration will have
a limited effect. In the third case, when a swirling flow is dominating (Fig. 13c), the
transport and exchange of cleaning solution is higher than in pipe flow. However,
since the wall shear stresses are lower the cleaning time will be longer than in the
case of fully developed pipe flow.

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Fig. 13. The influence of the different cleaning parameters on a) pipe flow, b)
cleaning of a dead end and c) cleaning of zones with swirling flows.

In cases when the flow is not sufficiently high it is


important not to compensate by increasing the
detergent concentration, but instead prolonging the CIP
sequence.

Three cases are described below, in which the role of the flow is crucial: flow in
dead ends, flow in expansions and flow in 180 bends. It is important to be aware of
cleaning problems related to these kinds of constructions which are caused by
shortcomings in the design of processing lines.

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Dead ends
The most difficult areas to clean are those exposed to low wall shear stress and low
fluid exchange, e.g. dead ends resulting in recirculation zones. There should be no
dead ends in a process line, but they are often encountered in processing lines that
have been rebuilt, as well as in new constructions. When cleaning dead ends it is
vital that the direction of flow is as illustrated in the left-hand diagram in Fig. 14,
i.e. directly towards the dead end. In the right-hand diagram the flow direction
results in a very low flow velocity in the dead end, leading to low wall shear
stresses and little mechanical action on the deposited soil.

Fig. 14. Cleaning of dead ends. The diagram on the left shows the CIP solution
reaching the bottom of the dead-end, while in the right-hand diagram it does not.
If the dead end is directed upwards, there is a risk that the cleaning solution will not
reach to the top of the dead-end due to trapped air (Fig. 15). In the case of a dead
end pointing downwards, there is a risk of debris being trapped.

Fig. 15. The direction of the dead end is important. If it points upwards there is a
risk that air will trapped in the top. The opposite orientation also poses a threat to
hygiene.
Tetra Pak employs a rule of thumb that the ratio L/d of a dead end must not exceed
1.5 in order to ensure a reasonable cleaning effect. EHEDG guidelines say a
maximum of 0.5 and cGMP/ASME BPE a value of 2. Fig. 16 shows the fluid
velocity in a dead end for a range of pipe velocities. The relative velocity (u/vm),
where vm is the mean velocity of the pipe flow and u the velocity in the dead end, is
plotted on the y-axis.

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For example, when L/d = 1.5 and the mean flow rate in
the pipe is 1.5 m/s, the velocity in the dead end will be
approximately 0.2 m/s (i.e. 12 % of the pipe velocity).

Fig. 16. Fluid velocity in a dead end (from The Federal Institute of Milk Research,
Kiel, Germany).

Rule of thumb:
The length of a dead end should not be more than 1.5
times its diameter:

L
< 1.5
d

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Expansions
Another flow situation is shown in Fig. 17, where the fluid is forced to flow through
a constriction. Zones of recirculation of will arise as the pipe opens up. As a result,
there will be little exchange of CIP solutions between the bulk flow and the soil on
the surface. The wall shear stress acting on the surface in the expansion zone is also
reduced.

Fig. 17. Fluid flow in a gradual expansion.


Is it possible to change the size of the recirculation zones by increasing or
decreasing the flow velocity? Changing the flow rate does not have any effect on
the location of areas where flow conditions are unfavourable for cleaning.
Increasing the flow rate will of course result in a general increase in flow rate, but
only very small increases will be seen in low-velocity areas. So the conclusion is:
Problem areas will remain where they are, regardless of
whether the flow velocity is increased or not; however,
the problem areas may be reduced.

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Bends
The wall shear stress generated by the flow in a 180 bend is shown in Fig. 18a. The
high wall shear stress zones are, not surprisingly, found on the outer side of the
bend, whereas the inner side of the outlet of the bend is exposed to low wall shear
stresses. Cleaning will be less effective in this zone due to the low mechanical
energy, as can be seen in Fig. 18b.

High wall shear stresses

Flow separation
Low wall shear stresses

Fig. 18a. Distribution of wall shear stress in a


180 bend.

Fig 18b. The results of cleaning,


showing the dependency on wall
shear stress.

Increasing the flow rate in a straight pipe will immediately give rise to a higher wall
shear stress and thus more effective cleaning. Unfortunately, similar behaviour is
not seen in a 180 bend. Increasing the flow rate will lead to a greater pressure drop,
but will not result in a corresponding increase in the wall shear stress.

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3.9 CIP Sequences for Certain Products


The cleaning procedure can generally be described as can be seen in Table 15:
Table 15. Example of a typical cleaning sequence.
Step
Purpose
Pre-rinsing with water
Cleaning with alkaline solution
Intermediate rinsing with water
Cleaning with acid solution
Rinsing
Disinfection/sterilisation
Final rinse

To remove gross soil


To remove attached soil (mainly proteins and
fat)
To remove cleaning chemicals and dissolved
soil
To remove attached soil (mainly minerals)
To remove cleaning chemicals
To reduce microbial load to a safe level
To remove sanitiser

Full CIP Sequences for Various Applications


Each step in an operation has an optimum operating temperature, depending on the
kind of soil. The initial pre-rinse is usually carried out with cold water, but warmer
water is sometimes used, 25 to 60 C. In general, for cold surfaces, alkali and acid
cleaning is performed at 60-80 C. However, in UHT processing equipment,
cleaning is performed at a higher temperature. Typically, alkali cleaning takes place
at about 140 C and acid cleaning at approximately 80-85 C (temperature measured
in the holding cell). The system is purged of product with warm water, followed by
a 50-minute alkali cleaning step. The equipment is then rinsed with warm water,
followed by a 30-minute acid cleaning step. The CIP sequence is then completed
with a warm rinse and then a final rinse at room temperature.
It is important to remember to flip the valves when cleaning a processing line in
order to ensure that the surfaces in contact with the product are sufficiently cleaned.

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Table 16. An example of CIP of a dairy production plant for ambient white milk
Cleaning step
Duration, minutes
Temperature, C
Daily cleaning of non-heated surfaces (e.g. tanks and pipes)
Water rinse
>10
NaOH circulation (1.5 %)
60-80
Water rinse
50*
Acid circulation (0.8 %)
60-65
Water rinse
Cold

Daily cleaning of heated surfaces (steriliser)


Water rinse
>10
NaOH circulation (2-2.5 %)
140
Water rinse
Cold or heated*
Acid circulation (1-1.5 %)
80-85 / 105
Water rinse
Cold

10-15
50
10-15
30
15

* Pre-heated water reduces cooling of the equipment during intermediate rinsing.


Table 17. An example of CIP of a dairy production plant for chilled white milk
Cleaning step
Duration, minutes
Temperature, C
Daily cleaning of non-heated surfaces (e.g. tanks and pipes)
Water rinse
>10
NaOH circulation (1.5 %)
60-80
Water rinse
50*
Acid circulation (0.8 %)
60-65
Water rinse
Cold

Daily cleaning of heated surfaces (pasteuriser)


Water rinse
>10
NaOH circulation (1.5-2 %)
75-95
Water rinse
Cold or heated*
Acid circulation (1-2 %)
65
Water rinse
Cold

10
30
5-10
20
10

* Pre-heated water reduces cooling of the equipment during intermediate rinsing.

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Table 18. An example of CIP of a dairy production plant for chilled fermented milk
Cleaning step
Duration, minutes
Temperature, C
Daily cleaning of non-heated surfaces (e.g. tanks and pipes)
Water rinse
>10
NaOH circulation (1.5 %)
60-80
Water rinse
50*
Acid circulation (0.8 %)
60-65
Water rinse
Cold

Daily cleaning of heated surfaces (pasteuriser)


Water rinse
>10
NaOH circulation (1.5-2 %)
95
Water rinse
Cold or heated*
Acid circulation (1-2 %)
65
Water rinse
Cold

10
30
5-10
20
10

* Pre-heated water reduces cooling of the equipment during intermediate rinsing.


Table 19. An example of CIP of a production plant for orange juice:
Cleaning step
Duration, minutes
Temperature, C
Daily cleaning of non-heated surfaces (e.g. tanks and pipes)
Water rinse
>10
NaOH circulation (1.5 %)
70
Water rinse
Cold

3-5
10
5

Daily cleaning of heated surfaces (e.g. plate heat exchangers)


Water rinse
>10
NaOH circulation (1.5 %)
70
Water rinse
Cold

3-5
20
10

Weekly cleaning of heated surfaces (e.g. plate heat exchangers)


Water rinse
>10
NaOH circulation (1.5 %)
70
Water rinse
Cold or heated*
Acid circulation (1 %)
65
Water rinse
Cold

5
20
5
10
10

* Pre-heated water reduces cooling of the equipment during intermediate rinsing.


During processing of juices containing pulp, the pulp can clog the equipment.
Therefore, the CIP flow is often reversed, so-called back-flushing, in order to
remove the pulp.

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Aseptic Intermediate Cleaning


Aseptic intermediate cleaning, AIC, is frequently used to prolong running times.
The aim is to maintain the process equipment in an aseptic condition while
performing CIP. When an acid flush is included it is of the utmost importance to
check for possible deterioration of stainless steel equipment and rubber gaskets.
Table 20. An example of an AIC procedure
Cleaning step
Temperature, C
Water rinse
NaOH circulation (2-2.5 %)
Water rinse

140*
140
140

Duration, minutes
15

Re-start of production
* Production temperature.
Table 21. An example of an AIC procedure where acid is included
Cleaning step
Duration, minutes
Temperature, C
Water rinse
NaOH circulation (2-2.5 %)
Water rinse
Acid flush (1 %)
Water rinse

140*
140
140
140
140

8-10
3-5

Re-start of production
* Production temperature.

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3.10 CIP of Specific Components in a Processing Line


Separators
In order to ensure the functionality of separators the parts of the separator in contact
with the product must be completely clean before beginning a new production run.
Normally, the separator is incorporated into a combined processing line together
with heat exchangers and other peripheral equipment. The cleaning times and CIP
solution concentrations must also meet the requirements of these parts.
The following general CIP sequence is taken from the Tetra Pak guidelines for CIP
of separators (Doc. No. AM-10002en3). Table 22 lists the usual steps. Disinfection
is to take place immediately prior to separation. If chemical disinfectants containing
chlorous components, such as sodium hypochlorite (NaOCl), are used, the
temperature must not exceed 25 C, as chlorine is highly corrosive at higher
temperatures. It is also recommended in these cases that a maximum of 0.1 %
NaOCl is used.
The reader is referred to Doc. No. AM-10002en3 for further details.
Table 22. An example of CIP of a separator
Cleaning step
Temperature, C
Daily cleaning
Water rinse
NaOH circulation (1.5 %)
Water rinse
Acid circulation (0.8-1 %)
Water rinse

>10
75
Cold*
70
Cold

Duration, minutes
15-20
35-45
10-15
20-30
10-15

* Pre-heated water reduces cooling of the equipment during intermediate rinsing.

Homogenisers
The homogeniser can be positioned either upstream of the aseptic side or
downstream of the steriliser, i.e. on the aseptic side.
The maximum lye concentration should be 2% at a maximum temperature of 85 C.
In the acid cleaning step, the concentration must not exceed 1.5%, and the
temperature should be no higher than 85 C (Table 23). The CIP inlet pressure must

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exceed 2 bar. The minimal required flow of cleaning agents must be equal to or
exceed 100% of the maximal production flow.
The CIP sequence should be the same as that for the process equipment.
The maximum sterilisation temperature is 140 C, for 30 minutes.
The reader is referred to Tetra Pak guidelines for CIP of homogenisers (Doc. No.
TeM-1245070-01) for further details.
Table 23. An example of CIP of a homogeniser
Cleaning step
Temperature, C
Daily cleaning
Water rinse
NaOH circulation (2 %)
Water rinse
Acid circulation (1.5 %)
Water rinse

Duration, minutes*

>10
85
Cold
85
Cold

* The duration of the different cleaning steps is the same as those in the cleaning
procedure for the process equipment.

Tank Cleaning
Tanks are used for a range of applications in a processing plant, such as reception,
handling CIP solutions, BTD, storage and buffer storage prior to the filling
machines. Depending on the application, different CIP sequences are required.
Generally speaking, the cleaning of tanks differs from that of pipe cleaning. The
main differences are:
CIP solutions are sprayed onto the walls and
there is no wall shear stress.
Normally, a CIP tank flow of 300 l/m2 per hour is used for horizontal tanks and 200
l/m2 per hour for vertical tanks.
Figure 19 illustrates some of the factors that should be kept in mind when cleaning
tanks. A general recommendation for the cleaning of tanks is that vessels should be
as empty as possible when sprayed with cleaning solutions to ensure complete
washing of the walls and bottom. Puddles should be no more than 50 mm deep, and
must be fully removed at some point during cleaning and at the end of the cleaning
process. Spraying of the tank can be interrupted to do this. Two or more spray balls
are often installed to ensure adequate cleaning. It is important to consider any
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equipment installed in the tank, e.g. baffles and sensors, that may prevent the
cleaning solution from covering the whole surface.
A centrifugal liquid ring pump should be used to ensure effective tank emptying
because it can handle liquids with a high gas or air content. If a centrifugal pump is
used as a CIP return pump, difficulties may rise due to pump cavitation.

Guidelines for tank cleaning


Complete drainage between CIP phases.
No mixing of water and detergent solution in
the tank.
The tank must be completely drained during
CIP to ensure adequate cleaning of the whole
wall surface.
The pump used for CIP return flow should be a
ring liquid pump to ensure complete drainage of
the tank.
Flow for horizontal tanks: 300 l/m2 per hour
Flow for vertical tanks: 200 l/m2 per hour

When applying the detergent solution it must be ensured that the whole surface area
of the tank is covered. Among available tank cleaning devices are fixed spray balls,
rotary spray heads and rotary jet heads. Alfa Laval tank cleaning devices are shown
in Fig. 20. The simple fixed spray ball is cheap, but the flow pattern in the tank is
not sufficiently effective, and cleaning is limited to a small surface area.
In most tank cleaning applications the removal of biofilms, precipitate or sludge/
sediments is required. The CIP solution tanks must also be cleaned, so-called
intrinsic cleaning, to prevent microbial growth.
The CIP tanks must be cleaned at certain time intervals
to avoid microbial growth.

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The volume to each object is


individually controlled
CIP Pressure

Return flow from object


are individually

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Volume control
guarantees cut-off
point

No mixing of
water/detergent
in the tank

CIP Return
Complete drainage
between CIP phases

Fig. 19. Illustration of tank cleaning to illustrate some important factors, i.e. no
mixing of water/detergent in the tank and complete drainage between CIP phases.

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Fig. 20. Fixed spray ball


Courtesy of Alfa Laval.

Rotary spray head

Table 24. An example of CIP of a Tetra Alsafe tank


Cleaning step
Temperature, C
Daily cleaning
Water rinse
NaOH circulation (1-1.5 %)
Water rinse
Acid circulation (1-1.5 %)
Water rinse

>10
65-80
Cold
65-80
Cold

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Rotary jet head

Duration, minutes

20
10

3.11 Control of Cleaning Result


It is imperative to check the results of cleaning. The document CIP Validation
Procedure, mentioned in Chapter 1, describes how the cleaning results can be
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controlled and validated. Chapter 5 of the CIP Validation Procedure document gives
a checklist of critical control points for controlling the results of cleaning.

3.12 Disinfection/Sterilisation of Equipment


After CIP the plant is sterilised/disinfected if it is to be used directly. If the plant is
not to be used for some time, a slightly acidic solution (pH around 5) is left in the
processing equipment. The reason for this is to restrict microbial activity and
growth.
Sterilisation
Processing equipment is sterilised immediately before starting aseptic production by
the circulation of hot water. After reaching the required temperature of 125 C the
water is circulated for 30 minutes to ensure aseptic status of the equipment. The
temperature sensor is positioned in the return circuit to ensure correct temperature
measurement.
Disinfection
There are two types of disinfection: thermal and chemical. Thermal disinfection can
be carried out with steam (< 1 bar) or hot water at 90-95 C. Commonly used
chemical disinfectants are chlorine, hydrogen peroxide, peracetic acid, and a
combination of hydrogen peroxide and peracetic acid. Chemical disinfectants are
usually used at ambient temperature.
A comparison between thermal and chemical disinfection can be found in Table 25.

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Table 25. A comparison between thermal and chemical disinfection


Properties
Thermal disinfection
Chemical disinfection
Bactericidal
Sporicidal

Good
None

Fungicidal

Good (except for


extremely resistant mould
spores)
Leaving chemical residues No
Rinsing with water
No
(pasteurised or filtered or
eqv.) after disinfection
Cooling of equipment
Yes
Penetration ability
Good
Corrosive
No
Energy consumption
High

Good
Certain effect but
dependent on temperature,
contact time and
concentration
Variable
Yes
Yes
No
Poor/None
Yes
Low

3.13 Guidelines for Determining Cleaning Intervals for


Sterilisers
The QAM document FSQ-588012-101 provides hands-on instructions for
determining the optimum ratio between production time and CIP for Tetra Therm
Aseptic sterilisers. The reader is referred to this document for further information.

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3.14 CIP Systems


There are two main types of CIP system: single-use systems, in which the CIP
solutions are discarded after use, and re-use systems, where the CIP solutions are
stored in tanks and chemicals are added as required (Table 26). Single-use systems
are further divided into single-path CIP and single-use CIP systems. Re-use systems
can be categorised as recovery CIP (centralised CIP) and satellite CIP (decentralised
CIP) systems.

Table 26. The two types of CIP systems, single-use and re-use systems.
Single use systems
Re-use systems
Single-path
Single-use
Recovery systems Satellite systems

Single-path CIP systems


This type of CIP system is used for heavily soiled equipment or when crosscontamination must be avoided. The freshly prepared CIP solutions are used
only once and then discarded. There is thus no recirculation of the cleaning
solutions. This type of system is frequently used in the pharmaceutical
industry. This type of system is associated with high operating costs.

Single-use CIP systems


This system is also used for heavily soiled equipment or when crosscontamination must be avoided. Unlike the single-path CIP system, the
solutions are recirculated before drainage. The volume of the cleaning
solution is low.

Recovery CIP systems (centralised CIP systems)


The CIP solutions are used many times, and can be used for several CIP
tasks. The solutions are stored in tanks between CIP sequences. Fig. 21
shows an example of a centralised CIP system.
Centralised CIP systems are of primary interest in small dairy plants with
short communication lines. This type of CIP system requires large volumes
of cleaning solutions, which can be considered a drawback.

Satellite CIP systems (decentralised CIP systems)


This type of CIP system can be an advantage for large dairies. Instead of
having a large central CIP station a number of smaller units are located close
to the processing equipment. Another name for this type of system is the
satellite CIP system. However, central storage tanks are needed to store the
alkali and acid detergents. Supply of water is arranged at the cleaning object
such as heating of water and detergent solutions.

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The main advantage of a small CIP unit is that the consumption of cleaning
solutions and water is kept to a minimum. Steam consumption is also
minimised. The white water produced during pre-rinsing is more
concentrated and it is therefore cheaper and easier to handle and evaporate.
As a result, the load on waste water systems is lower than with centralised
CIP systems.
Detergent solutions can be used once in decentralised CIP systems, which is
not the case in centralised systems where CIP solutions are recycled.

Fig. 21. The principle of a centralised CIP system. The cleaning unit is shown in the
shaded box. 1. Tank for alkaline detergent; 2. Tank for acid detergent; 3. Plate heat
exchanger. Object to be cleaned: A. Milk treatment equipment; B. Tank gardens; C.
Silo tanks; D. Filling machines.

Design of CIP Systems


A number of important issues must be considered when designing CIP systems.

The recovery CIP system should be located centrally and as close as possible
to the object to be cleaned.
Pipes for the supply and return of CIP media should be as short as possible
and of the correct diameter. Long pipes and small-diameter pipes result in a
large pressure drop requiring greater pump capacities, which in turn will
result in higher energy consumption.
Conductivity meters should be positioned on the CIP return side to indicate
the concentration of the CIP solutions. Conductivity measurements are also

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used to determine when rinsing periods can be stopped, and as a support tool
for product recovery.
Booster pumps must be considered in some cases in order to ensure the
correct flow rate in the equipment being cleaned.
Correct positioning of e.g. temperature sensors is crucial. The temperature
sensor should be positioned at the outlet of the production equipment in
order to measure the correct cleaning temperature.

For further information the reader is referred to the Plant & Production Requirement
report PPR_CIP Buffer.
Centralised CIP
The centralised CIP consists of various parts.
1. Tanks for CIP solutions
2. Tanks for holding water of different qualities
- cold water (potable water quality) for the final rinse
- rinsing water (re-cycled cold water and re-cycled hot water from
disinfection) used for pre-rinsing and intermediate rinsing
- potable water used for disinfection
3. Recovery tanks for:
- product recovery
- mixed phases
4. CIP stations
- each consisting of a number of CIP circuits

Raw is raw and processed is processed,


and never the twain shall meet.
It is an absolute requirement that there should be
separate centralised CIP for cleaning of equipment
used to process non-heat-treated and heat-treated
products. For cleaning objects containing both non-heat
treated and heat treated product, CIP solutions from the
CIP central working on the heat treated side must be
used.

CIP stations
A CIP station consists of the following components.
- A CIP pump (normally a centrifugal pump) positioned below or on the same
level as the outlet of the CIP solution tanks. A frequency converter is the
best way to change the CIP flow and obtain an optimised flow for different
cleaning situations. (The more old-fashioned approach of using throttling
devices requires more energy.)

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Pipes on the CIP pressure side. A back-pressure valve ensures that no CIP
solutions on the CIP pressure side can enter the CIP tanks.
Pipes on the return side. These are equipped with temperature and
conductivity sensors to control the status of the CIP solutions. A rule of
thumb for reuse of CIP solutions is that if the concentration is higher than
50 % of its original concentration it should be collected in the CIP tank for
reuse.

CIP circuits
Each CIP station includes a number of CIP circuits. CIP circuits consist of different
cleaning objects: tanks, pipes and heat treatment equipment. Each of these objects
requires a different CIP sequence.
- Tank cleaning requires breaks for draining of the tanks.
- Cleaning of pipes is fairly easy, but can be complicated if the pipes are long.
This requires booster pumps to compensate for pressure drops, and heat
exchangers to correct the fall in temperature.
- Heat treatment modules require longer CIP times than other objects.

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Further CIP Reading


CIP: Cleaning in Place, Society of Dairy Technology, Ed. Romney, A. J. D., 1990.
Cleaning-in-Place: Dairy, Food and Beverage Operations, Ed. Tamime, A. Y.,
Blackwell Publishing, 2008.
EHEDG Glossary, Version 2004/04.G01, www.ehedg.org/guidelines/glossary.pdf
Grasshoff, A., Cleaning of heat treatment equipment, Bulletin of the IDF, 328
(1997) 32-44.
Handbook of Hygiene Control in the Food Industry, Ed. Lelieveld, H. L. M.,
Mostert, M. A. & Holah, J., CRC Press, 2005.
Jensen, Stenby and Nielsen, Improving the Cleaning Effect by Changing Average
Velocity, Trends in Food Science & Technology, 18 (2007) 58-63.
Jensen, BBB and Friis, A., Fluid Flow in Cleaning of Closed Processes, New Food,
1 (2006) 64-67.
Jeurnink, T.J.M. and Brinkman, D.W., The cleaning of heat exchangers
and evaporators after processing milk or whey, Int. Dairy Journal, 4,
(1994) 347-368.

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Appendix
Extract from the EHEDG Glossary

A
Aseptic equipment
Hygienically designed equipment that is sterilisable and is impermeable to microorganisms to maintain its aseptic status.
Aseptic process
A process using equipment sterilised before use, and which, in running conditions,
is protected against recontamination by micro-organisms.

B
Biofilms
A microbial consortium adhering to a surface. Note: these are frequently but not in
every case embedded in extra-cellular polymeric substances.

C
CCP (critical control point)
A step at which control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable level. (Codex)
CIP (cleaning-in-place)
Automated wet cleaning system of a line and/or individual equipment in a closed
circuit without dismantling.
Note: CIP efficiency depends on 5Ts time, temperature, titration, turbulence and
technology. CIP can be done in a dry area, the aim being that the design precludes
any water passing into the environment.
Cleanability
The suitability of equipment to be freed from soil easily.
See also Comparative cleanability
Cleaning
The removal of soil, food residues, dirt, grease or other objectionable matter.
(Codex)

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Coatings
The result of a process where a different material is deposited to create a new
surface. (3-A)
Commercial sterilisation (see Sterilisation)
Comparative cleanability
The cleanability of equipment relative to a reference.
Contaminant
Any biological or chemical agent, foreign matter or other substance not
intentionally added to food, which may compromise food safety or suitability.
(Codex)
Contamination
The introduction or occurrence of a contaminant in food or food environment.
Controlled environment (see Zoning)
COP (cleaning-out-of-place) (see also Wet cleaning)
Manual cleaning of dismantled equipment.
Note: The main part of the installation may remain fixed in a position but parts may
be removed to another point for cleaning.
Corrective action
Any action to be taken when the results of monitoring at the CCP indicate a loss of
control. (Codex)
Note: Action taken to eliminate or reduce the causes of nonconformity, defect or
other undesirable situation after a deviation has been detected, in order to minimise
or prevent its recurrence. Every control point in a Quality Monitoring system must
include the corrective action to be taken in case of deviation.
Crevice
A crack with an opening accessible to contaminants.
For example, a narrow opening or fissure either in the bulk of a material or between
two closely fitting components, such as a flange and its gasket. Typically, a crevice
has a depth more than 20 times the width of its opening. Crevices may not only
harbour soils and micro-organisms and be inaccessible to cleaning agents, but may
also cause accelerated corrosion of the bulk material, rapidly increasing the size of
the crevice.

D
Disinfectant
A chemical that is used after cleaning for killing a certain proportion/type of viable
micro-organisms remaining on the surface.
Note: A disinfectant is not expected to kill all micro-organisms of any type,
including spores (see also Sterilisation). Nevertheless in the USA it is defined as an
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agent that will kill 100 % of infectious fungi and vegetative bacteria although it will
not necessarily kill bacterial spores on inanimate surfaces.
Disinfection
The reduction, by means of chemical agents and/or physical methods, of the number
of micro-organisms in the environment, to a level that does not compromise food
safety or suitability. (Codex)
Note: disinfection according to BSI 5283: the destruction of micro-organisms, but
not usually bacterial spores. Disinfection does not necessarily kill all microorganisms, but reduces them to a level acceptable for a defined purpose e.g. a level
which is harmful neither to health nor to the quality of perishable food. Specifically
in USA, the terms sanitiser and sanitisation are more commonly used in the food
industry (see Sanitiser/Sanitisation)
Dry-cleaning
Cleaning which does not involve any use of water, a technique which can be used as
a preventive measure to reduce risks of microbial development in equipment and in
the environment. It also reduces risk of contamination with e.g. residues of aged or
modified product. Mostly done manually using brushes and/or vacuum cleaners.

E
Easily or readily removable
Quickly separated from the equipment with the use of simple hand tools if
necessary. The latter are implements normally used by fitters, operating and
cleaning personnel such as a screwdriver, a wrench or hammer. (3-A)

F
Food hygiene
All conditions and measures necessary to ensure the safety and suitability of food at
all stages of the food chain. (Codex)
Food safety
Assurance that food will not cause harm to the consumer when it is prepared and/or
eaten according to its intended use. (Codex)

G
GHP (Good hygiene practice)
Measures applicable throughout the food chain (including primary production
through to the final consumer), to achieve the goal of ensuring that food is safe and
suitable for human consumption. GHPs are a subset of GMPs.

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GMP (Good manufacturing practice)


All procedures, processes, practices and activities aimed at ensuring that the quality
and safety objectives are met consistently. GMPs should apply throughout the
supply chain for food. Application of GMP is a prerequisite for any HACCP study.
(see HACCP) Note that GHPs are a subset of GMPs.

H
HACCP (Hazard Analysis Critical Control Point)
A system which identifies, evaluates and controls hazards that are significant for
food safety. (Codex) Note: A HACCP study must be performed during the
development of new products and processes, covering thus new equipment, and
when changes are made on existing lines or to products. All CCPs identified must
be monitored and corrective action taken in case of deviation.
Hazard
A biological, chemical or physical agent in, or condition of, food with the potential
to cause an adverse health effect. (Codex)
Hygiene
See Food Hygiene.
Hygienic equipment class I
Equipment that can be cleaned-in-place and can be freed from soil after reassembly.
Hygienic equipment class II
Equipment that is cleanable after dismantling and can be freed from soil after
reassembly.
Hygienic integration
The process of combining or arranging two or more entities to work together for a
hygienic purpose.

I
In-place cleanability
The suitability to be easily cleaned without dismantling.

M
Manual cleaning
Removal of soil when the equipment is partially or totally disassembled.

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Mechanical cleaning
Shall denote cleaning, solely by circulation and/or flowing chemical detergent
solutions and water rinses onto and over the surfaces to be cleaned, by mechanical
means.
Micro-organisms
Micro-organisms that can cause disease/illness in humans and animals. Note:
Distinguish from indicator micro-organisms, whose presence indicate a failure of a
GHP. The number present is assumed to be related to the probability of
contamination of a product with a pathogen.
Monitoring
The act of conducting a planned sequence of observations or measurements of
control parameters to assess whether a CCP is under control.

N
Non-absorbent materials
Materials which, under the intended conditions of use, do not internally retain
substances with which they come into contact.
Non-product contact surfaces
(See also Product contact surfaces)
All exposed surfaces other than those in contact or potential contact with
product.
Non-toxic construction materials
Materials which, under intended conditions of use, do not release toxic substances.

P
Pasteurisation
A microbiocidal heat treatment aimed at reducing the number of any harmful microorganisms, if present, to a level at which they do not constitute a significant health
hazard.
Note: pasteurisation applies to equipment as well as to food.
Product contact surfaces
All equipment surfaces that intentionally or unintentionally (e.g. due to splashing)
come into contact with the product, or from which product or condensate may drain,
drop or be drawn into the main product or container, including surfaces (e.g.
unsterilised packaging) that may indirectly cross-contaminate product contact
surfaces or containers.
Note: A risk analysis can help to define areas of potential cross-contamination.

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R
Relevant micro-organisms
Micro-organisms able to contaminate, multiply or survive in the product and be
harmful to the consumer or product quality.
Removable (see Easily or readily removable)
Risk
A function of the probability of an adverse health effect and the severity of that
effect, consequential to a hazard(s) in food. (Codex)
Risk is the potential for the occurrence of unacceptable food safety deviations but
may be extended to cover quality deviations.
Note: In Codex terminology risk pertains to public health issues. It relates to
safety and not to quality related matters.
Risk analysis
A process consisting of three components: risk assessment, risk management and
risk communication. (Codex)
Note: Whereas Hazard analysis is under the responsibility of food manufacturers,
Risk analysis is a public health matter.
Risk assessment
Risk assessment is the scientific part of the risk analysis process in which the
hazards and risk factors are identified and the risk is calculated.
Apart from an end point calculation of risk, the risk model developed can be of
value in determining the parts of the chain which contribute most to risk or to
investigate the effect of changes in practices or processes throughout the chain on
the risk level.
Risk assessment contains four elements:
- hazard identification which identifies particular hazards or contaminants in a
product or process
- exposure assessment which estimates the intake / exposure of the hazard by
the consumer
- hazard characterisation which relates exposure to the hazard with a public
health effect (illness / death) frequently by assessing the dose-response
relationship
- risk characterisation which calculates the risk from the exposure (intake) and
dose-response estimate (effect).
Risk management
Risk management is an evaluation of the acceptability of the risk posed and the
implementation of measures to reduce this risk if necessary.

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Risk communication
Risk communication involves transparent communication between the risk assessors
(scientists) and the risk managers (regulators, industry, government agencies etc.).
The results of risk assessment and risk management should be communicated more
widely to the relevant stakeholders, including consumers.
Risk zone (see Zoning)

S
Sanitation (USA)
Equivalent to hygiene in general terminology for the food industry.
Sanitising or sanitisation (USA)
A process applied to a cleaned surface capable of reducing the numbers of the most
resistant human pathogens by at least 5 log10 reductions (99.999 %) to 7 log10
reductions (99.999999 %) by applying accumulated hot water, hot air, or steam, or
by applying an EPA-registered sanitizer according to label directions. Sanitising
may be effected by mechanical or manual methods using hot water, steam, or an
approved sanitizer. See Disinfection.
Sanitiser (USA)
A substance that reduces the microbial contaminants on inanimate surfaces to levels
that are considered safe for public health. According to the official food contact
surface sanitizer test, a sanitizer is a chemical that reduces the microbial
contamination of two standard organisms, Staphylococcus aureus and Escherichia
coli, by 99.999 % or 5 logs in 30 seconds, at 25 C. Non-food contact sanitisers
must reduce contamination by 99.9 % or 3 logs in 5 minutes.
Soil
Any remaining, undesirable material in the equipment or process environment. It
may or may not contain micro-organisms.
Solutions
Water and/or those homogeneous mixtures of cleaning agents and/or disinfectants
and water used for flushing, cleaning, rinsing and disinfection.
Splash contact surfaces
Non-product contact surfaces that during normal use are subject to accumulation of
soil and which require routine cleaning to avoid soil to drop or to be drawn into the
main product or container.

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Sterilisation
A process aimed at removing or killing all forms of micro-organisms, including
bacterial spores.
Note 1: In the USA, commercial sterilization refers to the inactivation of all
organisms of significance to public health and the absence of spoilage under normal
conditions of storage.
Note 2: In the UK, still used to denote disinfection.
Note 3: Sterilisation can equally apply to treatment of food.
SIP (sterilisation in place)
Sterilisation without dismantling.
Surface rupture
Breaking or tearing of a surface commonly the result of impact from a shot- or
bead-blasting medium. Under magnification the damage to the surface will
generally appear like fish scales, the openings under which face forwards the source
of the shot or beads. These areas can harbour soils and micro-organisms and be
difficult to clean.
Surface treatment
A process whereby chemical or mechanical properties of the existing surface are
altered.

U
Ultra-clean process
A process using equipment disinfected before use, and which, in running conditions,
is protected against recontamination by micro-organisms that may harm the safety
and suitability of the specific product that is made.
Note: Measures for initial reduction of microbial load and against recontamination
can be less stringent than those applied for an aseptic process. Ultra clean or Aseptic
refers more to the process line and not the environment.

V
Validation
Obtaining evidence that the elements of the HACCP plan are effective. (Codex)
The obtaining of evidence that the food hygiene control measures selected to control
a specific hazard(s) in a specific food(s) are capable of controlling the hazard to the
level specified. (provisional Codex)
Note: In the context of ISO 9000-2000, this process is named qualification.
Validation is used in a much broader sense e.g. for validation of cleaning.
Validation, in general, intends to establish documented evidence, that a specific
process will consistently meet its predetermined objectives. In the case of cleaning
process: the objective is that the next batch of product, which will be processed in
the cleaned equipment, does not become contaminated from any microbiological
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and chemical sources, foreign material or environmental residues, having potential


affect on the food contact surfaces.
Verification
The application of methods, procedures, tests, and other evaluations, in addition to
monitoring to determine compliance with the HACCP plan. (Codex)
Note: In the context of ISO 9000-2000, this process is named validation, a situation
that may lead to some confusion.
In a wider sense can represent: Activities, including auditing, reviewing, inspecting,
challenging, testing, checking etc., that demonstrate whether items, processes,
services or documents conform to specified requirements for quality, especially
food safety e.g. as seen in the HACCP plan.

W
Wet-cleaning
(Cleaning-out-of-place as opposed CIP see specifically CIP)
Can refer to cleaning of equipment or processing environment. Cleaning procedure
carried out only when product is not exposed and using methods that limit the
amount of water applied and its spread. The main aim of wet cleaning is to remove
soil that may or may not contain micro-organisms.
Note: The objectives are basically to use as little water as possible and to be as dry
as possible rapidly after cleaning. This is a procedure specifically intended to reduce
risks of build-up of environmental Listeria monocytogenes populations in ice
cream, cheese and refrigerated products process areas.
Also referred to as Controlled wet cleaning

Z
Zoning
The physical or visual division of the plant into sub-areas, leading to the segregation
of different activities with different hygiene levels.
Related terms and explanations. The following are proposals for use in EHEDG.
Controlled environment refers to all zoning but may relate more to the high
hygiene case.
Zoning cannot be defined for all plants and processes in black and white as there
will always be local influences that play a role. Most important is that zoning fits
into the overall plan of prevention with respect requirements of process and safety
of consumers.
High hygiene = high care or high risk

Copyright 2008; Tetra Pak Processing Systems

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2008-11-14

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IDF states: a critical hygienic area within the plant where products and ingredients
vulnerable to contamination and/or microbial growth are processed, treated, handled
or stored. An area within a plants zoning plan where the following products and
ingredients are processed or stored either those destined for a highly susceptible
consumer group, being instant in nature or ready for consumption, or those which
will be handled in a refrigerated supply chain and which are susceptible to growth
of pathogenic micro-organisms such as Listeria monocytogenes.
Note: The term high risk area could also be used for a zone where there is a high
concentration of pathogens e.g. in fresh meat and chicken, raw cocoa bean, fresh
raw milk and vegetable areas. These areas present a high risk for other process area
and there should be adequate barriers to stop spread of pathogens.
High hygiene is equivalent for food to clean room.
Medium hygiene = medium care or medium risk
Can be a process area for products, susceptible to contamination but where the
consumer group is not especially sensitive and where also no further growth is
possible in the product in the supply chain. Can also be the intermediate area
leading into the high hygiene zone but where access is only across certain barriers.
Low (Basic) hygiene = Low care or low risk
Low (basic) relative to others but where minimal GHP must be applied. Low (basic)
hygiene areas can be sub-divided as proposed in EHEDG Doc. 26 on dry materials.
An area where products are not susceptible to contamination and are protected in
their final packages. Can also be an area where raw materials are handled before
being subjected e.g. to a thermal process step (a CCP).
Examples:
Related to cleaning for total zoning, some examples are given in the table below but
these are certainly only guidelines. Each establishment must make its own zoning
plans based on product and consumer group, local influences and legislation.

Copyright 2008; Tetra Pak Processing Systems

Tetra Pak Internal

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Anders Gransson

2008-11-14

Page

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Sample zoning plan in relation to cleaning:


High hygiene
(Controlled) wet
cleaning

Few cases, e.g.


chilled pasta
production

Dry cleaning

Infant formula
filling area

Copyright 2008; Tetra Pak Processing Systems

Medium hygiene
Bottling areas
UHT filling
Areas for icecream and frozen
food filling/
assembly
Filling of dry
soups, coffee,
chocolate
moulding

Low (Basic)
hygiene
Fresh/raw milk
reception
Mixing preparation
prior to
pasteurization
Warehouses

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