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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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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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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.
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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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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.
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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 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
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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 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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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.
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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:
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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
Detergent concentration
Water quality
Cleaning time
Cleaning temperature
Flow rate
Cleaning result
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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
50-60
30-50
4-8
(Type B)
%
15-20
70-80
4-8
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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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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.
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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
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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
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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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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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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
Organic acids
Formic acid
Citric acid
Lactic acid
Gluconic acid
Sulphamic acid
Inhibitors
Phosphonic acids
Surfactants
Non-ionic and
anionic surfactants
Defoamers
Hydrophobic
non-ionic
substances
Hydrotrophic
substances
Stabilisers
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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
Defoamers
Enzymes
Proteases
Lipases
Specific enzymes
Hydrotrophic
substances
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
Builders
Phosphates
Phosphonates
Citrates
Silicates
Surfactants
Non-ionic and
anionic
Defoamers
Sequestering
agents
Polyphosphates
Phosphonates
Corrosion
inhibitors
Silicates
Oxidising
cleaning
boosters
Hypochlorites
Stabilisers
Hydrotrophic
substances
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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
Surfactants
Non-ionic and
anionic surfactants
Defoamers
Stabilisers
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0,2
0,4
0,6
0,8
Lye concentration / %
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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
0.18
0.46
0.75
2
47.5
90.0
127.0
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350
1.0% w/w NaOH
300
Conductivity (mS/cm)
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).
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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60
70
80
90
Temperature / C
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
80-85
UHT plants
60-80
70-90
Milk pasteurisers
90-130
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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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Volume flow (m 3 / s ) =
Volume flow (l / h)
3.6 10 6
Area (m 2 ) =
(d i.d . (m) )2
4
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Velocity
v m/s
25 mm
38 mm
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51 mm
3.0
2.5
63.5 mm
2.0
76 mm
1.5
89 mm
1.0
0.5
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.
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.
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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.
Flow separation
Low wall shear stresses
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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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
10-15
50
10-15
30
15
10
30
5-10
20
10
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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
10
30
5-10
20
10
3-5
10
5
3-5
20
10
5
20
5
10
10
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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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>10
75
Cold*
70
Cold
Duration, minutes
15-20
35-45
10-15
20-30
10-15
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.
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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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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>10
65-80
Cold
65-80
Cold
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Duration, minutes
20
10
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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.
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Good
None
Fungicidal
Good
Certain effect but
dependent on temperature,
contact time and
concentration
Variable
Yes
Yes
No
Poor/None
Yes
Low
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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
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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.
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
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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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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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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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
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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.
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Dry cleaning
Infant formula
filling area
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