Hygdesign

Hygienic Design
Gerhard Schleining
BOKU - University of Natural Resources and

Applied Life Sciences, Vienna
Dept. of Food Science and Technology

http://www.dlwt.boku.ac.at
Muthgasse 18, A-1190 Vienna
Tel.: +43 1 36006-6294,
20.06.2007 Fax: +43 1 36006-6293,
ISEKI-Workshop Bucharest, 25 June 2007 1
gerhard.schleining@boku.ac.at
“Food Enterprises meet University”
contents
• role of hygienic design for food safety
• standards – guidelines
• scope of hygienic design
• aspects of building design and routing
• aspects of equipment design, installation und integration
• cleaning
• cleaning validation
• summary
20.06.2007 2
ISEKI-Workshop Bucharest, 25 June 2007
FOOD SAFETY is a matter of the whole food
supply chain
Product
Produkt- Agrarische
Primary Industrielle
Industrial Transport Handel Lagerung
Storage Konsum
Use
Production Product
Produkt Trade Houeshold Entsorgung
Disposal
Design
Planung Production
Primärproduktion Produktion Logistik
Logistics Verkauf Haushalt Consumtion
Nutzung
FOOD SUPPLY CHAIN
• biological HUMAN
• chemical hazards by ENVIRONMENT
• physical EQUIPMENT
20.06.2007 3
Influence of secondary processes
like cleaning, chilling on the:
Acceptable microbial count
chilling
cleaning, disinfection
raw materials heat treatment

Transport
Production Logistics Consumption
20.06.2007 4
Quality Hygiene is the essential basis
for the quality of a food
HYGIENE product
Product Hygiene: preventive measures

¾ Control of raw materials (supplier audits, acceptance tests)
¾ Control of intermediate and end products (shelf life) GMP
HACCP
Process Hygiene: ....

¾ requirements to building and equipment
HYGIENIC DESIGN
¾ cleaning, desinfection, pest control
¾ Compliance of temperature-time-relations, storage conditions ....
and product flow (kreuzungsfrei)
Preventive
¾ waste management
maintenance
Personal Hygiene:
¾ dress code, behaviour, if necessary adaption of sanitary rooms
¾ training !!!
20.06.2007 5
PRODUCT QUALITY depends also on
the quality of the used equipment
EQUIPMENT MANUFACTURER FOOD MANUFACTURER
equipment process product

design installation design
GMP/HACCP/...
cleanability functionality safety capability
processing
EQUIPMENT QUALITY
cleaning
PRODUCT QUALITY
20.06.2007 6
EQUIPMENT
MANUFACTURER
Machinery
DIN EN ISO 14159 Directive 98/37/EC
DIN EN 1672-2:2004 design equipment
2009: 2006/42/EC
POTENTIAL OPERATIONAL
HYGIENE
CONFLICT SAFETY
“hygiene package”: design and control process

4 regulations, 2 directives
(2002/178/EC on general directive 95/63/EEC
principles and requirements FOOD MANUFACTURER safety and health
of food law and on requirements for the use
procedures in matters of (equipment user)
of equipment by workers
food safety, 2002/99/EC on
animal health)
20.06.2007 7
REGULATIONS
Machinery Directive
degree of details Hygiene package
95/63/EEC: Minimum safety and health requirements for the use of
work equipment by workers at work
STANDARDS
DIN EN ISO 14159: 2002 Safety of machinery – Hygiene
requirements for the design of machinery
DIN EN 1672-2:2004 Food processing machinery – Basic concepts –
Hygienic Requirements
GUIDELINES
spezif. product requirements
spezif. process requirements
Interpretation must always be done in relation
available equipment
to the local situation:
available staff
environment
20.06.2007 8
EHEDG-GUIDELINES

general design criteria, materials of construction

closed equipment for liquid products

open equipment (conveyor belts, mixer, etc.)

technics: welding, passivation of stainless steel

aspects: air, water, lubricants

equipment: pumps, valves, pipes, couplings,
sealings
is a consortium of equipment processes: thermal treatment (pasteurisation,
manufacturers, food Industries, research sterilisation, chilling), dry products, packaging
institutes and public health authorities, (materials), cleaning
founded in 1989 with the aim to promote
hygiene during the processing and packing
of food products
(http://www.ehedg.org/) EHEDG-TEST-METHODS
Procedures for evaluation, test and certification of equipment for
authorisized test laboratories
in-place cleanability, in-line pasteurisation, in-line steam sterilisability
Bacteria tightness of equipment
Bacteria impermeability of membran filters
certified eqipment is listed at: http://www.ehedg.org/certequip.htm

VARIOUS ASPECTS OF HYGIENIC DESIGN
Source: K. Lorenzen, GEA Tuchenhagen

20.06.2007 10
HYGIENIC DESIGN
• BUILDING DESIGN
Plant Enclosure Related Aspects
Lay-Out Related Aspects
Air Related Aspects
Water Related Aspects
Zoning
EQUIPMENT DESIGN
EQUIPMENT INSTALLATION AND INTEGRATION
avoid any:
infestation by insects, birds, animals
accumulation of dust, surface/condensed water or product
contamination with micro-organism, chemicals, foreign bodies
20.06.2007 11
BUILDING DESIGN PLANT ENCLOSURE
RELATED ASPECTS
20.06.2007 12
BUILDING DESIGN
LAY-OUT RELATED ASPECTS
Placement of rooms (Zoning): separate dry and wet areas, short product
routing without crossings
Interior building element surfaces should be non-electrostatic, smooth, round
corners and have good accessibility for cleaning
No metal panels
high heat transfer -> condesation
-> expansion -> sealings
20.06.2007 13
BUILDING DESIGN
Materials
should be resistant to food components, cleaning agents and disinfectants
No standard glass in open processing areas, but polymer material like
polycarbonate or strengthened glass (standard glass with protective film)
STAINLESS STEEL
20.06.2007 14
BUILDING DESIGN
MATERIALS
PLASTICS
ELASTOMERS
20.06.2007 15
BUILDING DESIGN
Drainage:
not in dry areas,
as far away as possible from processing
equipment,
sufficient sloping,
ability to close during production,
water lock must be intact
20.06.2007 16
BUILDING DESIGN
Framework: open profiles, mounted with
tight fit, no hollow bodies and horizontal
surfaces, enclosed in concrete
Platforms and walkways: should be

minimised, not above open processes
20.06.2007 17
BUILDING DESIGN
avoid false/dropped ceiling constructions (control
rooms)
Windows: not be able to open or insect screens
(easily accessible, cleanable or replaceable), no or
45° sloped sills and ledges
20.06.2007 18
BUILDING DESIGN
Doors: without any hollow body and seals (should be monitored regularly)
ambient pressure differential should be preferred
• Insulations against noise or condensation:

avoid as much as possible, no perforated or electrostatic materials, water tight and
removable for inspection and cleaning
better: “hot/cold room concept”
20.06.2007 19
BUILDING DESIGN PIPING
in separate and accessible gangways and enter the process area through the ceiling
open trays without horizontal ledges, crevices or gaps
never be installed behind false ceilings and above open production lines
as short as possible
avoid “dead spaces”: couplings, seals, valves, sensors !!!!!
20.06.2007 20
RISK because of bad welding
cleaning and desinfectants effect the biofilm

only at the outer part
Particles from
corrosion are rinsed
from the crevice
only a small part of the biofilm is

The inner part of the biofilm removed with the cleaning agent
is not effected
20.06.2007 21
BUILDING DESIGN CABLE MOUNTING
avoid dust and condensations
hygiene risk correct
hollow body
acoustic insulation electric wires

full tray
open ends
horizontal grid funnel

grid or sheet, one-layer, sloped or vertical
20.06.2007 22
BUILDING DESIGN CABLE MOUNTING
20.06.2007 23
BUILDING DESIGN LIGHTING
avoid contamination not close to doors (insects)

not above open processes (foreign bodies)
avoid dust and condensations
horizontal surfaces
water tight integrated
soil
slope polycarbonate instead of glass
20.06.2007 24
BUILDING DESIGN AIR RELATED ASPECTS
avoid contamination with

environmental air
dust particles and
flow from higher to lower hygiene areas
from higher to lower dust loaded areas micro-organisms
USDA: minimum air change: 6/h,
20-30/h when high load of dust or moisture
light overpressure (~ >10%) with filterd air (~50 μ)
dust extraction
process and transport air

inlet at a single location,
> 3m above the ground level, >10m away from any exhaust discharge point
instrument air
outlet away from open and dry products
20.06.2007 25
BUILDING DESIGN
WATER RELATED ASPECTS
specify, separate and monitor
different water qualities
Water quality control
process/product water specifications
utility water no connections
potable water
Legionella spp
spp.. (EHEDG Doc. 24 2004)
right design and placing of equipment like cooling towers, evaporative condensers,
domestic water systems, pressure jetting systems, can/bottle washing systems,
emergency showers; fire sprinklers, fountains, garden hoses and sprinklers, spray
humidifiers and air washers, machine tool cooling units, conveyor lubrication, …
avoid stagnant water (drainage), formation of aerosols
20.06.2007 26
ZONING
means keeping out and keeping away of unwanted
items
specify areas and barriers
requires knowledge about products and processes
(what must be prevented)
glove box to prevent

emission of unwanted
contaminants
(www.plas-labs.com)
must be logically and practically for all persons concerned

must be economically
rules must be followed by all -> Training is essential
20.06.2007 27
Do not forget:
cleaning utensils
spare parts
drainage
fire protection
waste collection
air conditioning …..
ZONING CLASSIFICATION
according hygienic requirements:
B/L M H
(basic/low) (medium) (high)
no or temporary open open
closed production production production
and according cleaning requirements:
w cw d
(wet) (controlled wet) (dry)
With different rules for installation, personnel behaviour, cleaning, etc.
20.06.2007 29
example ZONING
cleaning requirements
wet controlled wet dry

hygienic requirements
Bw Bcw Bd
courtyard, car park office, store house dry store
Mw Mcw Md
bottle washing closed filling milling
Hw Hcw Hd
open filling open filling powder filling
20.06.2007 30
example ZONING
High hygiene areas: barriers should be installed as close as possible to the

product, e.g. integrated HEPA-Filter (pill press)
20.06.2007 31
ZONING BARRIERS
Zones should be clear visible (by barriers for staff and products)
walls, lines on the ground, drains (water lock!!), air filters, transfer
windows
access points for products, personnel, are critical and must be
air, utilities, systematically monitored
traffic conditions !!!!!
drains, seals
Elevators can not be barriers !!

non-accessible spaces, air drafts
If different hiegenic zones are accessable by stairs or elevators air
locks must be installed
20.06.2007 32
INTEGRATION
LEVELS
EQUIPMENT DESIGN - INSTALLATION, -INTEGRATION
avoid accumulation of dust / water(condensate) / product

designed without
horizontal surfaces,
ledges, hollow bodies,
dead spaces ....
dead space
support structures must be sealed to floor/wall/ceiling without any

pockets or gaps
accessability: > 0.3m above the floor and from walls

20.06.2007 34
EQUIPMENT DESIGN, -INSTALLATION, -INTEGRATION
avoid misalignment
product contact surfaces must be inert to

product, detergents, disinfectants or sanitizers
(migration, absorption), corrosion resistant,
non-toxic, mechanically stable, their surface
finish (roughness Ra ≤ 0.8 μm) must not be
affected under conditions of use
20.06.2007 35
EQUIPMENT DESIGN - INSTALLATION, -INTEGRATION
self draining hygiene risk

without dismantling correct
installation of sensors hygiene risk correct
dead space flow against sensor

• sensor not cleanable
• measured value not relevant
20.06.2007 36
INSTALLATION, INTEGRATION
avoid dead space
20.06.2007 37
20.06.2007 38
Source: Lelieveld H.L.M. et.al.:

Hygiene in Food Processing
Woodhead publishing Limited
20.06.2007 39
INSTRUMENTATION
20.06.2007 40
Cleaning
• definitions
• cleaning
• microbial destruction
• cleaning methods
• cleaning validation
• sampling
20.06.2007 41
SANITATION
“sanitas”: health
Is more than cleanliness
Creation and maintenance of hygienic and healthful conditions
Application of science to provide wholesome food, processed, delivered in a
clean environment by healthy workers to control hazards and prevent
contamination and spoilage
“soil”: material (dirt, dust, organic material) in an incorrect location, like fat
deposit on a cutting board, lubricant on a conveyor belt, ….
water soluble – no problem: inorganic salts, sugar, starches, minerals, …
soluble in acidic solutions (inorganic materials): rust, Ca-oxalats, metal (Fe,
Zn) oxids, water- and milkstone (precipitated by heat)
soluble in alcalic solutions (organic materials): fatty acids, proteins
“clean”: free of visible soil
20.06.2007 42
BIOFILMS
• layer of microcolonies of bacteria associated with an inert surface

attached by a matrix of complex polysaccharid-like material (glue) in
which other debris including nutrients and other microorganisms (also
viruses) may be trapped
• first stage: electrostatic attraction (reversible)
second stage: exudation of extracellular polysaccharids
• unique environment established resistent to sanitizing agents
(-1000x), heat more effective than chemical (watersoluble) sanitizers,
teflon easier to clean than stainless steel
• new microorganisms attach themselfes with the aid of filaments and
tendrils
• can behave like a tough plastic
20.06.2007 43
FACTORS EFFECTING CLEANING PERFORMANCE
• surface and material characteristics

• Smoothness (roughness
Ra ≤ 0.8 μm)
• contact time • hardness
• porosity
• physical force exerted: flow velocity, scrubbing
• concentration of cleaning•agent
wettability
• temperature, pH
• water quality
• composition of the soil

20.06.2007 44
MATERIAL CHARACTERISTICS
Source: Marriott, Norman G. :

Principles of food sanitation,
Springer 2006 p.144
20.06.2007 45
PROCESSES OF SOIL REMOVAL
1. SEPARATION OF SOIL FROM SURFACE

• Mechanical: High pressure water, steam, air, scrubbing
• Change of chemical nature: reaction with alcali, acid
• Surfactants (reduce surface tension)
2. DISPERSION IN CLEANING SOLUTION

• Solubility limits should not exceeded -> add fresh solution
• Supplied mechanical energy (agitation, high pressure water, scrubbing) is
of advantage to reduce soil to smaller particles or droplets
3. PREVENTION OF REDEPOSITION
• Removal of dispersed solution
20.06.2007 46
MICROBIAL DESTRUCTION
HEAT: steam, hot water
CHEMICALS (21-38ºC)
• Sterilants: destroy all forms of microbial life: ethylene oxid,
glutaraldehyd, peroxyacetic acid
• Desinfectants: destroy microbial life but not necessarely spores
• Sanitizers: reduce microbial life to levels considered as safe
oxidative biocides: peracetic acid, chlorine dioxide, ozon, anionic
sulfonic acid, quaternary ammonium compounds, phenolics,
formaldehyde, ….
Lack penetration ability (cracks, crevices,…)
20.06.2007 47
MICROBIAL DESTRUCTION
IONIZISING RADIATION
• inactivate cellular components -> cannot devide
• UV: no/few undesirable by-products, distance/shadow/dust !!, used for
drinking/process water
• electron beam: shortest penetration (7.5cm)
• gamma rays: penetration >1m
• x-rays: ELECTRONIC PASTEURIZATION: max 10 meV X-rays, limited
to packages < 10cm
PULSED LIGHT
• >8 logs of vegetative cells, 6 logs of spores on packaging materials or in
beverages
• 1-3 logs on rough surfaces like meat
20.06.2007 48
CLEANING METHODS
• brushes, scrapers, sponges
• High pressure water pumps
• Low pressure, high temperature spray units
• High pressure hot water cleaning
• Steam guns
fogging
• High pressure steam
-> mold,
• Hot water wash -> L. monocytogenes!!
• High pressure, low volume
• Foam or slurry (less air) cleaning: cleaning compound+water+air, visible
• CIP: combined chemical + mechanical effects, automated

rinse with hot/cold water
detergent wash • COP (c out of place): small disassemblied
rinse equipment parts
sanitization
final rinse
20.06.2007 49
CLEANING VALIDATION
validation of cleaning procedures is a very efficient strategy (FDA)
to remove sufficiently residues of products and cleaning agents

and to control potential contaminants
cleaning procedures must always be developed under consideration of the

product requirements
important issues are:

validation procedure
acceptance criteria, acceptance limits
sampling
20.06.2007 50
PROCEDURE
STEPS RESULTS DOCUMENTATION
Status Evaluation selected equipment and

cleaning procedures
products (composition) Cleaning Validation
acceptance criteria and
processes (potential risks)
equipment (construction) analytical methods Master Plan
cleaning procedures (cleaning agents)
Risk Analysis representative equipment,

product and sampling locations
worst case conditions
Cleaning Process Studies validated analytical and Cleaning Validation Protocol

sampling methods logbook, reports, SOPs
acceptance limits
Assessment and Implementation corrective actions assessment report
training, routine monitoring, change control
Validation of Representative approved representative Cleaning Validation Report

Approval
approved equipment Cleaning Validation Protocols,

Transfer to other Equipment
Reports and Approvals
20.06.2007 51
SAMPLING
• Sampling is most important for the representative validity of the results

• contaminate will not be uniformly distributed
and will not be worn off the surface uniformly
• the act of sampling itself is a cleaning step: only to be sampled once
DIRECT SURFACE SAMPLING

for flat surface areas and cracks, crevices, gaskets, seals
recovery effectiveness and reproducibility depend on:
swabbed material, sampling solvent, concentration range of residues, the swab
pattern and sequence
INDIRECT RINSE SAMPLES

for large surface areas, especially inaccessible areas of equipment that cannot
be routinely disassembled
do not necessarily correlate with residues on the equipment surface
20.06.2007 52
SUMMARY
• if buildings and equipment is of poor design - cleaning will be difficult and time
consumable
• operational requirements conflict with hygienic requirements in many cases
• knowledge, experiences and sometimes simple solutions are available, but
need to be transferred to equipment manufacturers and to food producers
main issues of hygienic design are to:
avoid contamination by foreign organisms and materials
avoid conditions which enhance the growth of micro-organism
improve cleanability
risks by poor hygienic design are caused by :

wrong placement of equipment and utility installations
horizontal surfaces, hollow bodies
dead spaces, bad drainage
insufficient cleanability/accessability
use of non-resistant materials, etc.
The concept of zoning and cleaning validation is well known in the
pharmaceutical industry and should be used more frequently in the food industry
20.06.2007 53

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Hygienic Design

BOKU - University of Natural Resources and

Dept. of Food Science and Technology

• scope of hygienic design

• aspects of building design and routing

• aspects of equipment design, installation und integration

FOOD SUPPLY CHAIN

raw materials heat treatment

Product Hygiene: preventive measures

Process Hygiene:  ....

EQUIPMENT MANUFACTURER FOOD MANUFACTURER

equipment process product

“hygiene package”: design and control process

certified eqipment is listed at: http://www.ehedg.org/certequip.htm

Source: K. Lorenzen, GEA Tuchenhagen

 Platforms and walkways: should be

• Insulations against noise or condensation:

better: “hot/cold room concept”

cleaning and desinfectants effect the biofilm

only a small part of the biofilm is

acoustic insulation electric wires

horizontal grid funnel

avoid contamination  not close to doors (insects)

avoid dust and condensations

hygiene risk correct

slope polycarbonate instead of glass

avoid contamination with

process and transport air

glove box to prevent

 must be logically and practically for all persons concerned

 according hygienic requirements:

 and according cleaning requirements:

With different rules for installation, personnel behaviour, cleaning, etc.

wet controlled wet dry

High hygiene areas: barriers should be installed as close as possible to the

 Elevators can not be barriers !!

avoid accumulation of dust / water(condensate) / product

hygiene risk correct

 support structures must be sealed to floor/wall/ceiling without any

 accessability: > 0.3m above the floor and from walls

 product contact surfaces must be inert to

 self draining hygiene risk

 installation of sensors hygiene risk correct

dead space flow against sensor

avoid dead space

Source: Lelieveld H.L.M. et.al.:

hygiene risk correct

“clean”: free of visible soil

• layer of microcolonies of bacteria associated with an inert surface

• surface and material characteristics

• composition of the soil

Source: Marriott, Norman G. :

1. SEPARATION OF SOIL FROM SURFACE

2. DISPERSION IN CLEANING SOLUTION

HEAT: steam, hot water

• CIP: combined chemical + mechanical effects, automated

validation of cleaning procedures is a very efficient strategy (FDA)

 to remove sufficiently residues of products and cleaning agents

cleaning procedures must always be developed under consideration of the

important issues are:

Status Evaluation  selected equipment and

Risk Analysis  representative equipment,

Cleaning Process Studies  validated analytical and  Cleaning Validation Protocol

Process Hygiene: ....

Platforms and walkways: should be

avoid contamination not close to doors (insects)

must be logically and practically for all persons concerned

according hygienic requirements:

and according cleaning requirements:

Elevators can not be barriers !!

support structures must be sealed to floor/wall/ceiling without any

accessability: > 0.3m above the floor and from walls

product contact surfaces must be inert to

self draining hygiene risk

installation of sensors hygiene risk correct

to remove sufficiently residues of products and cleaning agents

Status Evaluation selected equipment and

Risk Analysis representative equipment,

Cleaning Process Studies validated analytical and Cleaning Validation Protocol

Assessment and Implementation corrective actions assessment report

Validation of Representative approved representative Cleaning Validation Report

approved equipment Cleaning Validation Protocols,

risks by poor hygienic design are caused by :