Hygienic Design and Sanititation

contents
Gerhard Schleining
• role of hygienic design within food safety

• standards – guidelines

• scope of hygienic design

• aspects of building design

• aspects of equipment design, installation und integration

• sanitation

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FOOD SAFETY is a matter of the whole food Influence of secondary processes

supply chain like cleaning, chilling on the:
Acceptable microbial count
Produkt-
Product Agrarische
Primary Industrielle
Industrial Transport Handel Lagerung
Storage Konsum
Use
Production Produkt
Product Trade Houeshold Entsorgung
Disposal
Planung
Design Production
Primärproduktion Produktion Logistik
Logistics Verkauf Haushalt Consumtion
Nutzung

chilling

FOOD SUPPLY CHAIN

cleaning, disinfection

• biological § HUMAN
• chemical hazards by § ENVIRONMENT P
• physical § EQUIPMENT raw materials heat treatment
Transport
Production Logistics Consumption

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 HAZARDS
Biological
Quality
Hygiene is the essential basis for the
Ø parasites, vermints, pests, rodents HYGIENE quality of a food product
Ø microorganism
Ø Natural biological toxins
(Mycotoxins) Product Hygiene: preventive measures
Chemical
Residues of: Ø Control of raw materials (supplier audits, acceptance tests) § GMP
Ø pestizides, herbizides, fungizides, fertilizers, pharmaceuticals Ø Control of intermediate and end products (shelf life)
§ HACCP
Ø Processing contaminants (nitrosamins, fat oxidation, migration)
Ø Environmental contaminants: food allergens, heavy metals Process Hygiene: § ....
Ø lubricants, cleaning agents and desinfectants, paintings Ø requirements to building and equipment
§ HYGIENIC DESIGN
Ø cleaning, desinfection, pest control

Foreign bodies:
Physical Ø Compliance of temperature-time-relations, storage conditions § ....
and product flow (cross contamination!!)
Ø foreign food materials: last batch, seeds Ø waste management § preventive
Ø glass, wood, stones, hairs, debris (product) maintenance
Personal Hygiene:
Ø splitter of paintings, rust Ø dress code, behaviour, if necessary adaption of sanitary rooms
Ø dust, paper Ø training !!!
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PRODUCT QUALITY depends also on the design and EQUIPMENT

Machinery
MANUFACTURER
quality of the used equipment DIN EN ISO 14159 Directive
2006/42/EC
DIN EN 1672-2
design equipment

EQUIPMENT MANUFACTURER FOOD MANUFACTURER

equipment process product

design installation design POTENTIAL OPERATIONAL
HYGIENE
GMP/HACCP/...
CONFLICT SAFETY
cleanability functionality safety capability

processing design and control process

“hygiene package”
EQUIPMENT QUALITY
cleaning
FOOD MANUFACTURER directive 95/63/EEC
safety and health
(equipment user) requirements for the use
of equipment by workers
PRODUCT QUALITY

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 REGULATIONS
EHEDG-GUIDELINES
§ Regulation 852/2004: The layout, design, construction and size of
food premises are to permit adequate maintenance, cleaning and/or
general design criteria, materials of construction
§
disinfection, avoid or minimise air-borne contamination, and provide closed equipment for liquid products
§
degree of details
adequate working space to allow for the hygienic performance of all open equipment (conveyor belts, mixer, etc.)
§
operations……. technics: welding, passivation of stainless steel
§
§ 2006/42/EC : Machinery Directive aspects: air, water, lubricants
§
equipment: pumps, valves, pipes, couplings,
§
STANDARDS sealings
is a consortium of equipment § processes: thermal treatment (pasteurisation,
§ DIN EN ISO 14159: Safety of machinery – Hygiene requirements for manufacturers, food industries, research sterilisation, chilling), dry products, packaging
the design of machinery institutes and public health authorities, (materials), cleaning
founded in 1989 with the aim to promote
§ DIN EN 1672-2: Food processing machinery – Basic concepts – hygiene during the processing and packing
Hygienic Requirements of food products
(http://www.ehedg.org/)

GUIDELINES EHEDG-TEST-METHODS
Interpretation must always be done § specific product requirements Procedures for evaluation, test and certification of equipment for
in relation to the local situation: § specific process requirements authorisized test laboratories
§ available equipment § in-place cleanability, in-line pasteurisation, in-line steam sterilisability
§ available staff § Bacteria tightness of equipment
§ environment § Bacteria impermeability of membran filters
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certified eqipment is listed at: http://www.ehedg.org/certequip.htm

3A-STANDARDS check lists to evaluate equipment

• 01-08 Storage Tanks 11/2001
• Grocery Manufacturers Association (GMA, http://www.gmabrands.com/)
• 02-10 Centrifugal and Positive Rotary Pumps 1/2006 • American Meat Institute (AMI, http://www.meatami.com/)
• 04-04 Homogenizers and Reciprocating Pumps 11/1996 based on design principles
independent, not-for-profit • 10-04 Filters Using Single Service Filter Media 11/2000
corporation dedicated to advancing • 11-08 Plate-Type Heat Exchangers 1/2007
hygienic equipment design for the
• 12-07 Tubular Heat Exchangers 11/2003
food, beverage, and pharmaceutical
industries (founded 1920 ) • 13-10 Farm Milk Cooling and Holding Tanks 11/2003
http://www.3-a.org • 16-05 Product Evaporators and Vacuum Pans 8/1997
• ……

3A- ACCEPTED PRACTICES

• 603-07 Sanitary Construction, Installation, Testing, and Operation of High-Temperature Short-Time and
Higher-Heat Shorter-Time Pasteurizer Systems 11/2005
• 604-05 Supplying Air Under Pressure for Contact with Product or Product Contact Surfaces 11/2004
• 605-04 Permanently Installed Product and Solution Pipelines and Cleaning Systems 8/1994
• 606-05 Design, Fabrication, and Installation of Milking and Milk Handling Equipment 11/2002
• ………

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 SUMMARY SUMMARY
• food safety is a matter of the whole food • operational safety requirements conflict
supply chain with hygienic requirements in many cases
• hazards arise from human and environment
and also from equipment

• secondary processes like cleaning effect the

shelflife of products, if buildings and
equipment is of poor design - cleaning will • interpretation of regulations and standards
be difficult and time consumable must always be done in relation to the
local situation (specific product and
process requirements, available equipment
• hygiene is the essential basis for the and staff, environment)
quality of a food product
• product quality depends also on the
design and quality of the used equipment • guidelines (knowledge, experiences and
sometimes simple solutions) are available

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ASPECTS OF HYGIENIC DESIGN

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

Source: K. Lorenzen, GEA Tuchenhagen

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 HYGIENIC DESIGN STRATEGIES BUILDING DESIGN PLANT ENCLOSURE
RELATED ASPECTS
• avoid infestation by insects, birds, animals
• avoid contamination with foreign organisms
and foreign materials
• avoid conditions which enhance the growth
of micro-organism (accumulation of dust,
surface/condensed water, product)
• improve cleanability

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BUILDING DESIGN BUILDING DESIGN

LAY-OUT RELATED ASPECTS LAY-OUT RELATED ASPECTS

§ Placement of rooms (Zoning): separate dry and wet areas, short product § Materials
routing without crossings should be resistant to food components, cleaning agents and disinfectants
§ Interior building element surfaces should be non-electrostatic, smooth, round No wood and standard glass in open processing areas, but polymer
corners and have good accessibility for cleaning material like polycarbonate or strengthened glass (standard glass with
protective film)
STAINLESS STEEL
§ No metal panels
high heat transfer -> condesation
-> expansion -> sealings

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 BUILDING DESIGN BUILDING DESIGN
MATERIALS LAY-OUT RELATED ASPECTS
PLASTICS

Drainage

ELASTOMERS § not in dry areas

§ as far away as possible from

processing equipment

§ sufficient sloping

§ ability to close during production

§ water lock must be intact

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BUILDING DESIGN
BUILDING DESIGN
LAY-OUT RELATED ASPECTS LAY-OUT RELATED ASPECTS
§ Framework: open profiles, mounted with
tight fit, no hollow bodies and horizontal
Drainage surfaces, enclosed in concrete

Sloped floor to prevent water collection (upfront cost): $1.2M

If not sloped, 22 employees x 1.25 h/day x 220 days required to drain the floor § Platforms and walkways: should be
= 6 050 h/year minimised, not above open processes

6 050 h/year x $30/h = $181 500/year to draw water to a drain

Payback Period of $1.2M divided by $181 500/year = 6.61 years

A properly sloped floor would have lasted much longer than this, with savings
of $181 500 on manufacturing costs every year thereafter!

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 BUILDING DESIGN BUILDING DESIGN
LAY-OUT RELATED ASPECTS LAY-OUT RELATED ASPECTS

§ avoid false/dropped ceiling § Doors: without any hollow body and seals (should be monitored
constructions (control rooms) regularly) ambient pressure difference should be preferred

a) b) c) • Insulations against noise or condensation:

avoid as much as possible, no perforated or
electrostatic materials, water tight and
removable for inspection and cleaning
§ Windows: not be able to open or
insect screens (easily accessible, better: “hot/cold room concept”
cleanable or replaceable),
§ no or 45° sloped sills and ledges

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BUILDING DESIGN PIPING 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 double

ceilings and above open production
lines

§ as short as possible

§ avoid “dead spaces”: couplings,

seals, valves, sensors !!!!!

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 RISK because of bad welding 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

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growths of microorganism BUILDING DESIGN CABLE MOUNTING

avoid dust and condensations
microorganism duplicate at optimum conditions every 20 min
hygiene risk correct
Listeria monocytogenes:
0.5 °C - 50 °C
pH 4.5 - 9.6
NaCl: up to 12 %
hollow body
aw min 0.92

acoustic insulation electric wires

full tray

open ends

horizontal grid funnel

grid or sheet, one-layer, sloped or vertical

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 BUILDING DESIGN CABLE MOUNTING BUILDING DESIGN LIGHTING

avoid contamination § not close to doors (insects)

§ not above open processes (foreign bodies)

avoid dust and condensations

hygiene risk correct

horizontal surfaces
water tight integrated

soil

slope polycarbonate instead of glass

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BUILDING DESIGN AIR RELATED ASPECTS BUILDING DESIGN

WATER RELATED ASPECTS
avoid contamination with
environmental air
dust particles and
§ flow from higher care to low care hygiene areas
micro-organisms
from low to higher dust loaded areas
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

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