Professional Documents
Culture Documents
Hygdesign
Hygdesign
Gerhard Schleining
• standards – guidelines
• cleaning
• cleaning validation
• summary
20.06.2007 2
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
• biological HUMAN
• chemical hazards by ENVIRONMENT
• physical EQUIPMENT
20.06.2007 3
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
Influence of secondary processes
like cleaning, chilling on the:
Acceptable microbial count
chilling
cleaning, disinfection
20.06.2007 4
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
Quality Hygiene is the essential basis
for the quality of a food
HYGIENE product
HACCP
20.06.2007 5
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
PRODUCT QUALITY depends also on
the quality of the used equipment
processing
EQUIPMENT QUALITY
cleaning
PRODUCT QUALITY
20.06.2007 6
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
20.06.2007 7
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN PLANT ENCLOSURE
RELATED ASPECTS
20.06.2007 12
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN
LAY-OUT RELATED ASPECTS
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN
MATERIALS
PLASTICS
ELASTOMERS
20.06.2007 15
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN
LAY-OUT RELATED ASPECTS
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN
LAY-OUT RELATED ASPECTS
Framework: open profiles, mounted with
tight fit, no hollow bodies and horizontal
surfaces, enclosed in concrete
20.06.2007 17
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN
LAY-OUT RELATED ASPECTS
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN
LAY-OUT RELATED ASPECTS
Doors: without any hollow body and seals (should be monitored regularly)
ambient pressure differential should be preferred
20.06.2007 19
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
RISK because of bad welding
Particles from
corrosion are rinsed
from the crevice
20.06.2007 21
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN CABLE MOUNTING
avoid dust and condensations
hygiene risk correct
hollow body
open ends
20.06.2007 22
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN CABLE MOUNTING
20.06.2007 23
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN LIGHTING
horizontal surfaces
water tight integrated
soil
20.06.2007 24
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BUILDING DESIGN AIR RELATED ASPECTS
instrument air
outlet away from open and dry products
20.06.2007 25
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
ZONING
means keeping out and keeping away of unwanted
items
specify areas and barriers
requires knowledge about products and processes
(what must be prevented)
20.06.2007 27
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
Do not forget:
cleaning utensils
spare parts
drainage
fire protection
waste collection
air conditioning …..
ZONING CLASSIFICATION
B/L M H
(basic/low) (medium) (high)
no or temporary open open
closed production production production
w cw d
(wet) (controlled wet) (dry)
20.06.2007 29
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
example ZONING
cleaning 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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
example ZONING
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
20.06.2007 32
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
INTEGRATION
LEVELS
EQUIPMENT DESIGN - INSTALLATION, -INTEGRATION
dead space
avoid misalignment
20.06.2007 35
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
EQUIPMENT DESIGN - INSTALLATION, -INTEGRATION
20.06.2007 36
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
INSTALLATION, INTEGRATION
20.06.2007 37
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
INSTALLATION, INTEGRATION
20.06.2007 38
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
INSTALLATION, INTEGRATION
20.06.2007 39
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
INSTRUMENTATION
20.06.2007 40
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
Cleaning
• definitions
• cleaning
• microbial destruction
• cleaning methods
• cleaning validation
• sampling
20.06.2007 41
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
20.06.2007 42
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
BIOFILMS
20.06.2007 43
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
FACTORS EFFECTING CLEANING PERFORMANCE
• concentration of cleaning•agent
wettability
• temperature, pH
• water quality
20.06.2007 45
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
PROCESSES OF SOIL REMOVAL
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
20.06.2007 50
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
PROCEDURE
STEPS RESULTS DOCUMENTATION
20.06.2007 51
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
SAMPLING
20.06.2007 52
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”
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
20.06.2007 53
ISEKI-Workshop Bucharest, 25 June 2007
“Food Enterprises meet University”