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20.06.2007 1ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
Gerhard Schleining
Hygienic Design
BOKU - University of Natural Resources andApplied Life Sciences, Vienna
Dept. of Food Science and Technologyhttp://www.dlwt.boku.ac.atMuthgasse 18, A-1190 ViennaTel.: +43 1 36006-6294, Fax: +43 1 36006-6293, [email protected]
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20.06.2007 2ISEKI-Workshop Bucharest, 25 June 2007“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
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20.06.2007 3ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
• biological• chemical hazards• physical
FOOD SAFETY is a matter of the whole food supply chain
FOOD SAFETY is a matter of the whole food FOOD SAFETY is a matter of the whole food supply chainsupply chain
byHUMANENVIRONMENTEQUIPMENT
FOOD SUPPLY CHAIN
AgrarischePrimärproduktion
IndustrielleProduktion
ProduktLagerungHaushalt
EntsorgungProdukt-Planung
Konsum
NutzungPrimary
ProductionIndustrial
Production ProductTransport
Logistik
Transport
LogisticsStorage
Houeshold DisposalProductDesign
UseConsumtion
Handel
VerkaufTrade
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20.06.2007 4ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
Acceptable microbial count
raw materials heat treatment
ProductionTransportLogistics
cleaning, disinfection
Consumption
P
chilling
Influence of secondary processes like cleaning, chilling on the:
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20.06.2007 5ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
HYGIENEHYGIENE
Control of raw materials (supplier audits, acceptance tests)Control of intermediate and end products (shelf life)
ProductProduct HygieneHygiene::
ProcessProcess Hygiene:Hygiene:
Personal Hygiene:Personal Hygiene:
requirements to building and equipmentcleaning, desinfection, pest controlCompliance of temperature-time-relations, storage conditionsand product flow (kreuzungsfrei)waste management
dress code, behaviour, if necessary adaption of sanitary roomstraining !!!
QualityQuality
preventive measures
GMP
HACCP
....
HYGIENIC DESIGN
....
Preventivemaintenance
Hygiene Hygiene isis thethe essential essential basisbasisforfor thethe qualityquality of a food of a food
productproduct
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20.06.2007 6ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
PRODUCT QUALITY PRODUCT QUALITY dependsdepends also on also on thethe qualityquality of of thethe usedused equipmentequipment
EQUIPMENT QUALITY
GMP/HACCP/...
processing
cleaning
PRODUCT QUALITY
FOOD MANUFACTURER
cleanability functionality
EQUIPMENT MANUFACTURER
equipmentinstallationdesign
productprocessdesign
safety capability
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20.06.2007 7ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
EQUIPMENTEQUIPMENTMANUFACTURER
HYGIENEHYGIENE OPERATIONALOPERATIONALSAFETYSAFETY
FOODFOOD MANUFACTURER(equipment user)
POTENTIAL POTENTIAL CONFLICTCONFLICT
MachineryDirective 98/37/EC2009: 2006/42/EC
directive 95/63/EEC95/63/EECsafety and health
requirements for the useof equipment by workers
“hygiene package”:4 regulations, 2 directives(2002/178/EC on generalprinciples and requirementsof food law and on procedures in matters of food safety, 2002/99/EC on animal health)
design equipment
design and control process
DIN EN ISO 14159DIN EN 1672-2:2004
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20.06.2007 8ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
STANDARDSSTANDARDSDIN EN ISO 14159: 2002 Safety of machinery – Hygiene requirements for the design of machineryDIN EN 1672-2:2004 Food processing machinery – Basic concepts –Hygienic Requirements
GUIDELINESGUIDELINES
REGULATIONSREGULATIONSMachinery DirectiveHygiene package95/63/EEC: Minimum safety and health requirements for the use of work equipment by workers at work
degr
eeof
det
ails
Interpretation must always be done in relation to the local situation:
spezif. product requirements spezif. process requirementsavailable equipmentavailable staffenvironment
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EHEDG-GUIDELINESEHEDG-GUIDELINES
is a consortium of equipment manufacturers, food Industries, research institutes and public health authorities,
founded in 1989 with the aim to promote hygiene during the processing and packing
of food products(http://www.ehedg.org/)
certified eqipment is listed at: http://www.ehedg.org/certequip.htm
general design criteria, materials of constructionclosed equipment for liquid productsopen equipment (conveyor belts, mixer, etc.)technics: welding, passivation of stainless steelaspects: air, water, lubricantsequipment: pumps, valves, pipes, couplings,sealingsprocesses: thermal treatment (pasteurisation, sterilisation, chilling), dry products, packaging (materials), cleaning
EHEDG-TEST-METHODSEHEDG-TEST-METHODSProcedures for evaluation, test and certification of equipment for authorisized test laboratories
in-place cleanability, in-line pasteurisation, in-line steam sterilisabilityBacteria tightness of equipmentBacteria impermeability of membran filters
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20.06.2007 10ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
VARIOUS ASPECTS OF HYGIENIC DESIGN
Source: K. Lorenzen, GEA Tuchenhagen
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20.06.2007 11ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
HYGIENIC DESIGN• BUILDING DESIGN
EQUIPMENT DESIGN
EQUIPMENT INSTALLATION AND INTEGRATION
Plant Enclosure Related Aspects
Lay-Out Related Aspects
Air Related Aspects
Water Related Aspects
Zoning
avoid any:infestation by insects, birds, animals accumulation of dust, surface/condensed water or product contamination with micro-organism, chemicals, foreign bodies
avoid any:infestation by insects, birds, animals accumulation of dust, surface/condensed water or product contamination with micro-organism, chemicals, foreign bodies
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20.06.2007 12ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
PLANT ENCLOSURE RELATED ASPECTS
BUILDING DESIGN
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20.06.2007 13ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
LAY-OUT RELATED ASPECTS
Placement of rooms (Zoning): separate dry and wet areas, short product routing without crossingsInterior building element surfaces should be non-electrostatic, smooth, round corners and have good accessibility for cleaning
BUILDING DESIGN
No metal panelshigh heat transfer -> condesation
-> expansion -> sealings
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20.06.2007 14ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
LAY-OUT RELATED ASPECTS
Materialsshould be resistant to food components, cleaning agents and disinfectantsNo standard glass in open processing areas, but polymer material like polycarbonate or strengthened glass (standard glass with protective film)
BUILDING DESIGN
STAINLESS STEEL
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20.06.2007 15ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
MATERIALSBUILDING DESIGN
PLASTICS
ELASTOMERS
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20.06.2007 16ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
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
BUILDING DESIGN
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20.06.2007 17ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
LAY-OUT RELATED ASPECTSFramework: open profiles, mounted withtight fit, no hollow bodies and horizontal surfaces, enclosed in concrete
Platforms and walkways: should be minimised, not above open processes
BUILDING DESIGN
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20.06.2007 18ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
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
BUILDING DESIGN
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20.06.2007 19ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
LAY-OUT RELATED ASPECTS
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”
BUILDING DESIGN
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20.06.2007 20ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
PIPING
in separate and accessible gangways and enter the process area through the ceilingopen trays without horizontal ledges, crevices or gapsnever be installed behind false ceilings and above open production linesas short as possibleavoid “dead spaces”: couplings, seals, valves, sensors !!!!!
BUILDING DESIGN
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20.06.2007 21ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
RISK because of bad welding
only a small part of the biofilm isremoved with the cleaning agent
cleaning and desinfectants effect the biofilmonly at the outer part
The inner part of the biofilmis not effected
Particles fromcorrosion are rinsed
from the crevice
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20.06.2007 22ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
CABLE MOUNTINGBUILDING DESIGN
avoid dust and condensationsavoid dust and condensations
acoustic insulation electric wires
horizontal grid
correcthygiene risk
full tray
hollow body
open ends
funnel
grid or sheet, one-layer, sloped or vertical
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20.06.2007 23ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
CABLE MOUNTINGBUILDING DESIGN
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20.06.2007 24ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
LIGHTINGBUILDING DESIGN
avoid contaminationavoid contamination not close to doors (insects)not above open processes (foreign bodies)
avoid dust and condensationsavoid dust and condensations
horizontal surfaceswater tight integrated
slope
soil
polycarbonate instead of glass
correcthygiene risk
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20.06.2007 25ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
AIR RELATED ASPECTSBUILDING DESIGN
environmental airenvironmental airflow from higher to lower hygiene areas
from higher to lower dust loaded areasUSDA: minimum air change: 6/h,
20-30/h when high load of dust or moisturelight overpressure (~ >10%) with filterd air (~50 μ)dust extraction
process and transport airprocess and transport airinlet at a single location, > 3m above the ground level, >10m away from any exhaust discharge point
instrument airinstrument airoutlet away from open and dry products
avoid contamination withdust particles andmicro-organisms
avoid contamination withdust particles andmicro-organisms
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20.06.2007 26ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
WATER RELATED ASPECTSBUILDING DESIGN
Water quality controlWater quality controlWater quality controlprocess/product water utility water potable water
Legionella spp. (EHEDG Doc. 24 2004)LegionellaLegionella sppspp. (EHEDG Doc. 24 2004). (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
specificationsno connections
specify, separate and monitordifferent water qualities
specify, separate and monitordifferent water qualities
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20.06.2007 27ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
ZONINGmeans keeping out and keeping away of unwanted items specify areas and barriersrequires 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 concernedmust be economicallyrules must be followed by all -> Training is essential
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Do not forget:cleaning utensilsspare partsdrainagefire protectionwaste collectionair conditioning …..
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20.06.2007 29ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
ZONING CLASSIFICATION
according hygienic requirements:
M(medium)
H(high)
B/L(basic/low)
w(wet)
cw(controlled wet)
d(dry)
no or closed production
temporary open production
open production
and according cleaning requirements:
With different rules for installation, personnel behaviour, cleaning, etc.
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20.06.2007 30ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
example ZONING
office, store house dry store
MMww
HHww
BBww BBcwcw BBdd
MMddMMcwcw
HHcwcw HHdd
closed filling
open filling
bottle washing
courtyard, car park
milling
powder filling
cleaning requirementshy
gien
icre
quire
men
ts
controlled wetwet dry
open filling
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20.06.2007 31ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
example ZONING
High hygiene areas: barriers should be installed as close as possible to the product, e.g. integrated HEPA-Filter (pill press)
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20.06.2007 32ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
BARRIERS
walls, lines on the ground, drains (water lock!!), air filters, transferwindows
ZONING
access points for products, personnel, air, utilities, traffic conditionsdrains, seals
Elevators can not be barriers !! non-accessible spaces, air draftsIf different hiegenic zones are accessable by stairs or elevators air locks must be installed
are critical and must be systematically monitored !!!!!
Zones should be clear visible (by barriers for staff and products)
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INTEGRATION LEVELS
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20.06.2007 34ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
designed without horizontal surfaces, ledges, hollow bodies, dead spaces ....
EQUIPMENT DESIGN - INSTALLATION, -INTEGRATION
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
avoid accumulation of dust / water(condensate) / productavoid accumulation of dust / water(condensate) / product
correcthygiene risk
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20.06.2007 35ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
EQUIPMENT DESIGN, -INSTALLATION, -INTEGRATION
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
avoid misalignment
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20.06.2007 36ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
EQUIPMENT DESIGN - INSTALLATION, -INTEGRATION
self drainingwithout dismantling
correct
dead space• sensor not cleanable• measured value not relevant
flow against sensor
hygiene risk correct
installation of sensors hygiene risk
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20.06.2007 37ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
INSTALLATION, INTEGRATION
avoid dead space
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20.06.2007 38ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
INSTALLATION, INTEGRATION
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20.06.2007 39ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
INSTALLATION, INTEGRATION
Source: Lelieveld H.L.M. et.al.:Hygiene in Food ProcessingWoodhead publishing Limited
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20.06.2007 40ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
INSTRUMENTATION
hygiene risk correct
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20.06.2007 41ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
CleaningCleaning• definitions• cleaning• microbial destruction• cleaning methods• cleaning validation• sampling
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20.06.2007 42ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
SANITATION
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
“sanitas”: health
“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
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20.06.2007 43ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
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
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20.06.2007 44ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
FACTORS EFFECTING CLEANING PERFORMANCE
•Smoothness (roughness Ra ≤ 0.8 μm)
•hardness•porosity•wettability
• surface and material characteristics
• contact time
• physical force exerted: flow velocity, scrubbing
• concentration of cleaning agent
• temperature, pH
• water quality
• composition of the soil
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20.06.2007 45ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
MATERIAL CHARACTERISTICS
Source: Marriott, Norman G. : Principles of food sanitation, Springer 2006 p.144
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20.06.2007 46ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
PROCESSES OF SOIL REMOVAL
• Mechanical: High pressure water, steam, air, scrubbing• Change of chemical nature: reaction with alcali, acid• Surfactants (reduce surface tension)
1. SEPARATION OF SOIL FROM SURFACE
• 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
2. DISPERSION IN CLEANING SOLUTION
3. PREVENTION OF REDEPOSITION• Removal of dispersed solution
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20.06.2007 47ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
MICROBIAL DESTRUCTION
HEAT: steam, hot water
• 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,…)
CHEMICALS (21-38ºC)
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20.06.2007 48ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
MICROBIAL DESTRUCTION
• 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
IONIZISING RADIATION
• >8 logs of vegetative cells, 6 logs of spores on packaging materials or in beverages
• 1-3 logs on rough surfaces like meat
PULSED LIGHT
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20.06.2007 49ISEKI-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• High pressure steam• Hot water wash• High pressure, low volume• Foam or slurry (less air) cleaning: cleaning compound+water+air, visible
fogging -> mold, -> L. monocytogenes!!
• COP (c out of place): small disassembliedequipment parts
• CIP: combined chemical + mechanical effects, automatedrinse with hot/cold waterdetergent washrinsesanitizationfinal rinse
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20.06.2007 50ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
CLEANING VALIDATION
validation procedure
acceptance criteria, acceptance limits
sampling
to remove sufficiently residues of products and cleaning agentsand to control potential contaminants
cleaning procedures must always be developed under consideration of the product requirements
validation of cleaning procedures is a very efficient strategy (FDA)
important issues are:
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20.06.2007 51ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
PROCEDURESTEPS RESULTS DOCUMENTATION
Status Evaluation
Risk Analysis
Cleaning Process Studies
Assessment and Implementation
Validation of Representative
Transfer to other Equipment
products (composition)processes (potential risks)equipment (construction)cleaning procedures (cleaning agents)
selected equipment and cleaning proceduresacceptance criteria and analytical methods
Cleaning Validation Master Plan
representative equipment,product and sampling locations
worst case conditions
assessment report
validated analytical and sampling methodsacceptance limits
Cleaning Validation Protocollogbook, reports, SOPs
corrective actions
approved representative Cleaning Validation ReportApproval
Cleaning Validation Protocols, Reports and Approvals
training, routine monitoring, change control
approved equipment
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20.06.2007 52ISEKI-Workshop Bucharest, 25 June 2007“Food Enterprises meet University”
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
for large surface areas, especially inaccessible areas of equipment that cannot be routinely disassembleddo not necessarily correlate with residues on the equipment surface
INDIRECT RINSE SAMPLESINDIRECT RINSE SAMPLESINDIRECT RINSE SAMPLES
for flat surface areas and cracks, crevices, gaskets, sealsrecovery effectiveness and reproducibility depend on:swabbed material, sampling solvent, concentration range of residues, the swab pattern and sequence
DIRECT SURFACE SAMPLINGDIRECT SURFACE SAMPLINGDIRECT SURFACE SAMPLING
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20.06.2007 53ISEKI-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, butneed 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-organismimprove cleanability
risks by poor hygienic design are caused by :wrong placement of equipment and utility installations horizontal surfaces, hollow bodiesdead spaces, bad drainageinsufficient cleanability/accessabilityuse 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