hygienic design - esb - escola superior de biotecnologia · pdf file ·...

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]


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


• 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


Acceptable microbial count

raw materials heat treatment

ProductionTransportLogistics

cleaning, disinfection

Consumption

P

chilling

Influence of secondary processes like cleaning, chilling on the:


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


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


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


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

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


VARIOUS ASPECTS OF HYGIENIC DESIGN

Source: K. Lorenzen, GEA Tuchenhagen


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


PLANT ENCLOSURE RELATED ASPECTS

BUILDING DESIGN


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



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


MATERIALSBUILDING DESIGN

PLASTICS

ELASTOMERS



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


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



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



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


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


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


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


CABLE MOUNTINGBUILDING DESIGN


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


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


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


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

Do not forget:cleaning utensilsspare partsdrainagefire protectionwaste collectionair conditioning …..


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.


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


example ZONING

High hygiene areas: barriers should be installed as close as possible to the product, e.g. integrated HEPA-Filter (pill press)


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)

INTEGRATION LEVELS


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


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


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


INSTALLATION, INTEGRATION

avoid dead space



Source: Lelieveld H.L.M. et.al.:Hygiene in Food ProcessingWoodhead publishing Limited


INSTRUMENTATION

hygiene risk correct


CleaningCleaning• definitions• cleaning• microbial destruction• cleaning methods• cleaning validation• sampling


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


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


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


MATERIAL CHARACTERISTICS

Source: Marriott, Norman G. : Principles of food sanitation, Springer 2006 p.144


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


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)


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


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


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:


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


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


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

hygienic design - esb - escola superior de biotecnologia · pdf file ·...

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