化妆品清洗和消毒培训课件

Disinfection Peter Jay:Bioscience,UR&DPSTrumbull,US 14-16th November 2006Disinfection Peter Jay:BiosciBackgroundlRecent years weaknesses in cleaning and disinfection have been the major cause of incidents.lRecognised that greater emphasis on adherence to best practice principles is required.lOn site validation of procedures is a key area that needs to be improved.BackgroundRecent years weaknesIncident Learnings-Disinfection(1)lWater/Dilute Product Residues Left in Plant.Plant NOT disinfected prior to uselMANY incidentslDisinfection procedure NOT validatedlOperators INADEQUATELY trained lOperator did NOT follow documented disinfection procedurelDisinfection NOT performed when requiredIncident Learnings-Disinfect化妆品清洗和消毒培训课件化妆品清洗和消毒培训课件INCIDENT LEARNING C&DTime Immediately post clean=30 bugs/mlGrowth occurs.24 Hours later=10 million bugs/mlAssume undrainable pump holds two litresof dilute product residues:After 24 hours 20,000,000,000 bugs will be present in the 2 litres of water!-Would you bath in this?-Would you drink this?-Would you make product with this?Undrainable pipe arrangement-Leaving Dilute Product residues=“BUG FOOD”Water/Dilute Product Residues Left in PlantUndrainableINCIDENT LEARNING C&DTime-WoCleaningandDisinfectionRulesINCIDENT LEARNINGSEnsure Cleaning and Disinfection protocols are documented and operators are trained in the procedures.Regular checks by local hygienist are required to ensure complianceWHENWHOHOWMUST BE DEFINEDAND DOCUMENTEDTRAINING is keyDISIPLINE IN IMPLEMENTATION is essentialCleaning and DisinfectionCleaningINCIDENT LEARNINGSEnsuDisinfectionlDestruction of micro-organisms but NOT usually bacterial spores.lDisinfection does NOT necessarily kill all micro-organisms but reduces them to a level acceptable for a defined purpose,e.g.to a level which is not harmful either to health or to the quality of the goods being processed.DisinfectionDestruction of micCleaning and Disinfection-HACCPlCan be handled as a GMP or as defined CCPslPreferred route is as CCPslEspecially when starting on HACCPlConsider CIP system in HACCP studylConsider where need manual interventionCleaning and Disinfection-HAWhy CleanlProcesslPurpose to remove product soils and residues to produce clean equipment surfaces that will not taint the subsequent production of a differing variant.lMicrobiological lPreparation of the plant surfaces for disinfection.Residual product left in equipment can prevent effective disinfection:lDeactivate some chemical disinfectants.lPhysical barrier preventing the successful elimination of the micro-organisms by protecting them lRemaining product residues will also act as a food source for resident micro-organisms.Poor cleaning can increase the risk of contamination through the formation of dilute and hence more hospitable product residues(sub lethal preservative levels).Why CleanProcessWhy DisinfectlWe do NOT operate sterile processeslTherefore some micro-organisms WILL enter the manufacturing plantlDisinfection strategies are required to prevent the build up of contamination in the plant to a level that will result in out of specification productlDisinfection should reduce the microbial load on a surface to a level that will NOT be capable of surviving or growing in finished productWhy DisinfectWe do NOT operateDisinfection lEquipment must be clean to be effectively disinfected.lEquipment must be drained dry to remain disinfected for any period of time.lDisinfection only protects equipment for a limited time.Disinfection Equipment must beHow to DisinfectlTwo options:lHeat lChemicalsHow to DisinfectTwo options:Thermal DisinfectionlRecommended method of disinfectionlTemperatures of 70 degrees for 10 minutes will effectively disinfect plant(coldest part of plant must reach these conditions)lTarget temperature MUST be attained at the coldest part of the plant/circuit being disinfected.l10 minute contact time shall NOT be started until all parts of the circuit have reached this temperature.l It may take in excess of 15 minutes for all parts of plant circuit(varies with configuration/equipment)to reach this temperature.lValidation time/temperature is CRITICALl Lower temperatures and contact times will NOT deliver disinfection.Thermal DisinfectionRecommendeThermal DisinfectionlHeat more effective than chemical disinfection in destroying biofilmslEquipment must be able to withstand high temperatures and be engineered correctly to avoid implosion of tanks.lSteam:Rarely used outside US Plants not designed(seals/instruments etc.)to handle steamlOnly effective against non spore forming micro-organismslProtection against scalding requiredlThermal Disinfection Guidelines for the Manufacture of HPC Liquids.This document is available on the Global Hygiene Security Group website under Technical Documents.Thermal DisinfectionHeat more Chemical DisinfectionlRelies on physical contact with micro organismslChemical disinfection difficult on unhygienic plantlMany commercial disinfectants available.Most are NOT validated against HPC contaminants(especially on surfaces).lRecommended chemical disinfectants for HPC plants:lPeracetic AcidlSodium HypochloriteChemical DisinfectionRelies onRoutine Chemical Disinfection-RecommendationsMax.300ppm Sodium Hypochlorite for 20 minutes or400 ppm Peracetic Acid for 20 minutesRoutine Chemical DisinfectionDisinfection-Key PointsHigher numbers of organisms adhere to elastomers(Viton,EPDM)than to stainless steel.More survivors of disinfection occur on elastomersKey area for validationPseudomonas aeruginosa and Burkholderia cepacia proved to be most resistant Gram Negative bacteria to chemical disinfectants(Sodium Hypochlorite and Peracetic Acid).Disinfection-Key PointsHigheWhen to DisinfectlRequired to destroy micro-organisms which may be accumulating in a process plant.lWhenlPlant has been idle either for planned downtime(weekend or holidays)or for maintenance.lAfter a contamination incidentlPart of a preventative disinfection regimelPrior to commissioning new equipment/plantlDetection of significant contamination on plant surfacesWhen to DisinfectRequired to dPreventative DisinfectionlFactory should have a planned preventative disinfection schedule to prevent the accumulation of microbial contamination in a process plant.lFrequency of disinfection is typically based on lSusceptibility of the product to contamination.lHigher the product risk generally the more frequent the disinfectionlDegree equipment complies to hygienic design principleslHistory of incidentsPreventative DisinfectionFactoDisinfection Frequency GuidelinePlant AreaProduct RiskFrequency DisinfectionMakingHighWeeklyStorageHighMonthlyFillingHighTwo WeeklyMakingMediumThree MonthlyStorageMediumThree MonthlyFillingMediumThree MonthlyThe information is provided for guidance based on current practices.For operations with a history of problems a more frequent regime wouldbe appropriate.With validation using environmental mapping techniques disinfection periods may be slightly extended.Environmenmental mapping can be performed on individual plants by for example swabbing of key sitesDisinfection Frequency GuidelScheduling Preventative DisinfectionlBest practicelSchedule and monitor the implementation of disinfection events by building it into the plant control software.lColour code system can be used.For example if a storage tank is scheduled to be disinfected monthly:Green:Disinfected within 25 DaysAmber:Tank needs to be disinfected within the next 5 daysRed:Tank must be disinfected when it is empty.Scheduling Preventative DisinfSummary-When to Clean and DisinfectSummary-When to Clean and DiHolding Times Rules Finished ProductCONDITIONS FOR PRODUCT BEING HELD PRODUCT RISK LEVELSPeriod held between CleaningPeriod held between cleaning and disinfectionTime held after equipment is emptied of product before cleaning requiredTime held after equipment cleaning before disinfection required*Time held after disinfection before equipment must be used in production*Very High Risk(9-10)Never exceed 7 DaysAnd assess case by caseNever exceed 7 DaysAnd assess case by caseNever exceed 12 hoursAnd assess case by caseNever exceed 8 hoursAnd assess case by caseNever exceed 4 hoursAnd assess case by caseHigh Risk(6-8)Never exceed:7 days in Mixer30 days in Storage14 in days FillerNever exceed:7 days in Mixer30 days in Storage14 in days FillerNever exceed 12 hoursNever exceed 8 hoursNever exceed 8 hoursMedium Risk(3-5)30 Days verified40-90 Days verifiedNever Exceed 3 DaysNever exceed 24 hoursNever Exceed 16 hours*Best Practice is no delay(i.e.immediately)Holding Times Rules FinishedMaximum Holding Times Rules Finished Product CONDITIONS FOR PRODUCT BEING HELDPRODUCT RISK RANKINGHeld in a Vessel*before micro.test requiredHeld in a Pallecon(tote)*before micro.test requiredHeld in a Transit Tank*before micro.test requiredHeld in a tanker before micro.test requiredVery high Risk(9-10)Assess Case by Case(Must be 7 Days)7 DaysNot PermittedNot PermittedHigh Risk(6-8)30 Days30 Days14 DaysHome Care only.Assess Case by CaseMedium Risk(3-5)90 Days60 Days30 Days14 DaysMaximum Holding Times Rules Drain EffluentlEffluent produced during washing or disinfection must be rapidly drained from the equipment and the manufacturing area to minimize the possibility of microbiological adaptation in diluted product.Drain EffluentEffluent produce“Silicone”-Caustic Detergent(1)lWork has demonstrated that B.cepacia/Ps.aeruginosa biofilm ex silicone/CTAC(Hair Conditioner)containing products are difficult to disinfectlVisibly clean surfaces NOT good enoughlNeed to remove“invisible product residueslA Caustic Detergent will help in the removal of silicone/CTAC residues“Silicone”-Caustic Detergent“Silicone”-Caustic Detergent(2)lRecommendation:lPeriodic use of caustic detergent prior to disinfection for Hair ConditionerslPost incident STRONG recommendation to perform caustic detergent wash prior to disinfection for Hair Conditioners(Prudent to do this for other Silicone containing products)lMost effective commercial cleaning agents tested are:l10%Silox XT(ex TSI).Based on NaOHlIn use in Compeigne,Francel2%:2%solution of CIP 100&CIP Additive(ex Steris).Based on KOH.“Silicone”-Caustic DetergentValidation of Disinfection:When?lNew/modified plantlChange in protocollNew chemical disinfectantlInstalled CIP for thermal disinfectionlFrequencylWhole plant validated annuallylIn modules:Not all at the same timeValidation of Disinfection:WhValidation-DisinfectionlHowlPhysicallChemicallMicrobiologicalValidation-DisinfectionHowDisinfection Validation-PhysicallThermal(CIP)lStickerslpermanent colour changelkeep with records as evidencelREMEMBER TIMElThermocoupleREAL TIMEDisinfection Validation-PhysValidation of HeatDisinfection ProcessLocation points for thermal disinfection.The operators place the stickers at numbered points on the plant(i.e.within the yellow boxes)and once the time temperature criteria has been met,they take the sticker and put it into a record book10 20 30 40 50 60 70 80 90 degC10 20 30 40 50 60 70 80 90 degCBeforeAfterValidation of HeatDisinfectioREAL TIMEDisinfection Validation-ChemicallTitrationl50%of original concentration:Repeat Disinfectionl50-90%:Improvement Plan REAL TIMEDisinfection ValidatiThe following can be used for disinfection(or water treatment validations):Chemetrics V-2000 Multi-Analyte PhotometerWater testing using portable handheld LED photometer-uses specific kits to measure a broad range of analytes in water-uses disposable sample vessels(vacu-vials)to avoid cross-contamination/dirty vessels affecting reading-can store up to 100 readings and download data to PC-see for more info-Unit cost:Approx.$1600;Reagent cost$2 per testChemical Validation(1)The following can be used for Chemical Validation(2)Chemetrics V-2000 Multi-Analyte PhotometerAssays include:Chlorine(free/total)ppm:0-4ppmChlorine dioxide:0-11ppmOzone:0-1ppmPeracetic acid:0.4-4ppmFormaldehyde in water:0.4-8ppm(other kits are also available,see website)Chemical Validation(2)ChemetrValidation Disinfection Microbiological(1)lThis can be performed in a number of ways:lSurface Detection of Contamination:Environmental MappinglFor example:l Pressure Relief Valvesl Filter Basketsl Instrumentation Inletsl Pig Launch/Receiving Stations lElastomerslEtc.The target is 25 cfu/plate(for flat surfaces,the procedure is to swab a 10 by 10cm square area)with no Gram negatives(or objectionable organisms).NOT REAL TIMEValidation Disinfection MicrValidation Disinfection Microbiological(2)lRinse water checkslFirst product packed post disinfectionlFirst bottles packed on fillerValidation Disinfection MicrManual Cleaning and DisinfectionlSmall items of equipment often need to be fully dismantled for effective cleaning(and subsequent disinfection).lDesignated area conveniently and permanently established for the cleaning and disinfection of all mobile vessels,pumps,hoses,pipes,valves,other fittings,utensils,and any other ancillary equipment.lCleaning and disinfection shall be done in a purpose built hygienic wash bay.Manual Cleaning and DisinfectiWash Bay lHygienic surface coverings which are impervious to hot water and disinfection chemicals lEasily cleaned and fully drainablelClearly segregate clean from dirty equipment;lSeparated into two areas,lWet area for cleaning and disinfection.lDry area where the cleaned and disinfected equipment is stored for drying prior being reassembled lStore cleaned and disinfected equipment/fittings on a designated rack Wash Bay Hygienic surface covWash BaylCleaning of disassembled plant items is generally carried out using warm/hot water with subsequent disinfection of the equipment using chemical disinfectant solutions.lWater should be of good microbiological quality(same as Process Water)lIf disinfecting solutions are used the equipment is usually rinsed with treated water(same microbiological quality as process water)prior to drying.lDisinfectant solutions must be regularly changed to ensure they remain at effective concentrations.Wash BayCleaning of disassemblHoseslCleaned hoses hung off the floor in a manner that will allow any remaining liquid to drain.lDisconnect hoses not in use;drain,clean,disinfect,dry.lDo not let hose ends contact floor or drains.Use supports to hold hoses during flushing.lHandle connections and gaskets with washed/cleaned hands.HosesCleaned hoses hung off thDocumentation Documented Cleaning+Disinfecting Procedures must include HowWhenWhoWhatInclude pumps,hoses and utensils etc.These often get forgotten!Include validation requirementsDocumentation Documented CleanRecords/TrainingRecords of when and who conducted cleaning and disinfectionIn order to ensure that hygienic procedures are implemented,all personnel need to be trained in the principles of hygienic manufacture and specifically in the cleaning and disinfection procedures they are responsible forRecords/TrainingRecords of wheBiofilm ImplicationsBiofilm ImplicationsBacterial BiofilmsBiofilms are microbial“communities”that form on surfaces(or interfaces)Most bacteria can form biofilmsOver time biofilms can expand and become more complexBiofilms are much more resistant to chemical attack than free floating cellsBiofilm resistance is a result of many mechanisms including:Extrusion of protective slime by surface attached cells“Shielding”of bacteria within clumps that can contain many thousands of bacteriaSome bacteria attach to the surface,most exist as free floating(planktonic)cellsBacteria form surface structures,these caninvolve more than one species.Clumps of bacteria can be released which areresistant to chemical attackBiofilms are surface attached microbial communities that are resistant to chemical attack.More likely toform in unhygienic equipment/pipeworkTIMEFLOWBacterial BiofilmsBiofilms areBiofilm PreventionlMaterial SelectionlStainless Steel and Polypropylene lData supports low colonization of these materialslHigh Water VelocitieslHamper the attachment of planktonic cells to solid surfaces as time is required for attachmentlSmooth SurfaceslDecreasing surface roughness increases the probability organisms will not attach to surfaceslHygienic fittings which are easy to cleanlNon-hygienic fittings provide hideaways for organisms and are nearly impossible to cleanBiofilm PreventionMaterial Sel“Dealing with Biofilms”lPreventative Maintenance by Frequent Cleaning and DisinfectionlValidate Cleaning and Disinfection Effectivenessl“Control”by Biocides(Disinfectants)lPitfall:Planktonic cells are much more susceptible to biocides than biofilmslBiocides will weaken the biofilmlGood Manufacturing Design and Effective Cleaning and Disinfection Procedures Helps Manage the Risk from Biofilm.“Dealing with Biofilms”PreventAvoiding ResistanceB.cepacia(but applies to other Gram Negative bacteria)Avoiding ResistanceB.cepacia B.cepaciaWater UntreatedTreated WaterPlantB.cepacia Present-Approx.1%populationTreatment System99.9%reliableFailureLow LevelsB.cepaciaConditions to establish selfHigh NumbersINCIDENTResultB.cepaciaWater UntreatedTreateTransfer from Water to Dilute Product0123456780102030405060Time at 28C(hrs)Log number of bacteriaInoculation of 102 B cepacia into dilute product(10%)preserved with glydant.Demonstrates rapid recovery and growth rate to achieve high numbers in a short duration.Undrainable Pipe LoopRapid GrowthTransfer from Water to Dilute Adaptability:ConclusionsDont let it survive!Dont let it adapt!1 litre dilute residues10 T contaminated productHygienic&Drainable!Adequate Cleaning!Adequate Disinfection!1 litre of Burkholderia cepacia in dilute product residues will put a 10 Tonne batch of product at very serious risk from contamination Adaptability:ConclusionsDonBulk Transfer High Risk Raw Materials and Finished ProductsBulk Transfer High Risk Raw MaTankerslExtremely high-risk operationlSite where cleaning and disinfection is done should be audited to ensure that an adequate procedure is used.lRecommended that the local hygienist does this on an annual basis.lTankers must be cleaned&disinfected prior to use and certified as suchlDisinfection required:Usually steam lUse within 4 hoursTankersExtremely high-risk opeTankerslTanker design lComplete drainage after cleaning/disinfection lEnsure includes tanker pumplNo water residues are left to allow micro-organisms to growlAfter each disinfection of a tanker a certificate of conformity is required lFactory should NOT fill the tanker if documentation is not available.lReception points must be clearly labelled,clean,dry and terminal connections covered by end capsTankersTanker design HoseslGood hose/pump management is vital lFor high-risk products(and high-risk raw materials)lOff loading system and hose are disinfected immediately prior to use.lIf the haulier supplies the hose then this needs to be disinfected before use.l Steam cleaning certificate should cover the hose as well as the tanker).lHoses owned by the manufacturing site need to be kept clean and dry.Hoses should be stored hygienicallylSwabbing of hose connections and tanker off-loading connections can be used to validate the cleaning and disinfection procedures.HosesGood hose/pump managemenHigh Risk,Liquid Raw Materials:Intermediate Bulk Containers/DrumslIf reused by supplier,should be cleaned,disinfected and dried prior to refilllTops should be clean to avoid contamination of contents on openingl environmental dustl rainwaterlDrum stores must be coveredlConnections/pumps used to off-load to be part of Cleaning and Disinfection programmeHigh Risk,Liquid Raw MaterialIntermediate Bulk Containers/Drums cont.lLabelling the status of cleaned and disinfected containers is a good practicelBest practice for Personal Care products is to use TNT pallecons(or equivalent)with disposable bags:lPallecons have a one use disposable liner preventing any cross contamination issueslIf hygiene risk of the product/raw material is extremely high,then irradiated liners are recommendedlCleaning and disinfecti