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1、Disinfection,Peter Jay: Bioscience, UR&DPS,Trumbull, US 14-16th November 2006,Disinfection Peter Jay: Biosci,Background,Recent years weaknesses in cleaning and disinfection have been the major cause of incidents.Recognised that greater emphasis on adherence to best practice principles is required. O
2、n site validation of procedures is a key area that needs to be improved.,BackgroundRecent years weaknes,Incident Learnings - Disinfection (1),Water/Dilute Product Residues Left in Plant. Plant NOT disinfected prior to useMANY incidentsDisinfection procedure NOT validatedOperators INADEQUATELY traine
3、d Operator did NOT follow documented disinfection procedureDisinfection NOT performed when required,Incident 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&D,Time Immediately post clean = 30 bugs/mlGrowth occurs. 24 Hours later = 10 million bugs/mlAssume undrainable pump holds
4、 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 Res
5、idues Left in Plant,Undrainable,INCIDENT LEARNING C&DTime - Wo,CleaningandDisinfectionRules,INCIDENT LEARNINGS,Ensure Cleaning and Disinfection protocols are documented and operators are trained in the procedures. Regular checks by local hygienist are required to ensure compliance,WHENWHOHOW,MUST BE
6、 DEFINEDAND DOCUMENTED,TRAINING is keyDISIPLINE IN IMPLEMENTATION is essential,Cleaning and Disinfection,CleaningINCIDENT LEARNINGSEnsu,Disinfection,Destruction of micro-organisms but NOT usually bacterial spores. Disinfection does NOT necessarily kill all micro-organisms but reduces them to a level
7、 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 mic,Cleaning and Disinfection - HACCP,Can be handled as a GMP or as defined CCPsPreferred route is as CCPsEspecially when starting on HA
8、CCPConsider CIP system in HACCP studyConsider where need manual intervention,Cleaning and Disinfection - HA,Why Clean,ProcessPurpose to remove product soils and residues to produce clean equipment surfaces that will not taint the subsequent production of a differing variant.Microbiological Preparati
9、on of the plant surfaces for disinfection. Residual product left in equipment can prevent effective disinfection:Deactivate some chemical disinfectants.Physical barrier preventing the successful elimination of the micro-organisms by protecting them Remaining product residues will also act as a food
10、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 CleanProcess,Why Disinfect,We do NOT operate sterile processesTherefore some micro-organisms WILL
11、 enter the manufacturing plantDisinfection strategies are required to prevent the build up of contamination in the plant to a level that will result in out of specification productDisinfection should reduce the microbial load on a surface to a level that will NOT be capable of surviving or growing i
12、n finished product,Why DisinfectWe do NOT operate,Disinfection,Equipment must be clean to be effectively disinfected.Equipment must be drained dry to remain disinfected for any period of time.Disinfection only protects equipment for a limited time.,Disinfection Equipment must be,How to Disinfect,Two
13、 options:Heat Chemicals,How to DisinfectTwo options:,Thermal Disinfection,Recommended method of disinfectionTemperatures of 70 degrees for 10 minutes will effectively disinfect plant (coldest part of plant must reach these conditions)Target temperature MUST be attained at the coldest part of the pla
14、nt/circuit being disinfected. 10 minute contact time shall NOT be started until all parts of the circuit have reached this temperature. It may take in excess of 15 minutes for all parts of plant circuit (varies with configuration/equipment) to reach this temperature.Validation time/temperature is CR
15、ITICAL Lower temperatures and contact times will NOT deliver disinfection.,Thermal DisinfectionRecommende,Thermal Disinfection,Heat more effective than chemical disinfection in destroying biofilmsEquipment must be able to withstand high temperatures and be engineered correctly to avoid implosion of
16、tanks. Steam: Rarely used outside US Plants not designed (seals/instruments etc.) to handle steamOnly effective against non spore forming micro-organismsProtection against scalding requiredThermal Disinfection Guidelines for the Manufacture of HPC Liquids. This document is available on the Global Hy
17、giene Security Group website under Technical Documents.,Thermal DisinfectionHeat more,Chemical Disinfection,Relies on physical contact with micro organismsChemical disinfection difficult on unhygienic plantMany commercial disinfectants available. Most are NOT validated against HPC contaminants (espe
18、cially on surfaces). Recommended chemical disinfectants for HPC plants:Peracetic AcidSodium Hypochlorite,Chemical DisinfectionRelies on,Routine Chemical Disinfection - Recommendations,Max. 300ppm Sodium Hypochlorite for 20 minutes or400 ppm Peracetic Acid for 20 minutes,Routine Chemical Disinfection
19、,Disinfection - Key Points,Higher 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 dis
20、infectants (Sodium Hypochlorite and Peracetic Acid).,Disinfection - Key PointsHighe,When to Disinfect,Required to destroy micro-organisms which may be accumulating in a process plant. WhenPlant has been idle either for planned downtime (weekend or holidays) or for maintenance.After a contamination i
21、ncidentPart of a preventative disinfection regimePrior to commissioning new equipment/plantDetection of significant contamination on plant surfaces,When to DisinfectRequired to d,Preventative Disinfection,Factory should have a planned preventative disinfection schedule to prevent the accumulation of
22、 microbial contamination in a process plant.Frequency of disinfection is typically based on Susceptibility of the product to contamination.Higher the product risk generally the more frequent the disinfectionDegree equipment complies to hygienic design principlesHistory of incidents,Preventative Disi
23、nfectionFacto,Disinfection Frequency Guideline,Plant AreaProduct RiskFrequency DisinfectionMakingHighWeeklyStorageHighMonthlyFillingHighTwo WeeklyMakingMediumThree MonthlyStorageMediumThree MonthlyFillingMediumThree MonthlyThe information is provided for guidance based on current practices. For oper
24、ations 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 sites,Disinfection Frequen
25、cy Guidel,Scheduling Preventative Disinfection,Best practiceSchedule and monitor the implementation of disinfection events by building it into the plant control software. Colour code system can be used. For example if a storage tank is scheduled to be disinfected monthly:Green : Disinfected within 2
26、5 DaysAmber: Tank needs to be disinfected within the next 5 daysRed: Tank must be disinfected when it is empty.,Scheduling Preventative Disinf,Summary - When to Clean and Disinfect,Summary - When to Clean and Di,Holding Times Rules Finished Product,* Best Practice is no delay (i.e. immediately),Hold
27、ing Times Rules Finished,Maximum Holding Times Rules Finished Product,Maximum Holding Times Rules ,Definitions (Previous Tables),Vessel Storage Tank (Part of the Process Plant).Transit Tank Container where product can be stored (Usually 1 Tonne but size can vary). Often filled by flexible hose/porta
28、ble pump. Transit container would need to be disinfected prior to filling. PalleconOne use bag (plastic) held in place in a box. TNT pallecons widely used. Usually 1 Tonne but other sizes available.Often filled by flexible hose/portable pump. Plastic bag can be purchased sterile (irradiated).,Defini
29、tions (Previous Tables)V,Drain Effluent,Effluent 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 (
30、1),Work has demonstrated that B.cepacia / Ps.aeruginosa biofilm ex silicone/CTAC (Hair Conditioner) containing products are difficult to disinfectVisibly clean surfaces NOT good enoughNeed to remove “invisible product residuesA Caustic Detergent will help in the removal of silicone/CTAC residues,“Si
31、licone” - Caustic Detergent,“Silicone” - Caustic Detergent (2),Recommendation:Periodic use of caustic detergent prior to disinfection for Hair ConditionersPost incident STRONG recommendation to perform caustic detergent wash prior to disinfection for Hair Conditioners (Prudent to do this for other S
32、ilicone containing products)Most effective commercial cleaning agents tested are:10% Silox XT (ex TSI). Based on NaOHIn use in Compeigne, France2%: 2% solution of CIP 100 & CIP Additive (ex Steris). Based on KOH.,“Silicone” - Caustic Detergent,Rotation of Disinfectants,Some industries routinely rota
33、te disinfectantsDo you need to do this?If you have a hygienic plant/validated procedures - NOIf you have unhygienic plant/un-validated procedures - Treat the causes. Rotation could be a temporary measure until causes addressedRotation of biocides has little long term effect; best approach: thorough
34、cleaning with a caustic detergent & physical removal of biofilm then, disinfect,Rotation of DisinfectantsSome,Validation of Disinfection:When?,New / modified plantChange in protocolNew chemical disinfectantInstalled CIP for thermal disinfectionFrequencyWhole plant validated annuallyIn modules: Not a
35、ll at the same time,Validation of Disinfection:Wh,Validation - Disinfection,HowPhysicalChemicalMicrobiological,Validation - DisinfectionHow,Disinfection Validation - Physical,Thermal (CIP)Stickerspermanent colour changekeep with records as evidenceREMEMBER TIMEThermocouple,REAL TIME,Disinfection Val
36、idation - Phys,Validation of HeatDisinfection Process,Location 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 book,B
37、efore,After,Validation of HeatDisinfectio,REAL TIME,Disinfection Validation - Chemical,Titration50% of original concentration: Repeat Disinfection50-90%: Improvement Plan,REAL TIMEDisinfection Validati,The following can be used for disinfection (or water treatment validations):Chemetrics V-2000 Mult
38、i-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-
39、see for more info- Unit cost: Approx. $1600; Reagent cost $2 per test,Chemical Validation (1),The following can be used for,Chemical Validation (2),Chemetrics V-2000 Multi-Analyte Photometer,Assays include:Chlorine (free/total) ppm:0 - 4ppmChlorine dioxide: 0 - 11ppmOzone: 0 - 1ppmPeracetic acid: 0.
40、4 - 4ppmFormaldehyde in water: 0.4 - 8ppm(other kits are also available, see website),Chemical Validation (2)Chemetr,Validation Disinfection Microbiological (1),This can be performed in a number of ways:Surface Detection of Contamination : Environmental MappingFor example: Pressure Relief Valves Fil
41、ter Baskets Instrumentation Inlets Pig Launch/Receiving Stations ElastomersEtc.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 TIME,Validation Disinfection Micr,Validation Disinfection Mic
42、robiological (2),Rinse water checksFirst product packed post disinfectionFirst bottles packed on filler,Validation Disinfection Micr,Manual Cleaning and Disinfection,Small items of equipment often need to be fully dismantled for effective cleaning (and subsequent disinfection).Designated area conven
43、iently and permanently established for the cleaning and disinfection of all mobile vessels, pumps, hoses, pipes, valves, other fittings, utensils, and any other ancillary equipment.Cleaning and disinfection shall be done in a purpose built hygienic wash bay.,Manual Cleaning and Disinfecti,Wash Bay,H
44、ygienic surface coverings which are impervious to hot water and disinfection chemicals Easily cleaned and fully drainableClearly segregate clean from dirty equipment;Separated into two areas, Wet area for cleaning and disinfection.Dry area where the cleaned and disinfected equipment is stored for dr
45、ying prior being reassembled Store cleaned and disinfected equipment/fittings on a designated rack,Wash Bay Hygienic surface cov,Wash Bay,Cleaning of disassembled plant items is generally carried out using warm/hot water with subsequent disinfection of the equipment using chemical disinfectant solut
46、ions.Water should be of good microbiological quality (same as Process Water)If disinfecting solutions are used the equipment is usually rinsed with treated water (same microbiological quality as process water) prior to drying. Disinfectant solutions must be regularly changed to ensure they remain at
47、 effective concentrations.,Wash BayCleaning of disassembl,Hoses,Cleaned hoses hung off the floor in a manner that will allow any remaining liquid to drain.Disconnect hoses not in use; drain, clean, disinfect, dry.Do not let hose ends contact floor or drains. Use supports to hold hoses during flushin
48、g.Handle connections and gaskets with washed/cleaned hands.,HosesCleaned hoses hung off th,Documentation,Documented Cleaning + Disinfecting Procedures must include HowWhenWhoWhatInclude pumps, hoses and utensils etc. These often get forgotten!Include validation requirements,Documentation Documented
49、Clean,Records/Training,Records 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
50、for,Records/TrainingRecords of whe,Biofilm Implications,Biofilm Implications,Bacterial Biofilms,Biofilms 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 a
