化妆品清洗和消毒培训ppt课件

Disinfection,Peter Jay: Bioscience, UR&DPS,Trumbull, US 14-16th November 2006,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. On site validation of procedures is a key area that needs to be improved.,Incident Learnings - Disinfection (1),Water/Dilute Product Residues Left in Plant. Plant NOT disinfected prior to use MANY incidents Disinfection procedure NOT validated Operators INADEQUATELY trained Operator did NOT follow documented disinfection procedure Disinfection NOT performed when required,Incident Learnings - Disinfection (2),Disinfection procedure in a third party did NOT follow an approved practice. INADEQUATE control of shutdown procedures Portable equipment NOT adequately cleaned and disinfected prior to use.,INCIDENT LEARNING - C&D,Ensure water/product drains from all areas of plant by good design practice. If non drainable areas are identified, they MUST be managed by disinfection procedures prior to use of the plant,Undrainable pipe arrangement,Undrainable pump arrangement,Water/Dilute Product Residues Left in Plant,INCIDENT LEARNING C&D,Time Immediately post clean = 30 bugs/ml Growth occurs. 24 Hours later = 10 million bugs/ml Assume undrainable pump holds two litres of 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 Plant,Undrainable,Cleaning and Disinfection Rules,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,WHEN WHO HOW,MUST BE DEFINED AND DOCUMENTED,TRAINING is key DISIPLINE IN IMPLEMENTATION is essential,Cleaning and Disinfection,Disinfection,Destruction of micro-organisms but NOT usually bacterial spores. Disinfection 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.,Cleaning and Disinfection - HACCP,Can be handled as a GMP or as defined CCPs Preferred route is as CCPs Especially when starting on HACCP Consider CIP system in HACCP study Consider where need manual intervention,Why Clean,Process Purpose to remove product soils and residues to produce clean equipment surfaces that will not taint the subsequent production of a differing variant. Microbiological Preparation 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 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 Disinfect,We do NOT operate sterile processes Therefore some micro-organisms WILL enter the manufacturing plant Disinfection strategies are required to prevent the build up of contamination in the plant to a level that will result in out of specification product Disinfection should reduce the microbial load on a surface to a level that will NOT be capable of surviving or growing in finished product,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.,How to Disinfect,Two options: Heat Chemicals,Thermal Disinfection,Recommended method of disinfection Temperatures 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 plant/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 CRITICAL Lower temperatures and contact times will NOT deliver disinfection.,Thermal Disinfection,Heat more effective than chemical disinfection in destroying biofilms Equipment must be able to withstand high temperatures and be engineered correctly to avoid implosion of tanks. Steam: Rarely used outside US Plants not designed (seals/instruments etc) to handle steam Only effective against non spore forming micro-organisms Protection against scalding required “Thermal Disinfection Guidelines for the Manufacture of HPC Liquids“. This document is available on the Global Hygiene Security Group website under Technical Documents.,Chemical Disinfection,Relies on physical contact with micro organisms Chemical disinfection difficult on unhygienic plant Many commercial disinfectants available. Most are NOT validated against HPC contaminants (especially on surfaces). Recommended chemical disinfectants for HPC plants: Peracetic Acid Sodium Hypochlorite,Routine Chemical Disinfection - Recommendations,Max. 300ppm Sodium Hypochlorite for 20 minutes or 400 ppm Peracetic Acid for 20 minutes,Disinfection - Key Points,Higher numbers of organisms adhere to elastomers (Viton,EPDM) than to stainless steel. More survivors of disinfection occur on elastomers Key area for validation Pseudomonas aeruginosa and Burkholderia cepacia proved to be most resistant Gram Negative bacteria to chemical disinfectants (Sodium Hypochlorite and Peracetic Acid).,When to Disinfect,Required to destroy micro-organisms which may be accumulating in a process plant. When Plant has been idle either for planned downtime (weekend or holidays) or for maintenance. After a contamination incident Part of a preventative disinfection regime Prior to commissioning new equipment/plant Detection of significant contamination on plant surfaces,Preventative Disinfection,Factory should have a planned preventative disinfection schedule to prevent the accumulation of 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 disinfection Degree equipment complies to hygienic design principles History of incidents,Disinfection Frequency Guideline,Plant Area Product Risk Frequency Disinfection Making High Weekly Storage High Monthly Filling High Two Weekly Making Medium Three Monthly Storage Medium Three Monthly Filling Medium Three Monthly The information is provided for guidance based on current practices. For operations with a history of problems a more frequent regime would be 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,Scheduling Preventative Disinfection,Best practice Schedule 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 25 Days Amber: Tank needs to be disinfected within the next 5 days Red: Tank must be disinfected when it is empty.,Summary - When to Clean and Disinfect,Holding Times Rules Finished Product,* Best Practice is no delay (i.e. immediately),Maximum Holding Times Rules Finished Product,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/portable pump. Transit container would need to be disinfected prior to filling. Pallecon One 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).,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.,“Silicone” - Caustic Detergent (1),Work has demonstrated that B.cepacia / Ps.aeruginosa biofilm ex silicone/CTAC (Hair Conditioner) containing products are difficult to disinfect Visibly clean surfaces NOT good enough Need to remove “invisible product residues A Caustic Detergent will help in the removal of silicone/CTAC residues,“Silicone” - Caustic Detergent (2),Recommendation: Periodic use of caustic detergent prior to disinfection for Hair Conditioners Post incident STRONG recommendation to perform caustic detergent wash prior to disinfection for Hair Conditioners (Prudent to do this for other Silicone containing products) Most effective commercial cleaning agents tested are: 10% Silox XT (ex TSI). Based on NaOH In use in Compeigne, France 2%: 2% solution of CIP 100 & CIP Additive (ex Steris). Based on KOH.,Rotation of Disinfectants,Some industries routinely rotate disinfectants Do you need to do this? If you have a hygienic plant/validated procedures - NO If you have unhygienic plant/un-validated procedures - Treat the causes. Rotation could be a temporary measure until causes addressed Rotation of biocides has little long term effect; best approach: thorough cleaning with a caustic detergent & physical removal of biofilm then, disinfect,Validation of Disinfection: When?,New / modified plant Change in protocol New chemical disinfectant Installed CIP for thermal disinfection Frequency Whole plant validated annually In modules: Not all at the same time,Validation - Disinfection,How Physical Chemical Microbiological,Disinfection Validation - Physical,Thermal (CIP) Stickers permanent colour change keep with records as evidence REMEMBER TIME Thermocouple,REAL TIME,Validation of Heat Disinfection 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,Before,After,REAL TIME,Disinfection Validation - Chemical,Titration 50% of original concentration: Repeat Disinfection 50-90%: Improvement Plan,The following can be used for disinfection (or water treatment validations): Chemetrics V-2000 Multi-Analyte Photometer Water 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 test,Chemical Validation (1),Chemical Validation (2),Chemetrics V-2000 Multi-Analyte Photometer,Assays include: Chlorine (free/total) ppm:0 - 4ppm Chlorine dioxide: 0 - 11ppm Ozone: 0 - 1ppm Peracetic acid: 0.4 - 4ppm Formaldehyde in water: 0.4 - 8ppm (other kits are also available, see website),Validation Disinfection Microbiological (1),This can be performed in a number of ways: Surface Detection of Contamination : Environmental Mapping For example: Pressure Relief Valves Filter Baskets Instrumentation Inlets Pig Launch/Receiving Stations Elastomers Etc. 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 Microbiological (2),Rinse water checks First product packed post disinfection First bottles packed on filler,Manual Cleaning and Disinfection,Small items of equipment often need to be fully dismantled for effective cleaning (and subsequent disinfection). Designated 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. Cleaning and disinfection shall be done in a purpose built hygienic wash bay.,Wash Bay,Hygienic surface coverings which are impervious to hot water and disinfection chemicals Easily cleaned and fully drainable Clearly 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 drying prior being reassembled Store cleaned and disinfected equipment/fittings on a designated rack,Wash Bay,Cleaning of disassembled plant items is generally carried out using warm/hot water with subsequent disinfection of the equipment using chemical disinfectant solutions. 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 effective concentrations.,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 flushing. Handle connections and gaskets with washed/cleaned hands.,Documentation,Documented Cleaning + Disinfecting Procedures must include How When Who What Include pumps, hoses and utensils etc. These often get forgotten! Include validation requirements,Records/Training,Records of when and who conducted cleaning and disinfection In 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 for,Biofilm Implications,Bacterial Biofilms,Biofilms are microbial “communities” that form on surfaces (or interfaces) Most bacteria can form biofilms Over time biofilms can expand and become more complex Biofilms are much more resistant to chemical attack than free floating cells Biofilm 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 bacteria,Some bacteria attach to the surface, most exist as free floating (planktonic) cells,Bacteria form surface structures, these can involve more than one species. Clumps of bacteria can be released which are resistant to chemical attack,Biofilms are surface attached microbial communities that are resistant to chemical attack. More likely to form in unhygienic equipment/pipework,TIME,FLOW,Biofilm Prevention,Material Selection Stainless Steel and Polypropylene Data supports low colonization of these materials High Water Velocities Hamper the attachment of planktonic cells to solid surfaces as time is required for attachment Smooth Surfaces Decreasing surface roughness increases the probability organisms will not attach to surfaces Hygienic fittings which are easy to clean Non-hygienic fittings provide hideaways for organisms and are nearly impossible to clean,“Dealing with Biofilms”,Preventative Maintenance by Frequent Cleaning and Disinfection Validate Cleaning and Disinfection Effectiveness “Control” by Biocides (Disinfectants) Pitfall: Planktonic cells are much more susceptible to biocides than biofilms Biocides will weaken the biofilm Good Manufacturing Design and Effective Cleaning and Disinfection Procedures Helps Manage the Risk from Biofilm.,Avoiding Resistance,B.cepacia (but applies to other Gram Negative bacteria),B.cepacia,Water Untreated,Treated Water,Plant,B.cepacia Present - Approx. 1% population,Treatment System 99.9% reliable,Failure,Low Levels B.cepacia,Conditions to establish self,High Numbers,INCIDENT,Result,Transfer from Water to Dilute Product,0,1,2,3,4,5,6,7,8,0,10,20,30,40,50,60,Time at 28C (hrs),Log number of bacteria,Inoculation 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 Loop,Rapid Growth,Adaptability : Conclusions,Dont let it survive ! Dont let it adapt !,1 litre dilute residues,10 T contaminated product,Hygienic & 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,Bulk Transfer High Risk Raw Materials and Finished Products,Tankers,Extremely high-risk operation Site where cleaning and disinfection is done should be audited to ensure that an adequate procedure is used. Recommended that the local hygienist does this on an annual basis. Tankers must be cleaned & disinfected prior to use and certified as such Disinfection required: Usually steam Use within 4 hours,Tankers,Tanker design Complete drainage after cleaning / disinfection Ensure includes tanker pump No water residues are left to allow micro-organisms to grow After each disinfection of a tanker a certificate of conformity is required Factory should NOT fill the tanker if documentation is not available. Reception points must be clearly labelled, clean, dry and terminal connections covered by end caps,Hoses,Good hose/pump management is vital For high-risk products (and high-risk raw