化妆品清洗和消毒培训PPT.ppt

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 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 10 20 30 40 50 60 70 80 90 degC 10 20 30 40 50 60 70 80 90 degC 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 Elast