化妆品清洗和消毒培训分析.ppt

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 - CD INCIDENT LEARNING CD INCIDENT LEARNINGS 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 CCP’s Preferred route is as CCP’s 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 dilut