Transcription of Microbiological Aspects of Cleaning Validation
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Microbiological Aspects of Cleaning Validation
Dr. Tim Sandle Pharmaceutical Microbiology Resources: Microbiological Aspects of Cleaning Validation Introduction Cleaning Cleaning Validation & GMPs Microbiological concerns Microbiological risks Risk assessment Microbiological tests and acceptance criteria Why failures happen What is Cleaning ? Cleaning is assessed based on the level of residues that remain, either those directly found on the equipment or those indirectly contained within the final rinse after water has passed through or over the equipment. Whether the residues remaining have been reduced to a satisfactory low level is based on predetermined acceptance criteria.
the sense that disinfection is defined as the known reduction of a population of microorganisms as demonstrated through controlled laboratory studies. •Other aspects of the cleaning process can prove hostile to microbial survival: •Temperature of the water used for cleaning (above 60oC) •pH ranges below 4 and above 11.
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