Tim Sandle Microbial Cleaning Validation - Pharmig

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. An additional concern is with the Microbial bioburden. Cleaning Validation Cleaning Validation - methodology applied to give the assurance that a Cleaning process has removed residues and contaminants from a piece of equipment or machinery.

Dr. Tim Sandle Pharmaceutical Microbiology Resources: www.pharmamicroresources.com Microbiological Aspects of Cleaning Validation

Loading..

Tags:

  Tim sandle, Sandle

Information