Pharmaceutical manufacturer should evaluate and validate the cleaning process so that the detergents are completely washed away or removed, and with some ultra low detection methods the value of residue must be to very less. As the detergents are not the part of the process and they are added in to the equipment to facilitate cleaning of drug residue.
As the detergents composition and quality are likely to change over a period of time and many manufacturers do not provide complete chemical composition so that their residue detection may not be complete after cleaning by a regular method.
Therefore selection of detergent for cleaning should be done after considering these aspects. pharma manufacturing
Cleaning Validation Requirements
Cleaning Validation Protocol
LIMIT FOR RESIDUE AFTER CLEANING
Cleaning validation evaluation and general requirements
Cleaning Validation and sampling procedures
Cleaning validation and equipment design.
Clean Room Classification
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