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Sunday, May 22, 2011

Limit of Residue of detergent after equipment cleaning Pharma


Detergent selection for pharmaceutical equipment cleaning
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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