Microbiological testing, parenteral

It is recognized that physical and mechanical properties of a parenteral system affect seal integrity. However, physical and/or microbiological testing approaches may be used to challenge seal integrity or demonstrate that a seal has been achieved and is being maintained over the shelf life of the container system. 

There are no standard methods for verifying microbiological integrity of container-closure systems. Documents such as that published by the Parenteral Society in 1992 ° and the PDA in 1998 may be helpful in relating microbiological integrity to secondary physical tests, but they do not specify detailed microbiological test methods. 

To ensure that each of the aforementioned requirements for a parenteral product is properly met, the following chemical and microbiological tests are typically conducted for the finished products. 

Microbiological testing should be conducted on each lot of API required to be free of objectionable microorganisms. Appropriate testing should also be conducted on each lot of API required to be pyrogen free or with a specified endotoxin limit (e.g., APIs intended for use in the preparation of parenteral drug products). 

Cooper, J.F. Bacterial endotoxins test. In Microbiology in Pharmaceutical Manufacturing Prince, R., Ed. Parenteral Drug Assoc., Bethesda, Davis Horwood International Publication, Ltd. Modalmeny, UK, 2001 537-567. 

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