Validation of Sterility Test

The purpose is to develop a guideline to validate the efhcacy of the sterility test method for a specihc product or material. The similarity of the validation approach with the other pharmaceutical manufacturers shall be considered coincidental due to the similarity of operations and the nature of the work. 

The validation may be performed simultaneously with the sterility test of the 

Before tests for sterility for any product are initially carried out, it is necessary to demonstrate the validity of the test method used by recovery of a small number of microorganisms in the presence of the product. 

Validation should mimic the test proper in every detail, such as in the volumes of media used and quantities and dilutions of product 

The items to be tested for sterility should be tested for antimicrobial activity during the product development stages, if this is possible. If they are found to have such activity, preparatory or test procedures will need to be modified to neutralize this activity. If all items are found to be free of such activity when first tested or after modification of procedures, application of the test for antimicrobial activity to every sample is not necessary. 

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