A variety of issues with USP <71> make it a difficult test to understand, develop and follow within one’s laboratory. 

Everything from growth promotion testing of the media to assuring no inhibition/enhancement (I/E) of the product to be tested requires the knowledge and assurance that the test is being completed as required.

In addition, the number of units necessary for testing, the total volume required for the test and assurance that the media is providing accurate results all become important aspects of assuring the test is performed properly and the final result meet those specifications.

Finally, correct interpretation of the results and the proper procedures to use should a failure occur require a thorough knowledge of USP <71>.

Any failure of a Sterility Test will also cause one to potentially review all of the elements within the media fills or terminal sterilization validation that were involved in developing the process that would provide the final, sterile end product.