Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production lot.
Sterilization Validation
It is an essential element of sterilization validation and it must be performed in a manner which avoids the risks of both false positive and false negative results.
False Positive
False positive results are generally due to laboratory contamination from the testing environment or technician/technique error and cause additional work in terms of extra documentation required and adds significantly to cost as it delays or prevents release of the product for sale.