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.
Online course
11 modules