Sterility testing of pharmaceutical products is required to determine the acceptability of a production lot. 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. Sterility testing is one of the most crucial steps in ensuring the safety of your products. The introduction of contaminants through equipment failure and human error can result in false positives.
Product testing within isolated conditions can help to reduce the frequency of false positive results. Consequently, the occurrence of product re-testing and recall is also reduced, saving time, money and materials.
False positive results are generally due to laboratory contamination from the testing environment or from human error. This can cause additional work in terms of additional documentation and cost as it delays or prevents release of the product for sale.
Sterility Test Isolators are designed to protect the product from both the process and externally generated factors that would compromise product quality. Aseptic Containment Isolator (ACTI) and General Processing Platform Isolator (GPPI) have been developed to cover a wide variety of clients' needs in terms of containment solutions.