Telstra

Sterility Test Isolators

Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production batch. 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 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.

Telstar Pura Sterility Test Isolators are designed to avoid the risk of false results and to protect the product from both the process and externally generated factors that would compromise its quality.

The Telstar Pura range has been developed to cover a wide range of client’s needs. The units’ ability to provide a reliable aseptic environment for sterility testing and other aseptic processes is unquestioned. A minimum of log 6 reduction in spore forming micro-organisms is consistently achieved & validated using a BI challenge.