Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine 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.
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.
The Telstar range of rigid wall Sterility Test Isolators are designed to avoid this risk and protect the product from both the process and externally generated factors that would compromise its quality.
The Telstar Sterility Test Isolator has been developed to cover a wide variety of clients' needs. The units' ability to provide a reliable aseptic environment for sterility testing and other aseptic processes is unquestioned.