Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production batch. It is an essential element of sterilisation 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.
The Telstar Pura range comprises of five Sterility Test Isolators providing a reliable aseptic environment suitable for performing both direct inoculation and filter membrane sterility tests. With three base sizes and the option of a pass chamber, the Telstar Pura range is suitable for sterility testing from small batch to continuous production scale.
All Telstar Pura range Sterility Test Isolators provide a Grade A (ISO 4.8) positive pressure environment as either single pass directional flow or recirculatory unidirectional laminar flow designs. Manufactured to a high pharmaceutical standard from stainless steel with sealed glass vision panels, Telstar’s Pura range meets the high demands of GMP industry standards and stringent leakage criteria as required by ISO 14644-7.
As standard all Telstar Pura Isolators are PLC controlled and equipped with Telstar’s unique ionHP hydrogen peroxide based bio-decontamination system, providing rapid and effective sterilisation of the Isolator and a validated six log reduction of viruses, spores and fungi. Alternatively third party systems can be fitted to fulfil specific user requirements.
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