Sterility test isolators
Designed to avoid this risk and protect the product from both the process and externally generated factors that would compromise its quality.
Perform sterility testing in an aseptic environment providing assurance of material integrity
The Sterility test isolators from Telstar Life-Science range of rigid wall Sterility are designed to avoid this risk and protect the product from both the process and externally generated factors that would compromise its quality.
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.
It is suitable for performing both Direct Inoculation and Filter Membrane sterility tests with flexibility to be bio-decontaminated by different types of bio-decontamination systems available.
- Complies fully with ISO 14644-7:2004 producing an EU GMP Grade A environment throughout the chamber
- A minimum of log 6 reduction in spore forming micro-organisms is consistently achieved & validated using a BI challenge
- Sound ergonomic design of the unit is combined with thoughtful design-for-manufacture utilizing the latest techniques, assuring ease of assembly and efficient inspection and testing