Sterility Testing is an essential element of processed product sterilisation validation as found in the Pharma and Food sectors. Barrier isolators are employed to help eliminate risk and protect the product from both the process and externally generated factors.
The Standard Group of Companies design and manufacture a range of rigid Sterility Test Barrier Isolators that can be configured to suit customer specific requirements.
Our Barrier Isolators are designed in-house in both our UK and Indian facilities with specific attention to ergonomic design to provide a reliable aseptic environment for sterility testing and other aseptic processes.
The Standard Group range of Sterility Test Isolators are 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 and fully comply with ISO 14644-7 producing an EU GMP "Grade A" environment throughout the chamber.
Sterilization of the isolator is typically provided by Vapourised Hydrogen Peroxide (VHP) - Read More about VHP
The Sterility Testing Isolator is a fixed type unit chamber with positive pressure with multiple glove ports, with the following design features;
- Main Chamber is supplied with glove ports and is integrated with the transfer chamber.
- Transfer chamber is used for transferring samples for multiple times by sterilizing of internal surface of transfer chamber. It is not typically provided with Glove ports.
- The Isolator is constructed with a Double wall skin (Internal Wall is 316 Stainless Steel and External wall is 304 Stainless Steel)