Sterility Testing is an essential element of processed product sterilization 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.
Standard's 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 14644-7:2004 producing an EU GMP "Grade A" environment throughout the chamber.
Pharmacopoeias (the official publication containing a list of medicinal drugs with their effects and directions for their use), require the Sterility testing of sterile pharmaceutical products to determine acceptability of a production batch. Therefore all companies which process products on the Pharmacopoeias list should be interested in the Schematic solution".