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. Sterility Testing is therefore an essential element of sterilization validation and barrier isolators are employed to help eliminate risk and protect the product from both the process and externally generated factors.
Schematic design and manufacture a range of rigid Sterility Test Barrier Isolators that can be configured to suit customer specific requirements.
All of Schematic 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.
Schematic'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.