Closed restricted access barrier system
Pharmaceutical production techniques often require isolation of compounds and chemicals from an external environment and operators to preserve sterility, and/or to protect operators from contact with toxic compounds. CRABS and Isolators can be used with toxic and non-toxic compounds, and as standalone equipment in R&D and lab settings. Also, isolators can be used as fully configured enclosures as part of an aseptic production line.
Flexible in-line barrier systems for aseptic production
The Steriline range of CRABS and Isolators offers the ideal flexible solution for containment in a pharmaceutical production environment. Steriline closed Restricted Access Barrier Systems (cRABS) are designed for the production of any sterile products, toxic or non-toxic. They provide protection for operators from the product and protection for the product from operators by fully enclosing production areas.
Inside, HEPA-filtered, unidirectional air flows vertically over the process area. The pressure difference between the interior and the exterior is maintained by the exhaust fan which is HEPA-filtered by “Bag-in Bag-out” (BIBO) filters.
Steriline Isolators can be installed in Class C or D rooms. For in-line use they are custom-designed to complete a fully integrated aseptic production line, in compliance with all cGMP, GAMP and 21CFR Part11 regulations. They maintain uncompromised, continuous isolation of the unit interior from the external environment to ISO5 standards. This is achieved by using HEPA-filtered, unidirectional air that vertically flows over the process area. A pressure difference between the interior and the exterior is maintained by the exhaust fan. The exhaust air is then HEPA-filtered by BIBO filters.
Steriline CRABS and Isolators are designed to provide a maximum 2% leak rate and offer continuous automatic pressure monitoring and control. With LED lights for improved illumination and an integrated VHP generator they offer the perfect isolation solution for aseptic production.
Benefits
- Engineered specifically for in-line aseptic production lines
- 2% or less leak rate
- Maintains an ISO5 environment
- Engineered to meet all relevant cGMP, GAMP and 21CFR Part11 requirements