As people are the most common source of contamination during aseptic drug manufacture, limiting staff interventions in the process zone has a substantial impact on the end product’s quality.
Our expertise extends to all disciplines that demand special attention to asepsis during filling procedures for both non-toxic sterile and cytotoxic products, which require completely enclosed settings, from small to big batch manufacturing systems.
Our equipment is designed to meet all current aseptic processing requirements. A RABS protects a crucial process zone by forming a physical and aerodynamic barrier that allows for simpler access to the process in the event that human intervention is required.
Open Passive RABS: Barrier system that uses current cleanroom overhead air supply systems to deliver HEPA filtered air over a crucial process before returning air to the cleanroom.
Open Active RABS: Barrier system with an integrated ventilation system to supply HEPA filtered air over a crucial process before returning air to the cleanroom.
Closed RABS: A positive pressure barrier system with an integrated ventilation system that supplies HEPA filtered air over a key process and can pass through return filters before being recirculated. Closed RABS can also be combined with a VPHP (Vapor Phase Hydrogen Peroxide) bio-decontamination system to create a completely compliant CGMP class A/ISO 5 environment. cRABS must be fitted in class B.
These systems protect the operator from the product and the product from the operator, as well as prevent contamination by enclosing the manufacturing process in a limited space.
The cRABS enclose a compartment where unidirectional HEPA-filtered air flows vertically over the process area.
The exhaust fan maintains the pressure difference between the interior and outdoors. The air from the exhaust pipe is “Bag-in Bag-out” (BIBO) filters filter HEPA.