This third paper on the history of isolators describes the development and use of non-flexible film isolators including restricted access barrier systems (RABS). By non-flexible is meant that type of unit that has a metal or a rigid plastic structure. These are referred to as conventional isolators. Many of these models have been designed to enclose various types of filling machines for processing vials, ampoules, cartridges or syringes and are the descendants of glove boxes or safety cabinets for aseptic processing. RABS appear to have been largely devoted to aseptic filling of various forms of vial and syringe or filling products for terminal sterilisation and are dependent on unidirectional airflow as in conventional clean rooms. Other such isolator models have been used for handling, processing and compounding pharmaceutically active materials and for enclosing small tanks, washing utilities, analytical instruments, etc. Some of the flexible film units such as sterility testing or for hospital pharmacy use have also been replaced by rigid versions. One addition to mention is the preparation and compounding of radio-active products.
A courtesy of ‘Clean Air & Containment Review’ – www.cleanairandcontainment.com
- author: Thorogood Doug