Requirements on safety, versatility and performance of isolators in the production of aseptic parenterals - A contribution on the duties of dealt room isolators

Improving process sterility assurance level (SAL) is the main reason for the installation of isolator systems in the aseptic parenteral manufacturing. In most cases the investment costs for the plant around the isolator decrease more than the additional investment costs for the isolator equipment arise; the costs for continued use are always significantly lower than the running costs of conventional cleanroom technology. The parenteral isolator equipment must be designed not only in accordance with the rules of cleanroom technology but must also be suitable for the intended cleaning and sterilizing process (materials!); it shall be constructed according the rules of ergonomics and anthropometrics and it should be adjustable to defined operators. The containment shall have a system for pressure holding and monitoring and an air tight ergonomically designed interface for operator intervention. The transfer systems shall be simple, robust and easy to handle and shall grant a contamination free material transition; in case of manufacturing toxic substances they have to be designed as a pressure sink. The systems for monitoring and documentation measure, control and document the cleanroom conditions, the pressures and the pressure differences, the air thightness, the sterilizing parameters and the labour safety functions. A multistage procedure with intermediate check points is recommended for preventing risks during construction, start up and performance of isolator plants.