BS EN ISO 13408-6:2021

What is ISO 13408-6 about?  

ISO 13408-6 is one of a series of documents for Aseptic processing of health care products that outlines Isolator systems and specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation, and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. 

Note: ISO 13408-6 does not specify requirements for restricted access barrier systems (RABS), does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions, does not specify requirements for isolators used for sterility testing; however, some of the principles and information in ISO 13408-6  could be applicable to this application and does not define biosafety containment requirements. 

Who is ISO 13408-6 for? 

ISO 13408-6 is applicable to- 

• Manufactures of Isolator systems 
• Technical staff and doctors in hospitals 
• Medical laboratories 

Why should you use ISO 13408-6? 

An isolator system is a decontaminated unit supplied with grade A (ISO 5) or higher air quality that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel). Aseptic processing is an exacting and demanding discipline designed to maintain sterility through all stages of preparation, manufacturing, filling, and sealing in final containers. It relies on several independent factors for the prevention of recontamination of previously sterilized components during the assembly or filling of the product into a final container. 

ISO 13408-6 helps establish a controlled environment, reduction of viable and non-viable particulates within isolators is achieved by validated and reproducible cleaning and bio-decontamination processes, principally achieved using automated methods. In addition to control of bio-contamination and non-viable particulates, isolator systems can include control features, which together with operating practices provide product containment to control cross-contamination between process contaminants and product batches and to manage risk to operators. 

What’s changed since the last update? 

BS EN ISO 13408-6:2021 supersedes ISO 13408-6:2005, which has been withdrawn. BS EN ISO 13408-6:2021 has some significant technical changes with respect to ISO 13408-6:2005, these include: 

• Changes to the Introduction and Scope 
• Addition of the new Clause 5 "Basic principle of Isolator system" 
• Addition of risk management approach in Clause 6 "Isolator system specification" 
• Addition of new informative Annex A "Devices acting as transfer ports for portable and mobile equipment" 
• Addition of new informative Annex B "Isolator system – Explanation of terms used and flow of air and material" and Annex C "Isolator system – Direct/indirect product contact surfaces”