Die neue FDA Aseptic Guidance
Teil 1: Hygieneanforderungen
Biopharmaceutical Quality & Compliance / Mikrobiologie, Boehringer Ingelheim Pharma KG, Biberach/Riss
The New FDA Aseptic Guidance / Part 1: Hygiene requirements
The new version of the FDA Aseptic Guid-ance was published in September 2004. The document is intended to help manufacturers to interpret the requirements of cGMP set forth in the Code of Federal Regulations. The document does not establish legally enforceable responsibilities. Instead it describes the Agency’s current thinking on these topics. Alternative approaches are permitted.
The hygiene requirements of the paper are presented. A main aspect is the quality of air. Two clean areas are mentioned: “Critical Area” with class 100 (ISO 5) and “Supporting Clean Area” with at least class 10 000 (ISO 7). The guidance contains detailed statements regarding physical parameters as pressure differentials and necessary air changes per hour.
Detailed indications as to the room equipment and disinfection are given in the new version similar to the European GMP guidelines. In case of aseptic processes it is critical that the different aseptic process steps do not pose the risk of contamination. The document presents detailed instructions on process design how to avoid contaminations (e.g. possibilities of automation including the use of robotics).
The Aseptic Guidance treat the training of personnel, precaution rules in aseptic areas, gowning and qualification of gowning procedures.
The microbiological quality of components and containers/ closures (mostly stoppers) may influence the sterility of the final product. In order to succeed in getting the required microbiological quality (sterility) components and containers/ closures have to be sterilised or filtered. Also endotoxines in components and containers/closures are significant because parenteral products are intended to be non-pyrogenic. Therefore, components not containing endotoxines should be used, guaranteed by appropriate speci-fications and investigations.
Key words Aseptische Herstellung • FDA Aseptic Guidance