Qualifizierung von Reinräumen Dr. Jürgen Blattner BSR Ingenieur-Büro, Oberhausen-Rheinhausen Korrespondenz: Dr.-Ing. Jürgen Blattner, BSR Ingenieur-Büro, Marienstr.156, 68794 Oberhausen-Rheinhausen (Germany), e-mail: blattner@reinraum.info Qualification of Clean Rooms Manufacturing of products according to GMP requires continuous monitoring of equipment, systems and processes having influence on the product. Production environment, air, and premises have a major impact on the quality of the production process. The higher the demands to the quality of the product, the higher the demands to the production room. Up from a special quality of the production area it is called a clean room. Specifications of the requirements for clean rooms lead to their classification. Relevant directives, such as DIN EN ISO 14644 and EC GMP call for the qualification and continuous monitoring of clean rooms. It is the aim of the measurements for qualification to evaluate and document the required characteristics of a clean room. Key words Erholzeit • Lecktest • Luftwechselzahl • Reinräume, Qualifizierung • Reinraumklassenbestimmung |
|
|
pharmind 2008, Nr. 2, Seite 309
