Normenvergleich zu Isolatoren für die Herstellung steriler Gesundheitsprodukte
Hälsa Pharma GmbH, Diapharm Gruppe, Lübeck
Korrespondenz: Dr. Eckhard Milsmann, HÄLSA Pharma GmbH, Betriebsstätte Bielefeld, Immermannstr. 9,
Comparison of Standards for Isolators in the Manufacture of Sterile Healthcare Products
To become familiar with the state of the art in isolator technology, it is necessary have to review and evaluate numerous differently structured standards and guidelines. This work is especially time consuming because of the different document structures and taking into accout, that isolator technology is just one aspect in the field of aseptic manufacturing, where a lot of further requirements has to be followed. It is criticised, that different standards and guidelines are applied to drugs and drug-like medical devices for injection, as both are intended for the same route of administration by injection or infusion into the human organism. From the pharmaceutical industries point of view the responsible regulatory bodies are asked to speed up the process of international harmonisation (e.g. ICH) and to enforce harmonisation of the requirements for for sterile drugs and medicinal products for injection. In the light of rules set forth in Vienna, it is a strange observation, that at the same time CEN and ISO generate and release standards on isolators with contradictory requirements for the user.
Key words Herstellung steriler Gesundheitsprodukte • Isolatortechnik, Normenvergleich
pharmind 2006, Nr. 11, Seite 1313