Continous use of RABSIn the production of aseptic medicinal products RABS (Restrictes Access Barrier System) represents the optimum synthesis of production flexibility and process saftey. We have therefore introduced this technology consistently on all of our filling lines to guarantee optimal product safety.
RABS has fixed machine shields. Inside the shield is the cleanroom class 100 according to ISO 5. Doors with safety locks, a continous sterile air flowfrom the inside to the outside and handles operated by fixed installation gloves ensure an extremely clean environment. By the strict physical separation of product and producer the risk of contamination is reduced to a minimum.
Capping conform to GMPIn spring 2008 Annex 1 of the GMP guideline for aseptic production of liquid medicinal products was revised. One aspect is that the regulatory standards for the environment of the crimping process have been tightened up considerably.
In the new hameln pharma sterile production plant the complete sensitive process, from filling to crimping of the vials is carried out separately from the filling and sealing – as an aseptic process in the class A cleanroom. Operations in this area are performed exclusively using RABS technology which offers reliable protection from possible contamination.