Requirements for sterile production

In the production ofsterile medicinal products becomeHigh demands on purity. In particularBiopharmaceuticalsthat cannot be sterilised in the final container in accordance with the official requirements must be made from absolutely pure components and sterilised underaseptic conditions. A particularly complex group of impurities arePyrogenswhich can be very strong when administered into the bloodstream,adverse drug reactions cause. The reliableDepyrogenisation of the primary packaging material is therefore critical for thebiopharmaceutical manufacturing process. But when does successful depyrogenation of the primary packaging material take place? Download our white paper to find out more.