Short time-to-market and high production throughput, while meeting quality specifications and regulations and reasonable production costs are accompanying challenges in the pharmaceutical industry. In particular, the production of sterile medicine is subject to special requirements to minimise risks of particulate and microbial contamination. Stringent FDA and GMP guidelines are in place to limit exposure to such contamination, therewith preventing severe harm or life-threatening health risks to the patient. Dry heat sterilisation and depyrogenation are applied to ensure sterility of pharmaceutical aseptic preparations, as imposed by FDA regulation 21 CFR-211.94 and EU-GMP guidelines Annex 1. For aseptic preparations, such as vials, ampoules, cartridges or prefilled syringes, terminal sterilisation of the final container is not possible. The glassware, therefore, has to be rendered free from harmful contaminants that might affect the medicine, before filling. Depending on the process, either dry heat sterilisation or depyrogenation is applied.
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