Glatt - Sterility control with PUPSIT in pharmaceutical manufacturing скачать в хорошем качестве

Glatt - Sterility control with PUPSIT in pharmaceutical manufacturing

Elevating Sterility control with PUPSIT in Pharmaceutical manufacturing PUPSIT (pre-use, post sterilization integrity testing) is a method used to verify the integrity of sterilizing-grade filters at two critical points—before they’re used in production and after they have been sterilized. This ensures that the filter remains uncompromised and effectively performs its role in removing contaminants from the drug product. ✔ Pre-use testing safeguard’s the intactness and functioning of the filter correctly before the production. ✔ Post-sterilization testing confirms that the sterilization process hasn’t introduced defects in the filter. In 2017, the European Medicines Agency (EMA) mandated that pharmaceutical manufacturers implement PUPSIT to comply with Annex 1 of the EU GMP guidelines, emphasizing enhanced sterility assurance in injectable drug production. PUPSIT Applications ✔ Sterile Filtration Systems – To ensure aseptic conditions before drug formulation. ✔ Biopharmaceutical Manufacturing – Particularly for high-risk injectable drugs. ✔ Solution, Suspension, and Emulsion Suites –Applied across different formulation types, ensuring sterility regardless of product characteristics.