Pharmaceutical service providers face an increasingly paradoxical challenge to their aseptic fill-and-finish process. Blockbuster drugs are in worldwide demand, as are the large-batch production runs they require. At the same time, intensifying research on rare diseases is also driving the demand for smaller batch sizes. To meet the different requirements of both product groups, flexible manufacturing processes are of decisive importance—especially those processes that enable individual line set-up for product changeovers. What’s more, many global authorities are also increasing their regulatory requirements for process safety. New and revised guidelines are upcoming. This includes the Annex 1 of the EU GMP Guide “Manufacture of Sterile Medicinal Products”—considered the most important European regulatory standard for the manufacturing of sterile pharmaceutical products. The current draft of Annex 1 states that the expected result of microbiological findings within isolators and restricted access barrier systems (RABS) is 0 colony forming unit (cfu) recovered, and that “all critical surfaces that come into contact with sterile materials should be sterile.” Visual inspection requirements for particles are also becoming increasingly stringent. Regulatory trends are shifting from today’s best practice of “essentially free” toward the more demanding standard of “practically free.” This have multiple consequences for the aseptic filling of drugs. First… Click Here For Complete Article Text
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