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Creating a vital medication takes a huge commitment of time and money. Pharmaceutical companies must ensure a safe, effective drug supply for patients. Primary packaging components are an integral part of any drug product. Selecting the wrong primary packaging components can jeopardize success. Fluoropolymers have found utility in numerous commercial applications in primary packaging components. One is barrier films for elastomer components as a part of drug product storage/delivery systems. Based upon high density and hydrophobicity, fluoropolymers can retard both movement of leachable from elastomer into drug product and interaction of drug product with elastomer. This presentation focuses on use of Fluoropolymer barrier film for elastomer stoppers and plungers. Considering the resultant lower risk, stoppers and plungers with fluoropolymer barrier film should be a strong consideration for emerging advanced injectable products, especially those with accelerated development timelines.
SR. Technical Account Specialist - TCS