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Customers frequently ask: Do we need to wash secondary closures, such as West Flip-Off® seals? Like so many questions, the answer is “it depends”. But in general, the answer is “no”.
West does not recommend washing of Flip-Off seals, or exposure to any process that may involve collision or abrasion. The reason is that processes like these can result in the formation of particles. Therefore, for standard crimping in non-aseptic environments, washing is not recommended. However, if crimping is performed in clean or aseptic environments, with tight controls over cleanliness and safety, then controlling the cleanliness is critical. In this case gentle rinsing and sterilization processing is highly recommended. This is especially important for the European market; the European Medicines Agency (EMA) has a clause regulating specific requirements on clean and aseptic crimping in GMP environments: Manufacture of Sterile Medicinal Products Annex 1.
To meet customer needs, West offers a range of seals, both processed and unprocessed, in particular:
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.