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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:
For customers who wish to do their own sterilization, West can provide recommendations. For more on West products, visit our Knowledge Center or contact a Technical Customer Service representative.
In recent years, regulatory guidelines such as The European Medicines Agency (EMA) Annex 1 “Manufacture of Sterile Medicinal Products” have influenced the requirements for the seal crimping processes. EMA Annex 1 specifies that the manufacturing of sterile products is subject to “special requirements in order to minimize risks of microbiological contamination.” The EMA refers to two processes in fill-finish area of manufacturing plants performing aseptic filling: Aseptic Crimping and Clean Crimping. To ensure compliance, pharmaceutical manufacturers need to select the proper seal for each process.
Cell therapies show tremendous promise for the treatment of a variety of life-threatening diseases. Their approvals are increasing. Because cell therapies are extraordinarily expensive, it is imperative that the primary packaging system maintain integrity through the shelf life.
Known for a commitment to excellence in elastomeric components, West has complemented its vial closure portfolio with the Flip-Off® seal brand. Particularly in its ability to provide solutions for aseptic and clean crimping, the Flip-Off seal demonstrates potential to become an industry standard.
For injectable drug product package systems, seals are considered to be secondary package components. Though not in direct contact with drug products, they perform critical functions such as: Maintain an integral sterile seal by holding the stopper firmly in place, protect the injection site on the stopper and provide evidence of tampering (dependent on seal design).
Ensuring the sterility of sterile medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on the patients, as well as the potential for costly product recalls. The importance of control strategies to ensure sterile drug products has also been reiterated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines: <br /><ul><li>FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
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