Recommendations on Processing West Flip-Off® Seals
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 (https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf).
To meet customer needs, West offers a range of seals, both processed and unprocessed, in particular:
- West's Flip-Off® Seals – for crimping outside controlled environments.
- West’s Flip-Off® CCS seals (clean, certified, sterilized) – for crimping inside Grade A environments (these are delivered already in a clean, sterilized and ready-to-use state). Buttons are washed in a pharmaceutical washer and aluminum shells are treated with a specially developed coating to avoid particle formation resultant from abrasion. Washed buttons and coated shells are assembled in an ISO 8 cleanroom providing for low, controlled particle levels and pre-sterilization bioburden levels, prior to subsequent gamma sterilization.