Blogs

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”.

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.

The process of crimping an aluminum seal onto a pre-stoppered vial should not be overlooked or underemphasized. Within the pharmaceutical industry, there is a need for an elegant and effective seal not only from the cosmetic perspective, but also more importantly, because of the correlation between seal quality and container closure integrity. Even in laboratory settings and during early-stage evaluations of a drug product and containment system, reliable, robust and consistent crimped seals are necessary.

The LyoSeal® cap— an all-plastic, instant sealing solution for lyophilized drugs—recently launched at Pharmapack 2017. Plastic seals present a unique opportunity for commercial pharmaceutical manufacturing, as well as for R&D and pre-clinical applications seeking simplified manual capping options (no tools required).