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By Sylvia Marzotko

February 02, 2018

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.