Sterilization

West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.

At the recent CPhI China Conference, we introduced our Integrated Solutions Program to the Asia Pacific Market. The Program is designed to help reduce risk, mitigate regulatory complexity and Simplify the Journey™ from molecule to market for our pharmaceutical partners.

West is pleased to announce the launch of its Integrated Solutions program – a comprehensive approach that combines West’s high-quality packaging and delivery products with our expert analytical testing, fill-finish services, device assembly and manufacturing, and regulatory support.

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”.

Electron-beam irradiation (e-beam - sometimes called beta irradiation) is a technique used commonly to sterilize pharmaceutical packaging products and medical devices. It operates by directing a continuous flow of electrons through the articles being sterilized. Transfer of energy from the e-beam breaks the chains of DNA in organisms, rendering them inactive, and the articles irradiated as sterile. It is used typically for Ready-to-Use (RU) vials and syringes comprising Daikyo Crystal Zenith® cyclic olefin polymer, and Daikyo PLASCAP® seal products.

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.