We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Today’s regulatory guidelines and requirements for pharmaceutical manufacturers are getting more specific and stringent, ensuring that drug products are safe and that there is no compromise with the possible use of unsuitable and/or non-compliant packaging components. For instance, regulatory guidelines require use of clean components (inclusive of secondary seals for this context) for sterile filling operations.
The U.S. Food and Drug Administration (FDA) Aseptic Guide, section A. Components states: “Knowledge of the bioburden is important in assessing whether a sterilization process is adequate.”
Likewise, from European Medicines Agency (EMA) Annex 1, clause 80 states:
The bioburden should be monitored before sterilization. There should be working limits on contamination immediately before sterilization, which are related to the efficiency of the method to be used. Bioburden assay should be performed on each batch for both aseptically filled product and terminally sterilized products…
Clause 118 offers the following guidance: “The container closure system for aseptically filled vials is not fully integral until the aluminum cap has been crimped into place on the stoppered vial.”
As one of the pioneers to the pharmaceutical packaging industry, West introduced Flip-Off® (FO) CCS – Clean, Certified and Sterilized seals to meet pharmaceutical manufacturers’ needs for clean secondary closures in sterile filling operations.
FO-CCS seals are ready-to-use (RU) products sterilized by gamma sterilization. They are certified for bioburden (prior to sterilization) and particulate, meeting the requirements from EMA Annex 1.
To learn more these clean components, contact your account manager today!
Flip-Off CCS® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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.
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.
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>
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.
Customers frequently ask: Do we need to wash secondary closures, such as West Flip-Off<sup>®</sup> seals? Like so many questions, the answer is “it depends”. But in general, the answer is “no”.
English
Chinese
