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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.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.