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Packaging components are an integral part of a drug product. Selecting the right packaging system is not trivial--it can impact patients' health, operational efficiency, drug compatibility and drug stability. A good container closure system includes a glass or polymer vial, an elastomer stopper and an aluminum seal.
Regulatory bodies worldwide pay particular attention to the seal crimping process to ensure no contamination takes place prior to closure:
This raises the question of how to meet regulatory requirements. The regulatory bodies are not silent on this. For example, the above-noted Annex 1 defines two processes in the fill-finish area of manufacturing plants performing aseptic filling (Clause 120):
Of course, the right seal must be selected first. Selecting the correct seal depends upon the configurations and dimensions of the vial and stopper, and the compression level needed to ensure good container closure integrity. For selecting the right seals, and processing them the right way, West can help. Check out our Vial Containment Solutions section to view our packaging options and contact an Account Manager or Technical Customer Service (TCS) representative for more.
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.
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.
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.
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.
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>
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