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Pharmaceutical closures used in aseptic environments must be introduced in a sterile state. The most common methods to sterilize rubber closures (e.g., stoppers) are autoclaving (saturated steam) and gamma irradiation. Both methods can influence chemical (e.g., extractables profile) and physical/functional properties (e.g., break-loose and extrusion forces). Therefore, it is important to choose the right method.
To meet the diverse needs of customers, West offers a broad portfolio of rubber stoppers and plungers, as either:
For Westar RU sterile components, assurance is to a sterility level (SAL) of 10-6 or better, i.e., probability of microbial contamination is no greater than one component per one million (Guidance for Industry: Container Closure System Integrity Testing Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products – https://www.fda.gov/RegulatoryInformation/Guidances/ucm146074.htm)
Westar RS components must be sterilized by the pharmaceutical company. West typically recommends autoclaving: (a) a steam cycle at a minimum temperature of 121.1°C (not to exceed 123°C) for a maximum of 60 minutes, followed by (b) a drying cycle at 105°C for a maximum of 8 hours. For select applications, gamma irradiation may be the right choice. Whatever method is used, the pharmaceutical company must ensure that sterilized components meets sterility and compendial standards (USP <381> and EP 3.2.9).
West Technical Customer Support can assist in selecting the right sterilization method, and in collaboration with Analytical Laboratory Services, to perform compendial tests.
For more information on closures or sterilization, contact a Technical Customer Support representative or visit the Knowledge Center.
STERIlizableBAG™ and Westar® are registered trademarks or trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
As customer needs rapidly change to meet these new and unprecedented accelerated timelines, West’s steam-sterilized, ready-to-use Westar<sup>®</sup> and Westar<sup>®</sup> Select elastomer components play a critical role. They simplify component preparation and allow customers to focus on other aspects of the drug filling process.
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
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>
As the pharmaceutical industry evolves amidst changing patient needs, growing regulatory requirements and improved process understanding, West is moving forward with product improvements of its own. In addition to our continuous process and product improvements and optimizations, West is harmonizing its steam sterilizable ready-to-use (RU) product packaging material.
<p>In 2015, West Pharmaceutical Services, Inc. (West) announced that two materials of construction of the West STERI<span>LIZABLE</span>BAG™ packaging system will change:</p><ul><li>DuPont announced improvements to the manufacturing of Tyvek® 1073B Medical Packaging Material (using latest flash-spinning technology).</li><li>West’s polyethylene supplier announced discontinuation of current product.</li></ul>
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