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The future is now for parenteral pharmaceutical and biopharmaceutical sterile production. Traditional high-volume automated aseptic filling suites are maintained by contract filling services. But what’s emerging? Parenteral pharmaceutical and biopharmaceutical industries have transitioned to fully enclosed, isolator/restricted access barrier (RAB) systems. These small, efficient systems offer cost savings and can reduce the potential for particulate and microbial ingress during aseptic fill/finish manufacturing by eliminating direct human contact in the filling environment.
These systems often necessitate that supplies be introduced via a rapid transfer port in the isolator/RAB systems without breaking the system’s sterility. Port bags are a must for these sterile systems. The beta port on the port bag interlocks and docks to the alpha port on the isolator/RAB systems.
Port bags are available to transfer sterile packaging components and sterile items into the restricted sterile systems. The port bags, which are available in various sizes, meet steam or gamma sterilization requirements and are constructed with the necessary ports to dock to rapid transfer systems. For further information on West’s port bag packaging systems to overcome the obstacles of introducing sterile packaging components into isolator/RAB systems, contact your account manager today.
For more information read:
“RABS and Advanced Aseptic Processing,” May 1, 2006, James P. Agalloco, James E. Akers, Pharmaceutical Technology
“Restricted Access Barriers – RABS definitions and performance,” Bioquell UK Ltd, Pharmaceutical International
The supply of sterile pharmaceutical closures into a filling line is an essential element of the production of parenteral drug products. In addition to sterilizable bags, West offers closures in aseptic transfer bags – referred to as “port bags” or “ported bags.” Port bags contain a “beta” port that is attached to the actual bag <strong>(Figure 1).</strong>
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>
Overview of EU GMP Annex 1<br />EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.<sup>1</sup> It provides specific requirements for the manufacture of sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments, just to name a few. The objective is to ensure product quality and potency, as well as patient safety, by minimizing risks of microbial, particulate and endotoxin/pyrogen contamination through manufacturing and environmental controls.<br />In August 2022, the final draft of EU GMP Annex 1 was released after years of development and took effect on 25 August 2023. In this blog, a summary of the key changes of relevance to primary packaging components and how West can help with the implementation will be discussed.
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.
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
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