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We are committed to the continuous improvement of our products and services. We work to ensure our products are safe and effective by certifying that they meet the required specification and do not put patients at risk. One of the most important areas of risk mitigation is endotoxin reduction.
Endotoxins are pyrogens (fever-inducing materials) from the cell walls of gram-negative bacteria that can cause a fever and even septic shock. Regulatory agencies have expectations regarding the ability of a pharmaceutical wash process to demonstrate validation of a minimum 3-log reduction in endotoxin levels (i.e., removal of 99.9%). The design of the wash process for elastomer components considers both the wash cycle capability to remove the bacterial endotoxin from the surface and the quantity of water needed to dilute the endotoxin concentration.
West is introducing a new harmonized endotoxin test method for elastomer closures and lined seals at all sites. This method was developed and validated in accordance with ICH guideline Q2(R1) (Validation of Analytical Procedures) and meets compendial and industry standard requirements as defined in USP <1228>, <85>, <161>, EP 2.6.14, and ANSI/AAMI ST72:2011. Endotoxins are extracted from the product and extracts are analyzed using cartridge technology.
Cartridges utilize FDA-licensed chromogenic reagent to measure color intensity directly related to the endotoxin concentration in a sample. This new technology has higher sensitivity, is more robust than conventional kinetic testing, and provides quantitative and accurate endotoxin results. The endotoxin test method was developed with strong focus on endotoxin recovery from all representative elastomer components. A limit of quantification as low as 1 EU/pc could be successfully achieved during the test method validation.
West strives to provide the highest level of support to customers by delivering industry-leading scientific and technological advances. To find out more about endotoxin quantification on West products, contact an Account Manager or Technical Customer Service (TCS) representative.
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 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.
Focused on meeting customer needs in different markets and regions, West offer two types of washed Ready-to-Sterilize (RS) rubber closures: Regional-Washed RS and Westar<sup>®</sup> RS.
The Japanese Pharmacopeia (JP) has updated chapter 7.03 “Test for Rubber Closures for Aqueous Infusions” and the last date to transition to the new version is <strong>September 30, 2015</strong>.
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.
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