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The Parenteral Drug Association (PDA) has just issued Technical Report no. 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging.
This peer-reviewed document is especially intended for packaging manufacturers, and pharmaceutical companies that use rubber stoppers and aluminum seals with vials.
For the last four years, I co-chaired the task force of 24 industry experts who created this much-needed report, which standardizes terminology regarding components, designs and defects. Defects are described in detail: photographically, by location, and as critical/major/minor. This report will be a valuable resource in the pharmaceutical and packaging industries – for inspectors and those setting quality specifications.
To download, visit: https://store.pda.org/ProductCatalog/Product.aspx?ID=3441. PDA members may obtain this free through November 17.
In the realm of sterile pharmaceutical products, the pursuit of high-quality packaging components stands as the cornerstone of patient safety. The recent revision of the EU Good Manufacturing Practice (GMP) Annex 1, an integral guideline governing pharmaceutical manufacturing practices, has spotlighted the implementation of the Contamination Control Strategy.<sup>1</sup> This strategic framework meticulously controls the management and mitigation of contamination risks. Amidst these risks lies particulate matter – a challenge that underscores the need for meticulous scrutiny within sterile pharmaceutical product manufacturing processes.
<p><span>The overall quality of a final drug product depends on the components of its packaging and delivery systems. The use of visually inspected components reduces the risk of defective components and helps ensure patient safety.</span></p>
We are pleased to announce that our Scientific Insights Lab team members, Liang Fang and Marissa Rase, received the 2021 Fred Simon Award, and its Chief Scientific Officer, Fran DeGrazio, received the 2021 Edward Smith Packaging Science Award at the 2022 PDA Annual Meeting in Dallas.
<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>
One factor of parenteral drug product quality is the container closure integrity (CCI) of the primary packaging system. The interaction between the sealing surface of the elastomeric component and the vial is vital to ensure stability of the drug product over the shelf life. Therefore, defects found on the elastomeric component can increase the risk of failure or end-of-the-line rejects.
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