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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.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.