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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.
The celebration of Engineers Week was started in 1951 by the National Society of Professional Engineers in conjunction with President George Washington's birthday. President Washington is considered as the nation's first engineer, notably for his survey work. Prior to the start of National Engineers Week, the University of Missouri College of Engineering began celebrating the world's first Engineers' Week in 1903, 48 years before the National Society of Professional Engineers.
Diane Paskiet, Director Scientific Affairs, will provide an update on the PQRI-PODP working group at the Smithers Rapra Extractables and Leachables conference in Barcelona, Spain on November 10-12, 2014.
Recently, the generics pharmaceutical industry in the United States has seen the average time to market decrease significantly as approvals have steadily increased thanks to the introduction of the Generic Drug User Fee Amendments (GDUFA) in October 2012. The reduction in time has led pharmaceutical companies to seek out high-quality elastomer products that provide the regulatory simplicity necessary to bring their products to market quickly, helping to increase a company’s competitiveness and their drug product’s overall sales. The AccelTRA™ elastomer program is built on these features: Quality, Speed, Simplicity.<br />
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