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Follow on Google News | EMSL Materials Science Laboratory Now cGLP/GMP Compliant/FDA Registered LaboratoryPresence of Particulate Matter is Top Reason for Parenteral Product Recalls.
By: Joe Frasca, Senior Vice President, Marketing Inspection for visible particles is a worldwide pharmaceutical requirement. USP 28 provides clear guidance on how to identify sub-visible particles. However, there is not a defined size limit for a visible particle and a visual inspection alone will vary from one human inspector to another. Therefore, some “visual” particles may be missed. The potential adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal. These events include blood vessel obstruction causing pulmonary emboli, platelet or neutrophil activation causing anaphylactic reactions, foreign body granulomas, and blood vessel irritation. To help pharmaceutical companies resolve these and other product failures, EMSL offers particulate analysis, nanoparticulate analysis and unknown particulate identification in their state-of-the- EMSL has been offering quality and scientifically defensible laboratory services since 1981. For more information on pharmaceutical testing services and products provided by EMSL please call (800) 220-3675 x 2528 or go to www.MaterialsTestingLab.com. # # # EMSL Analytical Inc. is a nationally recognized accredited testing laboratory and locally focused provider of consumer product, environmental, microbiology, industrial hygiene, food and materials testing services to professionals and the general public. End
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