EMSL Materials Science Laboratory Now cGLP/GMP Compliant/FDA Registered Laboratory

Presence of Particulate Matter is Top Reason for Parenteral Product Recalls.

Cinnaminson, NJ

According to a recent study by the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), one of the most common reasons for recalling parenterals is due to the presence of particulate contamination. As a result, FDA has been challenging many of the visual inspection programs developed by pharmaceutical companies.

Inspection for visible particles is a worldwide pharmaceutical requirement. USP 28 (788) 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-art FDA registered Materials Science laboratory located in Cinnaminson NJ. Diane Miskowski, Business Development Manager at EMSL states: “According to recent trending data, the number of FDA 483 observations in this area seems to be increasing for parenteral products. Our diversification efforts allow us to help pharmaceutical companies nationwide address this issue as well as providing testing on WFI and USP purified water, medical devices, raw materials, API’s, and environmental monitoring.”

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.

About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of quality environmental and materials testing services and products to professionals and the general public. In addition to being an FDA registered laboratory, the company has an extensive list of accreditations from leading laboratory accrediting organizations as well as state and federal regulatory agencies.

Contact Information

Joe Frasca

Senior Vice President, Marketing

EMSL Analytical, Inc.

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