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Nelson Laboratories Fairfield Blog Archive (Formerly Gibraltar Laboratories)






April 9, 2018

Did You Know That the United States Pharmacopeia (USP) has Changed the Heavy Metals Chapter Effective January 1 2018?

By: Danina Rinaldi

The USP has been working on changing the guidelines for testing heavy metals for several years.  More specifically, the USP chapter to change will be <231> . The new USP chapters that will be effective are <232> and <233>. The...

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February 28, 2018

Did You Know the Environmental Protection Agency (EPA) has Made Some Changes on How to Test Against Spores of Clostridium difficile?

By: Danina Rinaldi

Established in 1970, the Environmental Protection Agency (EPA) is purposed to protect human health and the environment.  One of the responsibilities of the EPA is to provide guidance on how to evaluate products in the marketplace with claims.  One of...

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February 5, 2018

Did You Know the United States Pharmacopeia (USP) has Assembled an Expert Panel to Begin Discussions about Developing a Compendial Rapid Sterility test?

By: Daniel Prince

With an incubation period of at least 14 days, it’s no secret that the current compendial sterility tests are too long for a variety of industries and product types. The USP expert panel identifies four main stakeholders when discussing the need for...

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September 7, 2017

FDA Final Rule: Consumer Antiseptic Washes Are Neither Safe nor Effective

By: Derek Prince

On September 6, 2017 the Food and Drug administration (FDA) final rule banning a list of 29 consumer antiseptic wash ingredients officially became in effect. This rule strictly bans the usage of certain ingredients commonly used in the manufacturing of...

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June 7, 2017

Rapid Sterility Testing

By: Derek Prince

In June of 1936 the United States Pharmacopeia (USP) implemented the sterility test to better ensure the sterility of parenteral drug products. The test utilized one type of media and applied only to sterile liquids. Since then slight modifications have...

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