FDA

Rinsability Test

In the usage of high-level disinfectants, the possibility of contact with these substances is something that needs to be ensured does not occur if the active ingredient could be harmful. To ensure that the level of active ingredient in/on the surface in question is at a level that would...

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Simulated Use Test for High-Level Disinfectants

Prior to initiation of the experiment, the active ingredient in the test substance is measured, the pH is taken and the concentration of the test substance is validated using titration analysis. Then, the test substance is diluted to the minimum recommended concentration (MRC) and confirmed again by titration analysis...

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USP <61> – Microbial Enumeration Test

The USP <61> - Microbial Enumerations Test is a product safety test found in Chapter 61 of the United States Pharmacopeia. It is suggested for use by the FDA for pharmaceuticals as well as cosmetics and personal care products to ensure that a product's preparation complies with pre-set specifications...

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USP <61> Microbial Examination of Nonsterile Products

The US Pharmacopeial Convention (USP) has developed and maintains a compendium of several test methods, which are utilized by companies that produce drugs and cosmetics to ensure quality and product integrity. Individual chapters of the compendium - each detailing a different test method - are identified by the chapter...

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Medical Device Reprocessing Validation Studies

On March 17, 2015, FDA published new guidance describing testing and labeling requirements for reusable medical devices.  The updated guidance is timely, since recent outbreaks of CRE from endoscopes exposed several missing validation studies from implicated manufacturers. FDA's historical guidance pertaining to cleaning and disinfection of reusable medical devices was...

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Custom Virucidal Efficacy Testing

Custom Study Set-Up Custom virucidal studies can be performed for device testing, on-site antimicrobial active ingredient generators, and many other product types. All studies can be conducted according to EPA and FDA regulatory efficacy requirements, and customized according to the unique needs and timelines of the Study Sponsor with the...

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AOAC 966.04 Sporicidal Activity Test

AOAC 966.04 Sporicidal Activity Test: Procedure at a GlanceEssential for the registration and verification of sporicidal claims with the EPA as a countertop disinfectant and the FDA as a high-level disinfectant, the AOAC 966.04 Sporicidal Activity Test uses either Bacillus subtilis or Clostridium sporogenes as the model organism for...

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