MICROCHEM LABORATORY INC

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MicroChem Laboratory is a custom contract laboratory specialized in efficacy testing of disinfectants and other antimicrobial products. We offer a range of disinfectant testing and consulting services.

 

 

Company Profile        

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MicroChem Laboratory is a contract laboratory established in 1988 to test liquid chemical germicides.  We test sanitizers, general-, broad spectrum-, hospital grade-, and high-level disinfectants, sterilants, and other antimicrobial products.   We also validate swimming pool disinfectants and algaecides.

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MicroChem Laboratory is owned and operated by Dr. Norman Miner.  Dr. Miner was instrumental in creating an AOAC Task Force with the goal of improving the chapter 6 AOAC Disinfectant Test Methods.  Dr. Miner provides disinfectant and antimicrobial test method consulting services and is also available as an expert witness regarding disinfectants and disinfectant test methods.

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The scientists at MicroChem Laboratory produce reader-friendly, crystal clear, quality assurance audited final study reports promptly after a study is completed.  MicroChem Laboratory also conducts original research and publishes regularly in peer-reviewed journals regarding disinfectants and disinfectant test methods.

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Member:  AOAC, ASM, and ASTM.

Test Experience

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We are experienced with and knowledgeable of the published test methods of the Pesticide Assessment Guidelines as published by the EPA, the Guidance document for testing liquid chemical germicides as published by the FDA, the Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC), American Standards for Testing and Materials (ASTM), and Standard Methods for Examination of Water.

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Tests include the AOAC Sporicidal Test, Quantitative Tuberculocidal Rate of Kill Test, AOAC Use Dilution Test, AOAC Fungicidal Test, and many more.  See the Services Page for a more complete listing of our disinfectant tests.  MicroChem has over 30 years experience with sporicidal, mycobactericidal (tuberculocidal), bactericidal, and fungicidal testing for sterilants, all levels of disinfectants, sanitizers, and other antimicrobial products and surfaces.

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We are experienced with the 510(k) process of the FDA for approval to market high-level disinfectants and sterilants for heat-sensitive medical devices, and manage this process for clients.  See below for more details.

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Many of our test methods are custom-designed to address special research and development product questions.

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MicroChem Laboratory is periodically audited by the EPA and FDA for compliance with Good Laboratory Practice Standards.

FDA 510(k) Permission to Market

MicroChem Laboratory produces 510(k) applications for permission to market disinfectants including:

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Test work as defined in the Guidance Document

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Preliminary meetings with regulatory agencies

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Writing and compiling the 510(k) document

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Drafting the product label claims

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Representing the Client to the regulatory agency until permission to market is granted.

 

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