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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