Microchem Laboratory

What Microchem Laboratory does

Microchem Laboratory is an FDA and EPA GLP-compliant contract testing laboratory founded in 1988 and headquartered in Round Rock, Texas, with a second accredited facility in Richardson (Dallas-Fort Worth area). The company provides microbiological and analytical chemistry testing services to manufacturers of medical devices, disinfectants and sanitizers, antimicrobial products, cosmetics and personal care items, over-the-counter (OTC) drugs, and dietary supplements. Testing supports EPA and FDA regulatory submissions, product registration, efficacy claim substantiation, and routine quality monitoring across the product lifecycle (R&D, registration, lot release, surveillance).

The lab's technical platform centers on GLP/GMP-compliant methods (AOAC, ASTM, EPA, USP, ISO) executed across dedicated infrastructure: a cell culture laboratory for virucidal efficacy testing, an ISO 5 biological safety cabinet within an ISO 7 cleanroom for USP <71> sterility testing, CDC bioreactor capability for ASTM E3161/E2871 biofilm disinfection testing, and an analytical chemistry instrument suite including FTIR, GC, HPLC, ICP-MS, ion chromatography, Karl Fischer titration, UV-Vis, and a total organic carbon analyzer. Microchem maintains an extensive collection of hundreds of microorganism strains and performs DNA-based microbial identification. The company holds ISO/IEC 17025 accreditation via PJLA, GLP and GMP compliance, and federal audit status.

Microchem operates a fee-for-service professional services model with quote-based per-project pricing, direct B2B sales via website contact forms, phone, email, and downloadable PDF sample submission forms, and same-day response to quote requests. Customers include at least 11 named enterprises across diverse regulated verticals (e.g., Xenex, VitalOxide, R-Water, Lineus Medical, Catapult Products, SelenBio, Biosafe). The company is privately held, founder-operated by Dr. Benjamin Tanner (Ph.D.), with no disclosed institutional investor backing. Recent operational moves include a 2023 grand opening of a 46,110 sq ft facility, plus 2024 launches of sterility assurance and dietary supplement testing service lines.

Name

Microchem Laboratory

Legal name

Microchem Laboratory, LLC

Website

https://microchemlab.com

Company type

Private

Founded year

1988

Operating status

Operating

Headcount range

11–50 employees

Short description

Microchem Laboratory is an FDA/EPA GLP-compliant contract testing laboratory providing microbiological and analytical chemistry services for medical device, disinfectant, cosmetic, OTC drug, and dietary supplement manufacturers from two Texas facilities.

Ownership category

akta.pro rank

Product category

Contract Microbiology and Analytical Chemistry Testing Services

NAICS

Testing Laboratories and Services (541380), Testing Laboratories and Services (54138)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility) (HLAGADAE)

akta.pro secondary industries

Environmental Monitoring & Cleanroom Testing (GMP) (HLAGADAL), Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK)

Keywords

• Contract testing services
• Antimicrobial efficacy testing
• Medical device testing
• Disinfectant testing services
• Analytical chemistry testing

Headquarters

HQ city

Round Rock

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Testing Services: Microchem Laboratory generates revenue through fee-for-service contract testing. Clients submit samples for specific tests (disinfectant efficacy, medical device testing, sterility assurance, chemistry analysis, etc.) and receive reports. Pricing is quote-based and study-dependent. Revenue is recurring per project/contract basis, with clients returning for testing across product lifecycles (R&D, registration, lot release, routine monitoring).

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Microchem Laboratory is a B2B contract testing laboratory providing GLP- and GMP-compliant microbiological and analytical chemistry testing services to companies developing disinfectants, sanitizers, medical devices, personal care products, OTC drugs, and dietary supplements. Testing supports EPA and FDA regulatory submissions, antimicrobial efficacy claim substantiation, sterility assurance, and routine quality monitoring. The lab maintains ISO/IEC 17025 accreditation and an extensive in-house collection of hundreds of microorganisms.

Product overview

Microchem Laboratory is a contract testing laboratory offering a comprehensive portfolio of microbiological and analytical chemistry testing services. The company operates two facilities (Round Rock, Texas and Dallas/Richardson, Texas) providing testing across multiple verticals including disinfectants, sanitizers, antimicrobial devices, medical devices, personal care products, OTC drugs, and dietary supplements. Core service categories include disinfectant efficacy testing, medical device testing (efficacy, cleaning validation, disinfection validation, sterility), antimicrobial testing (surface, fabric, device), OTC/dietary supplement testing (preservative efficacy, microbial enumeration), and analytical chemistry testing. The company holds ISO 17025 accreditation, GLP and GMP compliance, and is federally audited, enabling regulatory submissions to EPA and FDA.

Differentiator

Problem solved

Functional benefit

Products and services

• Disinfectant Efficacy Testing Services Comprehensive testing of disinfectants and sanitizers including AOAC Use-Dilution Test, Germicidal Spray Products Test, and EPA method compliance for product registration.
• High-Level Disinfectant Tests (FDA) FDA-required suite of antimicrobial efficacy tests for high-level disinfectant registration including in vitro tests, simulated use tests, and clinical in-use tests.
• Disinfection Validation Studies Validation studies for cleanrooms and medical device reprocessing including disinfectant qualification and validation tests for FDA compliance.
• Virucidal Efficacy Testing EPA-compliant virucidal disinfectant testing using hard surface carrier methods with mammalian cell cultures to detect virus inactivation.
• Biofilm Disinfectant Testing Biofilm disinfection testing using ASTM E3161 and E2871 methods to assess disinfectant efficacy against bacteria in biofilm matrices.
• Medical Device Testing Services Comprehensive medical device testing including efficacy testing, cleaning validations, disinfection validations, microbial ingress testing, sterility testing, and bioburden analysis.
• Medical Device Efficacy Testing Antimicrobial medical device testing for catheters, ports, and wound dressings including microbial ingress testing with bioaerosols and custom device studies.
• Medical Device Cleaning Validation Validation studies determining efficacy of cleaning procedures on medical devices using soil loads with biomarkers such as protein and hemoglobin.
• Medical Device Disinfection Validation Validation studies for medical device reprocessing and disinfection procedures testing low, intermediate, and high-level disinfection efficacy.
• Microbial Ingress Testing Evaluation of medical device ability to resist or inhibit transfer of infectious microorganisms under repeated simulated use conditions.
• Sterility Assurance Testing Comprehensive sterility testing including USP <71> sterility tests, USP <85> bacterial endotoxins, and ISO 11737 bioburden testing in a dedicated cleanroom.
• Analytical Chemistry Testing Chemistry testing services including active ingredient quantification, purity screening, stability testing, raw material verification, and regulatory compliance testing.
• Cosmetic and Personal Care Product Testing Cosmetic and personal care product testing including preservative challenge testing, stability testing, and microbial identification services for cosmetic/personal care manufacturers.
• GMP OTC Lot Release Testing FDA-registered GMP drug facility testing including USP <61> microbial enumeration, USP <62> detection of specified microorganisms, and USP <51> preservative efficacy testing.
• Dietary Supplement Testing Dietary supplement testing including USP <2021> bacteria/yeast/mold testing, USP <2022> absence of specified microorganisms, and probiotic testing.
• Materials Compatibility Testing Testing disinfectants for compatibility with materials including materials soak tests, mechanical abrasion tests, and customized compatibility assessments.
• Hand Sanitizer Testing Services Testing services for hand sanitizer products to verify efficacy and compliance with regulatory requirements.
• Antimicrobial Surface Testing Testing of antimicrobial surfaces and treated articles for efficacy against microorganisms.
• Antimicrobial Fabric and Textile Testing Testing of antimicrobial fabrics and textiles for antimicrobial efficacy.
• Antimicrobial Device Testing Testing for antimicrobial devices including antibiotic-impregnated catheters and chlorhexidine-containing devices.
• Fungal Resistance Testing Testing for fungal resistance of materials and products.
• Environmental Monitoring and Swab Studies Environmental monitoring and swab studies for cleanrooms and manufacturing facilities.
• Microbial Identification Services Microbial identification using DNA sequencing and traditional methods.
• Customized Testing Services Custom testing services tailored to specific client requirements and product needs.

Named customers12 records

Segments6 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Scale indicators3 records

Recent moves9 records

Expansion highlights6 records

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/microchemlab
• Facebookfacebook.com/Microchem-Laboratory-695380787256952
• LinkedInlinkedin.com/company/microchem-laboratory

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Microchem Laboratory