Nelson Labs
Nelson Laboratories, LLC
★★★★★
3.2
/ 5
•
11 reviews
Nelson Labs is a leading global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies. They specialize in sterilization and microbiology testing, offering end-to-end solutions to ensure product safety and compliance.
Nelson Labs is a premier global provider of comprehensive laboratory testing and expert advisory services tailored for MedTech and pharmaceutical industries. With a strong focus on safeguarding global health, they offer end-to-end solutions, ensuring product safety and regulatory compliance through rigorous testing and expert guidance. Their expertise spans critical areas such as sterilization validation, including Ethylene Oxide (EO) and Radiation methods, as well as sterility verification for single-use systems. Nelson Labs is deeply involved in setting industry standards, with experts contributing to committees that shape testing protocols. They provide personalized service, leveraging a worldwide network of labs and facilities to deliver timely, high-quality results. The company is committed to building strong customer partnerships, evidenced by a high rate of repeat business. They understand the unique challenges faced by their clients and offer specialized advisory services to guide products through their development lifecycle. Nelson Labs also provides resources like seminars and downloadable brochures to further support their clients' needs in achieving successful testing outcomes and market compliance.
About
**Who they are**
Nelson Labs is a global provider of laboratory testing and expert advisory services for medical technology and pharmaceutical companies. They are headquartered in Salt Lake City, Utah, with an additional European Center of Excellence in Belgium.
**Expertise & scope**
* Specializes in sterilization and microbiology testing, offering end-to-end solutions.
* Expertise in Ethylene Oxide (EO) Sterilization Validation, including protocol generation, pre-validation testing, cycle development, routine monitoring, and revalidation.
* Offers RapidCert™ BI testing, reducing incubation time to 48 hours for Biological Indicators.
* Provides laboratory testing and advisory services for MedTech and pharmaceutical sectors.
* Conducts over 800 microbiological and analytical laboratory tests.
**Reputation / proof points**
* The Salt Lake City, Utah facility is FDA registered and ISO 17025 accredited.
* Actively involved in developing industry standards, including AAMI/ST/WG 01, AAMI/ST/WG 04, AAMI/ST/WG 63, AAMI/ST/WG 91, and AAMI/ST/WG 92.
Nelson Labs is a global provider of laboratory testing and expert advisory services for medical technology and pharmaceutical companies. They are headquartered in Salt Lake City, Utah, with an additional European Center of Excellence in Belgium.
**Expertise & scope**
* Specializes in sterilization and microbiology testing, offering end-to-end solutions.
* Expertise in Ethylene Oxide (EO) Sterilization Validation, including protocol generation, pre-validation testing, cycle development, routine monitoring, and revalidation.
* Offers RapidCert™ BI testing, reducing incubation time to 48 hours for Biological Indicators.
* Provides laboratory testing and advisory services for MedTech and pharmaceutical sectors.
* Conducts over 800 microbiological and analytical laboratory tests.
**Reputation / proof points**
* The Salt Lake City, Utah facility is FDA registered and ISO 17025 accredited.
* Actively involved in developing industry standards, including AAMI/ST/WG 01, AAMI/ST/WG 04, AAMI/ST/WG 63, AAMI/ST/WG 91, and AAMI/ST/WG 92.
Additional information
Nelson Labs offers comprehensive sterilization validation services, including Ethylene Oxide (EO) Sterilization Validation, which is crucial for ensuring product safety and compliance with national and international standards like ANSI/AAMI/ISO 11135. They guide clients through the entire validation process, from protocol generation to final report completion. Their expertise extends to Biological Indicators (BIs) and RapidCert™ BI testing for faster results. For those seeking to enhance their understanding of sterile medical device validation, Nelson Labs hosts seminars, such as the 'Validation of Sterile Medical Devices' event in Salt Lake City, taught by industry-leading advisors.
Key Highlights
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Offers RapidCert™ BI testing, reducing Biological Indicator incubation time to 48 hours.
Source
“Nelson Labs now offers RapidCertTM BI testing, reducing the BI incubation time to 48 hours.”
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Actively involved in developing industry standards for sterilization.
Source
“We’re actively involved in developing the standards that govern testing including: AAMI/ST/WG 01 committee working group for industrial EO sterilization, AAMI/ST/WG 04 biological indicators, AAMI/ST/WG 63 sterilization residuals, AAMI/ ST/WG 91 resistometer and AAMI/ST/WG 92 process challenge devices.”
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The Salt Lake City, Utah facility is FDA registered and ISO 17025 accredited.
Source
“The Salt Lake City, Utah location is the global headquarters of Nelson Labs. It is a U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited facility.”
Certifications & Trust Signals
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ISO 17025 accredited facility in Salt Lake City, Utah.
Source
“The Salt Lake City, Utah location is the global headquarters of Nelson Labs. It is a U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited facility.”
-
FDA registered facility in Salt Lake City, Utah.
Source
“The Salt Lake City, Utah location is the global headquarters of Nelson Labs. It is a U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited facility.”
Buyer Snapshot
Best for
- MedTech and pharmaceutical companies requiring sterilization and microbiology testing.
- Organizations needing Ethylene Oxide (EO) Sterilization Validation services.
- Companies seeking expert advisory on product safety and compliance.
How engagement typically works
- Direct engagement for testing and advisory services.
- Partnership for validation process guidance.
- Seminar participation for knowledge enhancement.
Typical deliverables
- Sterilization validation reports (e.g., EO Sterilization Validation).
- Microbiology testing results.
- Expert advisory on regulatory compliance.
- RapidCert™ BI testing reports.
Good to know
- Best when requiring specialized sterilization and microbiology testing expertise.
Pricing
Model:
Per project
HQ:
Salt Lake City, US
Languages:
English
Status:
listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, Mexico, Europe, Asia
Industries:
Medical Devices
Sterilization Methods Supported:
EtO (Ethylene Oxide)
Validation Types Offered:
Full validation (IQ/OQ/PQ), Revalidation, Other
Microbiology Tests Offered:
Sterility, Other
Standards Supported:
ISO 11135 (EtO), ISO 11138 (Biological indicators)
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
Ethylene Oxide (EO)
Validation Types Offered
Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered
Biological Indicators (BIs), RapidCert™ BI testing
Lead Time Band
Start in 4-8 weeks
Quote SLA
24-48 hours
Sample Return Policy
Dispose
Minimum Project Size
$50k+
Pricing Model
Per project
