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.
**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 for reduced incubation times.
* Provides a wide range of microbiological and analytical laboratory tests.
* Active involvement in developing industry standards, including those for industrial EO sterilization, biological indicators, sterilization residuals, resistometers, and process challenge devices.
**Reputation / proof points**
* Global headquarters located in Salt Lake City, Utah.
* European Center of Excellence located in Belgium.
* Salt Lake City facility is FDA registered and ISO 17025 accredited.
* Offers over 800 microbiological and analytical laboratory tests.
Nelson Labs is a global provider of laboratory testing and expert advisory services for medical technology and pharmaceutical companies.
**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 for reduced incubation times.
* Provides a wide range of microbiological and analytical laboratory tests.
* Active involvement in developing industry standards, including those for industrial EO sterilization, biological indicators, sterilization residuals, resistometers, and process challenge devices.
**Reputation / proof points**
* Global headquarters located in Salt Lake City, Utah.
* European Center of Excellence located in Belgium.
* Salt Lake City facility is FDA registered and ISO 17025 accredited.
* Offers over 800 microbiological and analytical laboratory tests.
Additional information
Nelson Labs provides comprehensive sterilization and microbiology testing services, with a particular focus on Ethylene Oxide (EO) Sterilization Validation. They guide manufacturers through the entire validation process, from protocol generation to final report completion, ensuring compliance with national and international standards like ANSI/AAMI/ISO 11135. Their services extend to routine lot release monitoring and revalidation requirements. For clients needing rapid results, Nelson Labs offers RapidCert™ BI testing, significantly reducing incubation times. They also emphasize their involvement in developing industry standards, showcasing deep technical expertise and a commitment to advancing the field.
Key Highlights
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Global headquarters in Salt Lake City, Utah, with an FDA registered and ISO 17025 accredited facility.
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.”
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Specializes in Ethylene Oxide (EO) Sterilization Validation, supporting manufacturers from protocol to final report.
Source
“Nelson Labs specializes in ethylene oxide sterilization validations, and we can partner with you as well as many contract sterilization facilities through the entire process from protocol generation to final report completion.”
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Offers RapidCert™ BI testing, reducing biological indicator incubation time to 48 hours.
Source
“The BI sterility test is performed on exposed BIs after completion of a sterilization load through either a validation or routine lot release monitoring. 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 and biological indicators.
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...”
Certifications & Trust Signals
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ISO 17025 accredited facility in Salt Lake City.
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.
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 companies requiring sterilization and microbiology testing.
- Pharmaceutical companies needing product safety and compliance assurance.
How engagement typically works
- Direct engagement for testing services.
- Expert advisory for process development and validation.
Typical deliverables
- Sterilization validation reports.
- Microbiology testing results.
- Expert advisory consultations.
Good to know
- Best when requiring specialized sterilization and microbiology testing expertise.
HQ:
Salt Lake City, US
Languages:
English
Timezones:
America/Denver
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, Mexico, Europe, Asia
Industries:
Medical Devices
Pricing model:
Per project
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
Is Accredited:
Yes
Accreditation Body:
ISO
Regions Served:
U.S., Europe
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
24-48 hours
Sample Return Policy:
Dispose
Minimum Project Size:
$25-50k
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
EtO (Ethylene Oxide), Radiation Validation method
Validation Types Offered
Ethylene Oxide (EO) Sterilization Validation, Sterility Verification
Microbiology Tests Offered
Microbiology testing, Biological Indicators (BIs), RapidCertTM 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
