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 MedTech and pharmaceutical companies. They specialize in sterilization and microbiology testing, offering end-to-end solutions to ensure product safety and compliance.

**Expertise & scope**
* Specializes in sterilization and microbiology testing.
* Offers end-to-end solutions for product safety and compliance.
* Provides sterilization validation services, including Ethylene Oxide (EO) Sterilization Validation.
* Offers RapidCert™ BI testing, reducing BI incubation time to 48 hours.
* Experts are 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.
* Performs over 800 microbiological and analytical laboratory tests.

**Reputation / proof points**
* Global headquarters located in Salt Lake City, Utah.
* European Center of Excellence located in Belgium.
* The Salt Lake City, Utah facility is FDA registered and ISO 17025 accredited.

Additional information

Nelson Labs provides comprehensive support for product safety and compliance, extending from initial sample submission through to final report completion. They offer advisory services, including testing, regulatory, and quality advisory, to guide manufacturers through complex validation processes. Their expertise in ethylene oxide sterilization validation is particularly noted, with specialists available to assist with protocol generation, pre-validation testing, cycle development, routine monitoring, and revalidation requirements. For clients seeking rapid results, their RapidCert™ BI testing significantly reduces incubation time. The company also facilitates sample submission and provides customer support for various inquiries, including testing status updates and questions about results.

Key Highlights

  • Specializes in sterilization and microbiology testing for MedTech and pharmaceutical industries. Source
    “They specialize in sterilization and microbiology testing, offering end-to-end solutions to ensure product safety and compliance.”
  • Offers RapidCert™ BI testing, reducing 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.”
  • Global headquarters in Salt Lake City, Utah, 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.”
  • Actively involved in developing industry standards for sterilization. Source
    “Nelson Labs experts have performed Ethylene Oxide Sterilization Validations in the U.S. and around the world. 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.”

Certifications & Trust Signals

  • 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 companies requiring sterilization and microbiology testing.
  • Pharmaceutical companies needing product safety and compliance assurance.
  • Manufacturers seeking validation for sterilization processes, especially Ethylene Oxide (EO).
How engagement typically works
  • Direct engagement for testing services.
  • Collaborative partnership for validation processes.
  • Advisory services for regulatory and quality guidance.
Typical deliverables
  • Sterilization validation reports.
  • Microbiology testing results.
  • Expert advisory opinions.
  • Compliance documentation support.
Good to know
  • Best when requiring specialized sterilization and microbiology testing expertise.
  • Best when needing to ensure product safety and regulatory compliance.
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), Other
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
Ethylene Oxide (EO), Steam (Moist Heat), Gamma Radiation, E-Beam, X-Ray, Plasma, Vaporized Hydrogen Peroxide
Validation Types Offered
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring, Biological Indicators (BIs)
Lead Time Band
Start in 4-8 weeks
Quote SLA
24-48 hours
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Custom
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