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 offer comprehensive microbiological and analytical testing to ensure product safety and compliance.
Nelson Labs is a premier global provider of laboratory testing and expert advisory services, specializing in supporting MedTech and pharmaceutical companies. With a strong commitment to safeguarding global health, they offer comprehensive microbiological and analytical testing solutions. Their services are crucial for ensuring product safety, regulatory compliance, and successful market entry. The company emphasizes building strong customer partnerships, driven by a shared goal of improving and saving lives. Nelson Labs' expertise is recognized globally, with a track record of quality and reliability that sets them apart. They provide personalized service through a worldwide network of labs and facilities, ensuring timely turnaround and superb quality. A significant 99.4% of their sales orders come from repeat customers, highlighting their dedication to client satisfaction and long-standing partnerships. Nelson Labs' experts actively contribute to industry standards and can guide clients through the entire product development lifecycle. They offer a wide array of over 800 microbiological and analytical laboratory tests, including specialized services like accelerated aging package testing. Their Salt Lake City, Utah headquarters is an FDA-registered and ISO 17025 accredited facility, underscoring their commitment to the highest standards.
About
**Who they are**
Nelson Labs is a global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies, with its global headquarters in Salt Lake City, Utah. The Salt Lake City facility is an FDA registered and ISO 17025 accredited campus offering over 800 microbiological and analytical laboratory tests.
**Expertise & scope**
* Comprehensive microbiological and analytical testing to ensure product safety and compliance.
* Specializes in packaging and shelf-life testing, including accelerated aging and real-time aging studies.
* Expert advisory services covering regulatory and quality aspects.
* Offers testing for EU MDR compliance.
**Reputation / proof points**
* ISO 17025 accredited facility.
* FDA registered facility.
* European Center of Excellence located in Belgium.
Nelson Labs is a global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies, with its global headquarters in Salt Lake City, Utah. The Salt Lake City facility is an FDA registered and ISO 17025 accredited campus offering over 800 microbiological and analytical laboratory tests.
**Expertise & scope**
* Comprehensive microbiological and analytical testing to ensure product safety and compliance.
* Specializes in packaging and shelf-life testing, including accelerated aging and real-time aging studies.
* Expert advisory services covering regulatory and quality aspects.
* Offers testing for EU MDR compliance.
**Reputation / proof points**
* ISO 17025 accredited facility.
* FDA registered facility.
* European Center of Excellence located in Belgium.
Additional information
Nelson Labs provides accelerated aging testing as a method to simulate product deterioration and establish expiry dates, based on the Arrhenius equation. While accelerated aging meets FDA requirements for demonstrating product integrity over time, it does not replace real-time aging. Test temperatures should not exceed 60°C, with 55°C being the commonly recommended temperature in the industry. This approach is crucial for manufacturers needing to bring products to market efficiently without waiting for lengthy real-time studies. They also offer advisory services to help manufacturers determine appropriate testing combinations for their unique product, packaging, and sterilization needs.
Key Highlights
-
Offers over 800 microbiological and analytical laboratory tests.
Source
“The five-building campus offers over 800 microbiological and analytical laboratory tests.”
-
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.”
-
Provides accelerated aging testing based on the Arrhenius equation, with recommended temperatures not exceeding 55°C.
Source
“The concept behind accelerated aging testing: Increasing the temperature escalates the chemical reaction rate of the samples and results in deterioration of materials which simulates artificial aging. Every 10°C increase in temperature doubles the reaction rate. ... Test temperatures should not exceed 60°C. The temperature used most often in the industry for accelerated aging is 55°C and is the temperature Nelson Labs recommends.”
Certifications & Trust Signals
-
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.”
-
FDA registered 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.”
Buyer Snapshot
Best for
- MedTech and pharmaceutical companies
- Manufacturers needing to validate packaging and establish expiry dates
How engagement typically works
- Direct contact for testing inquiries
- Customer portal for sample submission and status updates
Typical deliverables
- Microbiological and analytical test reports
- Accelerated and real-time aging study results
- Regulatory and quality advisory reports
Good to know
- Best when requiring ISO 17025 accredited and FDA registered laboratory services.
HQ:
Salt Lake City, US
Languages:
English
Timezones:
America/Denver
Status:
listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States, Mexico, Europe, Asia
Industries:
Medical Devices
Packaging Tests Offered:
Package integrity, Seal strength
Shelf Life Methods Offered:
Accelerated aging, Real-time aging, Both
Distribution Tests Offered:
Vibration, Drop
Standards Supported:
FDA Guidance
Is Accredited:
Yes
Accreditation Body:
ISO 17025
Regions Served:
Global, Europe
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Package integrity, Strength, Microbial barrier, Distribution testing, Accelerated aging, Real-time aging
Standards Supported
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices, FDA Guidance
Shelf Life Methods Offered
Accelerated aging, Real-time aging, Both
Distribution Tests Offered
Package distribution testing
Lead Time Band
Start in 4-8 weeks
Quote SLA
24-48 hours
Sample Return Policy
Dispose
Minimum Project Size
$25-50k
Pricing Model
Custom
