Nelson Laboratories LLC

About Nelson Laboratories LLC

About Nelson Labs

Expert Lab Testing & RCA Advisory Services

We are over 500 scientists, technicians and service specialists diligently performing more than 800 rigorous tests in 14 global laboratory locations.  With decades of foremost scientific and regulatory consulting expertise, we stand behind the quality of our results and the strength of our customer partnerships.

Safeguarding Global Health® - with every test we complete.

  • US
  • 2018
    On CPHI since
  • 4
  • 500 - 999
Company types
Contract Research Organisation (CRO)
Contract Service
Primary activities
Contract Research Organisation
Laboratory Services
Regulatory Affairs
Contact info
  • 6280, South Redwood Road, 84123, Salt Lake City, UT, United States
Meet us at

Pharmapack Europe 2024

Paris Expo, Porte de Versailles - Hall 7.2 | Paris, France
24 Jan 2024 - 25 Jan 2024

CPHI North America 2024

Pennsylvania Convention Center, Philadelphia
07 May 2024 - 09 May 2024

Products from Nelson Laboratories LLC (5)

  • Biocompatibility & Toxicology Testing

    Product Biocompatibility & Toxicology Testing

    Nelson Labs offers a full trifecta of services to meet the requirements of ISO 10993 for Extractables & Leachables, Biocompatibility and Toxicological Assessments of medical devices. Biocompatibility testing is very common in the medical device industry. However, with 24 possible categories, each with a u...
  • Extractables & Leachables Testing

    Product Extractables & Leachables Testing

    Nelson Labs Europe offers a comprehensive approach toward Extractables & Leachables testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined in a tailored approach for our customers.
  • Facility & Process Validation Testing

    Product Facility & Process Validation Testing

    Manufacturing facilities and processes can be a primary source of product contamination. Nelson Labs offers a range of services to assess these manufacturing environmental conditions, in addition to water system validations, raw material screening and residual manufacturing material tests.
  • Packaging Solutions Testing

    Product Packaging Solutions Testing

    We offer unparalleled breadth of packaging experience to help our clients deliver safe and effective products to market. Our services encompass consulting, package validation, material qualification and package development. Nelson Labs packaging solutions department has experience with successful valida...
  • Sterility Assurance Testing

    Product Sterility Assurance Testing

    Nelson Labs is a leading provider of sterility assurance test services for medical device, pharmaceutical and tissue manufacturers for both sterile and nonsterile products. Most tests follow United States or European Pharmacopeia (USP or EP) and similar international standards. Medical device standards are...

Nelson Laboratories LLC Resources (6)

  • Brochure Extractables & Leachables

    Benefit from our Unmatched Experience!
  • Whitepaper Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

    The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be largely realized with minimal adverse patient effects. However, since the practical reality is that drug products and medical devices contain impurities, a patient is exposed to these impurities during treatment and these impurities could potentially trigger an increase of adverse patient effects.
  • Video Nelson Labs Europe

    Nelson Labs Europe’s capabilities are complementary and additive to Nelson Labs’ existing testing portfolio and, in combination, makes Nelson Labs one of the premiere global E&L laboratory testing platforms for the pharmaceutical and medical device industries.
  • Webinar Extractables & Leachables Qualification of the Primary packaging for Biological Products

    In 2022, the final recommendations of the Product Quality Research Institute were published for Parenteral Drug Products. Apart from the wealth of information and considerations on design of extractable & leachable studies for parenteral drug products in general, it also contains valuable information on specific considerations for biological products. For biological products, not only the safety but also the quality of the product and related concerns about immunogenicity and leachables reactivity come into play. We will give an overview on the recommendations and how it affects the design of an extractable & leachable study for the primary packaging of biologics.
  • Webinar On the Origin of Extractable Species

    In this webinar, originally broadcast as part of the Pharmapack Europe show, Piet Christiaens, Scientific Director, Nelson Labs talks about the Universe of Extractables and how there are many different types of materials being used in the construct of a Container system. The impurities profile of a material is typically composed of compounds that were intentionally added to a material to protect the material during production or its life cycle or to increase performance or functionality. In this case, he is talking about polymer additives. However, there is even a longer list of compounds that are present in a material that were not intentionally added. These compounds have been introduced during the production process of the material, or they are the result of ageing of the material. The presentation will give an overview – for the most common materials used in the construct of container/closure systems or medical devices – of the main classes of compounds that are often detected in extractable studies.
  • Webinar The Necessity of Extractables & Leachables Qualifications for Lyophilized Drug Products

    When selecting and qualifying the Primary Packaging for lyophilized drug products, one of the obvious questions is “how deep should one go into the E/L-qualification process of a lyo-container”. As the drug product is in a solid state, it is expected that the interaction between the lyophilized drug product and the components of a lyo-container will be low. This is also reflected in the USP Monograph on Leachables and the EMA Guideline on “Plastic Immediate Packaging Materials” (2005). However, the mechanism of interaction between the lyo-cake and e.g. the rubber stopper (when considering a lyo vial) are not always fully understood. The interaction mechanism is based upon “outgassing” of the rubber stopper, where the lyo cake acts as an adsorbent. Not only can this lead to substantial accumulation of the volatile and semi-volatile leachable compounds onto the lyophilized drug product, it may also induce chemical reactions between the leachables and the drug product, i.e. when the adsorbed leachables show electrophilic properties. When you attend this webinar, you will have: A thorough understanding of the interaction mechanisms between a lyophilized drug product and it's container. An understanding of an Extractables and Leachables study design for a lyophilized drug product