Sterility Assurance Testing

Sterility Assurance Testing
Product Description

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 also found in ISO, AAMI and ASTM guidance documents.

Nelson Labs, LLC

  • US
  • 2018
    On CPhI since
  • 4
  • 500 - 999
  • Supplied from
    Belgium; United States

Nelson Labs, LLC

  • US
  • 2018
    On CPhI since
  • 4
  • 500 - 999

More Products from Nelson Labs, LLC

  • 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 unique set of testing requirements, the biocompatibility testing experience can be intimidating. Even after a device has been categorized, a myriad of decisions for each test remains. Generally we recommend customers perform the following for new products:
    • Biological Evaluation Plan (BEP)
    • Product Tests – Biocompatibility (in vivo, in vitro) and Chemistry – Extractables & Leachables (E&L)
    • Toxicological Assessment – Data summary and qualified safety assessment
    The biocompatibility team at Nelson Labs will work with you to develop a comprehensive testing plan that’s right for your product. We will also partner with you th
  • 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 validations encompassing multiple product, package and sterilization configurations throughout the medical and pharmaceutical industries. We use proven state-of-the-art technology to provide fast and accurate results.

Nelson Labs, LLC resources

  • Brochure Extractables & Leachables

    Benefit from our Unmatched Experience!
  • Brochure Pharmaceutical Test Services

    Nelson Laboratories pharmaceutical test services.
  • Brochure Identifying Unexpected Impurities In Drug Products

    Nelson Labs can help you identify unexpected impurities in drug products. Download our brochure and find out how we can assist you
  • Brochure Services for the pharmaceutical & medical device industries

    Download our brochure and find out what services we provide for the pharmaceutical & medical device industry
  • Brochure Pharmaceutical Solutions

    Read up on the pharmaceutical solutions we provide in our brochure
  • Brochure Why Choose Nelson Laboratories?

    Download our brochure and find out how we help safeguarding global health with every test we complete
  • 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.
  • Whitepaper When Drug Meets Device...

    When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility between the components can present a danger to the patient, but how can one demonstrate the fit between a medicinal product and a device? This paper describes the relevant definitions, the existing regulatory framework for combined products (or better the lack thereof), and focuses on stability testing to assess drug or biological-device compatibility.
  • 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.
  • Video The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

    The webcast will explain the outgassingmechanism of the lyo-stoppers, which may lead to further accumulation of leachables adsorbed onto the lyo-cake. In addition, an experimental testing strategy will be explained that covers both the discovery, identification, and quantification of those leachables, as well as the formation of secondary leachables through chemical reactions between these reactive leachables and the drug product and its ingredients.
  • Video Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems

    In the past decade, scrutiny has changed in the way EMEA or FDA regulators look at Extractables & Leachables data. Requirements gradually increased without official guidance, which left the Pharmaceutical Industry in the dark. Second-guessing the current position and requirements of regulators to support a submission became the norm. This presentation will address the following: Key success factors of E&L projects. An understanding of what regulators want and how to meet expectations. Facing the reality of the ever-evolving regulatory landscape, analytical testing labs need to be at the forefront with expertise in the field of Extractables and Leachables testing and state-of-the-art technology. Meeting development needs and requirements for the pharma industry and raising the bar for material suppliers. Mitigating risk through successful partnering between drug product vendors, material suppliers and the CRO performing the test. This webinar originally aired as part of Pharmapack Europe 2021
  • Video Where N-Nitrosamine Assessments for Drug Products Meet Extractable / Leachable Qualifications for Pharmaceutical Primary Packaging

    Recently there have been a number of drug product recalls due to the unexpected presence of N-Nitrosamines. While in most of those cases, N-Nitrosamine formation occurred at the level of the drug substance synthesis and stability, it is well known and documented that some materials, used in primary packaging can also be a source for NNitrosamine contamination of the packaged drug product (e.g. older grade elastomers and nitrocellulose laminated blister foils). The unanswered question is: do we know everything about the materials of construction of a container closure system and their ability to generate N-Nitrosamines? This presentation will offer insights into how an integrated approach for the N-Nitrosamine risk evaluation for a pharmaceutical container closure system could look like.This webinar originally aired as part of Pharmapack Europe 2021

Recommended products