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 Laboratories LLC

  • US
  • 2018
    On CPHI since
  • 4
    Certificates
  • 500 - 999
    Employees
Company types
Academic/Research
Contract Research Organisation (CRO)
Contract Service
Primary activities
Contract Research Organisation
Laboratory Services
Regulatory Affairs
Specifications
  • Supplied from
    Belgium; United States

Nelson Laboratories LLC

  • US
  • 2018
    On CPHI since
  • 4
    Certificates
  • 500 - 999
    Employees
Company types
Academic/Research
Contract Research Organisation (CRO)
Contract Service
Primary activities
Contract Research Organisation
Laboratory Services
Regulatory Affairs

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Nelson Laboratories LLC resources (4)

  • Brochure Extractables & Leachables

    Benefit from our Unmatched Experience!
  • Webinar A Risk-Based Approach Towards the Assessment of Process-Equipment Related Leachables - Case Study

    Manufacturing processes are composed of a complex set of plastic materials that may introduce process-equipment related leachables (PERLs) into the final drug product, thereby potentially compromising its biocompatibility, safety or quality. At the same time, not all manufacturing components have the same likelihood to contribute to PERLs. A risk-based approach in which process conditions, type of process material and composition of the process solution are evaluated, allows the definition of relevant test requirements with respect to extractables and leachables. In this presentation, you'll have the opportunity to explore the main principles of a risk-based evaluation through a case study.
  • 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.