Biocompatibility & Toxicology Testing
Product Description
Nelson Laboratories LLC
-
US
-
2018On CPHI since
-
4Certificates
-
500 - 999Employees
Company types
Primary activities
Categories
Specifications
Nelson Laboratories LLC
-
US
-
2018On CPHI since
-
4Certificates
-
500 - 999Employees
Company types
Primary activities
More Products from Nelson Laboratories LLC (4)
-
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. -
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. -
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... -
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 (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.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance