Nelson Labs

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.

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.

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 significant part of recent pharmaceutical products are combination devices, for which the packaging also serves as delivery system for the drug product to the patient. Impurities may be released from these polymeric systems (extractables) and may end up in the drug product (leachables) and as such pose a safety risk to the patient. In this presentation, an overview of different types of combination devices will be given, followed by a discussion on the importance of extractables and leachables testing. The regulatory landscape (and relevant guidelines) will be discussed for both EU and US markets. Lastly, relevant parameters for these studies such as extraction time, temperature and extraction solvents will be reviewed, while these will also be demonstrated in a practical case study.