Nelson Labs
Nelson Labs, a Sotera Health company, is an industry-leading global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.
With the addition of Nelson Labs Europe, we are a leading global extractables and leachables lab testing platform. We have over 500 scientists, technicians, and service specialists who diligently performing more than 800 rigorous tests in 14 global laboratory locations. With decades of expertise, we stand behind the quality of our results and the strength of our customer partnerships.
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Вопросы переработки при разработке конструкции многоразовых медицинских изделий
Sterilization by Filtration: Validating Filtration for an Aseptic Process
Beyond Biocompatibility: 10993-1 & FDA Expectations for Particulate Evaluation in Vascular Devices
A Dive into Disinfection Validations of Non-critical Devices
How to Address These Updates for Existing Products and In-Process Submissions
Updates to USP Class VI Impacting Medical Device Materials
Updates Coming to ISO 10993 1
Always Inspection-Ready: Mastering FDA Inspection Preparation and Response
ISO 10993-1 Panel Discussion: Preparing for Updates in the New FDIS
Qualification of Primary Container/Closures for Parenteral and Ophthalmic Drug Products
Reprocessing Rethought: Effective cleaning and sterilization of robotic devices
Navigating the New USP Class VI: Going Animal Free in Medtech
Microbiological Updates to 11137-1:2025. Demonstrating Stability in Bioburden Numbers and Types
Updates to ISO 10993-1: Focus on Foreseeable Misuse
Rapid Sterility Testing: Enhancing Compliance, Efficiency, and Accuracy
Nelson Labs Salt Lake City Headquarters
Approach to Cleaning Validations for Single-Use 3D Printed Devices in Healthcare facility
Reprocessing Rethought: An Open Forum Discussion On Novel Decontamination Methods for Reusables
Discoveries on Applying the New ISO 10993 17
Toxicological Safety Assessment of Process Equipment-Related Leachables in the context of USP (665)
Good Identification Practices in Non-Targeted Screening Analyses
Assuring Viral Safety of the Biopharmaceutical Process
Potential Designs for Leachable Studies on Biopharmaceutical Manufacturing Equipment
Extractables Testing of Bioprocessing Materials
Assisting Companies in the Qualification of Single-Use Materials
USP 665 и 1665 Экстрагируемые компоненты для фармацевтического и биофармацевтического производства
Leachable Risk Assessment Approaches:
Qualification of Single Use Materials for Biopharmaceutical Manufacturing