At Nelson Labs we have a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: Sterility (USP 71) testing in a cleanroom for isolator environment, particulates (USP 787, 788) testing using a variety of methods, bacterial endotoxin, filter validations, container closure integrity, and USP compendial testing. We have the expertise to support this testing whether the product is terminally sterilized with Gamma, e-beam, or EO.
Additional analytical services specialized for the pharma and biopharma industry include: stability testing, E/L, Impurities, and heavy metals. Quality Control of APIs, starting material, intermediates, finished products, impurities, and degradation products.
We can help to support your facility with environmental and water system testing and validate cleaning processes inside the clean room. Together with our sister company Sterigenics, we can help you evaluate alternatives to aseptic processing with a variety of terminal sterilization methods.
We are over 700 scientists, technicians, and service specialists diligently performing more than 400 rigorous tests in 11 global laboratory locations. With decades of foremost expertise, we stand behind the quality of our results and the strength of our customer partnerships.
- Biocompatibility & Toxicology – We offer a full range of material assessments using chemical characterization, in vivo and in vitro test services to meet US FDA, EU CE mark Japan MHLW and other international requirements.
- Extractables & Leachables – Our approach combines a technical and analytical expertise, polymer knowledge, understanding of regulatory requirements, all combined in a tailored approach to our customers.
- Sterilization Validations – Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.
- Sterility Assurance – Most tests follow United States or European Pharmacopeia (USP or EP) and similar international standards. Sterilized medical devices standards are also found in ISO, AAMI and ASTM guidance documents.
- Packaging Solutions – Our services encompass consulting, package validation, material qualification, and package development.
- Facility & Process Validation – 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.
- Other Services & Method Development – Nelson Labs offers a number of unique tests for product verification, validation, performance testing and material properties.