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At Nelson Labs we perform a variety of tests to support chemistry, manufacturing, and controls (CMC) for pharmaceutical and biopharmaceutical products from drug development through commercialization and life-cycle management.

We can support your internal quality processes, including sterility (USP 71) testing in a cleanroom or isolator, particulates (USP <787> and USP  <788>) testing using a variety of methods, bacterial endotoxin, filter validations, container closure integrity testing (CCIT), and USP compendial testing. We have the expertise to support this testing whether the product is terminally sterilized with gamma, e-beam, or ethylene oxide (EO).

We also provide analytical services, such as stability studies, stress studies, organic impurities identification and characterization, and testing for extractables and leachables (E&L) and elemental impurities (USP <232> and USP <233>).

Additionally, we provide quality control of active pharmaceutical ingredients (APIs), starting material, intermediates, finished products, impurities, and degradation products.

View any of the fact sheets listed below to learn how we can support commonly required tests for pharmaceutical and biopharmaceutical products .

We can also help to support your facility with environmental and water system testing and validate cleaning processes inside the cleanroom. Together with our sister company Sterigenics, we can help you evaluate alternatives to aseptic processing with a variety of terminal sterilization methods.

We have a long history of partnering with pharmaceutical and biopharmaceutical companies. We have over 700 scientists, technicians, and service specialists performing the tests listed above in multiple labs around the world. With our decades of expertise we stand behind the quality of our results and the strength of our customer partnerships.

Learn more about the major testing categories for pharma and biopharma below.


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.

Test Services