company insight

Nelson Laboratories Pharmaceutical and Biopharmaceutical Test Services

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 testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations, container closure integrity, and USP compendia testing. We have the expertise to support this testing whether the product is terminally sterilized with Gamma, e-beam, or Ethylene Oxide. 

Additional analytical services specialized for the pharma and biopharma industries include: stability testing, Extractable/Leachable, Impurities, and heavy metals. Quality Control of APIs, starting materials, intermediates, finished products, impurities, and degradation products.

01 /  Biocompatibility & Toxicology

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 unique set of testing requirements, the biocompatibility testing experience can be intimidating. Even after a device has been categorized, a myriad of decisions for each test remains.

Generally we recommend customers perform the following for new products:

  • Biological Evaluation Plan (BEP)
  • Product Tests – Biocompatibility (in vivo, in vitro) and Chemistry (E&L)
  • Toxicological Assessment – Data summary and qualified safety assessment

02 /  Extractables & Leachables

Nelson Labs Europe offers a comprehensive approach towards Extractables / Leachables testing for the pharmaceutical industry. Our approach combines a technical and analytical expertise, polymer knowledge, understanding of regulatory requirements, all combined in a tailored approach to our customers.

Extractables & Leachables test services include:

  • E&L for Medical Devices
  • E&L for Pharmaceutical Containers
  • Impurities in Drug Components & APIs
  • Material Characterization Screens for Raw Materials
  • Physiochemical USP Plastics Tests

03 /   Sterilization Validations

Nelson Labs offers unparalleled expertise in product sterilization validations across a broad range of technologies. With the combined resources and expertise of Nelson Labs and Sterigenics, our understanding of material compatibility, sterilization science, validation approaches and cycle optimization ensure customers have a reliable, defensible validation strategy.

Sterilization Validation services offered include:

  • Filter Sterilization Validations
  • Sterilization Validations – EO

Sterilization Validations – Radiation

04 /   Sterility Assurance

Specific to pharmaceutical manufacturers, Nelson Labs provides routine USP and EP compendial tests for product sterility (isolator), bacterial endotoxin, particulate analysis, antibiotoic potency assays (APA), antimicrobial preservative efficacy studies (APE), and microbial identification services. For non-sterile pharmaceutical products such as transdermal patches we also offer routine microbial enumeration studies for objectionable organisms (USP 61/62).

05 /   Packaging Solutions

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 validations encompassing multiple product, package, and sterilization configurations throughout the medical and pharmaceutical industries. We use proven state-of-the-art technology to provide fast and accurate results.

Packaging test solutions for the pharmaceutical industry include:

  • Accelerated & Real Time Aging
  • Container Closure Integrity – Dye Immersion
  • Container Closure Integrity – Mass Extraction
  • Integrity & Strength Tests
  • Stability Studies – Pharmaceutical
  • Thermal Cycling Studies
  • Transportation and Distribution Performance
  • Whole Package Integrity Tests

05 /  Facility & Process Validation

: 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.

Test services offered for facility and process validations include:

  • Environmental Monitoring Tests
  • Environmental Monitoring Supplies
  • Filter Sterilization Validations
  • Raw Materials Screening
  • Residual Manufacturing Materials

Water System Validations

05 /   Why Choose Nelson Laboratories

Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology testing industry, offering more than 400 laboratory tests and employing more than 700 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it’s our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.

Companies choose Nelson Laboratories for our:

  • Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.
  • Customer-centric culture. We take the time to understand your vision. Your goals become our goals.
  • Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.
  • Metric-driven testing processes. We're our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turn-around time, and testing accuracy.
  • Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.

See how we can help you mitigate risk, be first to market, and succeed with your customers.

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