Consultants Directory on Medical Device Link Index

Nelson Laboratories Inc.

6280 S. Redwood Rd.
Salt Lake City, UT 84123
Tel: 801/963-2600
Fax: 801/963-2630

Contact: Brandon Tillman
Year Established: 1985
No. of Employees: 230+

Web: http://www.nelsonlabs.com
E-mail: sales@nelsonlabs.com

World-Class Lab Services Offered by Nelson Laboratories
Nelson Laboratories is a premiere test services provider. Our services include more than 400 microbiological and analytical tests in our state-of-the-art laboratory (Lab Tour). The firm is FDA Registered and third-party certified to ISO 9001 and ISO 17025 and maintains a full-time training manager in addition to our Quality Assurance and Quality Control departments to ensure cGMP/cGLP compliance throughout all test systems.

Major Services
Nelson Laboratories is an independent test services provider specializing in: microbiology, sterilization validations, lot release tests (sterility, bioburden, B/F, pyrogen, particulates, etc.), biocompatibility, organism identification, residuals, filter validations, and much more. Within our 62,000 sq. ft. facility we maintain 80 labs, a custom-built 3,000 sq. ft. sterility testing cleanroom suite. Nelson employs more than 300 staff members, including more than 110 degreed scientists among whom are 45+ registered and specialist microbiologists (NRM).

Test reports have been submitted to government agencies in the United States of America (USA), including U.S. Food and Drug Administration (FDA) and U.S. Environmental Protection Agency (EPA). In addition, Nelson Labs has clients who submit our results to many international government agencies. More than 2,500 companies in over 50 countries trust our test services. Our constant goal has been to maintain the highest in quality testing services and technical expertise.

Medical Device Testing

For the medical device industry Nelson specializes in a range of tests for facility validation, raw materials screening, sterilization and packaging validations, biocompatibility, cleanroom and isolator facilities, routine quality control tests, and reusable device studies.

Facility and Process Validation Testing

Nelson Laboratories, Inc. performs environmental studies, which include water system validations, cleanroom validations, disinfectant studies and environmental monitoring.

Barrier Material Testing

The Aerobiology/Barrier Section at Nelson Laboratories specializes in testing of materials and medical devices which are designed to provide protection against biological exposures. Filtration efficiency tests are commonly performed to evaluate filter media for aerosol filtration.

Toxicology & Biocompatibility Testing

The Biocompatibility Section performs tests to predict how the body will react to product contact. Nelson Labs perform tests required under the ISO Biocompatibility Guideline, including cytotoxicity, hemocompatibility, mutagenicity and pyrogenicity. Nelson Labs has provided a matrix to help clients decide what biocompatibility testing is needed/recommended.

Reusable Device Testing

Nelson Laboratories validates product-specific cleaning, sterilization and disinfection procedures for reusable devices. By simulating clinical use, we assist our sponsors in developing reliable procedures for cleaning and disinfecting or sterilizing their devices between patient use. We can design comprehensive validation programs, complete with biocompatibility evaluations and multiple simulated reprocessing.

EO & Sterilization Validation Testing

The Sterilization Section specializes in the industrial sterilization of medical devices. This includes those sterilized using ethylene oxide, vapor phase hydrogen peroxide, steam, and radiation.

Radiation Sterilization Validation Testing

Nelson Laboratories provides services for both radiation validation and routine dose audits. Each radiation validation study includes all protocol, dose calculation, and final report fees. An initial bacteriostasis/fungistasis test is required to validate sterility tests.

Package Testing

Nelson Laboratories specializes in package integrity testing and has developed test methods for this testing. The basis for package testing is to help the manufacturer in the development and validation of their packaging operations.

Product Validation & Lot Release Testing

For testing pre- and post- sterilization of product, Nelson Laboratories, Inc. has a wide range of microbiological and analytical test services. Most routine quality control tests are started within 24 hours and preliminary results are available to assist the client with improving lead time on product.

Microbial Identification Testing

Identifying microorganisms can be a very difficult task. They are not all alike. There is not one system that can identify all microorganisms. Every system has its strong points and weaknesses. Sometimes additional testing is needed because one system failed to name an organism. Other times additional testing is needed to confirm that the name given is correct Nelson Laboratories has worked hard to put together different systems that will complement each other and work together to give the best IDs. These tests include the Vitek® 2 Compact identification system, Gram Stain, mold identification, MIDI Identification system, API strips and other biochemical tests.

Microbiological Analysis Testing

Testing includes Microbial Limits Testing, Antimicrobial Preservative Efficacy (APE) testing, Antibiotic Potency Assays, Plate Counts and Growth Promotion testing.

Disinfectant Testing

Validation of sanitizing agents for effectiveness against organisms found in cleanroom environments.

General Analytical Testing

The Chemistry Section specializes in materials characterizations using infrared spectroscopy (FTIR) and gas chromatography (GC) methods. We can also evaluate physicochemical properties and ethylene oxide residuals on products.

Categories this company is listed under in the Consultants Directory on Medical Device Link:

• Biocompatibility/Toxicology (7 companies)
• Europe: Marketplace/ Regulations (25 companies)
• Failure Analysis (13 companies)
• Good Manufacturing Practices/Compliance (53 companies)
• Outsourcing Services (22 companies)
• Packaging (14 companies)
• Quality Assurance (47 companies)
• Sterilization (14 companies)
• Testing (25 companies)