Industry: Medical Device

Facility and Process Validation (3 test sets)

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

Barrier Material Tests (4 test sets)

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 (9 test sets)

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. Click here for the matrix.

Reusable Device Studies (4 test sets)

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 & Steam Sterilization Validation (8 test sets)

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 (3 test sets)

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 (2 test sets) (14 tests)

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

Product Validation & Lot Release Testing (6 test sets)

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 (5 tests)

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 (4 test sets) (1 test)

Disinfectant Tests (10 tests)

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