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Assurance of Sterility

With the implementation of the European Union (EU) Medical Device Regulation (MDR), many medical devices have been reclassified into categories that are more conservative than in the past. Nelson Labs can help medical device manufacturers perform testing to define the sterilization process, develop and execute sterilization validation protocols, map the required ancillary tests needed to validate a sterilization process, and ensure ongoing sterilization process monitoring and control. When necessary, Nelson Labs can provide clinical batch release processing to help manufacturers obtain batches of sterilized medical devices for small-scale clinical use (e.g. clinical trials).

The following services are available to help manufacturers as they navigate from medical device design to conformity assessment phases:

Process Definition

Nelson Labs can help manufacturers perform the testing required to define the sterilization process for medical devices. Our testing services that help with process definition include comparative resistance testing, bioburden resistance testing, bioburden characterization, d-value testing of biological indicators and bioburden isolates, bioburden organism identification, functionality exposures, and other non-routine test services.

Sterilization Validations

Nelson Labs can help develop sterilization validation protocols and manage sterilization validation activities according to the MDR. Nelson Labs offers validation for multiple sterilization modalities, which include:

 
Gamma E-BeamEthylene OxideMoist HeatNitrogen DioxideNon-traditional

Ancillary Test Services

Nelson Labs testing services include the ancillary testing required to validate a sterilization process and to ensure ongoing sterilization process monitoring and control. Testing services include:

  • Bioburden Enumeration and Characterization
  • Endotoxin Testing
  • Ethylene Oxide (EO) residuals
  • Organism Identification
  • Product Sterility
  • Sterility Method Assessment
  • Biological Indicator Sterility Testing
  • Process Challenge Devices
  • Temperature and Humidity Profiling

 

Clinical Batch Release

Clinical Batch Release is a commonly used solution for delivering sterile product for clinical trials when the device design is not final and a full validation is not required. This service is often referred to as a “mini-validation” as it follows the same process, but with a reduced scope. We can help you determine if the sterilization modality you use allows for the sterilization of small batches of product.

Contact us today at +1(801) 290-7500 or advisoryservices@nelsonlabs.com.