Material Validation

 

As part of our Quality System, all Film, Tubing, and Components must be compliant with industry standard bio-compatibility tests.   We require toxicity test data from all our outside component suppliers and RIM Bio conducts its own testing on our proprietary NxFlex® Films.  All NxFlex® Films undergo extensive physical and biocompatibility testing before release.

Please refer to our Validation Guide which contains our complete Testing Package for all RIM Bio Films, Tubing, and Components

We utilize Toxikon USA as our testing lab for the following test protocols:

  • USP <87> Cytotoxicity
  • USP <88> Class VI
  • USP <661> Physico-chemical Test for Plastics

All our single-use products must meet the following Quality standards:

  • Complete Validation Package for all materials
  • 100% Leak Testing
  • 100% Visual Inspection
  • Integrity Testing
  • Endotoxin Testing
  • Gamma Sterilization (25kGy – 50kGy)
  • Certified No Animal Derived Components (ADCF)
  • Lot Traceability and Certificate of Compliance (COC)

No Animal Derived Components (ADCF)

All films, Tubing, and Components used in the production of these containers are certified to be Animal Derived Component Free (ADCF)

Endotoxin Testing

We conduct Endotoxin testing in our own test lab to ensure that our customers receive clinically sterile single-use products.  We perform Limulus Amebocyte Lysate (LAL) testing using the Charles River Endosafe® Test.