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 request our Validation Guide which contains our complete Testing Package for all RIM Bio Films, Tubing, and Components.

We utilize Toxikon USA and other registered testing labs for the following test protocols:

  • USP <87> Cytotoxicity

  • USP <88> Class VI

  • USP <661> Physico-chemical Test for Plastics

  • Additional L/E Testing and Validation

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Certified, Qualified & Gammafied

We maintain current certifications across our manufacturing floor and we back it with annual external audits.

 

Complete Validation Package for all Materials

100% Visual Inspection

100% Leak Testing

100% Gamma Sterilization

(25kGy - 50kGy)

Lot Traceability & Certificate of Compliance

GMP Compliant

On-Site Endotoxin Testing

Certified Animal Derived Component Free (ADCF)

ISO 9001:2016 Certified

Integrity Testing

ISO 7 - Class 10,000 Cleanroom