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:
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USP <87> Cytotoxicity
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USP <88> Class VI
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USP <661> Physico-chemical Test for Plastics
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Additional L/E Testing and Validation

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