For Medical Device OEMs
FDA-Registered Contract Sterilization
We provide our EO sterilization service to OEMs under formal contract. Parametrik is the contract sterilizer of record for Olympus America’s PJF-160 rental endoscope program.
Sterilizer of Record
Olympus America — PJF-160 Rental Program
Parametrik provides terminal Ethylene Oxide sterilization for Olympus America’s PJF-160 rental endoscope program. Every scope returned through the program is processed in our FDA-registered Elmsford, NY facility, sterilized in the Andersen EOGas4, and released with full cycle documentation.
What We Offer OEMs
FDA Registration
Our Elmsford, NY facility is FDA-registered for contract sterilization. Audit-ready documentation, validated processes, full chain-of-custody.
Andersen EOGas4 Platform
21st-century EO technology — the only system FDA 510(k) cleared for terminal sterilization of duodenoscopes and colonoscopes. Near-zero emissions.
OEM IFU Alignment
Validated processes built around manufacturer Instructions for Use. We work with your reprocessing engineers to qualify cycles for new device lines.
Volume Capacity
Contract sterilization is performed at our FDA-registered Elmsford, NY facility. Our Fort Lauderdale, FL facility supports non-contract OEM sterilization work.
Documentation Package
Each load shipped with biological indicator records, cycle parameters, and traceable lot data ready for your QMS.
24-Hour SLA Available
Standard turnaround is 24 hours. Custom SLAs available under contract for time-critical fleets.
Built for OEM Quality Systems
Validated
Cycles validated to ANSI/AAMI/ISO 11135 with biological and chemical indicators per load.
Traceable
Lot-level traceability and chain-of-custody from receipt to release.
Auditable
FDA-registered Elmsford, NY facility. Records retained per regulatory requirements.
OEM partnerships start with a conversation.
Tell us about your device, your fleet, and your sterilization requirements. We’ll come back with a contract proposal.