EO Sterilization
ServicesEO SterilizationEthylene Oxide (EO or EtO) sterilization is the routine process of using disinfectant gasses to sterilize a diverse range of life sciences products. Infinity Laboratories provides high-quality, fast turnaround contract EO sterilization and validation services for medical device and pharmaceutical companies using 3M pure EO sterilizers. Our team assists in eliminating microbial risks for heat and moisture-sensitive medical devices with robust solutions before, during, and after sterilization.
Ethylene Oxide (EO or EtO) sterilization is the routine process of using disinfectant gasses to sterilize a diverse range of life sciences products. Infinity Laboratories provides high-quality, fast turnaround contract EO sterilization and validation services for medical device and pharmaceutical companies using 3M pure EO sterilizers. Our team assists in eliminating microbial risks for heat and moisture-sensitive medical devices with robust solutions before, during, and after sterilization.
Four-Step EO Sterilization Process
Infinity offers a fast turnaround time for contract sterilization, typically 1–2 business days, and our team will work with you to develop a sterilization process that fits your medical device or pharmaceutical product. All sterilization procedures at Infinity are performed in adherence to ISO 11135 and CFR 820 standards.
The EO sterilization process itself follows four distinct steps:
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EO concentration -
Humidity
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Temperature
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Time of exposure
Infinity will execute all four steps of sterilization optimized to your unique needs. We will also provide robust analytics with our 3M Rapid Readout BIs and have seven 3M chambers available. As your laboratory partner, our service extends beyond just sterilization to validation.
Sterilization and Microbiology Validations
Whether you are developing a stent, catheter, complex device, custom kit, equipment with integrated electronics, using single-use bioprocessing equipment, or other life sciences products, Infinity will support you with sterilization and microbiology validations necessary to go to market. In compliance with ISO 11135 and CFR 820 standards, our team will perform cycle development and validation studies in our 3M EO sterilizers to ensure the smooth sterilization of your life science product.
Sterilizer and microbiology validations are equally as crucial as sterilization in ensuring the safe consumption of your pharmaceutical or medical device product. Infinity’s full suite of validation services for EO sterilization includes:
- Sterilization process development
- PQ protocol and final report preparation
- Sterilization process validation
- Full validation qualification
- Batch release qualification
- Pre-conditioning qualification
- Aeration qualification
- PCD qualification
- Product validation support
- Validation requirements for changes made to existing sterile products
Endotoxin & EO Residual Testing
Few sterilized medical device programs are complete without comprehensive endotoxin and EO residual testing. Endotoxin testing detects bacterial endotoxins on medical devices or pharmaceutical injectables using Limulus amebocyte lysate (LAL), prepared for use as an LAL reagent. Conducted after EO sterilization, these tests determine the presence and quantity of remaining sterilization residues.
Process Challenge Device (PCD) Studies
Process Challenge Devices (PCDs) are viable biological indicators for monitoring the effectiveness of EO sterilization processes. Infinity provides comparative resistance studies using your Master Challenge Pack/Internal PCD or External PCD to compare with our patented, in-house PCDs to empower your team with a better, more consistent PCD for internal use.
Product Package Exposure
In addition to our robust package and environmental testing services, Infinity offers product package exposure to EO in our 3M sterilization chambers. Our team exposes packaged products to EO for validation, verification, and R&D testing for biocompatibility, packaging, and functionality.
