Infinity Laboratories offers contract EO sterilization and validation services for medical device and pharmaceutical companies using 3M pure EO sterilizers.
- Infinity Laboratories offers contract sterilization services with a 1-2 business day turnaround time. We utilize 3M Rapid Readout BIs and have (7) 3M chambers available
- EO Cycle Development & Validation
- Per ISO 11135 and CFR 820 Quality System requirements we can validate your product in our 3M EO sterilizers in preparation for routine sterilization at our facility
- Comparative Resistance Studies
- Infinity Laboratories can use your Master Challenge Pack / Internal PCD or External PCD and compare that with our patented PCDs to establish a better, more consistent process challenge device
- Sterilizer & Microbiology Validation
- Infinity offers the following sterilization and microbiology validations:
- 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
- Infinity offers the following sterilization and microbiology validations:
- Product Package Exposure
- “Infinity can expose your products to EO in our 3M sterilizers for validation, verification and R&D testing (biocompatibility, packaging, functionality)
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