Infinity Laboratories Products & Solutions

Infinity Laboratories Products & Solutions

EO Sterilization Services

09 Dec 2022

EO Sterilization

Infinity Laboratories has over 30 years of experience helping our customers deliver safe and effective products to market and offers contract Ethylene Oxide (EO) sterilization and validation services for medical device and pharmaceutical companies using 3M™ Steri-Vac™ pure EO sterilizers.  We offer a wide range of expertise in product sterilization validations across a broad range of sterilization technologies and follow ISO 11135 and CFR 820 requirements.

Ethylene Oxide (also known as EO or EtO) is a process widely used to sterilize a variety of healthcare products, such as single-use medical devices and pharmaceutical containers. Through the use of a vacuum-based process, EO sterilization can efficiently penetrate the surfaces of most medical devices and its lower temperature makes it an ideal process for a wide variety of materials commonly used in the manufacture of medical devices.

EO is suitable for the terminal sterilization of a wide range of materials not compatible with other methods of sterilization like irradiation or steam.  Products commonly processed with EO include:

  • Catheters
  • Complex Devices (assembled)
  • Custom Kits
  • Equipment with integrated electronics
  • Long Lumens and tubing products
  • Stents

Materials that are sterilized with EO are not exposed to excessive moisture, heat or harmful radiation.  Material compatibility is one of the main advantages of EO and is described in AAMI TIR 17 (Compatibility of Materials Subject to Sterilization).  Products can be sterilized in their final packaging configuration since EO will permeate the sealed films, trays, and cartons that are used to package medical devices.

Infinity Laboratories offers contract sterilization services with a 1-2 business day turnaround time.  We utilize 3M™ Rapid Readout BIs™ and have 3M™ chambers available for routine production cycles.

We also offer 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
  • Product Package Exposure for biocompatibility or functionality testing

We continuously work to enhance and protect patient lives through the critical testing and sterilization services that we provide.  We believe we can make a difference in the lives of patients worldwide.  Our goal is to go Beyond Testing and become a partner in the success of our customers.