Ethylene Oxide (EtO) sterilization has had a turbulent year. Despite being the ideal sterilization method for a majority of medical devices, it harbors potential environmental and technician health concerns, which have increasingly come to light. New efforts and mandates require specific handling and use of this method to protect against its potential impacts, and a few provider shutdowns have even occurred, causing delays and a mad scramble by manufacturers to identify a new sterilization partner.
Medical device manufacturers can rest easy when they’ve found the right EtO partner, either as a primary or secondary resource, who will follow regulations and extra precautions to limit EtO impact to the environment and technicians who work with this sterilization method. But how can you be sure you’ve found the right partner? We’ve made it easy with the top six things to look for.
Six ways to identify the best EtO partner
1. Capacity for EtO
When considering an ideal sterilization partner, you’ll need to look at their processing capacity and ethylene oxide sterilization operations as project indicators. Will they be able to handle your sterilization projects? This goes beyond equipment and includes staff, skills, resources and more. Ask questions when discussing capacity with a new sterilization partner to ensure they are a good fit for your specific type of projects.
2. Bandwidth for validation phase
How about their bandwidth for the validation phase? Ask if they have the expertise and capability to write the protocol with overall validation requirements, including test procedures to be used, perform validation cycles, complete various testing and produce the final report. Not all facilities will have the ability to provide all of the above.
Where is the new potential partner located? While it’s easy enough to send product shipments back and forth in these modern times, there may be reasons why a closer proximity makes sense for your business. Ask about their primary location, if they have any secondary locations and if they have robust distribution capabilities to meet your needs.
4. Experience with EtO sterilization
EtO sterilization is a specialty that requires certifications, training and even specific facility needs. Above and beyond that is the experience your new partner has with the process. How long have they been performing EtO sterilization? What type of clients do they manage? What types of devices do they sterilize? Have they worked with your size of project before? All of these are important considerations.
Do all employees involved with the EtO process have complete training and certification? Gain an understanding of the employee and the business certifications, accreditations and also ensure the business meets current regulatory requirements as well.
6. Biological indicators testing
Biological indicators (BI) challenge EtO cycles and are frequently used for different sterilization types, including EtO. They are included in many standards such as ANSI, AAMI and ISO. Such testing is part of the validation and lot release. When considering new prospective sterilization partners, inquire about their process, the timing and final reporting to better understand how they will work with you and your sterilization project.
Finding your best EtO partner
You rely on external sources or even secondary options to fulfill your medical device sterilization needs. And you don’t want surprises after you’ve begun a project, only to have to switch to a new partner thanks to lack of experience, limited capacity or the inability to produce the final report from the original source you partnered with. Before you select your next EtO partner, perform your due diligence and inquire about these six ways to identify the best partner for you and your project.
Looking for more information on EtO sterilization? Read The Right Challenge Device for Ethylene Oxide (EO) Sterilization Validation.
Life Science Outsourcing is uniquely positioned to support R&D, custom product, and lean manufacturing EtO cycles in our two in-house, 3M Steri-Vac™ sterilizers ~8 cubic feet, validated chambers. We also provide in-house BI testing. Contact us for more information on our EtO processes and how they can help you achieve faster turnaround for your medical devices. Email us at firstname.lastname@example.org or call (714) 672-1090 today to get started.