When it comes to bringing a new or updated medical device to market, most startups and established OEMs know that sterilization is an essential step in the process. But these same manufacturers may have questions about which sterilization process will best fit their needs. What’s more, they’re undoubtedly looking for insights on how to make sterilization procedures as efficient and cost-effective as possible.
One of the most common methods is to conduct terminal sterilization or sterilization of reusable devices using ethylene oxide – abbreviated as EO or EtO. Life Science Outsourcing is one of the industry’s leading providers of EO / EtO sterilization services and large-scale EO sterilization partner services.
EO sterilization comes with its own challenges and opportunities. Namely, EO sterilization is complicated and costly – few contract manufacturers have EO sterilization capabilities in-house. As a result of COVID-19 and related delays, EO sterilization today often comes with long lead times – larger sterilization providers are backlogged for months, meaning validations can be a year or more away. For organizations eager to bring their innovation to market and scale up operations, that lengthy timeline is often unworkable. As medical device manufacturers look at EO sterilization solutions, here’s a rundown of four best practices to streamline the process and ensure an optimal outcome.
1. Decide if EO sterilization is the right method
Different sterilization methods are best suited to different medical devices and requirements. EO sterilization is preferred for circumstances requiring lower temperatures – sterilization occurs 55°C, whereas other methods such as steam typically require much higher temperatures. This is beneficial for sensitive plastics and polymers in products. EO also tends to have fewer impacts on the device compared to gamma sterilization, which can alter the color of some devices.
At the same time, there are some downsides to EO sterilization. EO is a volatile and hazardous substance that can require longer cycle times. What’s more, when not handled properly, it can present a risk to manufacturing teams, partners, and even patients. When conducting EO sterilization, it’s essential to work with experienced professionals who can navigate these risks and ensure sterilization is done safely and effectively.
2. Determine the needs for batch processing
EO is well suited to batch sterilizations during the development process, when chamber size and capacity are less of an issue. While design and processes are being finalized, smaller batch sterilizations can be completed to prepare devices for clinical trials. Understanding the sample size and timeline for batch processing can help streamline the process and reduce sterilization costs at the right time.
3. Develop the right protocol
Any sterilization efforts are only as good as their documentation and adherence to standards – namely ISO 11135. Batch release protocols must be written to comply with standards, and device manufacturers should expect these protocols to be audited. Organizations should make sure their EO sterilization protocols meet industry expectations and don’t create confusion or complications down the road.
4. Don’t overlook residuals
Gas residuals are perhaps the greatest challenge when it comes to EO sterilization. EO sterilization leaves residual gas on the product, and there are specific standards around limiting exposure to those materials. ISO 10993-7:2008 — Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals is the primary standard on this residual gas.
It’s advantageous to work with the right partner to help conduct aeration protocols to address these EO sterilization residuals and protect the device, staff members, health care workers, and patients.
Better EO Sterilization Processes Through Partnership
Life Science Outsourcing has conducted thousands of EO sterilization exercises, along with developing protocols and supporting aeration and residual removal efforts. Our batch processing capabilities ensure EO sterilization is done in a timely and cost-effective manner to help move product development forward to clinical trials and other essential steps. We also have proven partnerships that allow for large-scale EO sterilization when larger chambers and capacities are required.
To learn more about our Sterilization & Validation services, be sure to contact a member of our team today.
