Identifying and Evaluating Alternative Sterilization Methods for Medical Devices

Mark Twain once said, “Success is a journey, not a destination. It requires constant effort, vigilance, and reevaluation.” While he could not have imagined today’s medical device manufacturing industry, he certainly nailed the idea of what it takes to stay at the cutting edge of a constantly evolving and highly complex market.

One of these leading edges is sterilization methods. In recent years, several new sterilization modalities have emerged—and more change is on the horizon. Medical device manufacturers will have to successfully navigate this changing landscape while balancing the priorities of patient safety, compliance, and business success. In this article, we explore recent and anticipated changes as well as the imperative for OEMs to identify and evaluate alternative sterilization methods.

Market forces: shifts in sterilization methods for medical devices

Traditional sterilization modalities like gamma, electron-beam, and ethylene oxide (EO) have long been the industry mainstays to ensure patient safety. Since 2019, though, OEMs have confronted continued disruption to device sterilization modalities. First, the closure of key EO sterilization facilities upended sterilization capacity. Right behind came the supply chain squeeze of the pandemic with its ongoing shortages of sterilant and packaging. Now, proposed changes to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for EO are looming.

Amid this disruption, it’s not surprising that manufacturers are prioritizing contingency planning and monitoring the introduction of new sterilization modalities. Many of these are not new, but they are being used in new ways. And innovation has a regulatory champion: the FDA is supporting OEMs that are taking a proactive stance on their sterilization agility through its Sterilization Innovation Challenge and 510(k) Sterility Change Master File Pilot Program. These programs have been designed to help companies advance innovative ways to sterilize approved medical devices in a streamlined regulatory approach. And, of course, innovation that benefits all is good for the industry, good for business, and—most of all—good for patients.

Exploring alternative sterilization modalities

While some alternative sterilization methods are not entirely new, they are being imagined and applied in new ways. Let’s take a closer look.

Alternative sterilization options currently available to medical device manufacturers include :

• Gamma, electron-beam, and X-ray. These traditional sterilization methods are still essential. With multiple e-beam and x-ray suppliers entering the market, and several US irradiator facilities currently under construction, these technologies are fairly easy to source.
• Chlorine dioxide (CD), nitrous dioxide (NO2), and supercharged carbon dioxide (scCO2). These emerging methods offer advantages as well as considerations, including different temperature and pressure requirements, off-gassing considerations, and material compatibility concerns.

Some of these emerging methods are available as contract sterilization services, while others must be pursued in-house, which requires intensive capital investment from facility building to hiring for expertise.

Given the capacity, compatibility, and capital concerns, pursuing sterilization contingency planning via alternative modalities can be daunting. If none of the above is a viable option, an OEM should minimally consider validating a back-up chamber in a separate EO facility to ensure continuity in the face of continued disruption.

Understanding the impact of sterilization methods on lead times

Of course, any change or conversion—whether in established production or new product launches—introduces risk. A major concern in navigating sterilization contingency planning can be the impact on lead times.

Sterilizers often have long lead times for validation runs. Sterilization processes, of course, require rigorous validation runs, which can extend already long lead times and introduce very real business consequences for OEMs. In addition, the timeline for sterilization validations can be further lengthened by laboratory lead times, which can add several weeks to the overall process.

Manufacturers should factor three key things into sterilization contingency planning:

• The risk of disruption or delay to established sterilization method or capacity, and the consequences on continued production, accounts, and patients;
• Clear understanding of any potential partner’s current turnaround times for sterilization and laboratory testing;
• The value an expert partner and a single point of contact brings to navigating new and alternative modalities.

Selecting an expert sterilization testing partner

Finding the right partner gives an OEM an enormous advantage. This is because an expert partner will help with:

• Navigating complexity. The right partner will help an OEM navigate the broad range of available sterilization methods and associated concerns, which can be overwhelming. A single expert point of contact will streamline decision-making and facilitate connections, which can significantly lessen the time, effort, and cost of sterilization contingency planning.
• Validation procedures. An expert sterilization testing partner works to develop or follow validation protocols tailored to an OEM’s specific device and sterilization method. This ensures compliance and efficacy while also minimizing lead times for validation.
• Provide valuable expertise and support. Success truly hinges on finding a partner with a deep understanding of alternative and emerging sterilization methods, down to their technical nuances and regulatory requirements. A true expert also brings a birds-eye view of industry trends and anticipated regulatory shifts to planning for today as well as tomorrow.

In the end, innovation in sterilization is inevitable. So is keeping up with it. Finding the right partner can make all the difference in how an OEM navigates change, by streamlining the selection process, complying with regulatory requirements, and managing lead times.

Millstone’s lab testing services give medical device manufacturers access to the comprehensive product, packaging, and environmental testing service expertise they need with industry-leading turnaround times and a single expert point of contact.  In addition, Millstone’s end-to-end Tier 1 service, , provides a streamlined approach to expert sourcing, with contract manufacturing, quality critical inspection, in-process testing, cleaning, packaging, and sterilization with adjacent testing, handled under a single PO. Millstone’s testing services are also available as standalone contract services.

Today Millstone offers post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer packaging, testing and logistics —all with an unparalleled focus on quality.

What could we help you do better? Learn more at https://millstonemedical.com.