As industry changes spread to packaging, manufacturers had to align sterilization and packaging strategies to quickly pivot and meet expectations. Alternate sterilization methods made it essential to carefully consider package design to ensure feasibility and compatibility with selected sterilization techniques. Specific materials to be sterilized required certain sterilization methods and depended on packaging factors such as thickness, composition, and intended use. Tyvek®, tray, paper, foil, poly, and nylon were all factored into ideal sterilization method decisions.
Contract sterilization versatility and requirements were under new scrutiny by medical device companies who were looking for streamlined services under one umbrella that could swiftly address new industry challenges. Those that had used ethylene oxide (EtO) in the past had to consider the possibility for gamma irradiation or e-beam sterilization. Expert contract sterilization services needed to cover a broad range of capabilities, including many in-house services and on-staff microbiologists. They also needed to effectively expedite validation services that leveraged preexisting validated cycles for single use and reusable products and related documentation along with various sterilization options to meet increasing demand in a timely manner.
Manufacturers had to consider more options to meet their sterilization needs. Following are three ways medical device companies successfully navigated industry sterilization challenges and can continue doing so.
1. Identifying alternate contract sterilization partners
Many device companies have a reliable partner they already work with. But the changing times create an uncertain future. Some sterilization facilities experienced new restrictions—or worse, were shut down, leaving device companies scrambling to identify a new resource on a tight timetable. These events crafted the perfect storm for medical device companies, who then had to find new contract sterilization services that could provide effective solutions such as small-batch sterilization or just-in-time quantities, which would enable them to maintain an effective sterilization process. Adaptation has been key in staying consistent with sterilization production and adjusting to new ways of doing things. Proactively identifying and selecting alternate contract sterilization partners and having them at the ready before an emergency strikes, ensures you will be prepared if shutdowns or added restrictions occur.2. Working with versatile contract partners
The most successful contract manufacturers have established in-house sterilization capabilities that can expedite sterilization turnaround, including validation protocols for novel product development. Reducing lead time and tackling ongoing validation sterilization service complexities can be accomplished thanks in part to those in-house capabilities, as well as strong partnerships with other facilities. Take the time to verify if your sterilization contractor has the right capabilities and relationships to support your requirements.3. Considering alternate methods of sterilization
Medical device companies must be open to alternative sterilization methods when the option is needed, including gamma irradiation and e-beam sterilization, as well as package design to ensure feasibility and compatibility with the selected sterilization technique. Flexibility can lead to a faster time to market and reduced costs. While it may be intimidating at first, the outcome can support your long-term goals of waste reduction, time to market, and overall efficiency.Following are common sterilization methods to consider:
Ethylene oxide (EtO)
EtO has undergone a real transformation in the market, tied to escalating concerns around its use for terminal sterilization, waste reduction and environmentally friendly practices. U.S. EPA regulations have also created capacity constraints due to high-volume sterilization facility closures. It does remain an invaluable sterilization method, and while more regulations may be crafted in the future, it is still one of the most widely used methods of sterilization for medical devices.
EtO is an ideal sterilization method for heat and moisture-sensitive devices that cannot withstand moist heat or radiation. It uses a gas diffusion process to penetrate multiple layers to eradicate microorganisms. Most EtO runs are small batch, resulting in a faster turnaround time. Quick-turn, single lot release EtO sterilization and specialty small-batch EtO sterilization allow companies to be more agile and move quickly. To achieve new EtO standards, two pallet chamber cycles are based on sustainable “low concentration” cycles to meet future EPA guidelines.
Gamma and e-beam sterilization
As manufacturers explore sterilization options outside of their usual EtO process, they may discover that gamma irradiation and e-beam can be efficient and practical. Gamma irradiation is ideal for specific devices and materials, including heat-sensitive devices. The device does not experience significant temperature increase during the sterilization process. Instead, it is exposed to a high concentration of electromagnetic radiation able to pass through substances and kill bacteria by halting bacterial division. There is no residual or radioactivity remaining once the process is complete. E-beam sterilization uses ionizing energy at different dosage rates and penetration levels. It is somewhat similar to gamma irradiation.Steam sterilization
Medical device manufacturers can also work with contracted sterilizer companies to deploy steam sterilization. It is a widely used process and often the least expensive. Sterilization occurs in a gravity displacement autoclave or a high-speed prevacuum sterilizer. It is not ideal for electronic components of any kind, or fiberoptics, and high carbon steels can experience corrosion if an anti-corrosive solution is not used before the device enters the autoclave.Steam sterilization is nontoxic and fast-acting. The process exposes devices for a set amount of time to direct steam contact, pressure, and temperature at levels high enough to eradicate microorganisms. Biological indicators are used to monitor sterilization effectiveness.
Sterilization tests to consider
Biological indicator testing
In-house testing of biological indicator (BI) sterility is an advantage. The ideal contract sterilization partner who can meet your sterilization needs will be able to reduce turnaround times for lot releases using BI testing. Industry standards must be met, including for ANSI, AAMI, and ISO 11138, so medical device manufacturers must perform their due diligence to verify a contract sterilization resource that has the knowledge and expertise to meet those standards.
BI strips are used to measure how effective the selected sterilization process is for methods like EtO, steam or dry heat sterilization. The process is simple but efficient: Filter strips carrying bacterial spores are sterilized and then tested for any remaining bacteria. This process can validate the sterilization method and determine sterility assurance levels.
In-house BI testing can meet the needs of varied clients who require differing types of sterilization services and validations with reduced lead time.
Navigating an ever-changing future
Medical device companies can benefit from being aware of the transformational changes that are sweeping contract sterilization. Understanding how some sterilization methods may be less accessible can help them anticipate solutions such as identifying secondary sterilization partners with in-house capabilities, working with local sterilization facilities, anticipating necessary lead time, and being open to new ways of doing things. Alternate sterilization methods may need to be considered—and they may turn out to be an improved way of streamlining your sterilization process. As always, the primary objective should be to maintain the highest standards of quality to accelerate delivery of cutting-edge products to the market and benefit your end users.About the author
Andrew Gladd is the Director of Sales at Life Science Outsourcing, a medical device contract manufacturer with over two decades of experience perfecting services designed to support innovators and entrepreneurs with expertise handling various sterilization methods and in-depth knowledge with the correlating ISU standards to support validation paths.Andrew Gladd manages the onboarding process for all new customers at LSO. He is also responsible for supporting the sales team with new customer requests and existing customer expansions.
Andrew began his time at LSO in the Sterilization & Validation division (SVS), where his project experience focused mainly in Steam Sterilization & Ethylene Oxide Sterilization Industries. Over the years, he has become very well-versed in all of LSO’s divisions, as well as FDA, GMP and ISO Compliances, and has a unique blend of business experience, which encompasses local, national, and international customer management.