Inside Story: Trends in Packaging and Sterilization

A leading medical device testing partner with 40 years’ experience in Packaging and Sterilization testing, Eurofins Medical Device Testing (MDT) provides rapid turnaround times, extensive capacity, and the highest level of service and instrument technology to deliver a full scope of testing services. In this interview, Eurofins’ experts, Sunny Modi, PhD, Director of Package Testing; and Elizabeth Sydnor, Director of Microbiology; answer common questions on medical device packaging and sterilization.

Medical Design Briefs: What trends are currently impacting the packaging/sterilization sector? What factors are driving these trends?

Sydnor: Some manufacturers are considering alternative sterilization methodologies if they are using Ethylene Oxide (EO), which has been listed as a potential carcinogen by the International Agency for Research on Cancer (IARC). For the last few years there have been heightened environmental concerns for EO sterilizers, which have led to some manufacturers exploring the impact of revalidating with a comparable method. These manufacturers are also evaluating and improving packaging systems for comparable sterilization techniques. Such innovations will lead to packaging material changes to optimize the sterilization process. The good news is the FDA has been heavily involved with sterilization experts and other government agencies as alternatives are tested.

MDB: At what point in the product development process should packaging/sterilization services be considered?

Modi: Once the manufacturer has conceptualized a medical device, they should start considering both sterilization needs and packaging systems for products. There are several feasibility tests that Eurofins MDT conducts in the early phases of product development to assist with the packaging configuration of medical devices, and compatibility of packaging material with the sterilization process. It’s key to engage with a testing laboratory early to plan and achieve critical milestones to get to market quickly and efficiently.

MDB: How is sustainability impacting sterilization methods and packaging?

Modi: Sustainability is a high priority for many medical device companies. Their customers — and end users — are evaluating lifestyle choices based on sustainability and sustainability metrics. We’ve seen an increase in packaging materials being evaluated for sustainable sources and the optimization of package size to reduce waste. As a full-service testing lab, we also work with our clients who request packaging design improvements to maximize sterilization throughput and reduce the sterilization cycle.

MDB: How should medical device developers go about choosing the best method for sterilizing medical devices? What factors must be taken into consideration?

Sydnor: There are many factors to take into considerations when designing a medical device, all of which should be incorporated in the biological evaluation plan. The material composition of the product is a main contributor in deciding the best sterilization methodology, with product functionality post-sterilization a subsequent important factor to consider. We encourage our clients to carefully evaluate packaging materials when creating a sterilization plan to avoid any pitfalls or delays.

MDB: How soon should a lab get involved during the validation process?

Sydnor: This is a good question; a full-service testing lab such as Eurofins MDT should get involved during the early phases of device development. Once a device is in development and has progressed to the validation phase, it’s a cumbersome process to make even the slightest design change. Partnering with an experienced testing lab early helps establish a relationship and ensure all necessary testing is identified and understood upfront, accelerating the device’s time to market.

MDB: How long does it take for a sterilization validation to be completed?

Sydnor: There are many things that can impact a sterilization validation: The complexity of the device, number of samples available, and the sterilization itself. Most validations can be completed in 12 weeks from the time the product is received by the testing lab. These validations typically include bioburden recovery testing, sterilization cycles, sterility testing, and summary report writing. Depending on the sterilization methodology, dose mapping and load configurations need to be established prior to running the sterilization cycles.

MDB: How long does it take for a sterilization validation to be completed?

Sydnor: There are many things that can impact a sterilization validation: The complexity of the device, number of samples available, and the sterilization itself. Most validations can be completed in 12 weeks from the time the product is received by the testing lab. These validations typically include bioburden recovery testing, sterilization cycles, sterility testing, and summary report writing. Depending on the sterilization methodology, dose mapping and load configurations need to be established prior to running the sterilization cycles.

MDB: What are customers looking for in medical device packaging design?

Modi: Designing medical device packaging is a complex process of understanding the full range of needs to ensure the device reaches the customer and end user in a safe and effective manner. This process includes material selection, sterilization technique, packaging design, manufacturing and filling, validation testing, and many other criteria. At Eurofins MDT, we find our manufacturers are looking for partners that can help navigate the packaging design phase by using pre-validated packaging systems and leveraging expertise of our full-service packaging lab that is experienced in testing various packaging types.

To find out more about Eurofins Medical Device Testing, visit Eurofins.com/Medical-Device/Testing .

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