PackTalk is a blog for the Healthcare Packaging Industry

Sterile Barrier Packaging: The Impact of Sterilization Modalities


Published on August 19, 2020

Sterilization is a defining factor when it comes to healthcare products—it’s an essential step in the commercialization process for most single-use medical devices. The cleanliness of a hospital environment is crucial, and sterilization and correlating sterile barrier systems are key factors in ensuring your medical device remains free from contamination until the point of use.

With the importance of sterilization, a packaging engineer must understand the impact it can have on the packaging materials and configurations being used. But often, they are not deeply involved in the sterilization process. In fact, an engineer can go through their entire career and never actually see the sterilization process in person. Therefore, it is important for packaging engineers to partner with sterilization experts to understand the different sterilization methods and the potential risks. No one looks at packaging as deeply as the responsible engineer, so it’s important to know what to look for within each sterilization modality.

Below are three common types of sterilization modalities and potential defects associated with each:

  • Ethylene Oxide (EO): A combination of heat and vacuum in EO sterilization can lead to seal creep. In some cases, seal creep can be destructive to the sterile barrier by bursting through the entire seal. But in other cases, seal creep can only partially affect a seal and it may go undetected until later in the process.

  • Irradiation: When it comes to irradiation, it is important to look out for embrittlement and discoloration in the materials. Consider reviewing AAMI TIR17 to better understand the materials being used.

  • Vaporized Hydrogen Peroxide (VHP): As needs for alternative sterilization methods have risen, VHP has gained momentum. While there are many packaging materials that are unproven, there are plans in place to verify compatibility with existing packaging materials.

Brian McEvoy, Senior Director Global Technologies at STERIS, and I recently partnered to talk more about the relationship between sterilization methods and packaging materials. Watch the full webinar to learn more.

 

Jeremy Elwell
Senior Principal Engineer | Oliver Healthcare Packaging

Comments (2)

Related Articles

One Doctor’s Request for Sustainable Change in Asia

September 17, 2021

152 kilograms. 4500 tonnes. 134 hectares. No matter how you say it, it’s not positive or sustainable. These numbers reflect the amount of medical waste from just one surgery, in a study from four hospitals over three months in New Zealand. 152 kilograms is...

Learn More

Cracking the Age Old Dilemma: Compliance or Quality?

September 17, 2021

I recently read an article from Medtech Insights on how device giants Stryker and Baxter embrace a quality first culture – and yield positive results. In the article, Stryker’s Medha Trivedi, the company’s senior director of global quality and operations said...

Learn More

Power to the PDUFA

September 17, 2021

The Prescription Drug User Fee Act was passed into law by Congress in 1992. The PDUFA implemented a fee-based framework for New Drug Applications and Biologics License Applications. One of its primary objectives was to provide funding to speed up the glacial...

Learn More

Stay Informed

To stay up to date on innovative technology and products, as well as industry trends, subscribe to Oliver’s PackTalk blog below.