Peeling Back the Mystery: Package Test Lab Perspective

I’d say about 25-50% of the time we see double pouching. There are industries that tend to favor double barrier more than others, such as orthopedics. If you were to eliminate orthopedics, I would estimate that the amount of double sterile barrier systems we see coming in for testing drops to about 10-15%.

From my experience double sterile barrier pouch systems have a higher success rate of passing performance validation testing. A rough estimate from our Director of Operations stated roughly 30% of performance validation studies that come through our lab result in defects pertaining to single barrier pouch systems, while that number is reduced to roughly 15-20% for double sterile barrier systems. It should be noted that other factors such as secondary packaging, device, package design, etc. also contribute to the success of the packaging system.

Most common defects found on pouch systems tend to be pinholes (straight line punctures, abrasion, and flex cracking) for both single and double barrier pouch systems. Defects that are found on double barrier systems and not commonly found on single barrier systems tend to include certain types of seal defects. The types of seal defects we typically see are when the inner pouch is inadvertently sealed in outer pouch closure seal or flex cracking pinholes that are created by folding of the inner pouch into the outer pouch. Sometimes we see clients use the same size pouch for inner and outer barrier pouches—we don’t ever recommend this. All these defects are typically easily mitigated through detailed work instructions, and proper pouch sizing.

It may seem counterintuitive but, in my opinion, there is also a benefit to sustainability for double pouch systems. This is because there are often extra components prepped for procedures within the sterile field. If those extra components remain in the inner sterile pouch and are not used during the procedure, they can be saved for future procedures. However, if the component came from a single barrier pouch, those extra components are then scrapped and are not able to be reused.

There are substantial benefits of utilizing double pouch systems as it pertains to aseptic presentation and limiting risk in contaminating the device. First, the double pouch system allows healthcare professionals to have variability in the aseptic technique required to transfer the device as well as the ease in performing that technique. For a “dump” or “flip” technique performed by a single individual, the inner pouch which is intended to be transferred to the sterile field can land without bouncing or rolling off a sterile table which can occur if only the device is transferred. As for a “pick” technique performed by two individuals (one non-sterile and one sterile nurse), the orientation of the inner pouch within the outer pouch when aseptically opened provides an easy opportunity for the sterile nurse to cleanly pick the inner pouch with contents into the sterile field. Without the inner pouch, the sterile nurse may need to reach further into the outer pouch to retrieve the device or need to pick multiple times if there are multiple components. Finally, healthcare professionals claim to have a “second chance” for double pouch systems if there is a use error that occurs on the outer pouch as the inner pouch contents would still remain sterile and then could be transferred to the sterile field.