We are currently in the ideation stage of the 2nd iteration of our medical device pouch seal inspection device the VIU 2. Visual inspection can be can be an important part of your aggregate medical device packaging QC system and can play an important role in sterile packaging compliance. Hard empirical test methodologies, such as burst and peel testing, are where most medical device manufacturers hold the greatest amount of value historically when it comes to medical pouch testing. However, we should not discount the benefits of visual inspection as it can provide fast feedback thereby shortening testing cycles between potential failures.
It seems the industry is moving to these non-destructive pouch integrity test methods as a recent survey showed the two leading pouch integrity methods of choice are “Dye Penetration for Porous Packaging” per ASTM F1929-15, and “Visual Seal Inspection” per ASTM F1886-16. According to Pharmaceutical & Medical Packaging News, 80.4% of MDM’s utilize these test methods.
As you may already know Van der Stahl Scientific developed a patented visual inspection device for visually inspecting medical device pouches about 15 years ago. Our VIU device (visual inspection unit) is now in multiple clean rooms helping our sterile device packaging customers manage potential failures in their sterile device process. You can learn more about our VIU system by visiting this link.
Although visual inspection surely has its limits, we should not discount the simple process of “visual inspection” of a medical device pouch seal as valueless. When we bring together all of the tools of testing (both destructive and non-destructive) we will have a rounder understanding of the value of our medical device packaging process.
Remember, the diamond cutter utilizes a skilled and seasoned eye to create million dollar masterpieces, we too can train our staff to visually detect a host of potential seal failures that will fortify our medical device packaging testing plan. We are currently in the development of the “VIU 2 system” the 2nd iteration of our visual inspection system and will talk more about visual inspection in future blogs as this device gets closer to market, stay tuned