By Charlie A. Webb CPP, CMC
John Adams said, “The only maxim of a free government ought to be to trust no man living with power to endanger the public liberty” blind trust in machinery is similarly imprudent. Far too many medical device packagers are relying on medical packaging machinery to tell them whether or not their pouch is adequately sealed. It’s just bad science to ask a medical pouch sealer to tell you whether or not the machinery is performing as wholly as expected. In order to find true performance values, you must look outside the machine to extrinsic systems that provide output data such as seal strength and integrity. It seems all the rage lately for medical packaging machine companies to incorporate validation plugs and ports that are designed to give medical device manufacturers comfort that their pouches are sealing correctly. Many of these often-proprietary systems are nothing more than bells and whistles and they fail the spirit of the scientific method. It is important for critical packaging machinery to incorporate alarm systems that will lock the system out in the event that the sealers on-board sensors interpret trouble. However, again, it’s bad science to assume these systems are all we need in order to understand the quality of the seals being created by these packaging machines.
Our own philosophy at Van der Stahl Scientific is to create medical pouch sealers that alarm if the system sees some issues that may change the sealers performance. This is an important step in order to be certain that the basic systems are working, but extrinsic systems that are outside of core machine functions are critical if you want to be sure you are not inadvertently getting an un-sterile product into the market.
Regular testing of your medical pouches is a much more sensible approach to the seal quality verification loop. Just assuming that because your packaging machine has not alarmed your process is sound is a dangerous mindset. Which is, once again, akin to asking a barber if you need a haircut. The answer is always going to be yes. In short it is the wrong point to gather data. We need to look outside these systems to determine if our packaging program is on track. And the most cogent response is to test the pouches through a standardized testing method such as tensile, burst testing, dye penetration, visual inspection, etc. We believe so much in pouch testing and output as the final word in terms of the value of the sterile barrier; we incorporated a peel tester and a visual inspection system on board our MS-451-PV medical pouch sealer.
This year, our firm introduced the PTT-100V Medical Pouch Testing and Inspection Unit. This amazing device is designed to encourage regular testing of pouches in order to thwart possible seal failures out in the market. In fact, this unit is so small and handy; I keep one on my desk. It can access seal strength quickly and regularly for our own internal lab purposes. In fact, this new device will probably see as many mahogany desks as it will labs, since many quality managers and upper management have taken on the task of keeping an eye on seal strength themselves. And with a quick fixtured load system and the integrated VIU, visual inspection system, this process will be easy.
Once again, it’s important that any medical packaging machinery you utilize for the sterile barrier system be enriched with sensors to be certain that the machine is performing its basal functions. Machines that watch the critical attributes of the sealing triad are an important part of your IQ but it really doesn’t answer the total quality question as the more empirical off-board testing modalities. The new mantra at many medical device firms has become, test right and test often. And we share that simple philosophy. As I mentioned in an earlier blog post “Trust but verify” layered systems of testing and inspection is the pathway to a sound sterile device-packaging plan.