Right now floating around in your head is a 4-digit pin number for your ATM card. It’s a firewall to keep people from a 3-day shopping spree at Nordstrom’s. Is it valuable? Of course it is. If you develop a validation program and have engendered process settings for your medical device packaging machinery, you need to protect these setting from unauthorized users, just as you do with your bank account. As Mark Twain famously said “Put all your eggs in the one basket and Watch That Basket”.
If an operator at 2:00 in the morning wants to increase output of the machine for a longer cigarette break, your packaging program just collapsed. With our medical device packaging machinery you can create a 4-digit password that keeps operators from changing your validation settings and completely compromising your company’s quality mission. We have been told by some of our medical device manufactures that their packaging operators working the nightshift have manipulated sealer settings in order to increase or decrease output, this human behavior obviously creates a gapping breach in a quality control plan.
Beyond keeping operators from changing validation settings on the sealer, there are other new ways to manage packaging personal that will aid in assuring your medical device will make it to market sterile.
Systems like our model MS-451PV that requires operators to peel test pouches on a pre-determined pouch count or a specific day of the week or calendar date. The sealer’s microprocessor requires operators to test at predetermined intervals, as well as a predetermined number of specimens, and if the bags/pouches do not pass the user-defined peel strength threshold, the unit will stop packaging until the quality team can evaluate failure.
The MS-451PV also allows quality teams to program required stops and test functions into the machine. This function will automatically stop production, prompting the operator to first perform a visual seal inspection, then the sealer will prompt the operator to perform a peel test. If any of the seals test samples do not pass the peel test, the machine will not continue to operate until the supervisor on the quality team inspects possible causation for a seal failure.
Our development group finds it surprising that more automated system are not being used in industrial manufacturing and packaging. We all seem to feel quite comfortable with the smorgasbord of features that reside on our smartphones however we seem to have developed a “on the job” technophobia. Simple firewalls and calendar functions integrated into machinery is a great place to start as we implement Technology into industrial machinery. None of us need more marketing department engendered bells and whistles, but the sensible integration of usable features is essential for those of us bound by regulatory compliance. At the end of the day our collective goal as an industry is to provide efficacious medical devices that arrived to the point of care protected and sterile. So let us support and embrace Technology into our cleanrooms.
You can learn more about advanced technologies that will help automated you medical device packaging program by clicking here.