askralph

Charlie asks:

Are you aware of any corrugated material or other packaging material that is approved for packaging of medical devices? Basically they have products in a clean room, they use a poly bag over the box and inside the box currently…are you aware of something that is “clean room” friendly?

Well Charlie… When we think of corrugated, or most any paperboard product, “clean room” friendly is probably one of the last thoughts that cross our minds. Even the slightest amount of dust created by handling these products would be unacceptable in a true “clean room” application.

However, corrugated, while not necessarily approved for medical devices, isn’t disapproved either. Corrugated is approved by the FDA for indirect food contact, but that is certainly different than a medical device that may potentially be used, or placed inside the human body. The use of an inside poly bag and proper handling procedures should exclude any direct contact.

Some of the issues we often encounter are the need for pH neutral packaging for devices that have silver components. I believe my last ten cell phones where packaged in corrugated!!! However, even though some folks – especially teenage girls – seem to have these surgically attached, they certainly are not required to meet the same sterility standards as a medical device.

As far as clean room ready, corrugated needs to be stored in cool dry places where there is little or no chance of invasion by plants or animals, i.e. mold, mildew, fungus, insects and the odd stray varmint. However, you’ll still most likely require some type of sterile protective barrier inside, and depending on the application possible outside, of any type of paperboard container you may use.

I’m not aware of any particular paperboard product that is marketed as clean room ready. Let’s toss this one out to the masses and see if anyone else has any comments.