Articles to Teach
Welcome to this informative page on our website. This area is dedicated to exploring new trends in medical device manufacturing and medical device packaging through informative articles.

Over the next few years, we will continue to add to this area of the website so our medical manufacturing partners can gain access to the latest news and trends in sterile packaging, sometimes called the sterile barrier system. We hope you find these informative articles useful, but please keep an eye on this area of the website as it will be expanding quickly over the coming months.

Periodic Maintenance
As the saying goes, "garbage in, garbage out". You cannot expect to engender repeatable seals on critical packaging machinery with machinery that is poorly maintained.

Many sterile packaging programs are at risk of a 483 as their equipment is not being maintained per the manufacturer's guidelines. It is vital that quality teams closely monitor the ongoing PMs for not just packaging machinery, but any critical machinery. It seems that after the initial IQ OQ work has been complete, PM programs seem to decay as production gets main billing. Why risk a 483 when a simple PM schedule can be created that will assure the machine continues to perform and maintains the vital output repeatability. Read more

Baby boomers enter their 60s and the fast food generation seems to be the current target for industries such as the cardial stent arena. As our population ages, "procedures" to enhance the quality of life will become common-place. So how does the medical device market look in the face of this age shift? Read more

There is no question that constant in-process packaging testing is vital to assure products arrive at their point of use safe and sterile. Although destructive testing such as the ASTM F-88 and burst testing is a terrific way to understand failure thresholds, visual inspection holds a viable place in the quality assurance toolkit.

The ASTM 1886 provides important guidelines to visually inspect the seal area of dual-film pouches. Now with our new patented technology, medical device packagers can utilize the Viu device, which has been developed and designed to create a repeatable standard. The visual acuity gained by side-lighting the sealed area, in concert with 3x magnification, will create a fixtured solution that may have been lacking in the past. Learn more

The Sterile Barrier System
The ISO-11607 has been the definitive overview for packaging terminally sterile products. As this standard begins to tighten, medical device companies will be compelled to develop systems

that will assure compliance to the sterile device packaging process. So what has actually changed in this new and improved standard? Can your company comply? Let's take a look at the girth of this regulatory footprint. With the recent upgrades to this standard, quality assurance teams need to evaluate compliance. The good news to come out of this is that we are now working towards global harmonization in order for our industry to assure sterility compliance across world borders. Learn more



The F-88 Peel Study
Destructive testing is a prudent methodology to understand failure limits with flexible medical device pouches. Due to its relative ease of use, the ASTM F-88 study is a great tool for in-process seal integrity evaluation.

How can your company implement in-process testing and, possibly more importantly, how often should product be pulled offline to evaluate compliance?

Regular testing may well be the key to preventing 483 concerns and may in fact prevent all of our biggest fear, the unspeakable product recall. Learn more