Ten Years of Medical Device Packaging
Packaging may look the same, but the materials, machinery, and regulations behind it have changed considerably.
|Hal Miller, |
Director, Packaging Technology,
Johnson & Johnson.
Ten years ago, medical devices were packaged in pouches, rigid and flexible blisters, and header bags that were made with combinations of film, foil, paper, and Tyvek. Ten years later we still have the same packages and materials. Little progress, you say? Maybe in the types of packages or base materials, but a whole lot has happened in between.
Let's begin with materials. It used to be that the peelable part of peel-open packages would have this concoction of adhesive spread over one component to allow for easy heat sealing and peeling. Now, engineered layers of film are extruded or laminated together to provide custom needs for any particular package or machine application. Adhesive technology now provides us with a wide sealing range with minimal variation. And the introduction of metallocenes and new blends of resins gives us greater resistance to abrasion and puncture.
And how about equipment? Machines have gotten complicated, but yet, simpler. Programmable controllers and internal software have eliminated the "tweaking" of controls and the guesswork by the operators. Fail-safe systems have added redundant checks to ensure that every package is acceptable. Validation and control have become much easier with closed-loop systems and downloadable data.
Yes, technology has taken a giant leap forward in 10 years. Consider how these technologies have taken hold: digital printing, automatic identification with bar codes (linear and 2-D) and RFID, anticounterfeiting solutions, and Web-based systems. Additionally, package design applications of CAD/CAM, computer graphics, and predictive engineering have significantly reduced time to market.
Yet with all these technological advances in materials, equipment, and development, the one thing that has affected our work the most is regulation. Regulations and related standards have proliferated these last 10 years. Which one has affected the medical device packaging industry the most?
I believe it has been the European Union's (EU) Medical Device Directive (MDD). With the enactment of the MDD, we had to include multilingual labeling and symbols on packaging. In order to attain the CE mark, a conformity assessment was needed, in addition to FDA approval. Notified bodies needed something by which to judge packaging, so the EN 868 series of packaging standards was mandated. The initiation of European packaging standards begat an international standards process and ISO 11607.
With all these requirements now in place, how do we show conformance? ASTM has stepped up to the plate and developed consensus test methods and other standards to demonstrate conformity. It all started with the MDD. As long as we are addressing regulations, let us not forget the EU's Packaging and Packaging Waste Directive, and FDA's quality system regulation with design control added in.
With all this happening in the last 10 years, what lies ahead for the next 10? Technology will continue to advance at lightning speed. Trends developing now will be commonplace. New regulations and standards will emerge with which we must comply. Products will become more complex to package and sterilize. But medical devices will still be packaged in bags, pouches, and rigid and flexible blisters, in one form or another.