Medical Device Link.

Originally Published PMPN March 2002

EDITORIAL

If all you expect from your packaging equipment maker is equipment, you'll soon be pleasantly surprised. As I walked the floor of this year's Medical Design & Manufacturing (MD&M) West exhibition, I came across the usual suspects in packaging equipment. But as I stopped for a demonstration, I heard much more than the familiar hum of the machines. Their operators were talking about validation assistance, integration services, and even contract packaging services.

Such an expansion of service offerings is becoming pretty typical in the healthcare packaging industry these days. For instance, as senior editor Erik Swain reports in his feature, "More Than a Packager" on page 66, many contract packagers for the drug and device industries offer a breadth of services to provide a one-stop shop.

But equipment manufacturers typically tell a different story. Many of them do offer a variety of machines as well as line integration services. But most just provide machines, spare parts, and related technical support.

At MD&M West, though, a few equipment providers went beyond the hardware. Multivac Inc., a maker of thermoform-fill-seal rollstock systems, traysealers, and vacuum chamber machines, unveiled a three-part enhancement package for validation services. This new package includes factory documentation, multiple machine features including sensors that monitor the form-fill-seal process, and installation qualification. The documentation includes a software validation certificate, factory acceptance testing documentation, instrument calibration certification, and certificates of accuracy for all system sensors. "I don't know of any other machinery manufacturer that has gone into the level of detail that Multivac had me go into," says Don Barcan, president of Donbar Industries, a package engineering consulting firm, who was consulted when the documentation was written. "Customers who purchase this package will realize a major reduction in their efforts to validate the process while having a much higher degree of confidence in the outcome."

Perhaps the most creative extension of services at MD&M West was found at Doyen Medipharm's booth, where president Ray Johnson explained his firm's new contract packaging services. Based at Doyen's manufacturing facility in Lakeland, FL, its contract packaging operation includes a Class 10,000 cleanroom and a dry room and uses its line of automated and fully validatable four-side-seal and thermoforming machines. Johnson says that Doyen can "eventually deliver the same machine used on a contract basis along with a completely validated process, if and when the customer decides to bring packaging in-house." The program was designed for firms that cannot afford a machine, that have low product volumes, or that need a second contract line to back up an in-house line.

Don't take the above descriptions as absolute endorsements. Not every drug or device firm will be able to make use of these services—some are already ahead of the game in their validation efforts with their own consultants and documentation or have already planned for a sudden increase in demand. Or, as one director for a device firm recently told me when I asked whether he took advantage of all the services offered by a contractor, firms may be able to find such add-ons cheaper through other channels.

The good news is that machinery manufacturers are extending unexpected offers of help, and their efforts show that the machinery industry is adding service to its repertoire.

Daphne Allen, Editor