Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published September 1998

MEDICAL

Medical Packager of the Year 1998

PMP News recognizes Ethicon Endo-Surgery Inc. for its advances in automation and graphics.

by Erik Swain, Senior Editor

Early adoption of emerging packaging technologies has paid off for Ethicon Endo-Surgery Inc. (EES; Cincinnati and Albuquerque), a manufacturer of single-use surgical devices. In recent years, EES has embraced flexible packaging, converted to an automated form-fill-seal system, and upgraded its labeling system to print in several languages.

These changes have enabled EES to reduce its material, labor, and tooling costs. They have also provided a welcome decrease in packaging waste, benefiting both the environment and hospital waste managers.

Operators load staple removers into flexible packaging made by Mahaffy & Harder's form-fill-seal machine. Photo by Pat Berrett

EES's packaging operation has even been recognized by EES's president Nick Valeriani: in 1997, the packaging organization received the "President's Quality Award" for implementing the automated flexible packaging process and for converting to multilingual graphics. The award is given each year to a team within the company that makes noteworthy process improvements.

And last but not least, Pharmaceutical & Medical Packaging News has chosen EES as its "Medical Packager of the Year."

EES boasts an extremely sophisticated packaging development laboratory, and the entire company espouses the philosophy that packaging is not an afterthought but a crucial part of the product's delivery system.

"They have pushed the envelope on a lot of their technology, between equipment and materials selection and graphics development," says Tim Early, marketing specialist, DuPont Nonwovens Tyvek (Wilmington, DE), a division of Johnson & Johnson. Early nominated EES for the magazine recognition. "They have a lot of the most talented packaging engineers I have had the opportunity to interface with. Within their organization, packaging is recognized as an integral part of the success of the business." Early worked at EES for more than six years before joining DuPont.

COMPANY STRUCTURE

The company's organizational structure is set up to focus on packaging. The package research, development, suppli-er management, and graphics divisions in Cincinnati all report to Michelle DeJonge, EES director of packaging systems. In Albuquerque, the process gets the full attention of the business unit manager, technical services manager, and materials planning manager. And the distance between the Cincinnati and Albuquerque facilities doesn't impede communication. The packaging management teams from both facilities meet once a month—four of those in person and the other times by teleconference or videoconference—to set directions and allocate resources. Each project includes at least one engineer from both sites to ensure all development needs are met.

PACKAGING OPERATIONS

EES's operation in Albuquerque currently uses five form-fill-seal machines and has three others under development. These machines typically handle the firm's smaller devices, such as staples and sutures. Larger instruments are packaged using heat sealers from Atlas Vac Machine (Cincinnati). There are two other lines for the assembly and packaging of procedural trays. Labels for the procedural trays and form-fill-seal products are printed on-line, while carton and insert printing is done by suppliers.

When the company adopted formed flexible packaging, it was able to use "new materials, equipment, and processes," says Scott Otto, manager of research and development of packaging. "It has really pushed us from manual to automated packaging. It has reduced our tooling development cycle time by almost half through designing and fabricating our own tools in-house. It has brought millions of dollars to the bottom line in cost savings, both material and labor. It has had an environmental impact by significantly reducing packaging waste internally and for our customers. It brought us new testing methodologies and challenged current ones."

And EES is always looking for new technologies. "We are constantly searching for the latest advancement in printing and packaging equipment and systems to advance our operations further," says Kathleen Dolan, packaging technical services manager in Albuquerque. "We have found that partnering with our suppliers and other J & J companies is one of the most effective ways to accomplish that."

Customized equipment and proprietary software are two areas where the company is highly advanced, Otto says. An example Dolan cites is the use of a cobalt irradiator, which "allows us to package and sterilize product with very quick cycle times." Another is graphics. EES uses the Global Translation Process System to deal with European multiple-language labeling requirements. The system consists of a Web site on Johnson & Johnson's Intranet that allows anyone in the company to transport files for translations. For procedural trays, it uses the Multilingual Labeling System. "The system allows us to use approved text as variable information on a template," says Heather Russell, manager, packaging strategic systems. "The template contains all common text and symbols. It will scan a route sheet for a specific product code and then will compile all of the variable text to complete the label. Currently, we are investigating equipment and software to reduce and eliminate proofing steps in our process. We are also investigating software to house all labeling records and key historic details of each label we have created."

&All this technology has enabled the Albuquerque facility to more than double its volume since 1996, with minimal labor increases and continued cost reductions, Dolan says. That, in turn, has made it easy to adjust to the rapid growth of the company and the industry.

The plant is flexible enough to run at different speeds and volumes. "We schedule optimum lot sizes based on the rate of the process, customer demand, and sterilization scheduling," Dolan says. "The size of our lots is generally transparent to our customer since their orders are filled from our distribution center, and we generally are producing one lot that will fill multiple orders."

During production, "devices are bulk packaged at the assembly sites and shipped to Albuquerque where the packaging configuration for procedural trays and single sterile and bulk nonsterile packaging can be completed," explains DeJonge. "This requires a strong commitment to packaging by all aspects of the company. Development schedules need to include the time necessary to complete bulk packaging as well as single sterile."

The packaging development lab in Cincinnati has a sophisticated shock-and-vibration lab for running fragility, damage boundary, and transit analysis tests, and an extensive analytical lab for material evaluation.

PACKAGING DEVELOPMENT

EES also believes in starting packaging development early on in the product life cycle. "Another significant development is the use of solid modeling, the use of electronic databases for getting a jump on the packaging development for new devices," Otto says. "We can actually start the packaging design before we ever receive an actual model of the new device. It is also allowing us to start developing predictive analytical capabilities such as finite element analysis."

Packaging inventory is managed via a Web page that connects suppliers to a Joint Venture Service Facility, an entity owned and managed by the suppliers located one mile from the Albuquerque site. The facility delivers components as needed. The reason for the priority on packaging, DeJonge says, is that "delivering a sterile product to the end-user requires attention to the process of developing packaging as well as devices."

Through the use of high-tech equipment, flexible packaging, and multiple-language printing technologies, EES has been able to improve its own packaging operations as well as supply its customers with high-quality, efficient packaging. But such an accomplishment also takes a company-wide effort. "The commitment demonstrated by all members to improve packages and processes where necessary is tremendous," DeJonge says.

... and the Runners-Up Are...

Two other nominations were strong contenders for Medical Packager of the Year.

DeRoyal (Powell, TN) was cited by Multivac Inc. (Kansas City, MO) for being as sophisticated with its packaging as companies many times larger. "They're very advanced for a company the size they are," says Gary Fitzhugh, Multivac Inc.'s mid-South district manager.

"Packaging is now considered at the beginning of a project to optimize opportunities for savings instead of waiting until the product is ready for market," says Kristi Hodges, a packaging engineer DeRoyal hired in 1997 to pursue and implement new packaging ideas.

DeRoyal solved a problem that many other companies are still facing—European labeling language requirements—by setting up a language database, programming its Zebra printers to pull information from the database, and acquiring new printers from Bell-Mark Corp. (Pine Brook, NJ) to print on packages produced from two of DeRoyal's four Multivac form-fill-seal machines.

The company has found ways to save by consolidating packaging across all its divisions and combining products in its breathable pouches. And it established a warehouse and distribution system for its corrugated boxes with help from supplier Cooper Container (Maynardville, TN) in which inventory is held on consignment and sent as needed to its facilities.

But improving its efficiency doesn't mean DeRoyal is sacrificing its responsiveness to customers. Some jobs are hand-loaded and hand-sealed in order to customize the package exactly the way the doctor wants it. And, unlike some other companies its size, DeRoyal convenes focus panels of nurses to advise on issues such as sterility and convenience.

Other suppliers to DeRoyal include Accurate Paper Box Company, Inc. (Knoxville, TN); PeelMaster Packaging (Niles, IL); Kenpak Inc. (Commerce, CA); Oliver Products Co. (Grand Rapids, MI); and Doyen MediPharm Inc. (Morris Plains, NJ).

Another nominee, Medtronic Interventional Vascular (Danvers, MA), came up with an innovative response to regulatory and economic pressures.

Medtronic was nominated by Beacon Converters Inc. (Saddle Brook, NJ) for its redesign of its inflation device package, done with guidance from Beacon sales representative Greg Dahl. The change from a rigid to a flexible package has resulted in less material waste, less bulky packaging, more storage space for customers, and a decrease of nearly $2.50 in materials cost per unit. The 70% decline in package volume enabled three times as many devices to be sterilized in the company's EtO chamber at any given time, reducing costs.

The device is placed into a 5-ml Surlyn and polyethylene header bag. Along with accessories, it is then placed into a second bag, which fits tightly into an outer box.

This design was driven by Medtronic's customers, especially European ones needing to follow the Packaging and Packaging Waste Directive, says Paul Squadrito, a senior technician for the company. "The solution came rather quickly, but implementing took a while" because of having to purchase new equipment and to revalidate the packaging and sterilization processes.

Medtronic places a high priority on packaging. "We need to ensure that the package adds value for our customer but does not add product cost," Squadrito says.