Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published February 1998

MEDICAL

Cutting Costs and, Literally, Corners

by Tammy Flaherty , Features Editor

Cost cutting continues to be the creed of the late 1990s, and in view of that, device manufacturers are looking to packaging engineers to tackle the task in new ways. "The medical device market is becoming more and more competitive. Many products, such as angioplasty items, were unique to certain manufacturers years ago, but today, they are virtually commodity products selling for half the cost of their introductory rate," says Eloy Cantu, Jr., director of sales and marketing for Oliver Products Co. (Grand Rapids, MI), a manufacturer of adhesive-coated packaging materials for sterile medical devices. "This, plus continued industry consolidation, has led firms to look to packaging as a means to lower overall costs."

To respond to the cost-cutting challenge, many packaging companies are offering their clients alternatives to traditional rigid packages and lidding. For instance, as explained in "Thermoformed Trays: Less Is More" (PMP News; January 1998), some thermoformers are using recycled as well as recyclable materials to produce trays and are passing the cost savings on to their customers.

Medtronic Interventional Vascular's inflation device is now packed in two header bags (shown on right), which take up half the space of its original tray (shown on left). Photo courtesy of Medtronic Interventional Vascular/Roni Ramos

Packaging suppliers are also offering other options such as films and lid stock materials with lighter gauges than those of traditional materials and alternatives to trays and lid stock materials. In addition to reducing the cost of packaging, these options allow device manufacturers to reduce shipping costs, minimize their impact on the environment, and implement other cost-savings steps such as a change in package sterilization or a switch to an automated packaging line.

EVOLUTION OF LID STOCK

"We have customers who are looking at different ways to reduce packaging costs," explains Jerry Bennish, business director for film and bag products for Rexam Medical Packaging (Mundelein, IL), a supplier of packaging materials such as films, foils, lidding, and rollstock. "Customers are interested in reducing cost by downgauging or reconfiguring materials," Bennish explains. One of Rexam's clients, Baxter Healthcare (Deerfield, IL), recently switched from packing its IV sets in a chipboard pack to producing its own package on a thermoform, fill, and seal machine using Rexam's flexible base and top web rollstock.

To offer its customers a lid stock more economical than traditionally used materials, Rexam expanded its line of Integra heavy-grade coated papers, extruded films, and coated Tyvek. Jeff Greenlief, Rexam's business director for coated products and die-cut lids, calls the product line Rexam's step toward "reducing bulk." Bennish explains that "the Integra line is designed to provide options to meet the needs of those customers seeking to reduce costs."

Bennish points out that for some applications acrylic-reinforced paper provides the best performance and cost combination. But other applications still require traditional materials. "Tyvek has its place and always will," explains Bennish. "It is a high-performance, proven product with high strength and package integrity." Rexam plans to equally promote paper, Tyvek, and film for lid stock.

Full Study on Tyvek Test Protocol Delayed until 2000

Technical information about current product now available on the Internet.

As industry is well aware, DuPont Nonwovens is upgrading its manufacturing process for Tyvek spunbonded olefin.

So far, FDA has approved the first stage, known as the Preliminary Study, of a two-stage test protocol that will compare Tyvek 1073B produced using the current process in Richmond, VA, to Tyvek 1073B produced using the upgraded process in Luxembourg.

In accepting the Preliminary Study results, FDA issued a letter on October 14, 1997, stating that the manufacturing process does not result in a significant change in the functional performance of Tyvek during medical device sterilization and package integrity over time. Therefore, FDA says it is not necessary for medical device manufacturers to file amended 510(k)s or amended premarket approvals to use the new-generation product. However, FDA notes that the change in the source of Tyvek—whether coated or uncoated—should be documented in each applicable device record.

The final stage of the test protocol was to begin at the end of 1997. However, according to DuPont, "polymer technology is advancing rapidly and we want to take full advantage of these developments in the next generation of Tyvek for the medical device industry. Therefore, we have decided to delay the Full Study so that we can ensure our process is at a steady state with the new polymer technology with no further advancements planned."

Given this, DuPont says it plans to conduct the Full Study in the year 2000 so that it will have solidified the polymer package for the third-generation process, and transition only once to the upgraded process.

A copy of the DuPont Tyvek protocol is available by calling 1-800-44-TYVEK.

For technical or standards information about the current Tyvek, product packagers can visit DuPont's Web site at http://www.dupont.com/Tyvek/sterilepkg.

SWITCHING FROM RIGID TO FLEXIBLE PACKAGING

According to Michael Scholla, medical packaging segment leader for DuPont Nonwovens (Wilmington, DE), the manufacturer of Tyvek, many medical device companies are considering a switch from rigid to flexible packaging. DuPont is currently developing a new style of Tyvek that will better meet the needs of form, fill, and seal packaging applications.

Medtronic Interventional Vascular Inc. (Danvers, MA) recently redesigned the packaging for its inflation device. The original package, a rigid PETE molded tray sealed with a Tyvek lid and placed in an outer header bag, was replaced with two header bags that take up about half the space of the tray.

William Daly, president and CEO of Beacon Converters Inc. (Saddle Brook, NJ), the packaging manufacturer that provided Medtronic with the header bags, feels Medtronic's switch reflects what is occurring in the industry. "We are experiencing a shift in interest among our customers from rigid to flexible packaging," explains Daly, who is also the chair of the Sterilization Packaging Manufacturers Council of the Flexible Packaging Association (Washington, DC). "Flexible packaging provides source reduction, i.e., less material is put in the waste stream, shipping weights are reduced, and, not incidentally, flexible packaging is less expensive than rigid."

Switching from rigid to flexible packaging has helped Cordis Corp. (Miami Lakes, FL), a medical device division of Johnson & Johnson, to cut packaging costs substantially. The company is in the final phases of converting the packaging of its entire diagnostic catheter line from a Tyvek film/metallized film structure to a medical-grade paper/metallized film pouch on a new custom-engineered form, fill, and seal line. Complete conversion is expected by this summer. The paper/metallized film is manufactured by a firm that also produces films for lidding materials. Cordis's project demonstrates that lid stock manufacturers are finding new uses for their materials.

Rolando Gonzalez, principal manufacturing engineer for Cordis, pioneered the conversion and estimates it will provide the company with considerable packaging savings. "About three years ago I was asked to develop a package savings schedule for our diagnostic catheter line. What developed was an automated form, fill, and seal line. However, paper wasn't initially part of the equation," he notes.

Gonzalez explains that the packaging line he designed and patented consists of several automated pieces of equipment. Components include: pick-and-pack suction-cup systems that place both a mounting card and the catheter on a conveyor belt; the form, fill, and seal machine that sandwiches the product; a label printer and applicator; and a vision system. Once the product is packaged, it is sterilized using EtO. Package sizes are either 33/8 or 37/8 in. wide and range from 35 to 55 in. long. "When I presented the concept to the senior manager, he had the vision to see it could work and spearheaded the idea. However, at that time we weren't planning a material change," says Gonzalez.

As the project progressed, Gonzalez realized the packaging line did not support the use of Tyvek film because the tack seal caused the mounting card to pull up with the olefin material. So he began to investigate alternative materials. What resulted was the selection of a peelable, coated medical-grade paper.

"Today's medical-grade papers are highly synthetic and feature a lot of latex," says Gonzalez. "We've found no fiber delamination or fiber tears with the paper, and in my opinion, it's a formidable alternative to much more expensive materials. I estimate we'll save approximately 30% in material costs alone. And, when you factor in the volume of product we package, the new automated form, fill, and seal line, and the material savings, we're talking about a tremendous savings."

STERILIZATION AND PACKAGE CHANGE EQUALS SAVINGS

A few years ago, DePuy Orthopaedics (Warsaw, IN), the oldest manufacturer of orthopedic products in the United States, switched from gamma radiation for its polyethylene components to an in-house Plazlyte gas plasma sterilization from AbTox Inc. (Mundelein, IL). The move was made primarily to eliminate the harmful effects that gamma radiation had on the polyethylene material used for its artificial hip, knee, shoulder, elbow, ankle, and finger joints. However, the company also used the sterilization method as a cost-cutting measure as well as a means to provide its customers with faster turnaround.

Cordis Corp.'s new paper/metallized film pouch for its diagnostic catheter line will help the firm save about 30% in material costs. Photo courtesy of Cordis Corp.

Once the sterilization change was complete, DePuy began to investigate ways to reduce its packaging costs. When the sterilization change was made, DePuy started using a thermoformed, double-blister PETG tray with Tyvek lidding for most of its polyethylene products. However, according to Conrad Klotz, manufacturing and packaging development engineer for DePuy, this structure is now being phased out for a more cost-effective option.

Klotz says the company has just completed an extensive evaluation of peel pouch packaging and will slowly, but steadily, convert the packaging for its polyethylene products to these configurations. "Changing from a rigid tray to a peelable pouch is less expensive from both a material and a labor standpoint; plus it's more environmentally sound," says Klotz. "We've also found that the pouch construction provides more product protection. When a product is in a rigid tray, it has a tendency to bounce and shift in the dead space. The pouch actually acts as a filler or cushioning agent within the larger shipping box, so there is less room for product movement and damage," he explains.

Klotz says the new pouches will be phased in for the majority of its polyethylene products by the end of 1998. Once the conversion is completed, DePuy anticipates a 50% savings in packaging material costs. The pouch will comprise uncoated Tyvek 1073B on one side and a polyethylene/polyester laminate on the other. "We're switching the package construction, but still relying on the Tyvek material because of its compatibility with the gas plasma sterilization process," says Klotz. One of the requirements for gas plasma sterilization is that the packaging material be breathable and porous to enable the microbe-killing molecules to penetrate the package and flow freely around the device for complete terminal sterilization. "These types of products are implanted deep within the body," says Klotz. "We can't afford to take any risk with product sterility."

To remain competitive, device manufacturers are attempting to reduce their overall production costs, and many are turning to packaging suppliers for assistance. These suppliers are devising creative ways to meet this demand, offering alternatives to traditional rigid packaging and lidding including recycled or recyclable tray materials, films and lid stock materials with lighter gauges than those of traditional materials, and flexible packages.

However, device manufacturers won't abandon traditional rigid packaging in droves. DuPont's Scholla explains that many devices, such as orthopedic implants, still require the strength of rigid trays. In addition, switching packaging materials usually requires economic justification of the potential material cost savings versus the cost of qualifying the new materials. Switching from pouches or header bags to flexible packaging may require the purchase of form, fill, and seal equipment, which requires large-volume production to justify the capital expenditure.