Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published September 1998

SPOTLIGHT

Packaging for the Surgical Suite

There is no cookbook method to packaging surgical supplies — just ask any device manufacturer.

by Daphne Allen, Editor

Every medical device company has a slightly different approach to packaging its surgical supplies—some choose a customized tray-and-lidstock combination, some a sealed-tray-and-pouch combination, and still others a tray wrapped with a nonwoven material and then placed into a bag. And these aren't even all the possible packaging configurations.

Surgical nurses and technologists see such variety each day. But what matters to them most is not the packaging configuration, but rather the performance of the packaging. "It's not so much the packaging style as it is the ability of the package to maintain the sterility of the device," explains Kevin Frey, educational coordinator for the Association of Surgical Technologists (AST). "The only time we would complain is if the package is hard to open in a sterile manner."

A surgical technologist removes Baxter's oxygenator from a sterile barrier header bag through the use of injection-molded trays. Photo by Roni Ramos.

Should packaging designers worry about the lack of a definitive model for surgical supplies packaging? Probably not. This situation may in fact provide greater flexibility to meet end-users' as well as manufacturers' needs.

TRAYS

Market research firm The Freedonia Group (Cleveland) reports an increased demand for thermoformed trays, which it claims reflects an interest in ready-to-use, preassembled surgical kits. Mike Zwalley of kit manufacturer Maxxim Medical (Clearwater, FL) agrees. "Hospitals used to buy individually packaged devices, then unwrap them during surgery. Now, many are finding it's more efficient to open one tray than 100 individually packed devices."

Thermoformers can usually custom design trays to meet the exact dimensions of the kit components, enabling the trays to protect even the most fragile devices. Says John McNulty, director of sales at Alloyd Medical Products Group (DeKalb, IL): "A tray with a good fit doesn't allow product to move around during transportation." This is especially important for kit components made of glass, such as drug vials and ampules. McNulty says that doctors are particularly concerned with whether the tray fits the products. Some of the trays his firm develops are used to hold all the surgical devices necessary for a particular procedure.

Key to a tray's sterility is its seal. Lidstock made of Tyvek brand spunbonded olefin or coated paper is usually sealed to the tray using either a manual or an automatic heat sealer. Using heat sealers with built-in sensors that constantly monitor sealing parameters helps operators ensure that the packages are being sealed properly. For instance, Atlas Vac Machine (Cincinnati) offers units with seal parameter documentation systems that monitor and record all sealing functions. Companies such as Belco Packaging Systems (Monrovia, CA) and DT Industries' Sencorp. (Hyannis, MA) also offer process control monitoring systems on their heat sealers. Data acquisition systems are even available on some models.

But not all device manufacturers can afford the expense of trays, however. Alan Curtis, vice president of regulatory affairs and quality systems for start-up SURx (Pleasanton, CA), says his firm will move to a tray as soon as its device completes its clinical trials and has the production volume to justify the cost. "If you go to a thermoformed tray, you have to have a custom design, and that's what costs a lot," says Curtis, whose firm produces a single-use incontinence treatment device. For now, the firm packs the device into two pouches to maintain sterility and prevent punctures.

Because kits often contain an assortment of differently shaped components, kit assembly is usually done by hand in a cleanroom. But Stu Geraghty, vice president of sales and marketing for GSMA-Parish (Palm Bay, FL), says noncleanroom kit packaging can often be automated through the use of robotics. "Robotics can pick and place a variety of preoriented instruments into trays or blisters," he says. "For nonoriented components, however, you can use a vibratory bowl that will orient bulk-fed components for robots to pick up and then place into blisters. Products not oriented properly fall back into the bowl." Geraghty says that many robots are also suitable for cleanroom packaging.

TRAY-AND-BAG COMBINATION

In addition to using trays, many firms add supplemental packaging layers—inner and outer pouches. Martin Golden, senior packaging engineer for Boston Scientific, Meadox (Oakland, NJ), says its catheter delivery systems are contained within thermoformed trays specifically designed for the device system and then placed into inner and outer chevron Tyvek polyester peel pouches sized to fit the contents. "The thermoformed tray is the backbone of the package while the pouches provide the sterile barrier," Golden explains. "The use of the inner and outer pouch sterile barrier system is standard for these Meadox products."

Some kit packagers eliminate lidstock use by employing a tray-and-header bag combination. This is especially helpful for high-profile or long devices. To meet the barrier and strength requirements of heavy devices and trays, Perfecseal (Philadelphia) developed a linear low-density polyethylene called Perfecflex ShieLLD. The new film is thin yet strong—the 3-mil film can provide 150% more impact strength than many 4-mil conventional films—allowing many packagers to downgauge from their current materials.

Baxter Cardiovascular (Irvine, CA) is one such surgical device manufacturer that has benefited from the tray-and-bag combination. The firm packages its oxygenator into an injection-molded tray that is placed into a header bag from Kenpak (City of Commerce, CA). The coextruded film made of nylon and polyethylene "has allowed us to eliminate the use of other materials because it is so strong," says Baxter's Stuart Long. "It also allows hospitals to reduce their waste."

Baxter's packaging is also remarkable for another reason. Long explains that his firm recently started to develop injection-molded trays. The packaging system uses two such trays that sandwich the device. "Thermoforming has its place," says Long, "but with injection molding you avoid the loss of consistency typical of a thermoform draw. You also avoid the sharp edges of thermoformed trays." Long admits that tooling costs are high, but feels it is worth it. "You can have a consistency of 50 mil at the top and at the bottom of the tray, and you can contour intricate designs." In the operating room, the tray can be used as a presentation platform, Long explains.

Many kit makers double-bag their sealed trays or pouches. John Grimm, director of new product development for OEM and international divisions at Burron OEM Div., B. Braun Medical (Bethlehem, PA), says that users may want the devices double-pouched because "you could soil the outer pouch, so in the gray area outside of the operating room you can take off the outer pouch, and a sterile packaged product goes into surgery."

WRAPPED TRAYS

Another way to package surgical kits is to place all the devices into a tray, fold a nonwoven material around the tray, and place the wrapped tray into a large bag. Jeff Greenlief, business director at Rexam Medical Packaging (Mundelein, IL), explains that many companies use either central supply room (CSR) wrap or back table covers to envelop the trays. Says Dorothy Fogg at the Center for Nursing Practice, Health Policy, and Research, a division of the Association of Operating Room Nurses, "many surgical nurses prefer that packages include an inner impermeable wrap that can be opened up and act as a back table cover during surgery." In addition to meeting end-user needs, Greenlief says using CSR wraps and back table covers "permits greater flexibility in terms of use for a wider variety of trays." During surgery, the back table cover then functions as its name suggests—it covers the table on which surgical instruments lie, and it catches or absorbs any sterile fluids that may be spilled during the procedure. Rexam, a supplier of packaging materials, also makes back table covers and is currently reengineering the covers to be stronger so they can keep surgical kits intact throughout handling and setup.

Kit manufacturers that wrap some of their kits include Burron and Maxxim Medical. Burron's Grimm says his firm often wraps a tray filled with components and then places the wrapped tray into another tray. The second tray is then sealed with a Tyvek lid. Zwalley says Maxxim's procedure packs for operating and emergency rooms use thermoformed trays to position instruments in the packs. The trays are wrapped with a synthetic material, then placed into header bags.

POUCHES AND BLISTERS

But trays aren't the only way to package surgical devices. Burron's Grimm says that one of his OEM accounts recently switched from a rigid to a flexible blister to package its large irrigation system used in shoulder and knee surgery. "It was more efficient in the manufacturing process," Grimm explains. "For trays, we have to buy from a vendor. For a soft-pack blister, we just buy one type of rollstock and then form-fill-seal packages to the size we want. We don't have to fill our warehouse with preformed trays."

Many surgical devices can be packaged into form-fill-seal packages, says Craig Livingston, director of sales at Rollprint Packaging Products (Addison, IL). "Surgical devices as well as other sterile products used in the operating room ranging from catheters to syringes to sutures can be placed into flexible, formable bottom webs made of either film or foil laminates. The top web can be either Tyvek, film, or a foil composite, depending upon the product's barrier and sterilization requirements."

Another option for packagers is a pouch. "Flexible packaging is easier to pull open and is less bulky, so it takes up less space, especially in storage," says Grimm. Pouches usually consist of a clear film and a side of porous material, while header bags are made of film and have a strip of porous material. Kimberly-Clark Corp. (Roswell, GA) offers yet another option—Munising MP polymer-impregnated paper as an alternative porous material. "This is different from paper—this is reinforced with a polymer emulsion. EtO and steam can penetrate the paper but don't saturate it," explains Robert Duffy, market manager for medical packaging. "The polymer wraps around the cellulose fiber and strengthens the paper while maintaining a tortuous pathway against bacteria." Duffy says the paper is particularly suitable for surgical use. "It helps prevent the generation of particulate and has antistatic properties, so it reduces the attraction of airborne particles."

Pouches also take up less space than trays during disposal. "Most of the industry is looking for easy disposal," Grimm says. "And flexibles are easy to dispose of." Baxter's Long says that one benefit to his firm's use of nylon header bags is that hospitals that use its devices can reduce their waste.

CONCLUSION

There is no uniform way to package a surgical kit. Some firms may choose a form-fill-seal blister to reduce manufacturing costs while others may turn to injection-molded trays for their contoured shapes and soft edges. So how does one choose a configuration? Burron's Grimm recommends asking the following questions: "Is the package easy to form, place components in, and seal? Can it maintain shelf life and sterility over time and during shipping? Is it easy to dispose of? And, is it easy for users to handle?" AST's Frey adds that many manufacturers send sample kits to end-users, and the surgical technologists often try them "in surgery to see how we like them." If you can answer yes to all of Grimm's questions, and your package has met with the approval of a surgical team, you know you've chosen the right configuration.