Converters Taking a Flexible Approach

Medical device manufacturers are asking for packaging quality, performance, and service support, all with cost savings. Medical packaging converters are stepping up to the challenge.

According to a recent purchasing study conducted by Pharmaceutical & Medical Packaging News, pharmaceutical and medical device packaging professionals value quality above all other considerations when searching for suppliers. But, most likely to no one’s surprise, price is a close second. (Our 2012 Packaging Survey, conducted by Readex Research, revealed that on a scale from 1 to 5 with 5 representing a “very important” supplier/vendor characteristic, respondents rated quality 4.7 and price 4.3.)

Such ratings are readily apparent in flexible medical packaging materials. Quality, and even heightening requests for cleanliness, reign when it comes to demands placed upon suppliers. But with the already competitive medical device industry facing an excise tax in 2013, medical device manufacturers (MDMs) continue to take costs out where they can. Packaging is often a target.

CONTROLLING COST, ADDING SUPPORT
Medical packaging converters are being asked to provide some cost savings. “Given the medical device tax in the United States, there is more pressure on us to help MDMs save costs to fund the tax,” explains Nicholas Berendt, director of global medical market development, Sealed Air Medical Applications. “We have to look for savings, but our comprehensive value proposition is helping MDMs find ways to lower total pack costs. by offering benefits on customers’ line efficiency and yields or by reducing working capital. Thanks to new technology, these savings can be significant.”

Perfecseal offers a range of pouches.

Adds Ed Haedt, vice president of marketing for Perfecseal: “It will be an interesting year,” referring to 2013. “In the United States, we expect the device tax to drive new cost take out initiatives. In Europe, the economic conditions will likely have a great impact on device packaging volume. We will be watching the European economy closely to see whether a recovery can begin to improve higher levels of healthcare utilization and improved government reimbursement levels for the device companies. We feel our polymer technologies are well positioned to respond to these industry events.”

As converters work to devise new cost-savings materials and packaging formats, they are also fielding requests for more data and additional internal controls.

“The FDA has significantly increased its resources for inspections and analysis since 2009,” explains Berendt. “We are seeing more requests for multi-level documentation from our customers, and we are experiencing more frequent customer audits at our facilities as part of the increased trend in regulatory engagement.”

Kevin Zacharias, engineering program manager for Oliver-Tolas Healthcare Packaging, agrees that MDMs are looking for more data and more support. “We are seeing elevated requests for service, support, and data,” he explains.

“MDMs are scrutinizing cleanliness, looking for ultraclean cleanroom manufacturing,” says Zacharias. “There’s more attention to mitigating risk, more testing, and more validation, so therefore there is more pressure on suppliers.”

“Demands for heightened hygiene measures are increasing,” concurs Berendt. “We were getting customer requests to move from hair nets to full hoods and gowns in our cleanrooms. We are meeting this request.” He adds that Sealed Air has recently upgraded its cleanrooms in Cranston, RI, to hold full ISO 13485 and ISO 14644-1 accreditation for its thermoforming operations.

Rollprint Packaging Products Inc.’s new 6000-sq-ft cleanroom for converting pouches is now certified to ISO Class 8 and fully operational, reports Dwane Hahn, vice president of sales and marketing. Using rollstock produced on site in Addison, IL, the cleanroom houses five production lines capable of producing header bags; pouches with chevron, vented, or three-side weld seals; or pouches with corner peels.

Printpack Medical is upgrading all of its converting in Marshall, NC, to an ISO Class 8 (100,000) cleanroom, reports Brad Walker, vice president and general manager. “The facility has 28 years of service dedicated to the medical industry, and has a deservedly great reputation,” he explains. However, he adds: “We see trends toward more FDA oversight and increased quality. Thus we decided that our manufacturing facilities needed to look like those of our customers, so we are making enhancements to Marshall. All converting equipment will be in the new cleanroom space.” Printpack Medical’s upgrade is in process; Walker expects it to be complete by the end of 2012.

The Marshall facility will employ both automation and vision inspection. “We are investing significantly to ensure zero defects when it comes to the integrity of the sterility barrier,” says Walker. “Cameras will compare product to a standard and identify defects such as wrinkles and gels. The upgraded lines will be able to eliminate any deviations immediately.” Existing lines are being retrofitted to support vision inspection.

Perfecseal continues to focus on and invest in quality. “We have reduced sources for particulate and have certified to clean room standards in most of our production areas,” says Haedt. “Also, we have incorporated vision technologies to help catch and quarantine defective product before it gets to our customers. Our intentions are to continue to focus on offering the highest levels of quality in the industry while providing these offerings in a cost effective package.”

Forming films from Printpack Medical.

MATERIAL TECHNOLOGY
Medical packaging converters report that they can meet MDM’s requests for cost-cutting through material innovations. “Device manufacturers are facing tremendous cost pressures. It is more imperative than ever for us to deliver greater value through innovative products,” says Michael Wollberg, sales manager for Printpack Medical. “Our new KwikBreathe pouches and DirectSeal forming films eliminate the need to add costly secondary coatings to breathable substrates.”

Perfecseal reports it is developing stronger yet lower-weight, thinner film materials for medical packaging, says Haedt. “These nylon-reinforced films offer substantial light weighting and downgauging versus monolayer or non-nylon-containing materials. An engineered approach to incorporating a high-performance polymer like nylon results in cost-effective films that have substantially higher durability than non-nylon materials. The term “durability” encompasses the overall performance of the film including puncture resistance, repetitive flex crack resistance, abrasion resistance, and other tensile-related properties.” The company’s PerfecForm ICE forming film and Perfecflex QE bag film series 36670 represent some of the highest performance levels per unit thickness of any films offered in the industry, Haedt claims. Perfecseal has also developed Opalen MD, a proprietary nylon/PE co-extruded film designed for lighter-weight applications that can be run at high speeds, adds Haedt. “This film is thin (55 microns/2.2 mil) but due to the nylon component, has excellent puncture resistance and tensile strength.” The film can be sealed to substrates including films, heat seal coated and uncoated papers and Tyvek.

Sealed Air’s new forming film Latitude ML29C has allowed MDMs to “significantly downgauge from other films by as much as 30%,” reports Berendt. One customer with a procedural kit including a syringe and other light consumables for the U.S. market has moved from a 10-mil EVA/Ionomer/EVA film to a 7-mil Latitude film, he explains. Because the film is thinner than competing films with equivalent or better mechanical properties, more material can be wound on 50-lb rolls. “The higher-yield film has reduced the downtime required for roll changeovers and more time for production,” Berendt adds.

Sealed Air’s Nexmark film, too, is being investigated for its savings potential. The film incorporates a photochromatic additive that enables laser printing, eliminating the need for preprinted rollstock inventory, allowing shorter batch quantities, and so reducing working capital, says Berendt.

Sealed Air’s Nexmark film

Sealed Air is also using new film manufacturing technology Berendt hopes will bring about significant change. “If you can do something using completely different technology, that is the way,” says Berendt. He points to the new Cryovac CT-301 shrink film featuring microlayering technology. According to a data sheet, the 30-gauge film offers 7.5 lb of impact strength. “We identified technology from a different industry and adapted it to work on our machines. It offers a huge improvement in strength at half the thickness.” CT-301 can be used in shrink tunnels and on flow-wrappers and can be used to collate different products as well as provide tamper evidence.

Sealed Air is also researching new resins and developing qualified alternatives during new product development. “Shortages of materials can happen, so we are establishing a safety net. We are building data on alternatives and filing it away in case there is ever the need to switch,” Berendt says.

Perfecseal is employing film sealant technology to engineer medical grade peel opening systems designed to provide high seal strength with fiber free seal and peel performance to uncoated paper and medical grade DuPont Tyvek, explains Haedt. “We began by introducing our CPT (Clean Peel Technology) several years ago for Tyvek/film pouches and Tyvek/forming film for FFS systems. The success of that technology has been translated to more cost effective paper/film options under the PaperLock system name. The ability to seal pouch our forming films directly to uncoated papers is not new, but providing medical quality peel appearance with fiber free peel seals at the industry target of one pound seal strength is new. Most recently, we combined our highly popular PerfecForm ICE film platform with this new sealing technology under the PaperLock CP system. The system involves a range of forming web thicknesses and paper thicknesses to cover a broad range of package performance requirements.”

In October, Printpack Medical received its first pouch-making machine. The machinery will be able to support a full line of pouches, including Tyvek-to-film, paper-to-film, film-to-film, foil-to-foil, foil-header formats, and the abrasion-resistant KwikBreathe pouch, says Wollberg. “This will complement the existing line of header bags, forming films, breathable top webs, HIPS sheet, and film and foil laminates,” he says.

Oliver-Tolas offers its Ostasis reinforced pouch to provide a more-robust option for holding trays, reports Zacharias. “We had been getting MDM requests for a puncture-resistant pouch. So we’ve modified our process to produce a pouch with two Tyvek strips on both ends of the pouch, preventing tray edges or heavy devices from puncturing or abrading through the ends of the pouch. The pouch film can be a standard polyester or nylon, and it offers a window for package clarity.”

Collaboration is key for meeting needs for performance, quality, and cost reduction. “The challenge for the suppliers is to drive out both cost and risk. Taking a collaborative approach, we can do so. We can identify areas to save costs, downgauge materials, switch films. We can even help with validation,” says Zacharias.

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