Flexible Solutions

Flexible packaging suppliers have traditionally offered pharmaceutical and medical device manufacturers solutions that provide strength and protection, often helping to minimize package size and weight.

While today’s solutions continue to provide such support, suppliers are fielding newer requests for barrier and brand protection, among others.

Anticounterfeiting
To offer medical device and pharmaceutical manufacturers anticounterfeiting protection for their products,
Rollprint Packaging Products Inc. debuted new technology at Pack Expo Las Vegas that integrates overt watermarks into composite flexible packaging materials. Suitable for chevron pouches and more, Ghost can feature corporate logos, brand names, or symbology that allow visual confirmation of product authenticity.

Ghost builds upon the interest Rollprint has seen with a previous product, Chameleon Color-Changing Sealant, which was recognized earlier this year with an award from the Flexible Packaging Association. Using color to promote brand protection and identification, Chameleon can be applied to any thermally stable web such as polyester, nylon, and polypropylene or on any of Rollprint’s ClearFoil barrier structures.

“We received a lot of great feedback about Chameleon, so there is definite interest in anticounterfeiting,” Dwane Hahn, vice president of sales and marketing, Rollprint, tells PMP News. “Our goal is to put technology concepts such as Ghost and Chameleon in place to support industry’s efforts.”

Ghost from Rollprint features watermarks that are not affected by sterilization.

Ghost can be applied during the course of film manufacturing with no postprocessing, and it does not add any thickness to the film or weaken it in any way, says Hahn. Watermarks are not affected by sterilization nor do they have any effect upon heat-sealed areas. The size of the marks themselves can vary depending upon user need, he adds. Because specialized equipment is needed to produce the watermarks, would-be counterfeiters would struggle to duplicate them.

Ghost is currently being commercialized for transparent films, but it could be used with the same effect on foil laminations and many other opaque materials. The technology could also be used in conjunction with blister packs, packets, flow wrapping, tray lidding, or other formats. While Ghost can be used for virtually any product category, Hahn sees particular benefit for pharmaceutical media bags, given the high-value of such contents.

Hahn sees advantages to using Ghost over other anticounterfeiting approaches. “Companies that are currently using anticounterfeiting measures typically employ covert options that add significant cost and frequently require specialized equipment. Examples include inks only visible under UV light and micro printing. Because the watermark is added concurrently during normal processing, we can usually add the feature at little or no additional cost,” he said in a statement.

In addition, users do not need any additional equipment or capabilities to authenticate products with Ghost, Hahn told PMP News. “Nurses can quickly identify authentic items in the field,” he says. “They do not have a lot of time to scrutinize packaging, so they need to make quick and easy decisions. Ghost helps them do just that.”

Rollprint has already received some industry feedback, with one professional wondering whether a partial adoption of Ghost across product lines would prompt nurses to wonder about items that do not yet feature the watermarks. “We advise medical device manufacturers to employ Ghost for high-value items and communicate such use appropriately,” says Hahn.

Barrier Materials for Flow Wrapping
Perfecseal has launched PerfecPharm P232 to meet the demands of high-speed flow wrap machines, reports Georgia Mohr, marketing director – pharmaceuticals for Perfecseal. The company has been receiving requests for a high-barrier foil flow wrap for high-speed pharmaceutical, diagnostic, and medical device applications, she says. “Typically, the applications that we are working on require that the product first and foremost be protected from moisture. In most cases, the primary packaging does not offer adequate moisture barrier and then the secondary flow wrap material becomes critical,” she reports.

PerfecPharm P232 from Perfecseal offers a high-barrier foil option for flow wrapping.

The challenge has been identifying a barrier construction that can run at the line speeds that suit flow wrapping. “Flow wrap packaging machines, though capable of running at high speeds, are sometimes limited by the materials that are available in the market,” Mohr explains. “You can have a high-speed machine, but a packaging material capable of sealing at high speeds is also needed in order to deliver the desired output.”

In addition, the market needed hermetic seals. “Most products that require a foil laminate are hydroscopic. It is critical for product protection to keep moisture out, therefore in order to achieve this demand the seal must be hermetic,” she explains.

To offer pharmaceutical and medical device packagers a high-barrier option, Perfecseal turned to sealant technology initially designed to serve non-healthcare markets. “The sealant material allows the package to seal at high speed, and the foil delivers the needed moisture barrier required by many healthcare products. Perfecseal has a great deal of experience in barrier packaging, and we understand that materials play a major part in the success of the package. Our focus is to design materials that are fit for purpose, which takes into account the machinability of the material on the package equipment.”

Perfecseal worked closely with Bosch during development of PerfecPharm P232. “The Bemis food packaging division has worked on many projects over the years with Bosch and opened the door for Perfecseal to develop a design of experiments at Bosch. Working closely with the equipment suppliers is critical in specification selection.”

The team also needed to ensure that the solution would offer a wide sealing window. “Having a broader sealing window means you are going to produce a hermetic seal at a lower temperature, which will potentially allow the flow wrap machine to run at higher speeds. Basically, the heat-seal activation temperature is lower than standard materials,” Mohr says. “PerfecPharm P232 flow wrap material offers a wide sealing window (140°C–200°C) and the potential to run at lower temperatures than traditional materials, yet seals hermetically at speeds up to 300 ppm.”

PerfecPharm P232 is currently recommended to package products that are already sterile, says Mohr. “The PerfecPharm product line continues to expand to meet new packaging demands for new drug delivery methods,” she adds.

Autoclavable Barriers, Perforations, and More
Oliver-Tolas Healthcare Packaging has been seeing a number of specialized requests emerge for flexible packaging. For instance, the company is tracking interest in autoclavable barrier packaging. “There has been a missing link, so we are responding to the need for flexible barrier packaging that can survive high heat and high moisture while eliminating packaging processing steps,” explains Jody Beeck, marketing and product manager.

Oliver-Tolas has just commercialized autoclavable Dispos-a-vent pouches featuring foil laminations with a breathable header strip. After autoclaving sealed pouches, users would simply apply a third seal to remove the header strip for a barrier package, Beeck explains.

Beeck also reports industry interest in compartmentalized pouches to segregate certain items in the package. To meet that need, Oliver-Tolas has investigated ways to perforate Tyvek during inline pouch making. “The challenge is that the perforation process itself is intended to create holes. So we have developed a robust process to eliminate the chance that a hole is misplaced somewhere else in the pouch,” she explains. “We have maximized process control through machinery controls. And we have determined that the perforation process does not introduce any contaminants.”

Finally, Oliver-Tolas continues to see increased interest in manufacturing quality and cleanliness for heightened control over particulates and endotoxins, among other concerns. To support MDMs, the company introduced its Oclean program in early 2013 for identifying cleanliness requirements early during package design phases, says Beeck. “We can identify a product or process available to meet the needed cleanliness level,” she says.

While the medical device manufacturing industry has always been risk averse and therefore has traditionally expected high-quality materials, newer cost pressures may be driving some of the additional scrutiny, says Beeck. “Cost pressures have increased through healthcare reform, so there is heightened pressure on and scrutiny of packaging suppliers. Any contamination equates to more processing on the MDM’s behalf, so they seek to reduce this burden.”

Oliver-Tolas continues to expand its certified cleanroom manufacturing space. The company currently maintains 6000 sq ft of cleanrooms at its Grand Rapids facility; 918 sq ft currently in Feasterville, PA, with an expansion underway; 1800 sq ft at its Suzhou, China, facility; and 1300 sq ft at its Venray, Netherlands, facility.

Cost Remains an Issue
Cost continues to drive innovations in medical packaging, says Brad Walker, VP/GM Printpack Medical. The “increasing cost of healthcare along with constant pressure to make medical care more affordable cause manufacturers to look to suppliers for assistance with cutting costs.”

MDMs are seeking suppliers that offer broad product portfolios, he says. “The ability to purchase complete packaging solutions from one supplier creates cost savings and partnership opportunities,” says Walker.

Despite the pressure, Walker calls “this is an exciting time. While there is a need for cost savings, there are ample solutions available to the medical market across the various packaging formats,” says Walker.

Printpack Medical joined the medical packaging arena in 2010 with the acquisition of the former Kenpack facility in Marshall, NC. This facility has been serving medical device customers with quality products since 1985, says Walker. “While Printpack Medical has all of the necessary certifications to serve the medical device market (ISO 13485:2003 and ISO 9001:2004) our commitment to quality goes well beyond that. An example of this is the investment in a certified Class 8 cleanroom in March 2013,” he says.

Printpack offers cost savings with the development of KwikBreathe, an uncoated Tyvek header bag designed to breathe 2 to 3 times faster than other competitive products that utilize coated Tyvek, says Walker. “This bag is unique because it creates a plastic to plastic, fiber-free, easy opening peel seal by allowing a natural seal between uncoated Tyvek and the specialized KwikBreathe header strip. Customers can choose from a variety of bag styles and sizes. DirectSeal is another innovation from Printpack Medical that allows uncoated Tyvek or paper to seal directly to coextruded film.” Printpack also offers thinner gauged forming films that perform effectively. They use less material, creating less waste and more cost savings, Walker reports. 

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