Devising Sterile Packaging Solutions

With resources stretched tight, medical device manufacturers turn to suppliers for added support.

The foremost goal for manufacturers is keeping quality up and cost down. While the pressure to reduce packaging costs is not a new trend, it is an ongoing challenge. Regulations keep the sterile packaging market fairly stable, but manufacturers are still looking for ways to hold down costs and enhance product sterility assurance, within mandated requirements. Suppliers are coming up with ways to help them.

 
 Alcan Packaging's non-ionomer/non-nylon forming film alternatives. Contributed by Alcan Packaging Medical Flexibles.

Flexible Resources
Overall, most suppliers of sterile medical packaging materials and services are ahead of the game by helping customers maintain quality while minimizing costs.

Alcan Packaging Medical Flexibles plants are certified to ISO 13485 quality standards and provide total packaging solutions design to completion, including critical analysis and testing. Alcan’s technical data reports include information related to cytoxicity, pre/post sterilization, five-year aging comparison, microbial barrier, physical properties, seal curves, and root-cause investigation.
“We are finding ways to save cost and time by providing comprehensive technical data reports to our customers in advance of validation,” says Bret Melton, marketing manager. “Customers are using our certified data to supplement their own, which helps expedite justification for using Alcan Packaging solutions.”

See additional story: Heat Sealing Process Validation: Consider More than Time, Temperature, and Pressure

In addition, new material offerings tackle costly issues. According to Melton, Alcan Packaging’s new DesiShield and DesiVent foil laminations with desiccant built in to the sealant film reduces head space relative humidity to approximately 3%. “This will last 5+ years and will not release moisture back to the product,” he says. “It eliminates complexity, waste, contamination and cost and is suited for drug eluting devices, diagnostics, and pharmaceuticals.”

Amcor Flexibles (Mundelein, IL) also tailors packaging solutions to meet specific healthcare packaging requirements. “From packaging design through validation, we offer a range of value-added services to supplement our customers’ in-house resources and reduce the time to market,” says Brad Herbolsheimer, global marketing director.

He adds that they are seeing an increasing trend towards shorter, more aggressive sterilization cycles as manufacturers attempt to increase sterilization throughput. “Many legacy packaging materials were not designed to hold up in such situations. To address this, Amcor has several innovations—for example, our new peelable forming film seals to uncoated Tyvek and can offer composite pack savings. Peelability to uncoated Tyvek improves porosity, allowing customers to shorten EO sterilization cycles.”

Oliver-Tolas Healthcare Packaging (Grand Rapids, MI) has developed the VisiSeal adhesive, which addresses both cost and quality issues. “The VisiSeal adhesive on pouches or rollstock clarifies when [the package is] sealed to allow for in-line and point-of-use inspection without destroying the package,” reports Jeff Murak, vice president, sales and marketing. “VisiSeal also addresses the growing need of hospitals to decrease the occurrence of infections resulting from a breach in the sterile barrier system.”

To offer a single line up of diversified products, Perfecseal (Oshkosh, WI) provides both thermoformed trays/lids and premade sterile barrier packaging systems like chevron pouches and breathable header bags. “We provide a wide variety of high-barrier rollstocks utilizing various thicknesses of aluminum foil and clear high-barrier oxide coated materials that can be configured into premade sterile barrier system pouches and breathable pouches that are often used for combination drug/device applications,” says Ed Haedt, vice president of marketing. Perfecseal’s high-barrier blister forming materials and high-strength films suit applications requiring extremely strong, flexible packaging materials in either breathable or nonbreathable formats.

Added Support
Beacon Converters Inc. (Saddle Brook, NJ) manufactures a full range of flexible packaging with a focus on custom design. “We focus on identifying the requirements of the product and working with our customers to define the best package,” says Kathleen Daly Mascolo, vice president, director of sales and marketing.

See sidebar: On the Safe Side when In House

One recent project for Beacon involved the development of a barrier bag for bulk pharmaceuticals. It addresses the trend for added strength at a reasonable cost while meeting the needs of the product being packaged.

To add value to its services, Beacon’s strong technical team includes members that also serve as chairs of ASTM, AMMI, and IoPP. This keeps the company on the forefront of any emerging regulatory requirements. “Our team’s experience, knowledge, and understanding of current and upcoming requirements provides enormous assistance to our customers as they choose a sterile barrier system,” Mascolo says.

Amcor Flexibles offers a peelable forming film for medical device packaging.

Rollprint Packaging Products Inc. (Addison, IL), too, is active in ASTM and other industry groups. In addition, Rollprint provides a prototype lab that allows the rapid development of market-ready samples and package performance information that can dramatically shorten the design process. “Testing and analytical support are available through our fully equipped labs,” says Dhuanne Dodrill, president. “To meet the needs of an increasingly regulated environment, we take an active role in the regulatory development process and are ready with the material documentation and support needed to more easily navigate the regulatory maze.”

Rollprint produces a range of products, including two new clear ultra-high-barrier options, ClearFoil X and ClearFoil Z. “With these products we can provide oxygen and water vapor barriers into the fourth decimal place,” Dodrill says. In addition, its “recently introduced, StreamOne was designed to meet requests for a 100% polyester lidding engineered to provide consistent hermetic seals to CPET, APET, and PETG trays. It has a wide sealing window and is forgiving enough to provide consistent seals even with the variation that is often found in flange uniformity. The lid has a tamper-evident feature. When peeled, it will turn white where it had been sealed to the tray without leaving residue on the flange.”

The company is active in the Sterilization Packaging Manufacturers Council (SPMC; www.sterilizationpackaging.org) along with Alcan Packaging, Amcor Flexibles Healthcare, Beacon Converters, Oliver-Tolas Healthcare Packaging, Perfecseal, and Technipaq Inc. SPMC is actively engaged in the development of test methods and guidance documents for the sterilizable flexible packaging.

Tek Packaging (Huntley, IL) is also offering full-service support with design and development of medical trays, clamshells, blisters, and thermoforms for medical device and drug packages. Randy Loga, president, explains: “We have a full-time development group and are just as much a product development service as we are a repetitive manufacturer.”

Tek Packaging has already made steps to move up to ISO 13485 registration by next spring. “The reason is we are not just doing packaging but we are starting to do some actual medical device forming and have a medical device production facility that operates in a Class 1000 cleanroom. We will be the only thermoformer in the industry that is certified to that level,” Loga adds.
Because outsourcing manufacturing and packaging is also a growing trend, Kevin Volden, sales manager, Tek Packaging, says that the firm is working to ease development of IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) protocols. “Manufacturers are asking packaging and thermoforming providers to do an IQ/OQ/PQ, particularly when using a contract manufacturer to both make and package the device. A full IQ/OQ/PQ is expensive. We are trying to develop a tried-and-true process for doing this for our customers, so they won’t have to write one. We will have a standard protocol we can offer to the market,” he says.

Tek Packaging is also looking for lower-cost material alternatives. “There has been a thrust in the industry as far as implantable devices to find a lower cost alternative to polycarbonate. We have done a lot of research with high-heat polypropylene and polyolefin materials that can withstand the temperatures of autoclave and dry heat sterilization. This reduces the cost between 30 to 50%,” Loga says.

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