FDA’s Center for Devices and Radiological Health (CDRH) has affirmed the functional equivalence of transition Tyvek to current Tyvek for sterile medical packaging, DuPont Protection Technologies (DuPont) is reporting in a news release issued today. The notification from FDA represents what the company calls “a significant milestone in the DuPont Tyvek Medical Packaging Transition Project (MPTP).” The multiple-year program has been helping medical device manufacturers (MDMs) prepare for the transition to Tyvek 1073B and Tyvek 1059B manufactured with DuPont’s latest flash-spinning technology on production lines at its Richmond, VA, and Luxembourg facilities.

The MPTP team will discuss the latest news tomorrow (October 6) in the Webcast “Major Milestones Achieved — MPTP Enters Next Phase.” The team will also share DuPont’s plans for commercialization and ongoing support along with MPTP interim test results after 7- and 10-year accelerated aging. It will also offer tips for submissions to notified bodies. 

With affirmation of functional equivalence, the U.S. FDA states that it is not necessary for MDMs to file amended 510(k)s or PMAs when substituting transition Tyvek for current Tyvek during the manufacture of approved medical devices, in most cases, DuPont reports in the news release.

According to an FDA news bulletin, "absent a specific request or notice from FDA or a risk analysis to the contrary, it is not necessary for medical device manufacturers to submit a new 510(k) or PMA supplement for a change solely in packaging from the Legacy Tyvek to the Transition Tyvek manufactured using the upgraded spinning process, including both coated and uncoated styles 1073B and 1059B."

DuPont also reports that Health Canada has issued its guidance "on filing a modified license amendment for transition Tyvek in Canada." 

DuPont is also announcing that commercial sales of transition Tyvek can begin this month.

“Receiving FDA affirmation of functional equivalence and Health Canada guidance is the culmination of years of preparation, collaboration, and execution of a meticulous process,” states Michael H. Scholla, Ph.D., global director, Regulatory and Standards, DuPont Protection Technologies, in the news release. “We would like to thank the FDA, Health Canada, and all those who have participated in this process; it is a great demonstration of the power of an effective supplier-industry-government collaboration.” 

Throughout the MPTP, DuPont has worked closely with MDMs, sterile packaging manufacturers, testing laboratories, and regulatory bodies around the world.  

“We have worked successfully with DuPont for many years,” states Nick Fotis, global packaging director, Cardinal Health, in the news release. “Their handling of this complex regulatory challenge – the way they facilitated the challenging transition for their customers, coordinating with regulatory agencies around the world – is testament to why DuPont is a trusted partner in the medical packaging industry. DuPont has been a leader in our industry for many years and their collaboration with customers across the supply chain and throughout this complex global regulatory process, from package design and testing to data sharing and communications is why we choose DuPont Tyvek.”

MDMs can find a copy of the U.S. FDA letter affirming functional equivalence, as well as other regulatory information, Industry Summary Reports, and the latest MPTP testing results at www.areyouready.tyvek.com. DuPont will continue to post Industry Summary Reports on its Web site, and package testing will continue to examine real-time and accelerated aging time points. Following completion of each study time point, confidential regulatory reports will be issued to the U.S. FDA, Health Canada, and five Notified Bodies in Europe, the company states.

DuPont is also increasing the availability of current Tyvek, explaining that some MDMs, especially those with Class III devices sold in Europe, are awaiting Notified Body approvals. The company states it “will continue to produce this material on a schedule that is aligned with the needs of our stakeholders.”

A sterile medical packaging converter is using flexographic printing to coat lidstock in a single pass. 

SteriPax Inc. (www.steripax.com) is streamlining the adhesive-coating process for savings. The company has developed a  single-pass process for coating zones with six layers of adhesive in a single pass, explains Jack Roten, business development manager. Launched about 3 years ago, the patent-pending process utilizes a flexographic printing press to “print” the six layers.

The first three stations of the nine-color press print ink, followed by six that “print” adhesive, explains Roten. “At the end of the machine we have a die-cutter that separates the lidstock, and then it is stacked and poly bagged. We can process up to 100 feet per minute.”

Roten says he had envisioned such a process for years, but needed a special formulation and company support. “Achieving this with a flexographic press is tricky,” Roten says. “Adhesive tends to run, and it can be messy. We had to find a viscosity that would not bleed out and could be stacked upon itself. We chose a hot-melt acrylic hybrid material that allows us to layer it.”

Design Coat generally consists of three slightly different adhesives, with each one put on twice, he says. “There are various ingredients in each layer. The first layer adheres to the substrate, the second layer adheres to the first, the third adheres to the second, but the fourth does not adhere as much as the other layers do. (The fourth, fifth, and sixth layers do adhere to each other firmly.) This allows Design Coat lidstock to peel open smoothly between the third and fourth layers,” he says.

The adhesive can be clear, blue, or any color, really, says Roten, because the process uses a printer. The formulation can support peel strengths up to 5 lb/in., and it can also be adjusted to create a weld seal. In addition to coating lidstock, the company can also coat rollstock. All grades of Tyvek and paper can be coated, he adds. 

With Design Coat, the size of the strip in header bags can be reduced given the increase in breathable area, says Roten. The company is even experimenting with a header bag with a paper strip.

Roten says that the process reduces the likelihood of missing adhesive. With typical coated materials, missing adhesive is “not common, but it is not a rarity, either. It can affect seal strength,” he says.

Roten adds that there should be no concerns about sole sourcing or lack of redundancy. “We have the formula. If there is a flexographic press anywhere in the world, we can rent the machine to produce Design Coat. And if the customer is big enough, we can always go to their local printer,” he says.

SteriPax currently runs Design Coat on two in-house flexographic printers. The company is currently supporting a number of already marketed applications, including over-the-counter medical devices. “Validation has been pretty fast,” he reports. 

Photography by Harte Robba.

Article updated September 11, 2015. 

As an alternative to high-impact polystyrene (HIPS) for medical device packaging applications, Pacur LLChas begun extruding PETG foam made with Eastman Eastalite copolyester. “We believe the industry is looking for a friendlier material replacement for HIPS in terms of cleanliness and the environment,” Jim Banko, Pacur’s vice president of sales, tells PMP News. “Obviously, our focus going forward is full qualifications with medical OEMs.”

Pacur worked with Eastman Chemical Company and thermoformer Tek Pak Inc. to create the new lightweight opaque material. Aneta Clark, market development manager for Eastman Chemical, says that the PETG foam can be thermoformed into any given shape. “Any applications that call for rigid, opaque packaging, including primary trays, can benefit from Eastman Eastalite and its attributes,” she says. “Thanks to its flexibility in design, it’s not just for cushioning. The end application requirements, not the limiting factors of the material, dictate how it’s formed.

Banko explains that “the outer layers of Pacur PETG foam are virgin Eastman Eastar copolyester 6763, providing the same sealing surface as a clear PETG tray. Standard sealing films and papers can be used.”   

Adds Clark: “When Eastman developed Eastalite, we used the surface material that is already familiar to the industry: Eastman Eastar copolyester 6763. Testing has already been done, and it’s gone very well.” 

In terms of thermoforming, “the material is easy to process and allows for gaining efficiencies through optimization of process conditions,” she continues. “Eastman Eastalite also can be cut and trimmed without generating lots of particulates and angel hair, unlike HIPS. Cleanliness makes PETG foam more efficient.” 

Banko explains that the PETG foam has a density of 0.80 gram per cubic centimeter and is 20 percent lighter than HIPS. “As far as gauge, shrinkage, and toughness, PETG foam can be directly run on existing HIPS molds at the same gauge and attain similar shrinkage and improved impact resistance.”

Adds Tony Beyer, owner, Tek Pak: “Pacur PETG foam was easy to work with and has many qualities we value as a thermoformer. We were able to run the machine faster with the Pacur PETG foam than with an equivalent polystyrene material. We also found it to be cleaner when looking at angel hair and particulate generation. The material is easily trimmed and removed from the forming machine and has a beautiful pearlescent look. Overall, it’s an upscale material that has unique properties compared to other materials in the market.”

Clark expects original equipment manufacturers to find value in the material’s cleanliness. “As with Eastalite, there is a significant reduction in surface particulates as well as no requirement for the use of denesting agent,” she says. “Also, the unique design freedom allows for features such as durable life hinges, snap fits, and deep draws to be incorporated into the package design. This allows the final product to have a functional aspect.”

And “because of its foamed core, the same design uses less material, and the overall package is lighter,” she says.

Despite that light weight, the material is shock-absorbent for impact resistance during shipping, Eastman Chemical reports. Eastalite also can provide greater tear strength while retaining color stability and functional integrity following sterilization by ethylene oxide (EtO) or gamma irradiation. The Eastalite copolyester foam “can be easily sterilized via gamma irradiation, ethylene oxide (EtO), e-beam, and gas plasma, all without compromising its functional integrity and without discoloration,” says Clark. “It’s quite versatile. It can be sterilized many different ways without compromising functional integrity or changing the color.”

Containers can be thermoformed with deep undercuts and durable living hinges, and they exhibit less stress whitening than packaging molded from HIPS, Eastman reports. 

When asked what challenges companies face when switching from HIPS to the PETG foam, Clark says they mostly center around the qualification and validation process. “It can be a lengthy and costly process. The good thing is Eastman Chemical Company already has compiled a significant body of work to assess the performance of the material [and] its compatibility with ISO 10993 and select ISO 11607 standards. This can help save time and money. Also, we have a team of experts on hand, both technical and regulatory, to help customers through the qualification process.  Given that many customers will have unique requirements for their applications, our team often collaborates on a case-by-case basis to generate additional data as needed. Eastman has been in this business for a long time, and we understand there are different requirements. Our team is willing to work one-on-one with clients.” 

Eastman reports that Eastman Eastalite is made without materials of concern, including butadiene, bisphenol A, bisphenol S, ortho-phthalates or halogens such as chlorine or bromine. The material is compliant with ISO 10993 requirements for medical device biocompatibility and applicable parts of ISO 11607. 

For more information, visit these www.eastman.com/medical and www.pacur.com. 

Chuck Taylor’s packaging team at Medtronic is moving toward designs that support sustainability efforts and cost reductions. “We are trying to accomplish benefits for everyone in terms of usability and reducing waste on a weight basis in operating rooms,” he says. “We are also looking for solutions that can be recovered, reused, or recycled. There’s not a lot of [these programs] in hospitals, but we want to offer the opportunity.” 

For one particular Advanced Energy product, they are considering five different packaging options instead of a rigid PETG tray with a lid: a flexible blister as well as four different pouch alternatives with different internal options such as a die-cut insert card and a thermoformed insert.

While sustainability and cost efficiency are priorities, so is product protection. “We want to make sure the device is functional,” says Taylor, who serves as principal packaging engineer in the Surgical Solutions Group located in Boulder, CO. “There are jaws on the end of the device, and while durability is built in, there is susceptibility to damage if nurses were to dump the device. And we need to protect it from any distribution hazards.”

A die-cut insert card from Beacon Converters is under consideration, he says. “Most of our product lines don’t lend themselves to the insert, but this product was more applicable,” he says. “It presents an option to completely cover the jaws, and there is no chance that the device would come out of place.”

Also, the combination of a pouch and the die-cut insert—which can be made out of a monomer—“sufficiently reduces the weight going into the stream, reducing cost for us and for hospitals,” he says. 

Taylor approached Beacon with a few main objectives, reports Kathleen Daly Mascolo, Vice President and Director of Sales and Marketing, for Beacon. “We have worked with Chuck previously, and he came to us with this opportunity. His main objectives were management of the 10-ft-long cord and protecting the jaws from abrasion and shock. Ergonomics, ease of getting the device on the card, efficiencies with manufacturing, and getting nurses’ feedback were also objectives.”

Beacon designed a die-cut insert card (DCIC) for use with an outer pouch. “The DCIC stabilized the product in the pouch, protecting the device from the pouch and the pouch from the device,” says Daly Mascolo. 

She adds that the DCIC meets trends toward using flexible materials. In addition, “the DCIC is recyclable and serves as a cost-effective approach with reduced tooling and lead times,” she says. “It helps obtain a smaller footprint, and it offers manufacturing efficiencies while addressing ergonomic concerns.”            

Taylor is also considering a thermoform with snap-in features to hold the jaw. But he recalls comments made by nurses at HealthPack expressing concern that products could come out of snap-ins, he says, and the DCIC seems to protect areas of concern, even during dumping.

“Extreme events do happen,” he says.

To help Taylor determine whether implementing the DCIC would meet user needs, he submitted five options to the HealthPack 2015 nurses panel for evaluation and discussion. “It is a small sample, and there is no specific protocol, but you get valuable feedback to take back to your teams,” Taylor says. “I like the voice of the customer.” 

Taylor had actually submitted a different package to a previous nurses panel at HealthPack, he says. The team did take into consideration the nurses’ comments when making the decision.

The nurses at HealthPack 2015 appeared to favor the die-cut insert card, Taylor reports. All options will be further explored in a more-structured effort in terms of VOC, he adds.

Getting voice-of-the-customer input early on is ideal. “The best practice is getting involved in projects as early as possible in order to have the time and financial backing to get the voice of the customer before deciding,” he says. “Being early also allows you time to experiment and research.”

Other die-cut insert cards from Beacon Converters

Taylor hasn’t made a decision yet about the die-cut insert cards, so his team is examining the assembly process. “Fixtures may be needed for operators to place the card to facilitate assembly,” he says. The team is also looking at incorporating the insert into the cord assembly process. The cord is preassembled before the rest of the product assembly. “We would look at ways to reduce labor time and consider ergonomics. We may also have options for packaging upstream with the suppliers that process the subassemblies.”

Taylor adds that considering the die-cut insert card has enabled him to look at the entire process. “When you look at the whole system, you can look at other areas for product protection beyond packaging,” he says.

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Focused on medical device packaging?  Find medical packaging inspiration at MD&M West February 9-11 in Anaheim, CA.

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Oliver-Tolas Healthcare Packaging recently expanded its operations in Hamilton, OH, to include an additional high-speed coating line for producing its SealScience heat-seal coatings for sterile-grade packaging materials. The company recently celebrated the expansion with a ribbon cutting and will be at Booth #1939 at MD&M West 2016 in Anaheim, CA, February 9-11 to discuss the added capacity.

“The expansion supports business growth and continued increasing demand for flexible healthcare packaging,” Jody Beeck, Marketing & Product Manager, tells PMP News. “We chose to invest in Hamilton to leverage the skills and expertise of our team responsible for producing our SealScience coated products. Keeping the manufacturing site consistent lessens the scope of change for our customers.” 

Operational since 1992, the Hamilton site “will continue to supply adhesive coated substrates to our converting operations globally,” explains Beeck; those operations are Grand Rapids, MI; Feasterville, PA; Venray, The Netherlands; and Suzhou, China.

The added coating line also expands Oliver-Tolas’s redundancy programs. “We have strengthened redundancy of our SealScience adhesive coating operations with this investment,” she adds. “Previous investment to our Grand Rapids, MI, operation strengthened redundancy of our Xhale adhesive coating operations.”

Adds Russell Douglas, Global VP of Operations, in a statement: “This is one of many proactive steps we take to insulate our customers from the risk of supply interruptions. Producing high-quality heat-seal coated products for the healthcare market is extremely demanding. Our customers deliver life-saving products and we share a responsibility to ensure patient safety with safe and effective packaging materials.” The new coating line includes a sophisticated vision system for detecting defects and a number of automated process monitoring controls, Oliver-Tolas reported in the statement.

To help medical device manufacturers evaluate products produced on the new line, Oliver-Tolas developed a validation plan. “Our process and product validations for the newly installed line have been conducted with customer impact top of mind,” says Beeck. “While we are excited to install and work with the latest technologically advanced coating equipment, we must ensure that the equipment and processes for operating it generate equivalent coated product. Our customers rely on us to deliver consistent product meeting specification each and every time we deliver. Our customers will be able to leverage the data we generate during our verification and validation work to help conduct their own risk assessments.”

The Oliver-Tolas Hamilton team and project team members pose in front of the new coating equipment.

The expansion could also result in new products. “Our adhesive technology has evolved with market demands over the past 40+ years,” says Beeck. “The added capacity will allow us to expand our product portfolio while ensuring our heat seal coatings perform optimally. We’re preparing to introduce next generation coatings that leverage decades of formulation experience and meet the need for cost effective packaging options.”

States Jerry Bennish, President and CEO, of the expansion: “We are excited to enhance the value we deliver to our customers. Quality, cleanliness, continuity of supply, and controlling costs are of utmost importance to healthcare manufacturers. Our recent investments will ensure we are exceeding customer expectations in these areas.”

For more details, please visit Oliver-Tolas at MD&M West Booth #1939 February 9-11 in Anaheim, CA, or visit www.oliver-tolas.com.

Today SARONG provides thermoforming machines, packaging materials and contract packaging services worldwide. 
SARONG is a  market leader for pharmaceutical suppository packaging machines, with more than 600 machines sold in 50 countries; 
provides  food, cosmetic and personal care, household and cars monodose packaging solution with vertical and horizontal thermoforming machines; owns more than 30 patents. 
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