Cost-effective medical device packaging that complies with new ISO 11607 guidelines
TAUNTON, Mass.–(BUSINESS WIRE)–#ISO11607–Harpak-ULMA announced availability of a flow-pack solution capable of applying a chevron seal for medical packaging. Aseptic presentation is the single most important limitation of employing flow-wrapping for medical devices. Flow-wrapping is widely viewed as one of the most cost-effective methods for packaging high-profile products. However, in medical device applications it is more commonly applied to products where the product sterility of the outside of the product is not essential. For example, with flow-wrapping of infusion bags or IV sets, the fluid path is sterile and preserved by the device itself. It is also used in kits, where one or more devices are contained in an inner wrap that provides an adequate sterile barrier. Introducing chevron seals with peelable side seals dramatically improves ease of opening, making cost-effective flow-wrapping a feasible alternative for dimensional, larger, or bulky disposable products that require a strong, but easy-to-open seal. Chevron sealing is ideally suited to such products, as they can challenge seal integrity on all four package sides. This capability is particularly important given recently updated ISO 11607 guidelines that emphasize point of use aseptic presentation of terminally sterilized medical devices. The ISO updates were primarily to help manufacturers comply with EU Medical Device Regulations set to go into effect this year.
“Harpak-ULMA is committed to continuous innovation across all of our packaging platforms. We expect that introducing chevron seal capabilities in our flow-wrapping solutions will be well-received by medical device customers seeking affordable, compliant packaging options,” said Kevin Roach, Harpak-ULMA CEO. “Thought leadership is not just about envisioning the future for customers, it means executing on it. We are expanding the depth and breadth of options available to our customers on every front – from sealing technology to smart connected machines and even augmented reality. We know our customers want to do more and go faster with less resources.”
Harpak-ULMA flow-wrap chevron sealing samples will be available at this year’s MD&M West conference on February 11, 2020.
Harpak-ULMA is the North American arm of ULMA, a $1B industry leader in complete packaging line solutions for Food, Medical, Bakery, and Industrial products. Harpak-ULMA provides smart, connected packaging systems that deliver greater efficiency, uptime, and throughput, as well as better package quality and reduced waste. Well-designed, reliable solutions operate with faster changeovers, less labor, and lower maintenance costs, reducing customer total cost of ownership. In addition to offering ULMA primary packaging equipment, Harpak-ULMA is also the exclusive North American distributor of G. Mondini tray sealers, RAMA secondary packaging machinery, and DIGI weigh/price/labeling equipment. Harpak-ULMA joined the Rockwell Automation Partner Network in 2018 as part of its initiative to build and deploy smart, connected packaging solutions.
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