Rollprint Packaging Products Inc. reports that the 6000-sq-ft cleanroom it announced earlier this year to produce sterile medical packaging pouches has received certification as a ISO Class 8 cleanroom. The cleanroom houses five production lines capable of producing a variety of pouch structures, including header bags and pouches with chevron, vented, three-side weld seals, corner peels, and others.
“We received overwhelming response from medical device manufacturers soon after our announcement. The interest has been so significant that we will be adding additional production capacity,” said Dwane Hahn, vice president of sales and marketing, Rollprint, in a press release. “We started preparing for this two years ago with investments in vision systems, web cleaners, and other equipment and procedures to minimize particulateqs in our film converting area. We wanted to properly address upstream criteria before taking the next step.”
Rollprint will be using its latest proprietary structures to produce pouches and bags in a wide variety of configurations in the new cleanroom. The vertical integration allows Rollprint to cost-effectively control material quality and ensures best-in-class production for today’s demanding medical device, pharmaceutical, and life science applications, the company reports in the press release.
ISO Class 8 cleanroom certification dictates the following maximum concentration limits for airborne particulate (particles/m3) according to ISO 14644-1: 3,520,000 at 0.5 μm; 832,000 at 1 μm, and 29,300 at 5 μm, Rollprint reports.
“There is a big difference between ‘cleanroom environments’ that some manufacturers claim they have, and actual cleanroom certification. We are pleased to be able to announce that we have met the rigorous certification criteria and are now producing pouches in our cleanroom,” Hahn explained in the statement.
According to Rollprint, Rollprint Chairman of the Board Robert Dodrill designed and commercialized the foil header pouch in 1978. “Many of the packaging structures used today for pharma and medical device applications—such as film and foil header pouches, coextruded, peelable heat-seal films and silicon oxide/aluminum oxide composites—were first introduced to the industry by Rollprint. The new cleanroom capability builds on that legacy,” said Hahn.
The company is a founder of Alliantz Flexible Packaging Pte. Ltd., a joint venture with Acme Packaging Co. (Pte) Ltd., Singapore. Headquartered in Singapore, Alliantz serves the flexible packaging supply needs of Southeast Asia and China.