SteriPack is preparing to open its new ISO 13485 certified facility in Lakeland, FL, marking the debut of its U.S. medical packaging converting operations. The facility is also currently able to accommodate contract packaging and manufacturing services and is expandable to include future contract engineering and testing services, which the company offers at locations in Europe and Asia.

“SteriPack has been exploring several options in the United States for the past three years to find the ideal situation and location,” said Tony Paolino, president, SteriPack USA, in a statement. “The facility is a ‘first-in-class’ operation and draws on the nearly 20 years of experience that SteriPack has manufacturing converted products and providing contract manufacturing services in a Class 7 and 8 clean room.”

Gary Leonard, formerly SteriPack’s technical manager in Ireland, has moved to oversee operations as vice president of operations.

SteriPack USA has dedicated an initial 11,000 sq ft of the new 40,000-sq-ft building to an ISO Class 8/Class 100,000 cleanroom housing a pouch-manufacturing machine for making a variety pouches including chevron-style pouches. The brand new bag line will manufacture the company’s SteriBag as well as standard header bags. The high-speed, high-throughput machinery runs multiple webs and can produce several sizes using film, foil, paper, and Tyvek. The facility will also operate a four-color flexographic printing press that can produce rollstock and die-cut lids.

“We are seeing increased interest in replacing header bags with our lower-cost alternative, the SteriBag,” Paolino told PMP News, which visited the facility in August. “Using uncoated Tyvek and polyethylene, the SteriBag can save users up to 15%,” he told PMP News earlier this year.

The equipment—and SteriPack USA’s quality system—mirror those used in its other facilities to offer customers consistency. “We maintain continuity from facility to facility to support customers around the world. If validation work is completed in one SteriPack location, it can easily support and extend to our other locations,” Paolino told PMP News.

Cleanroom operations are supported by technical supporting teams in adjoining clean room offices so that they are close enough to collaborate with operations quickly, explains Paolino. This approach follows the concept SteriPack has instituted at its other locations.

Windows line the perimeter of the cleanroom, allowing facility visitors to view production operations.

Raw materials will be held under controlled conditions, accessible through air-locked doors and offering Class 100,000 areas when required.

For more details visit www.steripackgroup.com.