SteriPack, an international company converting medical packaging materials and providing contract manufacturing, contract engineering, and ISO 17025 accredited testing services, has purchased a facility for its first U.S. based operations. The 40,000-sq-ft building sits on five acres in Lakeland, FL, near two international airports and major ports, reports Tony Paolino, president, SteriPack USA. The location positions SteriPack to serve both U.S.-based manufacturers looking to export as well as international firms seeking to serve the U.S. market, Paolino states.

“Many of the global medical device companies we have been servicing for the last 18 years have been urging us to fill out our global presence with a U.S. location,” he adds, referencing SteriPack’s existing facilities in Ireland, Poland, and Malaysia. “Many of these are in fact U.S. companies that have been using SteriPack elsewhere,” he adds.

SteriPack will fashion its Lakeland facility after those other locations. “We are gearing up to bring SteriPack’s concept to the United States,” Paolino explains, describing it as being “transparent with all the necessary monitoring and security. Our concept entails situating the office for operation management and support right in the cleanroom, allowing for immediate interface,” he says. “Visitors to the facility will be able to enter the lobby and look right into the ISO Class 8 cleanroom production 
facilities.”

Over the next several months, SteriPack will be installing what Paolino calls “the same equipment used in our other facilities, purchased to our specifications. We will also be following the same processing and quality standards, so that we offer customers consistency from facility to facility. Everyone wants back-up manufacturing today, so this new location will add to our ability to offer continuity of supply.”

The first lines will include slitting, cutting, and printing equipment for producing chevron-style and corner-peel pouches, header bags, and the firm’s Steribag, an alternative to header bags. “Using uncoated Tyvek and polyethylene, the Steribag can save users up to 15%,” he adds.

Converting in Lakeland should begin by the end of Summer 2012, Paolino reports. “We should have two to three complete lines running, and the facility will be set up to be able to quickly expand,” he says.

The facility can also expand to accommodate contract packaging and manufacturing.

“Contract manufacturing will be driven by market demand, so today we are not sure what that will be yet,” says Paolino. “We provide injection molding and assembly services at our other locations, and we have also assisted customers with FDA 510(k) applications and CE marking. We are not afraid to make investments to meet customer needs.”

Contract engineering and package and material testing services may also be available in the future, as they are in Ireland and Poland.

SteriPack is also pursuing ISO 13485 certification, which Paolino expects to happen in time for the late summer opening.

Gary Leonard, SteriPack’s technical manager in Ireland, will move to oversee operations as vice president of operations in Lakeland. “He understands the DNA of our company,” Paolino says. In addition, Paolino expects to employ 20–25 employees.

SteriPack did consider U.S. locations in the Midwest, Northeast, and Southeast, as well as those in Costa Rica. “We decided on Lakeland given the area’s good labor pool and existing medical device companies,” Paolino says.

Other SteriPack facilities continue to evolve, too. “Poland is on the cusp of expansion,” says Paolino. “And we just received our pharmaceutical license from the Malaysian governing body to store and pack pharmaceutical products on site, allowing us to offer blister packaging services of tablets and capsules for pharmaceuticals.”

For more details visit www.steripackgroup.com or booth 1421 at MD&M West.