SteriPack USA continues to increase its support of medical device manufacturers, announcing an expansion in Lakeland, FL, and holding a recent program to educate its employees on the use of sterile products in hospitals.
SteriPack USA will be exhibiting at the upcoming MD&M East in New York City June 9-11 in Booth #2069.
SteriPack opened its FL facility in 2012, when it dedicated an initial 12,000 sq ft of its then-new 40,000-sq-ft building to an ISO Class 8/Class 100,000 cleanroom for bag and pouch manufacturing. The company is now designating 7000 sq ft for an additional cleanroom dedicated to contract packaging, manufacturing, and assembly services, reports Tony Paolino, President, SteriPack USA. “Phase two is underway and expected to be finished by fall,” he tells PMP News.
SteriPack offers contract manufacturing and packaging services (CMS) around the world. “We are following our model in Ireland, established 15 years ago, which houses both pouch and bag manufacturing and CMS under one roof,” says Paolino. “The expansion in Lakeland rounds out our offerings, which include converting and contract services in the United States, Europe, and Asia.”
When SteriPack needed additional capacity beyond its Ireland facility, the company established a new facility in Poland in 2006 entirely dedicated to contract services. That location underwent its own expansion in 2014, doubling its floor space from 35,000 to 70,000 sq ft.
Bernd Seidel, who opened and has run the Poland plant, including overseeing its recent expansion, will head up SteriPack USA’s new CMS facility, serving as VP Operations USA. “He’s an expert in contract manufacturing and packaging services," says Paolino.
SteriPack also offers pharmaceutical contract packaging services in Malaysia.
To help its employees understand how sterile medical devices are used in healthcare settings, SteriPack invited nurses from a local hospital in Lakeland to speak during a recent quarterly employee meeting.
“The intention was to have more of a classroom-conversation-type dialogue with our employees explaining how medical devices are handled in the hospital environment, specifically what nurses look for when opening the package of a medical device,” explains Paolino. “We wanted to provide our employees this direct connection to an end-user so they could hear firsthand about how the packaging we provide is used by the final customer. We felt an educational opportunity about how what we do here impacts the market and, more importantly, the patients.”
Nurses told the group how they inspect entire packages for any seal breaches, Paolino says. “If the package is ok, the nurses said they open it and provide the device into the sterile field or put it on the prep table. If there are any questions about the seal integrity, they said the device is immediately discarded,” he says.
The nurses demonstrated how they open pouches, header bags, and trays and lids. “This was not a session on package design, likes, and dislikes,” he explains.
Employees asked the nurses a lot of questions, such as what happens when devices are discarded. “Products are either thrown out or returned to the manufacturer for credit,” Paolino recounts.
When asked how often packaging failures are seen and what happens if they are not caught, the nurses said it was “very hard to put a number on it, but more frequently than you might expect,” he says. And if a package with a failure isn’t identified, “that’s when the chance of a patient acquiring an infection can increase due to the use of that non-sterile device. The nurses admitted that on occasion there isn’t enough time to thoroughly check each and every package. They have to count on the device manufacturer to ensure the products are provided and maintained as sterile, just as the device OEM counts on their packaging provider to ensure proper seals.”
Paolino says employee feedback was very positive. “Overall, it seemed to provide exactly what we wanted to accomplish: A better understanding of why we manufacture in the cleanroom and why we have certain protocols, tight specifications, in-process testing, and a variety of checks and balances to ensure what we put in the market is in compliance with our customers’ requirements.
“The biggest impact was that it helped our employees put the connection together between what they make and how it could affect them, their families, and friends,” he adds.
“We don’t just make plastic bags, and our employees get that! We plan to do this again as our employee headcount grows,” he says.