Perfecseal Facility Certified To Class 7 Cleanroom Standards

Perfecseal has certified its Oshkosh, WI sterile medical pouch and bag manufacturing facility to ISO 14644-1 (1999) Class 7 cleanroom standards. Though already operating the facility at a Class 7 cleanroom standard since 1997, it did not seek certification until 2011. Testing and certification was performed by CSI Testing, Inc., Plymouth, MN.
The cleanroom certification is part of an ongoing continuous improvement plan focused on risk reduction for Perfeseal customers. This plan involves further cleanroom certifications for Perfecseal’s other production facilities as well as further investment in vision inspection systems for its production lines, the company said.
Perfecseal’s medical, diagnostic, and pharmaceutical packaging production plant in Northern Ireland and its custom thermoforming plant in Mankato, MN have both been ISO Class 8 certified for several years.
“Our packaging products protect some of the most important and sensitive healthcare products in the world such as drug coated implantable stents and powerful pain reducing transdermal patches. Our mission continues to be focused on eliminating any packaging related risk that could negatively impact the efficacy of the products we protect that are used in various therapies, diagnostic tests, and medical procedures, said Perfecseal’s President, Paul Verbeten.
“We continue to invest in our facilities and capabilities using the model of our customers’ facilities and capabilities for our direction,” he added.
Vision inspection systems have already been installed on several production lines including the large coating line that applies industry recognized heat seal coatings like Perfecseal® CR27 to medical packaging substrates like DuPont™ Tyvek® brand medical wrap.
The company said additional vision inspection systems have been purchased and will be installed in 2012 on several more pouch and bag production lines, a blown film line, and a foil laminator. As expected, Perfecseal has found that vision inspection systems greatly reduce the number of defects shipped and have become a basic expectation of its customers in the medical device, diagnostic, and pharmaceutical markets.
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