CSI Testing certifies Perfecseal medical pouch converting to Class 7 cleanroom standards
CSI Testing, the cleanroom and controlled environment testing service based in Plymouth, MN, US has certified Perfecseal’s Oshkosh, WI, US sterile medical pouch and bag manufacturing facility to ISO 14644-1 (1999) Class 7 cleanroom standards. The healthcare packaging division of Bemis has been operating the facility to these standards since 1997, but did not seek certification until 2011.
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.
The firm says the CSI Testing certification is part of an ongoing continuous improvement plan focused on risk reduction. The firm intends to seek certification for its other production facilities and make further investment in vision inspection systems for its production lines.
Paul Verbeten, president of Perfecseal, commented: “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 have a negative impact on the efficacy of the products we protect.”
The firm has already installed vision inspection systems on several production lines including a large coating line that applies heat seal coatings to medical packaging materials.
Additional systems will be installed on several more pouch and bag production lines, a blown film line, and a foil laminator.
Perfecseal specialises in the manufacture of co-extruded films, laminated films, flexible forming films, foil barrier laminations, pouches, bags, thermoformed trays, lids, labels, heat seal coated DuPont Tyvek and heat seal coated medical grades of paper.