Originally Published MPMN
Originally Published MPMN January/February 2003
INDUSTRY NEWSFirm Constructs Class 100,000 Cleanroom for Blister Film Production
|Tekni Films' cleanroom initiative facilitates adherence to CFR 21, FDA GMPs, and ISO 9001 standards.|
Continuing an initiative it began in 2001, Tekni Films (Somerville, NJ; www.tekni-films.com) has become the first company to offer a Class 100,000 cleanroom for blister film lamination and conversion in North America. "The new cleanroom at our Somerville headquarters represents a major industry improvement in the levels of quality and control that can be achieved during the production of pharmaceutical blister films," says vice president Michael Franklin. "Now, pharmaceuticals can be packaged with the same level of cleanliness with which they're produced, making it easier for companies to meet CFR 21, FDA GMPs, and ISO 9001 manufacturing protocols," he says.
As part of the upgrade, the 54,000-sq-ft facility now offers temperature- and humidity-controlled air in the areas used for lamination, slitting, and rewinding. Stability and in-bound and in-process quality assurance testing have also been converted to areas that meet cleanroom standards. Other factory features include a computerized batch recordkeeping system, a just-in-time raw-material storage area for rush orders, and a secure final packaging and shipping area.
The Somerville cleanroom facility was constructed as a duplicate of one that has been in operation at the company's European headquarters in Erembodegem, Belgium since 2001. According to Franklin, this cleanroom film production facility was the first of its kind in the world and is being used to service pharmaceutical companies located in Europe, the Middle East, and Canada. The firm's Canadian and South American facilities are scheduled to complete cleanroom facilities in the first quarter of 2003.
In operation since 1971, Tekni Films supplies blister packaging films that provide a barrier to moisture vapor transmission and meet specific barrier and processing needs. The firm's product offerings include monolayer PVC, Aclar, VapoShield, and Novinex films.
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