TEKNI-FILMS OFFERS THE FIRST “CLASS 100,000”
GLOBAL STANDARD FOR BLISTER FILM PRODUCTION
World’s only cleanroom lamination centers meet all current manufacturing protocols
(Somerville, NJ) – Tekni-Films, a Tekni-Plex company, announces the introduction of a new global standard for pharmaceutical blister films lamination and production. Continuing a process that began in 2001, Tekni-Films plants around the world will soon feature industry-leading, cleanroom technology to help pharmaceutical customers comply with relevant CFR 21, cGMP and ISO 9001 manufacturing protocols.
In 2001, Tekni-Films commissioned an industry-first, Class 100,000 cleanroom blister film lamination and conversion facility in Erembodegem, Belgium to serve pharmaceutical companies in Europe, the Middle East, and Canada. Tekni-Films Europe’s duplication of the Somerville, NJ site, provides a very central European base to handle the company’s increased regional manufacturing needs for the foreseeable future.
In June of 2002, Tekni-Films completed extensive upgrades to the Somerville, New Jersey films lamination facility, including the launch of the industry’s second Class 100,000 blister film lamination production area. This overall 54,000 square foot facility now offers:
• In-bound, in-process QA/QC testing in a clean environment
• Clean-room stability testing on an Uhlmann thermoformer
• Carefully managed, computerized batch record-keeping
• “Just-In-Time” raw material storage area for rush orders
• State-of-the-art, temperature and humidity controlled Class 100,000 air
in clean room for lamination, slitting and rewinding processes
• Secure final packaging and shipping area
“These new global standards represent a major industry improvement in the levels of quality and control that can be achieved during the production of pharmaceutical blister films,” said Michael Franklin, Vice President of Tekni-Plex. “As we continue to ‘re-write the book’ on converting and laminating technology, Tekni-Films plants in Canada, and South America have been upgraded to meet these new manufacturing standards. In addition, we have standardized our Tekni-Films / Pureplast mono PVC film globally so we are now able to supply identical contact layer and laminate structures from all of our global manufacturing sites.”
Tekni-Films has been providing pharmaceutical blister packaging films to meet specific barrier and processing needs since 1971. To satisfy the exacting demands of the global pharmaceutical marketplace, Tekni-Films offers a wide range of products, including Mono PVC, PVdC, Novinex COC/COP films, and PCTFE.
Tekni-Films’ proprietary PCTFE (usually referred to as either Aclar®
or VapoShield™) film laminations are considered the pharmaceutical
industry standard, providing exceptional moisture barrier for outstanding
product protection. Tekni-Films is the only company in the world that
purchases PCTFE from two different and independent sources, providing
redundancy of raw materials and added security for today’s pharmaceutical
manufacturers.
Tekni-Films worldwide locations include:
TEKNI-FILMS US - Somerville, NJ
TEKNI-FILMS EUROPE - Erembodegem, Belgium
TEKNI FILMS CANADA - Cambridge, Ontario, Canada
TEKNI-FILMS SOUTH AMERICA - Buenos Aires, Argentina
TEKNI-FILMS SOUTHEAST ASIA – Singapore
For more information on Tekni-Films, please call (908) 722-4800 or visit the company’s website at www.tekni-films.com.
Visit tekni-plex.com.
