New Calendered Flexible Vinyl Films Withstand Heat and Cold of Therapy Packs

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CITY OF INDUSTRY, CALIFORNIA, October 20, 2001: Three new grades of calendered flexible PVC from the Vinyl Division of Teknor Apex provide the low- and high-temperature performance required for such healthcare products as the cold and hot packs used to relieve arthritis patients and in chiropractic therapy for tendon damage and other problems.

The new films exhibit brittle points as low as -40 deg. F. and can withstand the microwaving or boiling used to heat the gel contained in therapy packs, according to Richard J. Vega, Marketing Manager.

With the new grades, the line of calendered films available from Teknor Apex for medical uses now ranges from 68 to 92 in Shore A durometer (15 sec. delay), 2000 to 3200 p.s.i. in tensile strength, and 275 to 375% in ultimate elongation.

Though best known as a leading producer of medical-grade molding and extrusion compounds, Teknor Apex has manufactured calendered film for twelve years, noted Peter M. Galland, Industry Manager for Regulated Products. "Calendering is an important part of our business because many medical manufacturers require the highly consistent film for which calendering is best suited. Having this capability also enables us to offer a single-source option to companies that already purchase compounds from us for tubing and other components."

All calendered medical films from Teknor Apex contain only ingredients that are listed by the FDA in 21 CFR. Raw materials in each lot are documented by vendor and generic type. Grades are available to meet the requirements of U.S. Pharmacopoeia classes up to and
including Class VI. Also available are gamma-sterilizable products.

"Calendering is a specialized, high-volume, capital-intensive process employed by only a few suppliers to the medical-device industry and by no major compounder of flexible vinyl other than Teknor Apex," said Galland. "In addition, because we are the only independent vinyl compounder that is also a major producer of plasticizers, we can provide calendered film based on a wide range of plasticizers, in accordance with customer requirements."

Yet another synergy comes into play because Teknor Apex is also a manufacturer of extruded garden hose known nationwide under the trade name Apex (R). "Teknor Apex can recycle the excess trim generated by users of its calendered films," Galland said.

The Teknor Apex calendering plant is in City of Industry, California, just outside Los Angeles. "While this location is ideal for the concentration of medical device manufacturers in California and along the border in Mexico, we ship regularly to customers all over the United States," said Richard Vega. The plant produces film ranging in thickness from 5 to 30 mils (0.127 to 0.762 mm) and in width up to 60 in. (1,524 mm). Slitting can yield films down to 1.0 in. (25.4 mm) in width. Standard embossed finishes include glossy, matte, and taffeta. Films can be produced in many colors.

Calendering is the lowest-cost process for producing medical films, Vega noted, and it provides a uniformity of thickness surpassing that achievable with extrusion.