2008-02-06 Manufacturing News

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Polycarbonate Films in Medical Packaging

Makrofol polycarbonate films from Bayer MaterialScience AG have established themselves as a material of choice for medical packaging because of their high transparency.

Moreover other optical properties of the polycarbonate film Makrofol* DE 1-1, from Bayer MaterialScience, are also recommended for applications in medical technology.

Evidence for this is provided by the new generation of a blood and fluid warmer known as Fluido®. It is supplied by The Surgical Company International, a subsidiary of The Surgical Company Group headquartered in Amersfoort, the Netherlands, especially for use in operating theaters and intensive care stations. The warmer features a new type of disposable cassette with a transparent cover made of Makrofol DE 1-1. "The decisive factor in favor of our film was that it allows infrared light to pass through it. The use of infrared light means that blood and other fluids in the disposable cassettes can be warmed gently and within a few seconds to the exact temperature required by the patient," explains Georgios Tziovaras, a films expert in the Polycarbonates Business Unit of Bayer MaterialScience. The complete cassette and warmer system is manufactured by Medistad Medical B.V. in Medemblik, the Netherlands.

Makrofol DE 1-1 allows infrared light to pass through it. Click Here for High resolution image. photo: Bayer MaterialScience

The use of infrared light means that blood and other fluids in the disposable cassettes can be warmed gently and within a few seconds to the exact temperature required by the patient. See photo at right for illustration.

Makrofol DE 1-1 ensures that the cover is impact resistant and well able to withstand the harsh treatment routinely encountered in hospitals. Its high transparency allows operating theater staff to check what is happening inside the cassette at a glance. The high heat resistance of the film enables the cassettes to be sterilized using superheated steam under pressure at a temperature of 121 °C.

Another advantage of Makrofol DE 1-1 is its good resistance to body fluids. The grade of Makrolon* polycarbonate from which the film is made satisfies specific requirements of international standard ISO 10993-1 for the biocompatibility of plastics that come into contact with body fluids and tissue. The polycarbonate also complies with the biocompatibility criteria of the US Pharmacopeia, Class VI. This enables it to be used in many products approved by the U.S. Federal Drug Administration (FDA).

Makrofol DE 1-1 is supplied as standard in roll and sheet form with a high gloss finish and protective masking on both sides. The film is available as standard in thicknesses of between 175 and 1000 µm. Other thicknesses are available on request.

* Trademarks of from Bayer MaterialScience.

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