Dry heat sterilization of packaged medical products is becoming an increasingly attractive alternative to sterilization with EtO (ethylene oxide) gas and gamma radiation; the high temperatures required to achieve dry heat sterilization demand highly heat-resistant materials.
For ten years, Merrill's Packaging, Inc., has responded to this challenge by producing clear thermoformed packaging that reduces sterilization residence time by withstanding dry heat sterilization temperatures without deformation or degradation. The packaging is made of Makrofol PCEE polycarbonate film from Bayer, Inc., Pittsburgh, PA.
Prior to the use of polycarbonate film, dry heat sterilization had typically required exposure for up to 24 hours at 250° F; the polycarbonate film is used to package medical devices that undergo sterilization temperatures up to 325° F for periods ranging from one hour to 16 hours.
Not only can the Makrofol polycarbonate film be thermoformed into packages of any desired shape, but it also provides the good clarity and excellent physical properties required for medical product packaging. The superior clarity of the polycarbonate film allows surgeons and other medical personnel to easily identify and verify package contents, thus providing an additional degree of quality control. In addition, medical packaging made of Makrofol film may be shipped immediately following dry-heat sterilization. There is no need to wait for the stabilization period required following EtO sterilization.
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