Navigating the highly regulated world of medical manufacturing and clean room operations can be a daunting, time-consuming task. Regulations and standards, developed by such organizations as the U.S. Food & Drug Administration, the International Organization for Standardization (ISO) and others, are many and complex.

MedlineFor those who want to begin manufacturing medical plastic products and components, understanding the regulatory requirements is only the first hurdle to be overcome. Then specialized facilities, including cleanrooms, white rooms and hybrid rooms, need to be designed and built, and processing equipment needs to be sourced with special attention not only to performance, efficiency and quality, but also to cleanliness, calibration, maintenance and record-keeping. Mistakes can result in delayed start-up, lost production, quarantined parts, rework and lack of process validation.

To simplify the process of specifying, buying, installing, qualifying and operating plastics auxiliary equipment in a clean environment, Conair has introduced a line of products – 170 units in all – for molding and extrusion of medical products. The new MedLine® product line includes equipment for conveying and storage, resin drying, blending, heat transfer and downstream extrusion. All are based on proven Conair designs, but they have been specially sized, configured, documented and supported for use in cleanrooms and other controlled environments. Here is why that’s important:

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