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.
For 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.
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