The use of clean-room technology in medical device manufacturing: a tool in the service of quality.  Part II.
Part 1 of this two-part article outlined the contamination-control requirements for medical device manufacturing, and the basic technical concepts for effectively and economically achieving them.  Part II provides four case studies that illustrate how the basic principles of clean-room technology can be translated into industrial practice.  It features examples of controlled clean-air manufacturing environments used in the production of injection cannulae, orthopaedic endoprostheses, heart pacemakers, and porcine aortic bioprostheses.
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D002404:Catheterization / Q000295:instrumentation; D004780:Environment, Controlled; D004866:Equipment Contamination; D004867:Equipment Design; D006350:Heart Valve Prosthesis; D006801:Humans; D007595:Joint Prosthesis; D010138:Pacemaker, Artificial; D011786:Quality Control