Pharmaceutical manufacturing is heavily regulated, though standards designed to guide the selection of measurement and analytical instrumentation for sterile processes are not completely defined. To fill the void, some companies — and even individual plants — have created their own internal guidelines for instrument selection and verification to meet U.S. Food and Drug Administration current good manufacturing practices (cGMPs).
With the need for a comprehensive set of standards clear, the American Society of Mechanical Engineers (ASME) developed bioprocessing equipment standards specific to the requirements of hygienic industries. The resulting ASME BPE (Bioprocessing Equipment) standard addresses materials, design, fabrication, testing and certification.
Prior to the initial ASME BPE release, pharmaceutical manufacturers relied on other sanitary standards such as 3A, first developed for the dairy industry. These were used in conjunction with internally developed guidelines. Unlike the 3A standards, which establish requirements for a relatively narrow set of applications, ASME BPE uses broader applications as a starting point. Over the same time frame in Europe, the European Hygienic Engineering and Design Group developed its own standards to certify equipment and promote effective designs for food and pharmaceutical products.