| ASME Bioprocessing Equipment (BPE- 1997) | An American National Standard that covers, either directly or by reference, requirements for materials, design, fabrication, examination, inspection, testing, certification (for pressure systems), and pressure relief (for pressure systems) of vessels and piping for bioprocessing systems, including sterility and cleanability (Part SD), dimensions and tolerances (Part DT), surface finish requirements (Part SF), material joining (Part MJ), and equipment seals (Part SG) for the bioprocessing systems in which the pressure vessels and associated piping are involved. This Bioprocessing Equipment (BPE) Standard does not address all aspects of these activities, and those aspects that are not specifically addressed should not be considered prohibited.
Requirements of this Standard apply to:
1. All parts that contact the product, raw materials, and/or product intermediates during manufacturing, process development, or scale-up.
2. All equipment or systems that are critical part of product manufacture, such as Water For Injection (WFI), clean steam, ultrafiltration, intermediate product storage, and centrifuges. ASME/ANSI B31 Code for Pressure Piping
A number of individually published Sections, each an American National Standard. Rules for each Section reflect the kinds of piping installations considered during its development, as follows:
1. B31.1 Power Piping: piping typically found in electric power generating stations, in industrial and institutional plants, geothermal heating systems, and central and district heating and cooling systems.
2. B31.3 Process Piping: piping typically found in petroleum refineries, chemical, pharmaceutical, textile, paper, semiconductor, and cryogenic plants, and related processing plants and terminals. Certain piping within a facility may be subject to other codes and standards, including but not limited to: (a) ANSI Z223.1 National Fuel Gas Code: piping for fuel gas from the point of delivery to the connection of each fuel utilization device. (b) NFPA Fire Protection Standards: fire protection systems using water, carbon dioxide, halon, foam, dry chemical, and wet chemicals. (c) NFPA 99 Health Care Facilities: medical and laboratory gas systems. (d) Building and plumbing codes, as applicable, for potable hot and cold water, and for sewer and drain systems.
3. B31.4 Pipeline Transportation Systems for Liquid Hydrocarbons and Other Liquids: piping transporting products that are predominately liquids between plants and terminals and within terminals, pumping, regulating, and metering stations.
4. B31.5 Refrigeration Piping: piping for refrigerants and secondary coolants.
5. B31.8 Gas Transportation and Distribution Piping Systems: piping transporting products that are predominately gas between sources and terminals, including compressor, regulating, and metering stations; gas gathering pipelines.
6. B31.9 Building Services Piping: piping typically found in industrial, institutional, commercial, and public buildings, and in multi-unit residences, which does not require the range of sizes, pressures, and temperatures covered in B31.1.
7. B31.11 Slurry Transportation Piping Systems: piping transporting aqueous slurries between plants and terminals and within terminals, pumping, and regulating stations. |
