ASME BPE - Equipamento de Bioprocessamento BPE - 2019

Portuguese translation of BPE. ?This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification. ASME-BPE is unique in the world, having resulted from widespread industry requests for standardization. It is the leading Standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity and safety. Companies that rigorously apply ASME-BPE often can achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations. New topics from the last revision include: • Valves for Single-Use • Single-Use Process Instrumentation • Total Organic Carbon Requirements • Rigid PM Vessels • Metallic (diaphragm) Valves Certification • Physical Qualifications for Single-Use • Product Identification and Packaging • Animal Derived Ingredients ASME-BPE is referenced in ASME’s B31.3 Code on Process Piping. Moreover, two weld discoloration acceptance criteria color charts, ASME BPE MP-2024 and EP-2024, are available separately. They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and code-compliance. Intended for regulatory agencies, multinational corporations, plant owners, pressure-equipment fabricators, designers, constructors, materials suppliers, inspection organizations, and others. The ASME BPE Standard standardizes specifications for the design and construction of new fluid processing equipment used in industries that require a defined level of purity and bioburden control.