ASME BPE-2026 is an international standard for bioprocessing equipment used in pharmaceutical and biopharmaceutical manufacturing where defined purity and bioburden control are required.
This revision covers general requirements, certification, metallic and nonmetallic materials, multiuse and single-use system design, process components, instrumentation, fabrication, joining, surface finishes, inspection, testing, and supporting technical guidance.
Application Scope: Pharmaceutical and biopharmaceutical facilities, including the design, manufacture, installation, qualification, and maintenance of hygienic process equipment, components, and single-use systems.