ASME BPE-2026: Overview of the Key Updates

The ASME BPE (Bioprocessing Equipment) is a well-known industry standard of the American Society of Mechanical Engineers (ASME) that defines guideance for the design, construction, material selection, and testing of equipment and components used in the biotechnology and pharmaceutical industries. The new 2026 edition was published in May and includes changes both for traditional multi‑use stainless steel systems – covering materials, components, joining techniques, and surface finishes – and for single‑use systems as well as process instrumentation.

In the 2026 edition, updated documentation requirements have been included to support new regulations on biocompatibility. The certification program for manufacturers of tubes, fittings and machined parts, or diaphragm valves has been extended to include the fabrication of vessels. An overview of all certificate holders is provided by ASME on their website.

In the Metallic Materials (MM) section, the list of suitable materials has been expanded to include additional superaustenitic grades (5% Mo austenites). For a wide range of austenitic stainless steels, superaustenites, duplex steels, and nickel-based alloys, material designations and standards from the USA (UNS), Europe (EN), and Japan (JIS) are listed. In addition, specific corrosion testing requirements for austenitic stainless steel tubes have been introduced.

Several parts of the Systems Design for Multiuse (SD) section have been newly added or revised, including new material on mix proof valves (valves with product separation for the safe segregation of media), an update to the section on centrifuges, as well as revisions regarding cabinet washers (cabin washers), including the addition of immersion washers.

The Dimensions & Tolerances (DT) section now features updated and expanded dimensions and tolerances for various components/connections, in particular for instrument tees. The Multiuse Components (MC) section includes a new valve selection guide, new content, requirements, and illustrations on split butterfly valves, as well as new methods/requirements for testing “gasket intrusion” – i.e. cases where a gasket extends into the product or flow path.

In the Materials Joining for Multiuse (MJ) chapter, the focus is primarily on qualification, testing, and acceptance criteria. For 2026, a new WOPQ example has been added (WOPQ = Welding Operator Performance Qualification), in order to better align the requirements of ASME BPE and ASME B31.3 for the qualification of welding personnel. In addition, guidance on limits for heat tint in the heat-affected zone of orbital welds has been included. Furthermore, requirements for attachment welds used to fasten pipes to nozzle stubs on the valve body (valve body tube stubs) have been clarified. For product-contact surfaces of multiuse systems, the acceptance criteria for “pits/porosity” have been revised in the Process Contact Surface Finishes (SF) section. In addition, there has been harmonization with 3-A Sanitary Standards and European standards, such as the DIN 11866 series and related norms. A new paragraph on the training and qualification of personnel for surface treatment by grinding, electropolishing, or passivation has also been added.
For the single-use topic area, “biocompatibility updates” have been introduced in the 2026 edition to align with the United States Pharmacopeia (USP). In addition, the terminology related to the irradiation of single-use equipment has been updated. Online questionnaires on “SU particulate” (particles/particle issues in single-use systems) and “SU hose barbs” (hose connectors) have been added, as well as criteria for welding single-use tubing.

The scope of content in the areas of Process Instrumentation for Multiuse (PI) and Single Use Process Instrumentation (SI) has been significantly expanded. A total of eight new sections have been added. In addition, PI-2 (Temperature) has been updated. New or expanded content has also been included in SI-2, covering topics such as installation/mounting, connections/fittings, calibration, marking/identification, documentation, and change control. Section SI-3 has been extended to include topics such as handling, incoming goods inspection/receipt, and storage. A guidance document has been developed for the selection and design of measurement points and components for pH, flow, and level.

For pharmaceutical companies and their engineering/quality functions, these points are particularly relevant wherever standard requirements need to be translated into specifications, material and welding concepts, surface requirements, documentation, as well as qualification and change control processes. The innovations in the BPE-2026 edition are therefore relevant both for multiuse topics (e.g. material harmonization, welding/qualification, surfaces) and for single-use and instrumentation.

The ASME BPE-2026 is available from The American Society of Mechanical Engineers.