ASME Publishes a New Edition of the Bioprocessing Equipment Standard - ASME BPE 2002

ASME Publishes a New Edition of the Bioprocessing Equipment Standard - ASME BPE 2002

When the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment Standard, BPE-97, was introduced in 1997, it was the first standard to address criteria for orbital welds in bioprocess piping systems. Prior to that, standards used in the biopharmaceutical industry had been written for manual welding.

The BPE Standard applies to all parts of equipment and piping that contact either the product, raw materials, or product intermediates during process development, scale-up, or manufacturing. The BPE Standard is concerned with design criteria for equipment to enable it to be effectively cleaned and sterilized. For welded systems that have direct contact with the process, the weld surface quality must be smooth and crevice-free so that it can resist, insofar as possible, colonization by micro-organisms.

In addition to meeting the requirements for ASME Section IX of the Boiler and Pressure Vessel Code and ASME B33.3 Process Piping, the Materials Joining (MJ) part of the standard includes visual weld criteria defining an acceptable weld bead profile and sets limits for inside diameter (ID) and outside diameter (OD) concavity and convexity, as well as misalignment and discoloration. All welds must be fully penetrated to the ID.

Interest in the BPE Standard has increased dramatically since its original release in 1997. While the first edition was an American Standard, it has now been recognized in more than 20 countries and the 2002 edition in an International Standard. End users have supported it because they feel they can present a united front to the FDA who otherwise might keep increasing the level of requirements.