scope:

At the 1988 ASME Winter Annual Meeting (WAM), many individuals expressed interest in developing standards for the design of equipment and components for use in the biopharmaceutical industry. As a result of this interest, the ASME Council on Codes and Standards (CCS) was petitioned to approve this as a project. The initial scope was approved by the CCS on June 20, 1989, with a directive to the Board on Pressure Technology to initiate this project with the following initial scope:

This standard is intended for design, materials, construction, inspection, and testing of vessels, piping, and related accessories such as pumps, valves, and fittings for use in the biopharmaceutical industry. The rules provide for the adoption of other ASME and related national standards, and when so referenced become part of the standard.

At the 1989 WAM, an ad hoc committee was formed to assess the need to develop further the scope and action plan. The committee met in 1990 and there was consensus concerning the need to develop standards that would meet the requirements of operational bioprocessing, including:

(a) the need for equipment designs that are both cleanable and sterilizable;

(b) the need for special emphasis on the quality of weld surfaces once the required strength is present;

(c) the need for standardized definitions that can be used by material suppliers, designers/fabricators, and users; and

(d) the need to integrate existing standards covering vessels, piping, appurtenances, and other equipment necessary for the biopharmaceutical industry without infringing on the scopes of those standards.

The BPE Main Committee was structured with six functioning subcommittees and an executive committee comprised of the main committee chair and the subcommittee chairs.

The subcommittees are:

(a) General Requirements;

(b) Design Relating to Sterility and Cleanability of Equipment;

(c) Dimensions and Tolerances;

(d) Material Joining;

(e) Surface Finishes; and

(f) Seals.

Through out the development of the Standard, close liaison was made with the European CEN, ASTM, and the AAA Dairy Standards. The purpose was to develop an ASME standard that would be distinctive, germane, and not in conflict with other industry standards. Wherever possible, the Committee strived to reference existing standards that are applicable to biopharmaceutical equipment design and fabrication.

This Standard represents the work of the BPE Standards Committee and includes the following Parts:

(a) General Requirements;

(b) Design for Sterility and Cleanability;

(c) Dimensions and Tolerances for Stainless Steel Automatic Welding and Hygienic

(d) Material Joining;

(5) Stainless Steel and Higher Alloy Interior Surface Finishes; and

(6) Equipment Seals.

This edition was approvedas an American National Standard on May 20, 1997.

Requests for interpretations or suggestions for revision should be sent to Paul Stumpf, Secretary, BPE Committee, The American Society of Mechanical Engineers, United Engineering Center, 345 East 47th Street, New York, NY 10017.