- Rick Zinkowski, Chair, BPE Executive Committee

The ASME BioProcessing Equipment (BPE) Standard, launched in 1997, is one of the youngest standards in ASME’s roster of over 500 codes and standards. Keeping pace with industry's rapid growth the BPE quickly elevated to international level, now recognized in over 30 countries serving the needs of those involved in the bioprocessing, pharmaceutical, and personal care product industries.

ITS BEGINNINGS - The genesis of the ASME-BPE Standard evolved from the inability of component and equipment manufacturers to manufacture fittings, tubing, process components and equipment to the same critical dimensions and/or standards. In the early eighty’s there was simply no widely accepted standard addressing this issue for the Bioprocessing industry. It was not uncommon for fittings, tubing and process components to be un-weldable in field installations. In the fall of 1988, a group of manufacturers and end-users met at the ASME Winter Meeting (WAM) in San Francisco to begin discussions related to creating meaningful standards for the Bioprocessing industry. In June of 1989, the ASME Council on Codes and Standards approved the project. The first sub-committee meetings were held in 1990 with the first BPE Standard being published in 1997.

As the needs of the BioPharm industry have evolved, so has the BPE Standard. In addition to defining dimensions and tolerances for fittings, tubing and process components; the Standard also addresses: designs relating to sterility and cleanability, material joining, surface finish, seals, metallic materials of construction and polymer-based materials as related to fittings, components and equipment.

CHARTER - The scope of the ASME-BPE Standard is as follows;
“This Standard deals with the requirements of the bioprocessing, pharmaceutical, and personal care product industries as well as other applications with relatively high levels of hygienic requirements, covering directly or indirectly the subjects of materials, designs, fabrication, pressure systems (vessels and piping), examinations, inspections, testing, and certifications.”

The BPE Standards Committee is by charter, a balanced committee established with volunteers from the following industry segments; Industry Users, Designer / Constructors, Material Manufacturers, Equipment Manufacturers, Insurance / Regulatory and General Interest. The organization is comprised of a Main Standards Committee, Sub Committees and Task Groups see figure #1. Task Groups, of which there are currently forty six (46), report directly to their sponsored Sub-Committee. In short, information that is requested for possible inclusion in the standard begins at the task group level. This information is then bubbled up to the Sub-Committee where the merits of inclusion of this information are reviewed, discussed and formally voted upon. Once approved at the Sub-Committee level, the document is forwarded to the Executive and then the Main Committee for review and ballot for inclusion as part of the Standard or as non-mandatory appendices associated with the Standard.

PROCESS - The BPE Standard is currently on a two (2) year publishing cycle. The 2007 Standard will be available in December of this issue. A typical two year publishing cycle includes; the approval cycle of the BPE Standards organization mentioned above, ANSI Public Review, Review by the ASME Board of Pressure Technology Codes and Standards and finally ANSI Board of Standards review. In addition, the BPE maintains liaison reporting activities with other industry organizations such as ISPE, P3A, 3A, DIN, and EHEDG. The resulting Standard is therefore assured to be substantive and meet the critical review of established
standards organizations.

The development of a scope for the Certification of fittings, tubing, process components and equipment is currently underway. The intent is to have a phased integration of the Certification program beginning with tubing and fittings which will appear in the 2009 ASME-BPE Standard. This program will emulate the ASME RTP-1 Standard’s Accreditation Program.

THE ROAD AHEAD - The ASME BPE is currently finishing up a global marketing study which will assist in framing the future for BPE.

The future for the ASME BPE is indeed bright. Through the hard work of its volunteer organization, this globally recognized document will continue to address the needs of the BioPharm industry providing a clear and substantive Standard to meet the future challenges and opportunities of this industry.

I offer you an invitation to attend our next ASME BPE meeting and actively participate in the discussion as well as the creation of this industry recognized document.

Rick Zinkowski, Chair, BPE Executive Committee