What is BPE?
The question comes up a lot — What is BPE? The short answer is that BPE stands for bioprocessing equipment. The longer answer is that it’s the body of standards for bioprocessing equipment developed by the American Society of Mechanical Engineers (ASME), composed of volunteer professionals worldwide in 36 technical sub-fields. BPE establishes standards for the design of equipment used in bioprocessing, pharmaceutical and personal-care products, and other industries with strict hygienic requirements. It covers system design, materials, fabrication, inspections, cleaning and sanitization, testing, and certification.
In the late 1980s-early 1990s, a small group of ASME members that included CSI employees recognized the need to standardize construction methodologies for the fast-evolving pharmaceutical and biotech industries. Not only were the industries changing quickly, but how their processing equipment was made was also transforming. There was a need to standardize practices to optimize equipment quality and, thus, product quality.
The first official version of BPE, issued in 1997, was about 85 pages.
The latest update, from 2019, clocks in at 380 pages, and the BPE Committee now has over 200 members. As the bioprocessing sector has burgeoned, so has BPE–for example, the first system design standard was only one page covering transfer panels - now it’s six. Cleaning in place content has expanded from barely one to about 20 pages of detailed design information.
It’s clear that since 1997, bioprocessing knowledge and technology has leaped ahead, creating an even-greater need for standards to navigate the way forward. A key part of ASME’s mission is to continually improve people’s lives by advancing engineering – including improving the quality of bioprocessed products like medicine. In a field where so many options and advances are emerging, written standards and procedures are necessary as the basis of mutual understanding to drive quality in to production processes and, as a result, into end-user products.
CSI produced its first transfer panel in 1979. Over 30 years later, the fabrication process has changed drastically. Welding, for instance, has gone from being hand-done to being totally mechanized, making welds more dependable and uniform from one to the next. The original BPE didn’t include many quality procedures for orbital weld heads – but the ones now in place mean the quality of welds has improved substantially in the past few decades.
BPE has also addressed the fact that technology has significantly reduced the size of equipment. Thirty years ago, weld heads were about six inches wide – now they’re two inches or less. A fitting that was once 12 inches long may now be only 3 inches. These scale reductions dramatically change the amount of equipment needing to be cleaned and minimize the floor space customers need for production facilities – two critical aspects of the customer experience.
CSI was part of the original group that got BPE rolling at ASME, and has been an active player ever since. Why is it a key priority for CSI to stay involved?
Picture BPE like a round table discussion – and anyone qualified to take part can. A seat at the table brings critical advantages:
- A voice in building the guidelines.
The BPE group develops consensus-based standards by which everyone in the industry is intended to abide. To the extent a company’s actual experiences, pain points, and insights are brought forward as part of the process, the easier compliance with the standards is likely to be. - A role in shaping the direction of the industry.
The BPE group is a center for exploring what’s new and what’s possible technologically, but its job is also to serve as a reality check. New technology might seem promising, but is it cost-effective? How would it affect the lifecycle cost of equipment ownership? As the industry strives for ever-improving quality, being part of the discussion means a role in agreeing on and documenting exactly what quality means. - Deep insight into the customer experience.
Being part of developing BPE gives an invaluable window into customer expectations and pain points across the bioprocessing sector. The internet means customers now have a wealth of product and process information at their fingertips. They expect high quality, and companies have to continually up their game to meet those expectations. At the same time, a fast-moving world means new pain points arising – for instance, the increasing cost of land and buildings means customers want equipment that fits into smaller spaces – which will, in turn, influence BPE design standards. - Seeing the bigger picture.
BPE looks at pieces of equipment on a detailed, individual level, but stepping back you realize that these individual components make up a whole facility. The quality built into the pieces rolls up to the whole system, and then the products the system makes. So participating in standard-setting means a hand in advancing how products like medications are made, which improves life for everyone as well as advancing the industry.
What’s at stake if your organization is not aware and involved?
The BPE group and interest in its work has proliferated, but not all companies that could benefit are adding their voices, and they may not be informed of the latest knowledge and standards. While participating and staying plugged in means committing both time and resources, the price of not participating is real and increasing because industry change is happening so fast. It’s becoming more and more costly to be unplugged from the leading edge. Companies that aren’t up to date on the latest standards and practices won't be able to help their customers construct processing facilities that are designed to optimize cleanability and sterility – the key to maximizing yields. Not knowing the latest acceptance criteria could mean equipment you’re manufacturing is substandard and has to be reworked – not a position in which a company ever wants to be.
Building BPE standards into products also goes a long way towards helping bioprocessors comply with mandatory federal cGMP (current Good Manufacturing Practices) for design, monitoring, control, and maintenance of drug manufacturing processes and facilities (part of 21 CFR Parts 210 & 211: Processing, Packing, or Holding of Drugs, administered by the Food and Drug Administration). FDA reps are well aware of BPE standards and can call it into question when manufacturers aren’t compliant.
ASME also offers a program – which CSI represents - through which companies are granted authorization to use the ASME certification mark on tubing and fittings they make by volunteering to use the BPE standards as a mandatory part of their manufacturing processes. This extra mark of quality and assurance goes a long way toward boosting customer confidence and influencing purchase choices.
BPE At A Glance
Latest version: 2019
Last prior update: 2016
Next New Version: projected for 2022
Overseeing body: ASME BPE Standards Committee and Executive Committee
BPE topics covered: General Requirements, Systems Design, Metallic Materials, Polymeric and Other Nonmetallic Materials, Dimensions and Tolerances for Process Components, Process Instrumentation, Sealing Components, Materials Joining, Process Contact Surface Finishes, Certification Requirements. Each section is developed by working subcommittees that range from around 10 to around 50 members.
Length: Latest version is 380 pages – long, but a lot of information is conveyed through diagrams, photos, tables, and other graphic form.
How do I know what’s changed from version to version?
Near the front of each new version is a summary specifying changes from the prior one. You can also be notified of changes by signing up here on the ASME website.
What’s the best way for organizations to get BPE information and updates, and to get involved in contributing to BPE and the future of bioprocessing?
Visit the ASME website, specifically:
- Purchase the BPE Standards and Codes here (note there is a drop-down to choose different editions – the latest is 2019)
- Learn how you and your organization can get involved in BPE and other ASME activities
- Connect directly with the BPE Committee staff contact
- Find out how the products your company manufactures (applies to tubing and fittings) can become part of the ASME Bioprocessing Equipment Certification Program
ABOUT CSI
Central States Industrial Equipment (CSI) is a leader in distribution of hygienic pipe, valves, fittings, pumps, heat exchangers, and MRO supplies for hygienic industrial processors, with four distribution facilities across the U.S. CSI also provides detail design and execution for hygienic process systems in the food, dairy, beverage, pharmaceutical, biotechnology, and personal care industries. Specializing in process piping, system start-ups, and cleaning systems, CSI leverages technology, intellectual property, and industry expertise to deliver solutions to processing problems. More information can be found at www.csidesigns.com.