Most of us have some familiarity with the ASME BPE Standard. While you may know of the ASME BPE and you may even know a little bit about the details, you should also know that the Standard is a living document that is constantly evolving to provide the best possible requirements for equipment and fabrication processes used in the biotech industry and other industries that require high levels of hygienic quality. With that said, not only is this a new year, but a new 2012 edition of the ASME BPE was just released. This edition of the Standard is the most comprehensive update ever done and it is a good time to renew your knowledge.
Back to Basics
The scope of the ASME BPE is to define the requirements of equipment and fabrication processes for the bioprocessing industry and other industries requiring high levels of hygienic quality. To achieve this, the Standard is divided into 10 parts. Below, we’ve listed each of the parts of the ASME BPE with a brief overview of some of the subjects they cover. I encourage you to get a copy of the most recent edition (http://www.asme.org/products/codes—standards/bpe—2012-bioprocessing-equipment) because of the significant changes it has gone through and because there are over 60 pages of new information—including an entire new part on Process Instrumentation.
Part GR, General Requirements
General Requirements covers information that applies to the entire BPE. It begins with the introduction and scope of the Standard. It has six additional sections: manufacturer’s quality assurance program, inspection, documentation requirements, metric, references, and terms and definitions.
The introduction gives you an overview of the BPE. It defines what components and systems it typically applies to and what other standards, laws, and regulations that equipment needs to meet when used under pressure conditions. The Scope defines more specifically what equipment is covered by the BPE and under what conditions it is covered.
The documentation section is new for 2012. In this edition, it is simply all the documentation requirements moved from the other parts of the Standard into a single location. It gives you one place to look up the typical documentation requirements for equipment and processes. This is the section to keep an eye on in future revisions to the Standard as it becomes more concise and organized.
Part SD, Systems Design
Systems Design was almost completely revised for 2012. Part SD establishes design guidelines for equipment and systems for efficient cleanability and bioburden control. It is divided into six sections: purpose and scope, general guidelines, process components, process utilities, process systems, and testing.
The general guidelines section applies to all equipment and covers topics ranging from containment to drainability. For example, it defines the minimum slope requirements for gravity-drained lines to prevent pooling. The process components section covers individual pieces of equipment by type, such as agitators and spray devices. Process systems outlines requirements for entire systems like bioreactors and filtration systems. One final item to note is that the figures for this section (actually the figures for the entire BPE) have all been redone by a dedicated group of individuals and look spectacular.
Part DT, Dimensions and Tolerances for Process Components
As you might have guessed, Part DT provides requirements for dimensions and tolerances for process components. It is divided into 12 sections: purpose and scope, pressure rating, wall thickness, dimensions, materials, tests, tolerances, weld ends, hygienic clamp unions, minimum examination requirements, marking, and packaging.
Among the changes to DT is an excellent reorganization of the dimensions section. This now encompasses fittings, non-standard fittings, special angle fittings, and valves, all in one location.
Part MJ, Material Joining
Part MJ defines requirements for joining metallic materials. It is divided into ten sections: purpose and scope, materials, weld joint design and preparation, joining processes and procedures, procedure qualifications, performance qualifications, examination—inspection and testing, weld acceptance criteria, documentation requirements, and passivation.
The weld acceptance criteria section includes an excellent set of tables on acceptance criteria for different weld types as well as graphics for weld profiles of tubes. For 2012, it also includes an incredible two full pages of pictures in full color showing the acceptance criteria for discoloration of weld heat-affected zones on tubing. This section also references the new Nonmandatory appendix M on weld heat-affected zone discoloration acceptance criteria. This chart is also available as a stand-alone document for field inspection of these types of welds.
Part SF, Product Contact Surface Finishes
Part SF defines requirements for surface finish acceptance criteria for metallic and polymeric materials. It is divided into three sections: purpose and scope, metallic applications, and polymeric applications.
Regarding metallic materials, SF includes requirements for electropolishing and passivation (to get an idea of why this is so important make sure you read The Truth Behind Mechanical Polished Surfaces). The polymeric section now includes a very useful tables for product contact acceptance criteria, such as scratches and inclusions, as well as a new table for Ra readings.
Part SG, Sealing Components
Part SG provides requirements for sealing components: seals, valves, and fittings. It is divided into five sections: purpose and scope, sealing component types, sealing component general design requirements, seal performance requirements, and seal applications.
Like SD, this section was significantly modified for 2012. This reorganization gives you a better way to go through this part of the Standard. Starting with sealing component types, this section doesn’t just define static seals, but also defines the different types of static seals—hygienic unions, o-rings, and other static seals. The same is true of dynamic seals, from diaphragm valves to dual mechanical seals. The section on seal applications is another area to keep an eye on because there is a lot of future development that will be happening in this area.
Part PM, Polymeric and other Nonmetallic Materials
Part PM defines requirements for polymer and nonmetallic materials. It is divided into four sections: purpose and scope, materials, properties and performance, and applications. This is another significant reorganization (this used to be eight sections) that provides you a much easier way to navigate this material.
The section on properties and performance covers biocompatibility, extractables, and leachables, as well as chemical and physical properties of different nonmetallic materials. It also references Nonmandatory appendices N and O on choosing materials and extractables and leachables. The applications section here is also one to keep an eye on for future updates.
Part CR, Certification
Part CR defines the requirements for certification of companies providing components that meet the requirements of the BPE. It is divided into four sections: purpose and scope, general, acquiring an ASME BPE certificate, and requirements subject to change.
This section now includes the official ASME BPE mark for companies that have been certified by the ASME. This is similar to the ASME mark you may have seen on a pressure vessel. To learn more about certification, visit http://www.asme.org/kb/standards/certification—accreditation/product-certification/bpe-bioprocessing-equipment-certification.
There are a couple of important items to note. First, this certification program is still in its infancy and they are currently only certifying tubing and fitting manufacturers. Over the next few years they will add other types of equipment to the certification list. This means that equipment such as valves, pumps, mixers, etc. cannot be marked with the ASME BPE certification mark.
The second item to note is that the certification mark should not be confused with the marking requirements in Part DT to provide, “reference to this Standard (BPE).” In other words, if you see the words ASME BPE or BPE labeled on a part it means that the equipment meets the requirements of the BPE, but the supplier has not been certified by ASME.
Part MM, Metallic Materials
Part MM defines requirements for metallic materials. It is divided into eight sections: purpose and scope, alloy designations, uses of specifications, referenced specifications, fabrication, mechanical properties, corrosion resistance requirements, and unlisted alloys.
This part contains some tables that make it easy to review material compositions for different material types, such as wrought stainless steel, wrought nickel, and filler metals. The section on fabrication covers details like the sulfur content requirements for weld ends on tubing/piping, filler metals, or consumable inserts used during fabrication and draws attention to ferrite levels in 316 material.
Part PI, Process Instrumentation
New for 2012, Part PI provides requirements for process instrumentation. It is divided into nine sections: purpose and scope, process instrumentation, general requirements, instrument receiving—handling and storage, flowmeters, level instruments, pressure instruments, temperature instruments, and analytical instruments.
This Part, as with the rest of the BPE, covers equipment as it relates to cleanability and bioburden control. The graphics in Part PI do an excellent job of showing you the different types of equipment and how they look installed in systems. It covers details such as the different instrumentation types—in-line, at-line, off-line—and which are covered by the BPE and which are not. It also references the new Nonmandatory appendices P and Q.
Even though this was a very brief overview, I suspect many of you saw at least one item you would be interested to learn more about. As I stated before, I would highly recommend picking up a copy so you can learn more about your industry and equipment. Have a great year and stay tuned.