Bpe journal on system design volume 2 issue 1 abstract. Introduction the standard was started in 1988 with a small task group at the asme annual meeting asme bpe standard is a worldwide standard for the. Our bpe direct products are in accordance with the current revision. Iso 2852 standard was replaced by iso 2037 in 1982, in turn iso 2037 standard was then replaced by iso 1127 in 1996. In the case of the component related standards, these are generally adopted. View a complete list of asme bioprocessing equipment bpe standards and related elearning courses. The asme bioprocessing equipment standard was the asme bpe standard provides requirements for developed to aid in the design and construction of new systems and components that are subject to cleaning fluid processing equipment used in industries that and sanitization andor sterilization including systems require a defined level of purity and. It incorporates current bestpractices for enhancing product purity and safety.
This is a companion guide to the asme bioprocessing piping and equipment bpe standard and explains what lies behind many of the requirements and recommendations within that industry standard. The standard is approved as an american national standard by the american national standards institute ansi. When the american society of mechanical engineers asme bioprocessing equipment standard, bpe97, was introduced in 1997, it was the first standard to address criteria for orbital welds in. Asme bpe 2012 asme bpe mp2012 asme bpe ep2012 this asme standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personalcare products industries, as well as other applications with relatively high levels of hygienic requirements. Asme bpe electropolishing standard able electropolishing. If sf1 asme bpe tubing and standard 316l sanitary tubing both come with a 20ra id polish, why should i pay the premium to buy the bpe tubing. A technical journal of the asme bioprocessing equipment standard.
Triclamp coupling, eye nuts and eyebolt screw from aisi 316 1. Closure clamp with vprole, for equal pressure over the whole circumference. Asme bpe 2014 revision of asme bpe 2012 bioprocessing equipment an international standard two park avenue new york, ny 10016 usa. Every label includes a qr code which directs to the fittings material test report please refer to page 46. The matrix not only provides a listing of passfail testing protocols taken from. Interpreting the new asmebpe1997 guidleines for high purity. What is the difference between asme bpe tubing and standard.
All pharma and biotech fittings comply with the current version of asmebpe standards. All pharma and biotech fittings comply with the current version of asme bpe standards. Iso 2852, din 32676, bs 4825 asmebpe non standard material. Bioprocessing equipment is an international standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals. It is the leading standard on how to design and build equipment and systems used in the production of biopharmaceuticals. Outside diameter mm wall thickness mm nominal outside diameter nominal wall thickness dimensional standard. A technical journal of the asme bioprocessing equipment.
Asme bpe the american society of mechanical engineers first published this standard in 1997 for bioprocessing equipment and it has since become a standard specification worldwide for the biotechnological and pharmaceutical industries. Asme offers a continuously evolving portfolio of standards across a wide range of topics, including pressure technology, power plants, elevators, construction equipment, piping, nuclear components, and many more. The only comprehensive and authoritative reference guide to the asme bioprocessing piping and equipment bpe standard. Any other reproduction or use of this document, in full or part, is strictly prohibited. Demarcation if 5% of the total area when visually inspected and r a is met. Bpe standard, namely dt7 to dt30 as the industry is already familiar with these items.
Bioprocessing piping and equipment design wiley online books. Aasme bioprocessing equipment standard or asme bpe 1 asme bpe scope this standard deals with the requirements of the bioprocessing, pharmaceutical, and personall care product d t industries i d t i as well ll as other applications with relatively high levels of hygienic requirements, covering directly or indirectly the. Each fitting is capped, bagged and labeled in full compliance with the asme bpe standard. Unlisted components can have pressure ratings but the owner andor the designer has the responsibility to verify that the design, materials, fabrication, examination, and testing of the component meet the requirements of asme b31. The author draws on many years experience and insights from firsthand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. A dead leg in a piping system is defined as a pocket, tee, or extension from a primary piping run that exceeds a defined number of pipe diameters l. Asme bpe 2002 pharmaceutical biotechnology industries. The first edition of the standard was approved on may. Asme bpe is unique in the world, having resulted from widespread industry requests for standardization. As mentioned above, the asme bpe standards have additional acceptance criteria for surfaces finishes beyond simple ra readings.
Such requirements will include standards for components and material of construction moc, as well as specialized needs such as those carried in the asme bpe bioprocessing equipment standard. High shearvelocity environment pump impeller, sprayball, tees, etc. Asme bpe2009 table d2 considerations that affect the amount of rouge formation during the operation of a system variables corrosive process fluid bleach, halides, etc. Asme bioprocessing equipment standard or asme bpe 2007 edition introduction the standard was started in 1988 with a small task group at the asme annual meeting asme bpe standard is a worldwide standard for the biopharmaceutical, personal care, api industries and other hygienic industries. Lanl engineering standards manual pd342 chapter 17 pressure safety section d20b31. In appendix e of the bpe standard it provides a test matrix for the evaluation of cleaned andor passivated surfaces. Asme publishes a new edition of the bioprocessing equipment standard asme bpe 2002. Asme bpe standard of electropolishing the american society of mechanical engineers asme provides a set of standards for the manufacturing and finishing of bioprocessing equipment. Operating temperature and temperature gradients gaseous phase composition, including dissolved gases o2, co2, n2, etc. Ferrules for pharmaceutical and biotech we stock thousands of bpe compliant sanitary ferrules so we can get you what you need, when you need it. Ra readings are mesured according to the standard methods. When the american society of mechanical engineers asme bioprocessing equipment standard, bpe97, was introduced in 1997, it was the first standard to address criteria for orbital welds in bioprocess piping systems.
The use of filtration in the bioprocessing industry is an essential step as a standard unit operation or in conjunction with other unit operations for separation, isolation and purification of the biotherapeutics, be it recombinant proteins, vaccines, gene therapy. Codes and standards beyond those requirements captured in b31. Bioprocessing equipment american society of mechanical. Asme bpe2014 revision of asme bpe2012 bioprocessing equipment an international standard two park avenue new york, ny 10016 usa. Examination, inspection and testing then precede the asme bpe certification process, concluding with a discussion on system design. The new asme bioprocessing equipment standard, asme bpe1997, was released in october of 1997, but the process of writing this standard began much earlier when individuals at the 1989asme winter annual meeting determined that there was interest in the industry for such a standard, and approached the asme council on codes and standards to. Asmebpe is referenced in asmes b code on process piping. A143c5 discoloration acceptance criteria for welds and heataffected zones on electropolished uns s31603 tubing has been added to your cart. Interpreting the new asmebpe1997 guidleines for high. Bioprocessing equipment bpe standard this document is for asme committee use only, and not for any other distribution, republication or resale purposes. Asme s comprehensive portfolio of bioprocessing equipment codes, standards and elearning solutions. Asme bpe tubes and fittings m a s t e r i n g p u r i t y. The use of filtration in the bioprocessing industry is an essential step as a standard unit operation or in conjunction with other unit operations for separation, isolation and purification of the biotherapeutics, be it recombinant proteins, vaccines. Asme bpe offerings bioprocessing and equipment setting the standard.
Ferrules for pharmaceutical and biotech we stock thousands of bpecompliant sanitary ferrules so we can get you what you need, when you need it. Astm and asmebpe standards and the pharmaceutical industry. Table sf5 acceptance criteria for interior surface finishes of valve bodies anomaly or indication acceptance criteria cluster of pits none accepted. Sign up to receive email notifications when standards are updated. The asme bpe standard provides requirements for systems and components that are subject to cleaning and sanitization andor sterilization including systems that are cleaned in place cipd andor steamed in place sipd andor other suitable processes used in the manufacturing of biopharmaceuticals. These standards, known collectively as asme bpe, ensure the high quality and continued safety of parts used in pharmaceutical, bioprocessing and other industries. Asme bpe 1997 pharmaceutical biotechnology industries. Standard dt fittings are offered to sf1 surface finish at 0. Asmebpe is unique in the world, having resulted from widespread industry requests for standardization. In its 2009 publication the asmebioprocessing equipment bpe standard makes reference to these astm protocols in its nonmandatory appendixes. The new asme bioprocessing equipment standard, asme bpe 1997, was released in october of 1997, but the process of writing this standard began much earlier when individuals at the 1989asme winter annual meeting determined that there was interest in the industry for such a standard, and approached the asme council on codes and standards to. Mar 14, 2000 the design part of the asme bpe standard calls for holdup volume, or that amount of liquid which remains in the system after draining is complete, to be minimized by design. Print sitemap flowsource process fittings, unit 2d hockney road industrial estate, bradford, west yorkshire, bd8 9hq.
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