Jan 25, 2019 today, however, we are going to give a general overview of just what kind of equipment and design standards the asme bpe standard covers. Operating temperature and temperature gradients gaseous phase composition, including dissolved gases o2, co2, n2, etc. Asmebpe is unique in the world, having resulted from widespread industry requests for standardization. Asme bpe 2012, ferrule, dt22a standard length ferrule data sheet asme bpe 2012, ferrule dt22. They allow you to match acceptable discoloration levels perfectly. 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. 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.
This standard provides the requirements applicable to the design of equipment used in bioprocessing. The purpose of this subcommittee is to establish design guidelines applicable to. High shearvelocity environment pump impeller, sprayball, tees, etc. European automakers typically apply iso standards and us automakers apply asme standards. Moreover, two weld discoloration acceptance criteria color charts, asme bpe mp2012 and ep2012, are available separately.
Asme bpe 1997 pharmaceutical biotechnology industries. Today, however, we are going to give a general overview of just what kind of equipment and design standards the asme bpe standard covers. The asme bpe standard provides requirements for systems and. Asme bioprocessing equipment bpe standards for engineers worldwide 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. A companion guide for the asme bpe standard wileyasme press series by william m. The initial scope was approved by the ccs on june 20, 1989, with a directive to the.
As mentioned above, the asme bpe standards have additional acceptance criteria for surfaces finishes beyond simple ra readings. It covers materials, design, fabrication, inspections, testing and certi. 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. The number of different standards being used by different equipment manufacturer has created a great deal of confusion and misunderstanding throughout the industry.
Lanl engineering standards manual pd342 chapter 17 pressure safety section d20b31. 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. Using asme bpe standards is critical for component and system validation according to cgmp and fda requirements. This front matter contains the asme bpe organization and roster of members, dedication, table of contents, list of figures, list of tables, list of forms, series preface, preface, acknowledgments and about the author. Read online and download ebook bioprocessing piping and equipment design.
Astm and asmebpe standards and the pharmaceutical industry. Asme bpe bioprocessing equipment asme s comprehensive portfolio of bioprocessing equipment codes, standards and course offerings. Asme issues written replies to inquiries concerning interpretations of technical aspects of this standard. Asme accepts responsibility for only those interpretations of this document issued in accordance with the established asme procedures and policies, which precludes the issuance of.
This standard represents the work of the bpe standards committee and this edition includes the. The asme bpe standard standardizes specifications for the design and construction of new fluid processing equipment used in industries that require a defined level of purity and bioburden control. Asme bioprocessing equipment bpe certification is a company level certification for organizations manufacturing or supplying tubing and fittings under the scope of the asme standard bioprocessing equipment, which dictates specific conditions for design. Asme bpe 2002 pharmaceutical biotechnology industries. Asme bpe pipe fluid conveyance mechanical engineering. Asme international asme is a notforprofit membership organization that enables collaboration, knowledge sharing, career enrichment, and skills development across all engineering disciplines, toward a goal of helping the global engineering community develop solutions to benefit lives and livelihoods. In its initial development and ongoing maintenance it works with other american national standards developers to harmonize the many standards associated with the design, engineering, and construction of bioprocessing facilities.
Material and traceability wcbflow products offers fittings to bpe dimensions in 316l, and other specialty alloys. Every fitting is passivated according to asme bpe and astm a967 standards. Asme bpe 2012, ferrule, dt22c extra short length ferrule data sheet asme bpe 2012, ferrule dt22. Standards for the pharmaceutical industry w m huitt co. Asme bioprocessing equipment bpe standards for engineers worldwide asme bpe2012 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. A270bpe high purity stainless steel tubing mechanically polished tubing to 20 in ra id for pharmaceutical, semiconductor, biotechnology, and other high purity processes. Bioprocessing equipment american society of mechanical. All pharma and biotech fittings comply with the current version of asme bpe standards. Provides the requirements applicable to the design of bioprocessing equipment, including aspects related to sterility and cleanability, dimensions and tolerances, surface finish, material joining, and seals. Codes and standards, 1719 committee on bpe certification cbpec, 161.
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. The current asme bpe standard was published in 2016 and has an extensive chapter on systems design chapter 2, part sd. As a result of this interest, the asme council on codes and standards ccs was petitioned to approve this as a project. Bioprocessing equipment bpe standard this document is for asme committee use only, and not for any other distribution, republication or resale purposes.
Asme bpe2012 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 tubes and fittings m a s t e r i n g p u r i t y more than a century of experience in high and ultrahigh purity industries en. The only comprehensive and authoritative reference guide to the asme bioprocessing piping and equipment bpe standard 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. All fittings are permanently marked with original heat numbers allowing full traceability back to the original stainless steel supplier. 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 bpe bioprocessing equipment asmes comprehensive portfolio of bioprocessing equipment codes, standards and course offerings. A companion guide for the asme bpe standard wileyasme press series. Ece applies asme bpe and provides validation services for. View a complete list of asme bioprocessing equipment bpe standards and related elearning courses. 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. Codes and standards, 1719 committee on bpe certification cbpec, 161 compendial waters, 106. Iso is predominate in western european countries like germany, france, and italy. Scope of the asme bpe standard 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.
Harmonization of asme codes and standards by barbara henon, vince molina, richard campbell, and william huitt this article presents interactions between the asme bioprocessing equipment bpe standard and asme b31. Errata to codes and standards may be posted on the asme web site under the committee pages to provide corrections to incorrectly published items, or to correct typographical or grammatical errors in codes and standards. 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. This front matter contains the asme bpe organization and roster of members, dedication, table of contents, list of figures, list of tables, list of forms, series preface, preface, acknowledgments and. Pdf bioprocessing equipment asme bpe2016 md abdullah. In 1997 the american society of mechanical engineers asme published the first bioprocessing equipment bpe standard. Validation challenges the entire system for compliance according to good engineering practices, engineering specifications, process integrity and product quality. Asme bpe more than just a standard for fittings holland.
Periodically, certain actions of the asme bpe committee may be published as cases. What is the difference between asme bpe tubing and. They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and codecompliance. We stock thousands of bpe compliant sanitary ferrules so we can get you what you need, when you need it. Manufactured to the stringent asme bpe and astm a270 s2 specifications, this high quality tubing is 100% borescoped and mechanically polished on both the id and od. Bioprocessing piping and equipment design a companion guide for the asme bpe standard. Full traceability we provide full traceability for each of our products by supplying all necessary production process data. What is the difference between asme bpe tubing and standard. With the advent of asme bpe the pharmaceutical and biotechnology industries finally have a standard that can be universally applied. Following an introductory narrative to the standards early history, industry. 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.
Astm and asmebpe standardscomplying with the needs of. Asmebpe is unique in the world, having resulted from widespread industry. Asme publishes a new edition of the bioprocessing equipment standard asme bpe 2002. 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. We stock thousands of bpecompliant sanitary ferrules so we can get you what you need, when you need it.
Any other reproduction or use of this document, in full or part, is strictly prohibited. Starting from certifications and incoming inspection of raw materials, through inprocess quality control, final inspection, marking and packaging. With the advent of asmebpe the pharmaceutical and biotechnology industries finally have a standard that can be universally applied. Our bpedirect products are in accordance with the current revision. Tri clamp ferrules and blank caps bs, 3a, asme bpe. All pharma and biotech fittings comply with the current version of asmebpe standards. Above stages could take 1824 months depending on issue date. But not necessarily in eastern european countries like poland, hungary, and romania these countries have adopted asme, because it provides them access to the.
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