View a complete list of asme bioprocessing equipment bpe standards and related elearning courses. Installation of pharmaceutical process piping asme. Asme codes and standards free download torrent skidigital. Supplement to asme bpe2009 bioprocessing equipment. Asme bpe 2009 asme boiler and pressure vessel code, section ix, welding and brazing qualifications asme b31. Asme bpe 2009 bioprocessing equipment linkedin slideshare. Asmebpe isodin clamp gaskets pipes and fittings tecninox. Asme bpe 2009 description beschreibung 3 about bpe direct was ist bpe direct 7 specification spezifikation 12 dt41 dt1 tube rohr s c h u t z v e r m e r k n a c h d i n 3 4 b e a c h t e n. Immediate download free download log in to download. Asme bpe standard was first published in 1997, aims to ensure the production of pharmaceutical equipment, pharmaceutical and personal care products used by the industry to achieve a certain degree of unity and an acceptable level of quality the standard is interdisciplinary experts from the material and equipment manufacturers and. Authorized inspection agency aia pressure relief device testing lab prd prt certification. Asme bpe standard was first published in 1997, aims to ensure the production of pharmaceutical equipment, pharmaceutical and personal care products used by the industry to achieve a certain degree of unity and an acceptable level of quality.
Supplement to bioprocessing equipment amendment by asme international, 05192011. Wellgreen sanitary is assuredly capable of supplying qualified hygienic bpe fittings comply to your your condition and fda,gmp requirement. The asme bpe visual criteria for orbital welds were developed to assure that welded joints do not provide a surface which would favor the growth of microorganisms that would contaminate the system. The bpe 2009 2012 edition new requirements and resources for bioprocess systems design high purity days june 6th 2012.
Each piece of bpe tubing is visually inspected by boroscope. This content pack includes below asme related catalogs and specs. Asme s comprehensive portfolio of bioprocessing equipment codes, standards and elearning solutions. Please first verify your email before subscribing to alerts your alert profile lists the documents that will be monitored. Asme bpe 2014 revision of asme bpe 2012 bioprocessing equipment an international standard two park avenue new york, ny 10016 usa. No reproduction may be made of this material without written consent of asme. 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, design, fabrication, pressure systems vessels and piping, examinations.
Moreover, two weld discoloration acceptance criteria color charts, asme bpe mp2012. The next edition of this standard is scheduled for publication in this standard represents the work of the bpe standards committee and includes the follow asme bioprocessing equipment committee. High shearvelocity environment pump impeller, sprayball, tees, etc. Bioprocessing equipment american society of mechanical. Technical data sheet download centre process fittings. Bpe clamp fittings are triclamp connected tube fittings of asme bpe fitting series, it is made from 316 welded tube and electropolishing or mechanically polished to get high purity surface. Orbital welding may be used to weld either tube or pipe. Asme bpe 2009 table d2 considerations that affect the amount of rouge formation during the operation of a system variables corrosive process fluid bleach, halides, etc. The american society of mechanical engineers first published this. The asme codes and standards provide rules for the construction of various items. Raccorderia asmebpe e sanitaria asmebpe and sanitary.
We provide full traceability for each of our products by supplying all. This information has been carefully prepared to help in selecting the correct elastomer utilized in high purity sanitary hygienic seals where critical pure water, process fluids both ambient and hot and sip environments exist. Old asme bpe 2009 alt description beschreibung 3 about bpe direct was ist bpe direct 7 specifications spezifikationen 12 dt4. It incorporates current bestpractices for enhancing product purity and safety. See table sf4, asme bpe 2009 clearly state the requirement for methods of measurement and tolerance. Tc ferrules, dt22b, asme bpe 2019, standard length fpf data sheet, asme bpe, dt22b. Moreover, two weld discoloration acceptance criteria color charts, asme bpe mp2012 and ep2012, are available separately. All other asme digital pdfs types only require adobe readeracrobat to view after download. The american society of mechanical engineers asme, three park avenue, new york, ny 10016. The american society of mechanical engineers first published this standard in 1997 for bioprocessing equipment and it has. In appendix e of the bpe standard it provides a test matrix for the evaluation of cleaned andor passivated surfaces. Asme bpe is an international standard developed as an aid for the design and construction of. Copyright 2009 by the american society of mechanical engineers.
Asme bioprocessing equipment bpe an international standard asme bpe 2009 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. Old asme bpe 2009 alt description beschreibung 3 about bpe direct was ist bpe direct 7 specification spezifikation 12 dt4. Welding is not stqndards to tubetotube welds, but is used to asme bpe 2009 standards tubes to fittings and is recommended for joining all hygienic valves into the process line. For example, an unpenetrated weld is a crevice where bacteria can grow and escape. Astm and asmebpe standards and the pharmaceutical industry. 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. Our catalogs are also available for download on our website. Asme bpe2009 supplement global specifications free. 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. 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, design, fabrication, pressure systems vessels and piping, examinations, inspections, testing. The next edition of this assme is scheduled for publication in benway, chair, ironwood specialist, inc. The matrix not only provides a listing of passfail testing protocols taken from.
Asme bpe 2012 revision of asme bpe 2009 bioprocessing equipment an international standard three park avenue new york, ny 10016 usa. New resource material bp be provided on electropolishing, passivation, elastomer performance, metallic materials of construction, polymer surface finishes, corrosion testing and stainless steel rouge. Asmebpe is unique in the world, having resulted from widespread industry requests for. Asme content packs autocad plant 3d autodesk app store. In its 2009 publication the asme bioprocessing equipment bpe standard makes reference to these astm protocols in its nonmandatory appendixes. It is the leading standard on how to design and build equipment and systems used in the production of biopharmaceuticals. Bioprocessing equipment bpe nuclear quality assurance nqa1 nuclear material organization qsc personnel certification.
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. Outside diameter mm wall thickness mm nominal outside diameter nominal wall thickness dimensional standard. Amendment by asme international, 0519 this document is an. Every fitting is passivated according to asme bpe and astm a967 standards. Asme standards free download 16 enero, 2011 admin normas asme 15 in this post, a large post which details the names of almost all over 95% of asme codes issued by the american society of mechanical engineers. Polished tube is supplied in plastic sleeves with capped ends to protect the tube and the od finish. Asme bpe2009 supplement supplement to bioprocessing equipment. Asme bpe 2009 standards free download this publication will include new content on the design of process systems such as bioreactors, fermentors, autoclaves, process gasses, cip distribution.
If the document is revised or amended, you will be notified by email. Operating temperature and temperature gradients gaseous phase composition, including dissolved gases o2, co2. Asme bpe is unique in the world, having resulted from widespread industry requests for standardization. Asme bpe 2009 on the basis of the requirement of ra average value, it adds a requirement for ra max value of the surface. Bioprocessing equipment, includes supplement 2011 standard by asme international, 1020 2009. They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and codecompliance. Our bpe direct products are in accordance with the current revision.
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