BPE 2009 BIOPROCESSING EQUIPMENT PDF
Buy ASME BPE: BIOPROCESSING EQUIPMENT from SAI Global. 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. ASME BPE Supplement. Supplement to Bioprocessing Equipment. Amendment by ASME International, 05/19/ This document is an amendment.
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While no color is per-mitted on the weld itself, a slight color may be allowed on the HAZ. An example of how a manufac-turer of bioprocessing equip-ment optimized their production, Sartorius BBI Sys-tems, Inc.
One of the contributions of the BPE Standard to achieving high quality hygienic welds was to specify the amount of color permitted on the ID of the weld and heat-affected zone HAZ.
Stadler, Henon and Koiro.
ASME BPE 2009 B P E
The MJSC developed a set of weld criteria that, in addition to code criteria for adequate structural integrity, was designed to minimize the growth of microorganisms and promote cleanability. Reasons for greater percent of orbital welds In the past there were many places in systems and equipment that an orbital weld head would not fit so a larger percentage of welds had to be done man-ually.
If you want to vote on changes and updates to an international standard. This presentation will summarize the new BPE resources and requirements for the design and delivery of components and process systems for use in bioprocessing, pharmaceutical, and personal care product industries.
Photo courtesy of Kenyon Engineering. Orbital welds are smoother than manual welds and, when done properly, are free from crevices, pits and other defects that could harbor microorganisms. The BPE Committee has reached its initial goal of achieving welds of consistent high quality compatible with the princi-ples of hygienic design.
This publication will include new content on the design of process systems such as bioreactors, fermentors, autoclaves, process gasses, CIP distribution and single-use equipment.
The Qualifications for Inspectors and Examiners must also be included. Orbital weld cut open for inspec-tion of the ID surface. The BPE has also been expanded to include new sections on process instrumentation, hygienic pumps, hygienic hose assemblies and rotary spray devices. Material chemistry is important because stainless steel shows considerable heat to heat variation in weldability so that weld parameters that produced successful welds on one heat of material would need considerable adjustment for other heats.
Welding documentation includes docu-ments certifying the welding procedures and welding personnel to ASME Sect.
The BPE Standard applies only bpr construction and only to those systems and components that are in direct or indirect contact with the product.
ASME BPE 修改说明介绍_图文_百度文库
Photo cour-tesy of Arc Machines, Inc. Weld discoloration was shown to increase with increasing amounts of oxygen added to the ID argon purge.
Guidelines for Cleaning Vessels? If you have the time and interest to be y an active participant. This figure allows owners, installing contractors and QA people to agree in advance to the amount of weld discoloration acceptable for a particular appli-cation. New Nominal one inch fitting design. The BPE Standard deals with the requirements bioprocwssing the bioprocessing and pharmaceutical industries, as well as other applications with relatively high levels of hygienic requirements or bioburden control.
In the past there were many places in systems and equipment that an orbital weld head would not fit so a larger percentage of welds had to be done man-ually. Compendial Water Pump Seals?
Arc Machines Model power supplies and Model 8 weld heads used in the manufacture of bioreactors and fermentors. Determine where your technical strengths would help. Coupon welds are done at specified intervals throughout the project such as at the beginning of a shift, when the power supply is moved, etc. In an bioproceseing at a biotechnology plant in San Francisco, California was preparing to install some process equipment and recognized that the welds on the equipment were of insufficient quality to meet the stringent hygienic requirements necessary for growing cells in culture.
Multiple stages of approval before publication? Test coupons or sample welds are made and evaluated pior to bioprocessing welding to demonstrate that the welding equipment is working properly and that the purge is satisfactory Figure 5. Equipment size is generally staying about ll t i b t the same size or getting smaller.
Contaminants other than oxygen, including moisture, oil or grease on the tubing, etc. Unpenetrated welds are entrapment sites for product and are difficult to clean. Should I become a member?
ASME BPE – Wikipedia
New resource material will be provided on electropolishing, passivation, elastomer performance, metallic materials of construction, polymer surface finishes, corrosion testing and stainless steel rouge. Consistent dimensions are important as the welding current is based eqipment wall thickness. This has virtually eliminated all of the problems related to sulfur content and greatly improved installation of biopharmaceutical systems.
Welds at that time were often discolored due to poor inert gas purging. Since the amount of discoloration has been shown to correspond to a loss in equipmentt resistance, and the products of corrosion can result in con-tamination of the system, this is not just a cosmetic issue.
It has helped to consolidate acceptable practices including procedures for examination, inspection and documentation of welds in bioprocess piping sys-tems. D2 East Induction Pack.