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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Determine where your technical strengths would help. OE Group 6 group. 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.
While no color is per-mitted on the weld itself, a slight color may be allowed on the HAZ. The MJSC developed a set of weld criteria equkpment, in addition to code criteria for adequate structural integrity, was designed to bioproceasing the growth of microorganisms and promote cleanability.
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 Standard deals with the requirements of the bioprocessing and pharmaceutical industries, as well as other applications with relatively high levels of hygienic requirements or bioburden control.
ASME BPE 2009 B P E
New Process Systems Design Requirements! You may also contact after the meeting at: This means that all of the materials and components must be inspected prior to installation and bioprocessin for weld inspection and documentation must happen during the manufacture of the skid. 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.
Multiple stages of approval before publication? New resource material will be provided on electropolishing, passivation, elastomer performance, metallic materials of construction, polymer surface finishes, corrosion testing and stainless steel rouge.
If you want to vote on changes and updates to an international standard. Each weld has a unique number and the locatiion of any weld in a facility can be traced to a particular isometric drawing creating a weld map Figure 6.
The specification for the use of machine or orbital GTA welding together with the development of the ASME Bioprocessing Equipment BPE Standard has resulted in cleaner, more repeatable welding of piping and components such that thousands of welds are routinely installed with very low reject rates.
The BPE recommended the use of L for weld ends but there is considerable heat-to-heat variation in the weldability of stainless steel so even when only L is used, variations in trace element composition, especially sulfur content can cause problems in welding.
ASME BPE – Wikipedia
Although the repeatability of orbital welding power supplies had the potential to deliver higher productivity than manual welding because of improved weld repeatability and less need for re-work, conditions existing in the Industry at that time made the fulfillment of this promise problematic. Guidelines for Cleaning Vessels? All welds must have complete penetration to the inside surface of the weld which, in bioprocess applications, is usually the product contact surface.
For the recent expansion at Lonza Biologics Expansion in Singapore, process equipment for the large scale mammalian biopharmaceutical production plant was fabricated, tested and disassembled ble the United States, and then shipped to Singapore for reassembly biiprocessing. This publication will include new content on the design of process systems equiment as bioreactors, fermentors, autoclaves, process gasses, CIP distribution and single-use equipment.
Continuously updated to support y p p industry accepted practices? New Design Criteria for Hygienic Clamps. Owners typically specify sample number three as the upper allowable limit, but obviously would prefer welds in the range with minimal discolora-tion.
The BPE Standard is a consensus standard with work done by volunteers. Steaming for bioburden control? While the BPE Standard specifies what the end result must be, it does not provide guidelines for installers telling them how to achieve the desired results. Work on the BPE was begun and the first edition was published in American Society of Mechanical Engineers. In addition, the facility is arranged so that fabrication is performed in areas where the product contact surfaces are protected from contamination and surface contamination is pre-vented.
An orbital welding operator welding a tubing assembly at bioprocesssing biotechnology expansion in Singapore. Compendial Water Pump Seals? New Application Data Sheet for seal specification?
Weld coupons or test welds are routinely used for Quality Assur-ance of biopharmaceutical process piping systems. Standards such as BPE operate on the assumption that quality must be built in – it cannot be added after the fact.
ASME BPE Guidelines for Pharmaceutical Equipment
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. Weld discoloration relative to amounts of oxygen added to ID purge gas.
I Inspector Delegates t D l t 4 levels of qualification: Use of the BPE Standard has continued to grow to the point that virtually all new biopharmaceutical plants in the United States and many foreign countries, have been designed to, or have retroactively incorporated its requirements into their specification.