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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It has helped to consolidate acceptable practices including procedures for examination, inspection and documentation of welds in bioprocess piping sys-tems. For the recent expansion at Lonza Biologics Expansion in Singapore, process equipment for the large scale mammalian biopharmaceutical production plant was fabricated, equipnent and disassembled in the United States, and then shipped to Singapore for reassembly onsite.
The BPE Standard is a consensus standard with work done by volunteers. New Supplier Certification Program!
ASME BPE 修改说明介绍_图文_百度文库
One facility has to be accepted by: 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.
When electropolishing of welded assemblies is specified, SBBIS does the electropolishing in-house to prevent the contamination that would result from transport to another facility. Go to a meeting and listen to the Subcommittee Sessions. This has significantly improved the hygienic aspects of installation technology in their facility.
Equipment Installation Installation of equipment in biopharmaceutical applications have been made more efficient by the use of skid-mounted equipment modules so that nioprocessing and fabrication can be telescoped into a shorter timescale.
ASME BPE – Wikipedia
Continuously updated to support y p p industry accepted practices? Achieving welds of consistent high quality compatible biopdocessing the principles of hygienic design was an initial goal of the BPE Committee, but the Standard is by no means limited to welding and fabrication issues.
Arc Machines Model power supplies and Model 8 weld heads used in the manufacture of bioreactors and fermentors. The Standard is continuosly being updated to represent a consensus of current good manufacturing practices cGMP for the biopharmaceutical industry.
Unpenetrated welds are entrapment sites for product and are difficult to clean. This in-process borescopic examination is done in lieu of radiography that would otherwise be required. Any component welded into the system is identifiable and the materials from which it was fabricated can be traced back to the mill.
The Qualifications for Inspectors and Examiners must also be included. A good machined end-preparation is important for fit-up of the weld joint and for achieving repeatable orbital welds. ASME 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 subjects of materials, design, fabrication, inspections, testing, and certification.
Photo courtesy of Protech Process, Inc. Installation of equipment in biopharmaceutical applications have been made more efficient by the use of skid-mounted equipment modules so bioproceessing installation and fabrication can be telescoped into a shorter timescale. Orbital welding in a clean facility done in accordance with the BPE Standard assured the compliance to hygienic design concepts.
Field welds in hygienic piping systems are typically left in the as-welded con-dition; the only post weld treatment being chemical passivation with nitric or equipemnt acid solutions following installation.
Meets 3 times annually to: This means that all of the materials and components must be inspected prior to installation and provision for weld inspection and documentation must happen during the manufacture of the skid.
The BPE Standard applies only new construction and only to those systems and components that are in direct or indirect contact with the product. Compendial Water Pump Seals? OE Group 6 group. 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.
ASME BPE Guidelines for Pharmaceutical Equipment
The yel-low control document travels with the part as it is fabricated. Since existing standards were insufficient for this new technology, the engineer recruited a group of suppliers and end users in the industry and they approached the American Society of Mechanical Engineers ASME for permission to begin the biopfocessing of a new standard for the developing Bioprocess Industry.
Reasons for greater percent of orbital welds In the past there were many places boe systems and equipment that an orbital weld head would not fit so a larger percentage of welds had to be done man-ually.
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.
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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. Contaminants other than oxygen, gioprocessing moisture, oil or grease on the tubing, etc. Consistent dimensions are important as the welding current is based on wall thickness. Examination is done by the installer or the person performing the weld while inspection must be done by the owner or his representative which may be a third party QC company or consultant.
Not too restrictive or expensive? Photo cour-tesy of Arc Machines, Inc.
In the past there were many places in systems and equipment that an orbital weld bioprocessihg would not fit so a larger percentage of welds had to be done man-ually. Installation practices at modern biopharmaceutical, pharmaceutical and some food and dairy plants today are quite different than those at bioprcoessing construction sites 20 years ago. ASME BPE has emerged as the definitive international standard on bioprocessing equipment and facilities, covering the subjects ofmaterials, design, fabrication, inspections, testing, and certification.
ASME BPE 2009 B P E
An orbitally welded assembly for a CIP pump for a l fermentor. 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. Standards such as BPE operate on the assumption that quality must be built in – it cannot be added after the fact.