ASME BPE (Revision of ASME BPE). Bioprocessing. Equipment. AN AMERICAN NATIONAL STANDARD. Three Park Avenue. Buy ASME BPE Bioprocessing Equipment from SAI Global. No reproduction may be made of this material without written consent of ASME. ASME BPE (Revision of ASME BPE) Bioprocessing.
|Published (Last):||8 January 2009|
|PDF File Size:||19.87 Mb|
|ePub File Size:||3.34 Mb|
|Price:||Free* [*Free Regsitration Required]|
Ahluwalia, Material Selection Resources, Inc. The proposed code or standard was made available for public review and comment that provides an opportunity for additional public input from industry, academia, regulatory bp, and the public-at-large. Hose assemblies shall not be used as as substitute for rigid tube fittings or as tension or compression elements. The discoloration or heat tint produced by oxidation has been associated with the onset of corrosion in stainless steel piping hpe.
Blessman, Trent Tube D. This is usually achieved at a velocity of 5 fps 1. Recommended tolerances are per Table SD-7 and Fig.
This section covers isolation, regulation, and control valves that are part of the clean steam system and are subject to continuous steam service. The advance of the welding is manually controlled. Raney, UltraClean Electropolish, Inc. Process lines should be bpr at a velocity to ensure turbulent flow in pipelines, and maintain a fully flooded line.
Wells, 22007 Sarco K. If a branch from a primary pipeline has demonstrated flow during cleaning and sterilization, it does not constitute a dead leg. See also gas tungstenarc welding. The use of a ferrous magnetic material is required; however, it must be fully encapsulated to ensure that the ferrous material does not contaminate the classified manufacturing area.
The bore of the ball valve assembly shall match the inside diameter of the tube see Fig. Special Provisions for Seals in Bioprocessing Service. Design for Sterility and Cleanability.
Functional components of the CIP such as filters, pumps, vessels, tubing, and piping shall be designed to be self-cleaning and abide by the guidelines of this Part. Seal Piping and Lubrication Plans.
Carnes, Purity Systems, Inc. Shielding is obtained from a gas or gas mixture. For nominal metric size tubing and fittings, refer to the appropriate international standards. Dvorscek, Abbott Laboratories 207. If screwed fittings are used, an Pbe or gasketed fitting, where the inside diameter I.
Materials shall meet the requirements of SD SD Dip Tube Nozzles: Surfaces exposed to bioprocessing fluids, cleaning and sterilizing conditions must be a homogeneous in nature b impervious c inert d nonabsorbent e nontoxic f insoluble by process or cleaning fluids g resistant to corrosion, scratching, scoring, and distortion SD Minor, Paul Mueller Co. SD Redesignated as Fig. Weir Style Diaphragm Valve. Orbital welding can be done with the addition of filler material or as a fusion process without the ame of filler.
Frames should have rounded rather than sharp edges. Supporting skid frame structures and modules should be constructed from fully sealed tubes or pipes, which are easily cleaned. The test may be performed with ambient temperature water and before the riboflavin dye has dried.
The use of preservative fluids is not 200.
ASME BPE Bioprocessing Equipment_图文_百度文库
SD-4, illustrations b and cmay be required to achieve the target ratio. Uncompressed Compressed O-ring Detail 15 deg to 45 deg min.
Elbows furnished to this Standard shall not be mitered. For a tubeto-tube weld, no unfused portions of the weld joint shall be visible on the bpw diameter of a fully penetrated weld. All internal instruments shall be installed e. Return system engineering shall give consideration to balancing solution flow i.
ASME BPE Guidelines for Pharmaceutical Equipment
The CIP skid and system is one of the most important pieces of equipment when considering cleanability and cross-contamination. Sometimes referred to as dross. Campbell, Bechtel National, Inc. All process piping systems that include piping, tubing, and fluidic components shall be sloped for adequate drainage.
Campbell, Chair, Bechtel National, Inc. Figures in this Part show several levels of design and fabrication. SD may be used to prevent ingress of seal face wear particles that could contaminate the process fluid.