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.
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Shielding is obtained from a gas or gas mixture.
Kranc, Tech Source M. A discontinuity is not necessarily a defect.
It is the responsibility of the end-user to establish complaince with applicable standards e. For special cases, the radii may vpe reduced to 1? Bolted attachments should be eliminated whenever possible. Kimbrel, UltraClean Electropolish, Inc.
Refer to Nonmandatory Appendix C for suggested method of slope measurement. SD-7, illustrations a and b ]. SD-4, illustrations b and cmay be required to achieve the target ratio. Typical Ball Valve Configuration.
Bongiorno, Flow Smart, Inc. Sisto, Purity Systems, Inc. In other cases a minimum of 4 in. Newman, Newman Sanitary Gasket Co. Dvorscek, Abbott Laboratories E.
Obertanec, LJ Star, Inc. Kranc, Tech Source P. The intended function is to collect spilled fluids that can occur during jumper or cap removal.
ASME BPE Bioprocessing Equipment_图文_百度文库
Better Design [Notes 3 — 5 ] Fig. Removable Designs 07 d During handling and transportation, vessels and their parts and piping assemblies shall be suitably protected to prevent damage to polished surfaces. The designer will ensure that the selected mounting arrangement is adequate for expected agitator mounting design loads while achieving an appropriate seal.
No telltale holes are allowed on product contact surfaces and axme, which are outside, should be cleanable. The fused glass shall wsme circular in shape within the metal frame. Customary units, and are for reference purposes only unless specified otherwise. The maximum working temperature should relate to the maximum working pressure and 207 fluids involved.
This is accomplished by sizing pump impellers, sizing lines, and when necessary installing restrictors to control flow.
A sanitary weld must be completely penetrated on the weld ID, with little or no discoloration due to oxidation, and be otherwise without defects that would interfere with maintenance in a clean and sterile condition. Rau, Dockweiler AG P. SD Dip Tube Nozzles: The outlet valve shall be opened, and the vessel allowed to drain by gravity.
Short Outlet Run Tee. Gravity then provides for a continuous solution sheeting over the sidewall and bottom head. A crack may not be detected with a stylus. See examples in Fig. Such equipment shall conform to the following: The committee met in and there was consensus concerning the need to develop standards that would meet the requirements of operational bioprocessing, including: The discoloration or heat tint produced by oxidation has been associated with the onset of corrosion in stainless steel piping systems.
ASME BPE Guidelines for Pharmaceutical Equipment
Gonzalez, Retired, Amgen, Inc. Wherever possible, the Committee strived to reference existing standards that are applicable to biopharmaceutical 20007 design and fabrication.
In all cases sufficient annular space to allow access for CIP coverage shall be provided. The use of overhead, direct-coupled, pressurized condensate return systems should be avoided see Fig.
See also automatic welding.