ASME BPE 2007 PDF

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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The purpose of this Part is to create a design framework using proven practices, for maintaining clean and sterile process systems. GTAW may be performed by adding filler material to the weld, or by a fusion process in which no filler is added.

Cleaning of impellers may have to be verified during production CIP validation, i. SD-2, illustration c ].

ASME BPE – Wikipedia

The particles are usually compounds such as oxides, sulfides, or silicates, but may be a substance foreign to and essentially insoluble in the matrix. The number of isolation valves should be minimized. All encompassing lines including long runs with the exception of subheaders, manifolds, and nozzles may be sloped as defined in SD For a tubeto-tube weld, no unfused portions of the weld joint shall be visible on the inside diameter of a fully penetrated weld.

Operating conditions include heat-up, hold, and cooldown. Dvorscek, Abbott Laboratories G. Consideration should be given to increasing the drain port connection size in lieu of increasing pan depth. Double Block-and-Bleed Valve Assembly.

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ASME BPE Bioprocessing Equipment_图文_百度文库

Colors may range from pale bluish-gray to deep blue, and from pale straw color to a black crusty coating. ANSI raised face or flat face flanged joints should be avoided where possible see Fig. See also machine welding.

O-ring grooves should be designed with cleaning in mind pbe diminishing their functionality. As a proposed test procedure, the following shall be considered. Rau, Dockweiler AG P. An examiner, defined as a person who performs quality control examinations for a manufacturer as an employee of the manufacturer as defined in ASME B Carnes, Purity Systems, Inc.

Galvin, George Fischer, Inc.

Dvorscek, Abbott Laboratories M. Recommended c Typical Hygienic Clamp Union — 1.

Cirillo, Jacobs Field Services B. For nominal metric size tubing and fittings, refer to the appropriate international standards. However, facsimiles may be used for the purpose of fostering the use of such construction.

The bottom head of the vessel shall be leveled with the outlet nozzle flange face to within a tolerance agreed to and shall be filled approximately to the weld seam. Examples of sealed fasteners are shown in Fig.

It floats to the surface when the metal solidifies also called slag. However, it may not be achievable with certain equipment and process configurations as they are currently manufactured. If this is not acceptable, two shutoff valves may be used instead.

Actually, the blowhole is stretched out in the direction of rolling. Inspectors shall have the right to audit any examination, to inspect components using any examination method specified in the Design Specification including Purchase Orderand review all certifications and records necessary to satisfy the requirements of GR The depth of the drain pan is determined by calculating the largest spill volume and accommodating it with a sufficient pan holding volume.

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SD and new Fig.

ASME BPE Guidelines for Pharmaceutical Equipment

A discontinuity is not necessarily a defect. To ensure the highest degree of hygienic design, Copyright c by the American Society of Mechanical Engineers. All hygienic valves should be welded into the process line. Flow Rate mm gpm 12 16 24 31 39 to to to 207 to 14 19 28 38 47 Lpm 45 60 90 to to to to to 53 72 1, 1, Flow rate p 2. The centrifuge manufacturer should identify all asem of primary and incidental product contact that require manual cleaning in addition to CIP.

The materials used must also be compatible with cleaning or sterilizing conditions. Threaded ferrules are not acceptable to convert standard instrumentation to hpe standards. These inclusions are often considered defects that must be removed and the weld repaired prior to final acceptance.

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