ASME BPE 2007 PDF

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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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It floats to the surface when the metal solidifies also called slag. If a smaller bpf space is provided, other methods of cleaning this space should be provided, 0207 as holes in the dip tube that CIP the nozzle spacing.

If there are 54 SD Threaded ferrules are not acceptable to convert standard instrumentation to hygienic standards. All internal surfaces shall be passivated. The product contact surfaces shall be free of crevices, pockets, and other surface irregularities.

See also machine welding. For special cases, the radii may be reduced to 1? Fisher, Fisher Engineering G. Gravity then provides for a continuous solution sheeting over the sidewall and bottom head.

Fluid retention due to capillary action should be considered when using tubing less than 3? In addition to fittings, this Part also covers the tolerances and marking of commercial stainless steel process components including, but not limited to, tubing, vessels, valves, pumps, filter housings, and instrumentation.

The inclusion of this equipment does not guarantee a cleanable process, if not properly applied. ASME issues written replies to inquiries concerning interpretations of technical aspects of this Standard. Minor, Paul Mueller Co.

Other methods for preventing moisture accumulation in vent filters, such as vent heaters or condensers, could be considered. SD, illustrations d and e ].

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ASME BPE Guidelines for Pharmaceutical Equipment

Return system engineering shall give consideration to balancing solution flow i. The discoloration or heat tint produced by oxidation has been associated with the onset of corrosion in stainless steel piping systems. This is accomplished by sizing pump impellers, sizing lines, and when necessary installing restrictors to control flow.

Where necessary, increases in height should be achieved by vertical risers see Fig. Materials shall meet the requirements of SD Inspection, Examination, and Testing. Reinhold, Purity Systems, Inc. Banes, Oakley Specialized Services, Inc.

All vessels should be checked for drainability during fabrication. A common drain port on the skid is preferred. Cleanability should be checked using the full CIP protocol at the facility where the vessel is installed including cleansers and temperatures.

Kettermann, Rath Gibson K. For bioprocessing equipment, tube does not include pipe.

ASME BPE Bioprocessing Equipment_图文_百度文库

All internal angles of deg or less on product contact surfaces shall have the maximum radius possible for ease of cleanability. Typical Ball Valve Configuration. ASME accepts responsibility for only those interpretations of this document issued in accordance with the established ASME procedures and policies, which precludes the issuance of interpretations by individuals. O-ring grooves should be shaped in accordance with the O-ring manufacturer recommendation for functionality.

For each test documentation sheet, signatures of the test personnel and a supervisor ble be required, confirming the test results. If a branch from a primary pipeline has demonstrated flow during cleaning and sterilization, it does not constitute a dead leg. Murphy, Global Stainless Ltd. Attention shall be paid to the weld between the sensor stem and the jumper.

The equipment may or may not perform the loading and unloading of the works. To ensure the highest degree of hygienic design, Copyright c by the American Society of Mechanical Engineers. This Part describes the fittings made for use with nominal outside diameter O. Baram, Clifton Enterprises L. They can be synthesized either through chain reactions or by templating. The CIP recirculation tank shall be selfcleaning via a spray device and the b;e valving and piping to accomplish this action as a part of each cycle.

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Davis, GE Healthcare J.

SD, illustrations a and d ]. Acceptance Criteria for Tube-Attachment Welds. No telltale holes are allowed on product contact surfaces and those, which are outside, should be cleanable. Avery, Nickel Institute E.

Concavity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes.

O-ring grooves should be designed bpf cleaning in mind without diminishing their functionality. However, facsimiles may be used for the purpose of fostering the use of such construction. If piping support is required within a classified space, a hygienic support system bep be used. Linear porosity generally occurs in the root pass from inadequate joint penetration.

The equipment may or may not perform the loading and unloading of the work. However, all the previously mentioned construction codes shall be satisfied including those instances where these codes are not referred to in the current BPE Standard e. Current design and operating practices developed by the pharmaceutical industry to meet FDA ssme as published in the Code of Federal Regulations, Chapter 1, Title 21, Parts and