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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All internal angles of deg or less on product contact surfaces shall have the maximum radius possible for ease of cleanability.

ASME BPE Guidelines for Pharmaceutical Equipment

The integrated system makes it possible to achieve complete and uniform control of time, temperature, and chemical concentration, all of which are important to success with any mechanical spray or pressure recirculation CIP process.

The fused glass shall be circular in shape within the metal frame. Carnes, Aske Systems, Inc. This standard is intended for design, materials, construction, same, and testing of vessels, piping, and related accessories such as pumps, valves, and fittings for use in the biopharmaceutical industry. Rotman, Integrated Project Services R.

It is the aim of the Society to provide recognition of organizations so authorized. Page asmw, 3 11 15, 17, 19, 20 Location GR-9 Fig. Elbich, Exigo Manufacturing R. The first edition of 20077 Standard was approved as an American National Standard on December 22, The break shall be at least 1 in.

SD and new Fig. Ankers, LifeTek Solutions, Inc. Gas Lubricated Noncontacting Double Seal. Side and Bottom Connections. All testing and quality assurance documentation will be stamped with date and time.

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Hose assemblies shall not be used as as substitute for rigid tube fittings or as tension or compression elements. Kranc, Tech Source P. The particles are usually compounds such as oxides, sulfides, or silicates, but may be a substance foreign to and essentially insoluble in the matrix. 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 asmme cleaning fluids bp resistant to corrosion, scratching, scoring, and distortion SD 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.

All encompassing lines including long runs with the exception of subheaders, manifolds, and nozzles may be sloped as defined in SD Gravity then provides for a continuous solution sheeting over the sidewall and bottom head. Straight Tee and Cross. Consideration should be given to increasing the drain port connection size in lieu of increasing pan depth.

Henon, Arc Machines, Inc. Regulator designs, where a portion of the valve stem penetrates the sensing diaphragm, shall be avoided unless provisions are made to avoid entrapment of foreign matter and any leakage through the interface between stem and diaphragm, especially after steam sterilization.

The notification of an impending inspection should be mutually agreed to by the manufacturer and the inspector. Wells, Spirax Sarco K. Flow Rate mm gpm 12 16 24 31 39 to to to to to 14 19 asmw 38 47 Lpm 45 60 90 to to to to to 53 72 1, 1, Flow rate p 2.

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The physical characteristics aasme the system e. For special cases, the radii may be reduced to 1?

ASME BPE Bioprocessing Equipment_图文_百度文库

To achieve gravity drainage, lines should be pitched to designated points at a specific slope. 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 It floats to the surface when the metal solidifies also called slag.

Gravity then provides for a continuous solution sheeting over the lower surfaces. Brown, Chair, Swagelok Co. Once formed, these materials can be reshaped. The equipment manufacturer shall indicate the be orientation to optimize drainability.

Kranc, Tech Source M. Zero static diaphragm valves are recommended for low point drains if available from the manufacturer [see Fig. SD Shaft Coupling Construction 15 deg to 45 deg min.

ASME BPE – Wikipedia

If a smaller annular space is provided, other methods of adme this space should be provided, such as holes in the dip tube that CIP the nozzle spacing. Process equipment connection Min.

The dimensions in metric units are conversions from the U. Threaded ferrules are not acceptable to convert standard instrumentation to hygienic standards. SD Dip Tube Nozzles: