ASME BPE
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ASME BPE-2014

Bioprocessing Equipment

MDM PUMPS LTD specialises in tailor-made hygienic ASME BPE pumps using components machined from solid stainless steel 316L bar to give smooth, crevice-free internals, fitted with FDA-approved seals and hygienic connections. 

The pumps are built to last, and are widely sought after by the pharmaceutical industries.

This ASME (The American Society of Mechanical Engineers) standard is an American National Standard and was developed to aid in the design and construction of new fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purity and bioburden control is required.

Equipment refers to vessels, piping, and related accessories such as pumps, valves and fittings. A bioprocess is used in the manufacture and / or purification of biopharmaceuticals or other biological materials, eg microbial fermentation, cell culture, tissue culture, blood, or milk fractionation.

ASME BPE-2014 was effective from 10/04/15 (6 months after publication). 

Edition Published Pages (approx)
ASME BPE-2014 10/10/14 300
ASME BPE-2012 28/09/12 270
ASME BPE-2009 20/10/09 210
ASME BPE-2007 21/03/08 120
ASME BPE-2005 28/04/06 110
ASME BPE-2002 26/07/02 90
ASME BPE-1997 First edition 80

 

The user needs to specify:

-  The pump service parameters and all conditions under which the seal may be expected to operate. These include, in addition to the service temperature and pressure, any parameters that may affect the seal performance [SG-3.1]. In particular, the owner / user shall supply the complete sterilization procedure, cleaning procedure and passivation procedure (including methods, frequency and length of operation) [SG-3.1.5 to 3.1.7].

Will the pump be subjected to SIP (Steam In Place) ? [SD-2.3.1.1]

The Application Data Sheet, form R-1 (Appendix R) can be used to communicate the service parameters.

-  Surface finishes, metallic (see table below) [SF-2.4]. Only one SF designation is allowed [DT-10.1].

-  Pump connections [SD-3.1.1(b)].

-  Pump containment level [SD-2.1].

-  Where ferrite levels are deemed necessary, the owner / user shall specify required ferrite ranges [MM-5.1.4].

-  Exterior design: for equipment located in clean areas, painted surfaces should have advance approval of the owner / user. All paint systems shall be FDA compliant [SD-2.4.4.2(m)]. Note: unless otherwise specified, the motor paint will not be FDA compliant.

-  Whether the pump discharge connection is to be tilted at 45 to allow for full venting of the casing (the drain then has to be fitted in the lowest point) [SD-3.3.2.2(h)].

-  Whether there are any special welding examination, inspection and testing requirements [MJ-7].

-  Seal types and materials.

-  Material selection remains the responsibility of the owner / user [SG-3.3.1(b)].

-  Selection of the proper mechanical seal is the responsibility of the owner / user [SG-2.3.2.1(b)].

-  Mechanical seal surface finish requirements for the process side [SG-3.3.2.4(4)].

-  For seals, any assembly lubricant is the responsibility of the owner / user [SG-3.3.1(f) & SG-3.3.2.4(10)].

-  Whether the seal supplier needs to provide a Certificate of Compliance to this standard (ASME BPE) [SG-3.4.1].

-  Seal intrusion category (for hygienic union seals) [SG-4.2].

Metallic process contact surfaces. 
Surface designation Ra, max -in Ra, max m Electro-polished
S F 0 - - No
S F 1 20 0.51 No
S F 2 25 0.64 No
S F 3 30 0.76 No
S F 4 15 0.38 Yes
S F 5 20 0.51 Yes
S F 6 25 0.64 Yes