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).
The user needs
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-220.127.116.11]
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-18.104.22.168(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-22.214.171.124(h)].
Whether there are any special welding examination, inspection and testing
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
Mechanical seal surface finish requirements for the process side [SG-126.96.36.199(4)].
For seals, any assembly lubricant is the responsibility of the owner / user
[SG-3.3.1(f) & SG-188.8.131.52(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.