ASME BPE-2005

Bioprocessing Equipment

This ASME (The American Society of Mechanical Engineers) standard is an American National Standard and is a revision of ASME BPE-2002. It is applicable to the design of equipment used in the bioprocessing, pharmaceutical, and personal care product industries, including aspects related to sterility and cleanability, materials, dimensions and tolerances, surface finish, material joining and seals.

Equipment refers to vessels, tanks, piping, tubing and related accessories such as pumps, valves and fittings. Bioprocessing is the creation of a product utilizing a living organism.

The user needs to specify:

-  Cleanability and sterility procedures [SD-3] (eg is the pump steam sterilised? [SD-3.2.2]).

-  Surface finishes (see table below) [SD-3.3.1].

-  Inlet and outlet connections [SD-3.7.3].

-  Approval of any painted exterior surfaces (eg the motor - note: for uncowled motors, unless otherwise specified, paint will not be FDA compliant) [SD-3.8 (m)].

-  Whether the pump outlet connection is to be tilted at 45º to allow for full venting of the casing (the drain then has to be fitted in the lowest point) [SD-4.5.2 (f)].

-  Whether there any special welding inspection, examination, testing and record requirements [MJ-7.2].

-  Seal types and materials.

-  When choosing a seal material, the end-user should consider the biocompatibility, cleanability, steam stability, low temperature flexibility, creep resistance, sealability, leak resistance, solvent resistance, lot traceability and other factors, depending upon the application requirements [SG-2.4].

-  Whether the seal supplier needs to certify compliance to this standard (ASME BPE) [SG-3.4.1].

-  The end user shall supply the complete sterilisation procedure, cleaning procedure and passivation procedure (including methods, frequency and length of operation). [SG-3.1.4 to 3.1.7]