ASME CODES AND STANDARDS

Bioprocessing
Equipment (BPE)
Standard

Updates for 2009

Page 3-1

Part DT Dimensions and Tolerances

This part will have over 20 items changed, added, or deleted. These changes include new
tables depicting Hygienic Clamp Ferrule: Design Criteria and Hygienic Clamp: Solid End
Cap, additions to existing tables (Type A & B Hygienic Ferrule Face Design and new
nominal one inch fitting design) and a new figure DT-1 showing hygienic clamp conditions at
installation. Future work includes working together with Part SD on shortening the length of
reducers and Part MJ on tolerance issues at hygienic weld joints.
Part CR Certification (NEW)
This part is new for the 2009 edition of the standard. It provides the requirements for a
certification program for suppliers. Through this program, a certificate of authorization will
be issued to qualified applicants to confirm that the certificate holder has systems in place to
ensure compliance with this standard. A symbol stamp will be issued to the certificate of
authorization holder to mark components as being in compliance with this standard. As
such, this certification program also sets forth requirements that will regulate the use of the
ASME BPE symbol stamp. The certification program will be adopted in phases, starting with
tubing and fitting manufacturers.
Part GR General Requirements and Editorial Review
This part will include definitions of 40 new terms such as, mechanical seal, bioburden ,
biofilm and rouge . There is an addition to the scope clarifying new construcition versus
existing construction and installations between them. And finally, references to a dozen
standards, including ASTM, EHEDG and ISO, primarily dealing with elastomers will be
added.
Part MJ Material Joining
This part has added notes on the use of duplex alloys, clarified sample weld criteria, and
added welding operator qualification requirements. Future work includes working together
with Part MMOC on filler metal requirements, Part DT on ovality and mismatch, Part SD on
process gas systems in the near future and ASME B31.3 regarding various issues related to
material joining.
Part SD Design Relating to Sterility and Cleanability of Equipment
This part will include substantial new content on equipment and process systems plus
significant updates to existing sections of the standard. These changes include several new
sections with requirements for the design of bioreactors/fermentors, sterilizers/autoclaves,
CIP distribution systems, and process gas distribution systems. The entire CIP Systems and
Design section has been revised to meet current industry practices. Requirements have
been expanded for CIP skid design, CIP flow rates, process vessel cleaning, CIP supply and
return headers, and CIP spray devices. It has also been updated with enhanced content on
the design of hygienic pumps, ball valves, O-ring connections, top-entering mixers, and
steaming for bioburden control.

www.asme.org/Communities/Technical/BPE

ASME CODES AND STANDARDS

Bioprocessing
Equipment (BPE)
Standard

Updates for 2009

Page 3-2

Part MMoC Metallic Materials of Construction (NEW)

This part is also new for the 2009 edition of the standard. The purpose of part MMoC is to
identify metallic materials of construction which are commomly used in hygienic service.
This part will identify materials, their testing standards, properties, surface finish,
fabrication guidelines, and other attributes. Additionally, this part will define a method by
which other metallic materials of construction can be submitted and evaluated for inclusion
into this standard. Non-Mandatory Appendices have been added to address commonly used
corrosion tests, ferrite impact and measurement, and electropolishing procedure
qualification.
Part SG Seals
This part has been enhanced for the 2009 edition of the standard with the following sdditions:
A section has been added for the application of Seals for Centrifugal Compendial Water
Pumps. An appendix on Standard Process Test Conditions, to assess a seal's fitness for use
in industry systems, is added. An Application Data Sheet has been added as an appendix to
provide to provide a standard framework for listing process conditions to select the correct
materials of construction and process configurations.
Part SF Surface Finish
This part will have substantive changes, most importantly information regarding
passivation, electropolish, and the ever so controversial, rouge. Several sections of this
part were revised and updated with references to new appendices. Two new sections were
added: Part SF-9: Normative References and Part SF-10: Rouge and stainless Steel. A subsection was also added: Part SF-P: Polymer Product Contact Surface Finishes. NonMandatory Appendices were added for Electropolishing Procedure Qualification,
Passivation Procedure Qualification, and Rouge and Stainless Steel. Future work includes
Mechanical Polishing and Alloys.
Part PM Polymers and Elastomers
This part will include new sections on Elastomer Performance, Hose Assemblied, Single
Use Application, Surface Finish of Polymers, and a new Non-Mandatory Appendix
Interpretation of Elastomer Material Property Changes. Future work includes
chromatography, filtration, leachables/extractables, lined vessels, support of polymer pipe,
and mold-in-place/flare through hose connections.
Part PL Process Instrumentation (NEW for 2012)
This is a new part to be included in the 2012 Edition, and will focus on requirements
applicable to the proper design, installation and use of process instrumentation. It will
address any process instrumentation and associated integrally mounted components in
direct contact with the product, raw materials, or product intermediates.

www.asme.org/Communities/Technical/BPE

ASME BPE
2009 ASME BPE
Page 3-3

20
ABDT-1
Part SDPart MJ

2009

ASME BPE.

Part GR
40
ASTM,EHEDGISO,

Part MJ

Part MMOC Part DT Part SD ASME B31.3

Part SD
//
CIPCIP
CIPCIP CIP
O

Part MMoC Metallic of construction(new)

2009MMoC

Part SG Seals

Part SF Surface Finish

Part SF-9:SF-10:rough Part:SF-P:

rough

Part PM

//

Part PI Process Instrumentation (2012)

2012

www.asme.org/Communities/Technical/BPE