ASME BPE 2009

New Requirements & Resources for

BioProcess Equipment Design
David M. Marks, P.E.
ASME BPE Design Subcommittee Chair
President and Senior Consultant

June 17, 2009

What is ASME BPE and

Why is it Important???

ASME
BioProcessing
Equipment
standard

or

ASME BPE

1
 ASME BPE Scope
This Standard deals with the requirements
of the bioprocessing, pharmaceutical, and
personall care product
d t industries
i d t i as well ll
as other applications with relatively high
levels of hygienic requirements, covering
directly or indirectly the subjects of
materials, design, fabrication,
inspections, testing, and certification.

Familiar BPE Topics:

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New publication every 2 years that address
current system and facility topics:

BPE 2009 Addresses Biopharm

Business Needs with New Content!
Fermentor & Bioreactor Electropolishing &
Design Passivation
CIP Distribution Systems Rouge & Stainless Steel
Process Gas System Polymer Surface Finishes
Design Metallic Materials of
Steam Sterilizers / Construction
Autoclaves Corrosion Testing
Hygienic Pump Design Elastomer Performance
CIP Skid Design Hygienic Hose
Single-Use Product Assemblies
Requirements Process Instrumentation
Compendial Water ASME Certification
Pump Seals Program

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Voluntary Consensus Standard
Developed and maintained by a
balanced group of experts
Multiple stages of approval before
publication
Continuously updated to support
industryy accepted
p practices
p
Corrections and clarifications can
be requested by anyone

ASME BPE Committee Structure

4
 BPE Standards Committee
(Main Committee)

Meets 3 times annually to:

Review Subcommittee Progress
Coordinate Efforts Between Subcommittees
Delegates from Europe and Japan participate
Liaison Reports with other Organizations
ISPE ASTM
P3-A 3-A SSI
DIN EHEDG
Next Meeting October 5-8, 2009
Radisson Hotel Boston, Boston, MA

Whats New???
The most extensive
revision
i i to date!
d !
New Process Systems
Design Requirements!
New Sections!
Process Instrumentation
Metallic Materials
New Supplier
Certification Program!

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 BPE Certification Program
(Part CR)
Certificate of Authorization
issued to qualified BPE

component suppliers.
ASME BPE Symbol Stamp
will mark components in
compliance
compliance.
Program is starting with
tubing and fitting
manufacturers.

Dimensions & Tolerances

(Part GR)
GR-4 (Inspector Delegates)
New section defining the
qualifications of personnel
involved in inspection of bioburden
BioProcessing,
Pharmaceutical and other
mechanical seal corrosion
systems involving a high
degree of bioburden control.
rouge
g
Inspector
I t Delegates
D l t biofilm
(4 levels of qualification):
Trainee passivity
QID-1
QID-2
QID-3

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 Dimensions & Tolerances
(Part DT)
New Design Criteria for
Hygienic Clamps.
New Nominal one inch
fitting design.
Reducing the length on
eccentric
i & concentric
i
reducing fittings.

Metallic Materials of
Construction (Part MMoC)
Metallic materials
commonly used in
hygienic service
Testing standards
Mechanical & chemical
properties
Surface finish
Fabrication guidelines

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 Material Joining
(Part MJ)
New Content:
Use of duplex alloys
Sample weld criteria
Welding Operator
Qualification Requirements

Polymers and Elastomers

(Part PM)
New subsection on Single-Use
Components & Assemblies
New appendix on Interpretation of
Elastomer Material Property Changes
Other new content:
Hose assemblies
Elastomer performance
Surface finish of polymers in product
contact

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 Surface Finishes
(Part SF)
New acceptance criteria for passivated
product contact surfaces
New section SF-P on
Polymer Product Contact Surfaces
New Non-mandatory Appendices
Electropolishing Procedure Qualification
Passivation Procedure Qualification
Rouge & Stainless Steel
(Rouge Remediation)

Equipment Seals
(Part SG)
New Standardized Process Test
Conditions for Seals fitness for use.
Simulated SIP & CIP conditions
New Application Data Sheet for
seal specification
New section
i on sealsl for
f
compendial water pumps.

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 Design for Cleanability and Sterility
(Part SD)
New Design Content
Hygienic Pumps
Spra Devices
Spray De ices
Ball Valves
O-ring connections
Top-entering mixers
Steaming for bioburden
control
New Process Systems
Bioreactors
Autoclaves
CIP Distribution
Process Gas Systems

Steam Sterilizers / Autoclaves

(SD-4.14)
Cycle Capabilities
Materials/Finish
Elastomers
Door Design
Sterile filters
Loading carts/trays
Jacket design
Instrumentation

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 CIP Systems and Design
(SD-4.15)
System Functionality &
Operating Capabilities
CIP Skid Design
Flow Rate Guidelines
Guidelines for Cleaning Vessels
Spray Device Design
CIP Distribution Design
Supply & Return
Looped Headers
Zero Static Chains
Multiport Valves
Transfer Panels
Swing Elbows & Transfer Spools
CIP Return Pumps
CIP Return Eductors

Bioreactors and Fermentors

(SD-4.17)
Vessel Internals OPTIONAL

S
Sampling
li System
S t Indicates Sterile Boundary OPTIONAL
EXHAUST

CIP

Sterile Boundary INOCULUM

Inlet Gas Assembly LIQUID ADD

Inlet filters OPTIONAL

FIC
COMP. AIR
NUTRIENT

Sparger design OPTIONAL

PROBE
(TYPICAL)
FIC
COMP. GAS

Exhaust Gas Assembly SAMPLE

ASSEMBLY
AGITATOR
Note: Design May Vary
CLEAN STEAM
SEAL

Vent filters
Vent heaters & condensers
Feed lines & Diptubes
Harvest valves
Agitators & foambreakers
CIP/SIP requirements

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 Process Gas Distribution
Systems (SD-4.18)
Materials of Construction
Process Requirements
Piping Design
Filtration

Gas systems are not designed

G d i d or
configured with the intent or provisions to
be cleaned, passivated or chemically
treated after installation.
SD 4.18(d) BPE 2009 (pending)

Hot Topics under Development

Science-based L/D 2.5

requirements 2.0
D L

Cleanable
Chromatography &
Flow Rate (m/s)

1.5

Filtration Systems L/D has no significant effect

1.0
Project 2012
0.5 L/D has significant effect Un-cleanable

A0
3 4 5 6 7 8
B
Dead End Length (L/D) model residue: BSA+glycerol
pipe size: 10A to 1.5S

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 What are the current trends in
the BioPharm industry?

How is the ASME BPE used to

address these trends?

Trend #1
Multi-Product, Contract Manufacturing
Facilities
One facility has to be
accepted by:
Several operating
companies
Several regulatory
agencies from around
the globe.
g
International Standards
are CRITICAL to
address this trend

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 Trend #2
Better yields Higher titers than ever before

Equipment size is
generally
ll staying
t i about
b t
the same size or getting
smaller.
Better use of current
designs and materials
The demand for larger
andd larger
l equipment
i t
has decreased.
Higher energy
efficiency.
Limited by downstream
processing equipment.

Trend #3
Focus on quality Fittings, Tubing, and Valves
is being replaced by todays demand for better
performing Materials (ie: Alloys,
Thermoplastics, Elastomers)
2 year lifespan
Resistance to steam and
corrosives
Consistent (Repeatable)
Material Performance is
CRITICAL
End Users just expect fittings,
tubing, and valves to meet the
standards.

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 Internationally accepted Acceptance
Criteria is required for all 3 trends.
Science-Based
Requirements
q
Not too restrictive or
expensive
Consideration for the 5-10
year old system Not just
thee new
ew system
sys e ((they ey aree
only new for a short time)
Updated regularly to reflect
the current acceptance
criteria.

Regulatory Update
State of California to Adopt the ASME BioProcessing Equipment (BPE)
Standard by Reference

The State of California has developed an L (Laboratory) Occupancy

designed for R&D Laboratories, which has been proposed for use in
all areas by the State Fire Marshal, Chief Kate Dargan. Part of the L
Occupancy adoption was the reference to supporting standards, one
of which is the ASME BPE Standard. The L Occupancy has been
approved by the State Fire Marshal as well as the State Building Fire
and Other Uses Committee. It has been advanced to the Building
Standards Commission for ratification and then to the Legislature for
inclusion in Title 19 Code of California Regulations (CCR). Visit
http://www.fire.ca.gov or http://osfm.fire.ca.gov for further updates.

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 How do I get involved in the
ASME BPE?
Go to a meeting and listen to the
Subcommittee Sessions.
Determine where your technical
strengths would help.
Participate in a Task Group.
Speak up and be an active
participant in the Subcommittee
Sessions.

Should I become a member?

If yyou have the time and interest to be
an active participant.
If your company will support your
ASME BPE work.
If you want to vote on changes and
updates to an international standard.
You do not have to become a member
to participate in ASME BPE.

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 Questions?

You may also contact after the

meeting at:
David.Marks@dmealliance.com
Presentation Contributors:
Jay Ankers
Chair, BPE Standard Committee
Principal,
P i i l Lifetek
Lif t k Solutions
S l ti
Rick Zinkowski
Vice-Chair, BPE Standard
Committee

BPE 2009: New Requirements &

Resources for BioProcess Equipment
ASME BPE has emerged as the definitive international standard on
bioprocessing equipment and facilities,, covering the subjects of
materials, design, fabrication, inspections, testing, and certification. The
BPE 2009 edition will be the most extensive revision of ASMEs
BioProcess Equipment Standard since it was first published in 1997.
This presentation will summarize the new BPE resources and
requirements for the design and delivery of components and process
systems for use in bioprocessing, pharmaceutical, and personal care
product industries.
This publication will include new content on the design of process
systems such as bioreactors, fermentors, autoclaves, process gasses, CIP
distribution and single-use equipment. New resource material will be
provided on electropolishing, passivation, elastomer performance,
metallic materials of construction, polymer surface finishes, corrosion
testing and stainless steel rouge. The BPE has also been expanded to
include new sections on process instrumentation, hygienic pumps,
hygienic hose assemblies and rotary spray devices.

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