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1ASME BPE 2009
New Requirements & Resources for BioProcess Equipment
Design
David M. Marks, P.E.ASME BPE Design Subcommittee Chair
June 17, 2009
ASME BPE Design Subcommittee Chair
President and Senior Consultant
What is ASME BPE and Why is it Important???
ASME BioProcessing
Equipment standard
or
ASME BPE
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2ASME BPE ScopeThis Standard deals with the requirements This
Standard deals with the requirements of the bioprocessing,
pharmaceutical, and of the bioprocessing, pharmaceutical, and
l d t i d t i lll d t i d t i llpersonal care product industries
as well personal care product industries as well as other
applications with relatively high as other applications with
relatively high levels of hygienic requirements, covering levels of
hygienic requirements, covering
directly or indirectly the subjects of directly or indirectly
the subjects of materials, design, fabrication, materials, design,
fabrication,
inspections, testing, and certification.inspections, testing,
and certification.
Familiar BPE Topics:
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3New publication every 2 years that address current system and
facility topics:
BPE 2009 Addresses Biopharm Business Needs with New Content!
Fermentor & Bioreactor
Design Electropolishing &
PassivationDesign CIP Distribution Systems Process Gas
System
Design Steam Sterilizers /
Autoclaves Hygienic Pump Design
Passivation Rouge & Stainless Steel Polymer Surface Finishes
Metallic Materials of
Construction Corrosion Testing Elastomer Performance
CIP Skid Design Single-Use Product
Requirements Compendial Water
Pump Seals
Hygienic Hose Assemblies
Process Instrumentation ASME Certification
Program
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4Voluntary Consensus Standard
Developed and maintained by a balanced group of experts
Multiple stages of approval before publication
Continuously updated to support industry accepted practicesy p
p
Corrections and clarifications can be requested by anyone
ASME BPE Committee Structure
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5BPE 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 ASTMISPE ASTMP3-A 3-A SSIDIN EHEDG
Next Meeting October 5-8, 2009 Radisson Hotel Boston, Boston,
MA
Whats New??? The most extensive
i i d !revision to date! New Process Systems
Design Requirements! New Sections!
Process Instrumentation Process Instrumentation Metallic
Materials
New Supplier Certification Program!
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6BPE Certification Program(Part CR)
Certificate of Authorization issued to qualified component
suppliers.
ASME BPE Symbol Stamp will mark components in compliance
BPE
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
BioProcessing, Pharmaceutical and other systems involving a high
degree of bioburden control.
I t D l t
bioburden
rougemechanical seal corrosion
Inspector Delegates (4 levels of qualification): Trainee QID-1
QID-2 QID-3
biofilmg
passivity
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7Dimensions & Tolerances(Part DT)
New Design Criteria for Hygienic Clamps.
New Nominal one inch fitting design.
Reducing the length on i & ieccentric & concentric
reducing fittings.
Metallic Materials of Construction (Part MMoC)
Metallic materials commonly used in hygienic service Testing
standards Mechanical & chemical
propertiesproperties Surface finish Fabrication guidelines
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8Material 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-UseComponents & 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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9Surface 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
i l f New section on seals for compendial water pumps.
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Design for Cleanability and Sterility (Part SD)
New Design ContentHygienic PumpsSpra De icesSpray DevicesBall
ValvesO-ring connectionsTop-entering mixersSteaming for bioburden
control
New Process SystemsBioreactorsBioreactorsAutoclavesCIP
DistributionProcess Gas Systems
Steam Sterilizers / Autoclaves(SD-4.14)
Cycle Capabilities Materials/Finish Elastomers Door Design
Sterile filters Loading carts/trays Loading carts/trays Jacket
design Instrumentation
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CIP Systems and Design(SD-4.15)
System Functionality & Operating CapabilitiesOperating
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
Vessel InternalsS li S t
EXHAUST
OPTIONAL
Bioreactors and Fermentors(SD-4.17)
Sampling System Sterile Boundary Inlet Gas Assembly
Inlet filters Sparger design
Exhaust Gas Assembly Vent filters
NUTRIENT
INOCULUM
CLEAN STEAM
COMP. AIR
EXHAUST
COMP. GAS
FIC
FIC
Indicates Sterile Boundary
PROBE(TYPICAL)
AGITATORSEAL
OPTIONAL
OPTIONAL
OPTIONAL
SAMPLEASSEMBLY
CIP
LIQUID ADD
Note: Design May Vary
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
G d i dGas systems are not designed 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
requirements2.5
D L
2.5
D LD Lrequirements Chromatography &
Filtration Systems Project 2012 Flo
w R
ate
(m/s
)
0.5
1.0
1.5
2.0Cleanable
Un-cleanable
Flow
Rat
e (m
/s)
0.5
1.0
1.5
2.0Cleanable
Un-cleanableL/D has significant effect
L/D has no significant effect
Dead End Length (L/D)3 4 5 6 7 8
0
model residue: BSA+glycerol pipe size: 10A to 1.5S
Dead End Length (L/D)3 4 5 6 7 8
0
model residue: BSA+glycerol pipe size: 10A to 1.5S
A
C
B
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What are the current trends in the BioPharm industry?
How is the ASME BPE used to address these trends?
Trend #1Multi-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 #2Better yields Higher titers than ever before
Equipment size is ll t i b tgenerally staying about
the same size or getting smaller. Better use of current
designs and materials The demand for larger
d l i tand larger equipment has decreased.
Higher energy efficiency.
Limited by downstream processing equipment.
Trend #3Focus on quality Fittings, Tubing, and Valves is being
replaced by todays demand for better performing Materials (ie:
Alloys,performing Materials (ie: Alloys, Thermoplastics,
Elastomers)
2 year lifespan Resistance to steam and
corrosives Consistent (Repeatable)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 Requirementsq
Not too restrictive or expensive
Consideration for the 5-10 year old system Not just the new
system (they are e ew sys e ( ey eonly new for a short time)
Updated regularly to reflect the current acceptance
criteria.
Regulatory UpdateState of California to Adopt the ASME
BioProcessing Equipment (BPE)
Standard by ReferenceStandard 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 activeSpeak up
and be an active
participant in the Subcommittee Sessions.
Should I become a member?
If you have the time and interest to be yan 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 theYou may also contact after the
meeting at:
[email protected]
Presentation Contributors:Jay Ankers
Chair, BPE Standard CommitteeP i i l Lif t k S l tiPrincipal,
Lifetek Solutions
Rick ZinkowskiVice-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
, covering the subjects of materials, design, fabrication,
inspections, testing, and certification.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
bioprocessing, pharmaceutical, and personal care product
industries. 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.
