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Asme Bpe 2009: New Requirements & Resources For Bioprocess Equipment Design
Asme Bpe 2009: New Requirements & Resources For Bioprocess Equipment Design
BioProcessing
Equipment
standard
or
ASME BPE
Electropolishing &
Passivation
Rouge & Stainless Steel
Polymer Surface Finishes
Metallic Materials of
Construction
Corrosion Testing
Elastomer Performance
Hygienic Hose
Assemblies
Process Instrumentation
ASME Certification
Program
ASTM
3-A SSI
EHEDG
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!
BPE
Inspector
I
t Delegates
D l t
(4 levels of qualification):
Trainee
QID-1
QID-2
QID-3
bioburden
corrosion
mechanical seal
rouge
g
biofilm
passivity
Metallic Materials of
Construction (Part MMoC)
Metallic materials
commonly used in
hygienic service
Testing standards
Mechanical & chemical
properties
Surface finish
Fabrication guidelines
Material Joining
(Part MJ)
New Content:
Use of duplex alloys
Sample weld criteria
Welding Operator
Qualification Requirements
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
Cycle Capabilities
Materials/Finish
Elastomers
Door Design
Sterile filters
Loading carts/trays
Jacket design
Instrumentation
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Vessel Internals
S
Sampling
li System
S t
Sterile Boundary
Inlet Gas Assembly
Inlet filters
Sparger design
OPTIONAL
EXHAUST
OPTIONAL
CIP
INOCULUM
LIQUID ADD
OPTIONAL
FIC
COMP. AIR
NUTRIENT
PROBE
(TYPICAL)
FIC
COMP. GAS
OPTIONAL
SAMPLE
ASSEMBLY
CLEAN STEAM
Vent filters
Vent heaters & condensers
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Materials of Construction
Process Requirements
Piping Design
Filtration
2.0
Cleanable
Science-based L/D
requirements
Chromatography &
Filtration Systems
Project 2012
1.5
A0
Un-cleanable
0.5
B
Dead End Length
(L/D)
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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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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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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
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