ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Transfer Technologies
Beth Brock, Consultant Engineer
Eli Lilly and Company
Agenda – Transfer Technologies
Transfer Technologies Overview– Beth Brock
Dover Transfer Technologies – Scott Patterson
GEA/Niro Transfer Technologies – Tom Smith
IMA Twin Valve – Paul Egee
Panel Discussion / Q&A / Hands-On
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Learning Objectives
• At the conclusion of this session,
participants will be able to:
• Understand the importance of “critical
interfaces.”
• Understand basic transfer technologies
available to address these interfaces.
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Critical Interfaces
• Occur when there is a risk of exposure to the
product and/or the worker
• Product Exposure
• Contaminants, including cross-contamination from
nearby processes
• Occupational Exposure
• Exposure to hazardous substances, including active
pharmaceutical ingredient or drug product
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Critical interfaces
• Raw material, intermediate, and final product
transfer into or out of equipment ports
• Delivery of components, tools, containers,
samples, etc. into or out of an enclosure
• Connection of critical utilities and/or liquid
supply or waste drains
All of these require specialized transfer
technologies to protect the product or worker!
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What are we really trying to achieve?
• Transfer of powders with low exposure
to environment
• CONSIDER: 1 granule of sugar ~ 3 mg
• Therefore: 3 µg/m3 is equivalent to dispersing
1/1000th of 1 granule of sugar in 1 cubic meter
of air!
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Containment 101 – Follow the Hierarchy!
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Contain at the source
Avoid technique dependent systems
FOCUS ON TRANSFER SYSTEMS
Design below the OEL
Consider ergonomics, cleaning, sampling,
waste, material compatibility
• Provide redundancy / secondary containment
• Engineer out reliance on PPE
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Typical Containment Levels
&
*
'( )% +
!""# $
%
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Transfer Systems Overview
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Designs
Typical Performance
Cost comparisons
Vendors
• NOTE: these are just some examples of
vendors for these types of items.
• This presentation is not intended to
endorse certain vendors.
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Transfer Systems
The movement of materials, supplies, tools,
wastes, and recovery systems into and out of
the contained environment is the key to
successful containment.
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Rapid Transfer Ports (RTPs)
Split Butterfly Valves (SBVs)
Cone Valves
Bag Systems
Continuous Liners
Air Locks
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Rapid Transfer Ports (RTPs)
• Also known as “Alpha-Beta Ports”.
• Alpha (active) port is attached to an isolator
and a beta (passive) port is connected to the
portable container.
• Beta is docked and locked to alpha by
rotation before the door can be opened.
• Well proven in industry.
• Performance: < 0.1 µg/m3
• Requires an isolator / glovebox.
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RTP Vendors
• Getinge / LaCalhene
• Applied Containment Engineering (now
Telstar-ACE)
• Central Research Labs
• Isolation Systems Inc.
• Walker
…etc.
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Telstar-ACE Containment Transfer System (CTS)
ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
RTP example (LaCalhene)
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RTP example (LaCalhene)
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
RTP Example (exterior view)
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RTP Example (interior view)
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
RTPs Pricing
• Sizes range from 100mm to 460mm
(manufacturer dependent).
• MOC – SS, Hastelloy, HDPE, Acetal
• $2000 to $20,000+
• Beta containers (polyethylene or SS) ranging
from around $400 to $6000, dependent on
size and MOC.
• Isolator costs $50K and up (RTP’s typically
require an isolator/glovebox).
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Split Butterfly Valves
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Split Butterfly Valves
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Split Valve Vendors
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GEA Buck Valve
ChargePoint (spun off from PSL)
Glatt
IMA (Twin Valve)
LB Bohle
Andocksysteme
And more…
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Split Valve Designs
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Standard (manual) or automated
With air extraction shroud (external to valve)
Air or liquid wash systems (between faces)
Pressure-rate, non-pressure-rated
MOC: Stainless, Hastelloy, “plastics”
Sizes ranging from 2-inch to 12-inch.
Designs vary from vendor to vendor.
Main concern – powder between faces when
disconnecting.
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Split Valves, cont’d
• Designs vary from vendor to vendor.
• Main concern – powder between faces when
disconnecting (addressed by upgraded
design options such as washing between
faces, vortex removal, etc.)
• Alignment is also key on large containers
(may require special hoist/alignment system).
• For more information, see vendor websites.
• IMA and Buck will be presenting here. . .
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
SBV Performance
• Standard, manual, no extraction: 1-10 µg/m3
• With addition of external exhaust shroud: 0.5-3
µg/m3
• With vortex removal or liquid wash between
faces: < 1 µg/m3 , down to less than 50
nanograms/m3
(Reminder – do your own evaluation and testing on your
system!)
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SBV Pricing (average, 2008 data)
• Standard 4-inch valves (manual, no extraction):
• SS, Non-Pressure-rated: around $9-11K for active (A) and
$3.5-5K for passive (P)
• SS, Pressure rated: active $9-16K, passive $4-6K
• Hastelloy, Pressure rated: active $16-22K, passive $10K
• Added extraction shroud (4”): around $5000.
• “Total Containment” (4”) SS with wash between faces:
$54,000 for valve (A/P) plus $30K for wash system.
• Vortex system (extraction between faces) somewhat
less expensive – 4” SS active $22K.
• PLC’s required for some installations.
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Cone valves (bulk discharge)
Example: MATCON
IBC Discharge Station
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Cone Valve Capabilities
MATCON Data:
Standard Discharge Station: >100 µg/m3
Air Wash Discharge Station: 10-100 µg/m3
Air Wash Plus Extraction Discharge Station:
1-10 µg/m3
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Flexible technologies
Continuous Liners
Bag Technology
Transfer Sleeves
Hicoflex®
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Continuous Liner
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Continuous Liner w/ Inflatable Head
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Continuous Bag-Out Sleeve
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Bag Technology
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Hicoflex® (GEA Process Engineering)
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Flexible technologies
Capabilities
• Dependent upon design and interface.
• Very operator dependent.
• Typically 1-10 µg/m3 range, can get below 1 µg/m3.
Cost / Other Considerations
• Varies – check with vendors.
• Typically less expensive than hard solutions.
• Most parts disposable – no cleaning required.
We’ll hear more about Dover and Hicoflex® . . . .
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Airlocks
Performance:
> 10 µg/m3
Can vary greatly,
dependent upon
design.
Some, as shown,
have controlled air
extraction.
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Walker Barrier Systems
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www.walkerbarrier.com
ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Powder transfer systems (PTS)
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Photo courtesy of Dec Group
PTS with Drum Containment System (DCS)
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Photo courtesy of Dec Group
ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Powder transfer systems
ProClean® Conveyor
(PCC 200) with WIP unit
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Photos courtesy of Hecht
PTS/DCS Typical Installation
Costs:
• PTS: $40-$60K
• Liquid Separator: $7300
• Vacuum Pump: $13K
• DCS: $95K
Capabilities:
• Dependent upon connections, proper use of Drum
Containment System, etc.
• Claims to < 1 µg/m3
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Protection around your Transfer System
Unidirectional or
Laminar flow booth
Cost: $75-150K
Performance very
technique dependent,
typically 25-500 µg/m3.
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Protection around your Transfer System
Addition of movable screen aids in protecting operator.
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Don’t forget the containers!
Must connect well to the transfer mechanism (best if
designed for it).
Preferably, visibility should be good (so you can see fill
or discharge levels).
Package to weight if you can, to avoid additional
transfers.
Sampling needs must be considered.
(plan into the transfer mechanism,
or find another contained method to
sample prior to transfer)
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Conclusions
Many options available.
Transfer systems are a KEY COMPONENT to your
containment solution.
Performance varies from installation to installation –
verify performance in your facility with your operators!
Consider cleaning, maintenance, and sampling when
designing and selecting your system!
There’s no one right answer – do your homework to find
what will work best for your situation. Involve the
operators!
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Acknowledgements
Information from ISPE Annual Meeting 2008:
Paul Richards, Pfizer
Julian Wilkins, PharmaConsultUS
Vendor websites and contacts
Lilly Containment Group
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Questions?
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ISPE Great Lakes Chapter Meeting
28-29 April 2010
Kalamazoo, Michigan USA
Thank You!
Beth Brock, Consultant Engineer
Eli Lilly and Company
Lilly Corporate Center, DC 5611
Indianapolis, IN 46285
(317) 276-6870
bethbrock@lilly.com
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