Connectors, Manifolds, Sampling &
Storage
 Locally owned &
operated
 Supplier of Fluid System
Components &
Technologies
 Clean & Sterile
Assemblies
 Inventory Management
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Ease of connectivity
Tube sets assembled onsite & sterilized in
autoclave
Pre-assembled tube sets & components
provided sterile (gamma irradiation) or
non-sterile.
Barbed Connectors: Straight, Tee, Wye
Overmolded
Luer Fittings: Twist to connect, formatted
for smaller fluid path
Flow control external to tubing: ARTeSYN
Valve
 Closed System is the ability to make
sterile fluid transfers in a non-sterile
environment utilizing capsule filters,
single use valves and aseptic connectors.
 Closed systems are configured and
assembled to customer approved
designs, pre-sterilized, and ready for
immediate use.
 These systems can be configured as tube
sets, bag & tube set, containers, and in
many other user defined shapes, sizes,
and styles.
 Tubing
 Storage (Bags)
 Connectors
 Barbed
 Molded
 Sterile Barrier
 Filtration
 Sampling
 Measurement
 Pump vs. Transfer
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ID & OD or Size 14, 16, 73, etc.
 Silicone(Platinum & Peroxide Cured)
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Excellent biocompatibility
No leachable additives
Odorless & non-toxic
USP VI
Moldable, not sealable or weldable
 TPE(Advantaflex, C-Flex, G-Flex)
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Low absorbtion, adsorbtion & permeability as
compared to Silicone
Pumpable (most types)
Sealable & weldable
Moldable
 Other(PVC, Tygon, Viton, Norprene)
 Pump Elements
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Sta-Pure PCS
Sta-Pure PFL
Tube welders & sealers from Terumo, GE,
Sartorious and others allow for “Closed
System” sterile fluid path connections to be
made when using Single Use Systems.
The process allows the connection of
multiple fluid paths utilizing TPE
(Thermoplastic Elastomer) tubing. A welder
is useful for connecting tubing between
process containers and equipment, and is
designed to connect small or large
diameter tubing enabling high flow rates
and large transfer volumes.
NOT NECESSARY: a laminar flow cabinet,
a clean room, or similar environmental
control device.
 Bags
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Most common storage vehicle
Size & shape flexibility
Standard films
 Polyethylene (PE)
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Biopharmaceutical, laboratory & diagnostic
Low extractables
Two films
 Ethyl Vinyl Acetate (EVA)
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Biopharmaceutical, laboratory & diagnostic
Single film
Freezable
 Polypropylene (PP)
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Medical Packaging Applications
Autoclavation
Single Film
Standard Connections: Open & Closed
System
• Hose Barb Connections
– Fixed Tube-to-Tube / Bag-to-Tube
• Luer Fittings
– Small Bags / Sampling
• Plastic Sanitaries /Tri-Clams
– Tube-to-Stainless / Tube to Filter
• Quick Connections
– Tube to Tube / Tube-to-Stainless
© 2011 Colder Products Company. All rights reserved.
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Tradition is barb & cable tie.
Ultimate flexibility
Low cost
Minimal inventory components
History of performance
History of failure
Easily applied in the lab or clean space
Easily misapplied in the lab or clean space
Pressure & Size can be a factor
Unobstructed flow path can be an issue
Cleanliness considerations although this is
single use
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Newer technology
Less flexibility due to manufacturing
requirements for molds & tooling
Silicone & TPE can be molded
High performance clean flow path
Molded interface is as strong as parent
materials (non-braid reinforced)
Supplied by manufacturer to customer
specified configuration
Size limitations
Higher cost
Longer lead time
Some assemblies cannot be molded
Sterile Connectors
Make a Sterile Connection
in Any Environment
• Sterile Barriers
– Moved or Remove During
Connection Process
• Single-Connect Function
– Designed to Not Separate
© 2011 Colder Products Company. All rights reserved.
Sterile Connectors
• Pall – Kleenpak Connector
• GE Healthcare – ReadyMate (formerly BioQuate)
• Millipore – Lynx S2S
• Saint Gobain – Pure-Fit SC
• Sartorius Stedim – Opta SFT-I
• Colder – AseptiQuik
© 2011 Colder Products Company. All rights reserved.
Combination Connectors
Multifunction Connectors
• AseptiQuik-DC
– One-Time Sterile Connection
– One-Time, Push-Button, Aseptic
Disconnect
• AseptiQuik-Steam-Thru II
– SIP Connection to Process Equipment
– Sterile Connector to Single-Use
© 2011 Colder Products Company. All rights reserved.
Capsule Filters (Pall, Meissner, Millipore,
Sartorious)
When attached to irradiated tubing sets & bag
systems a capsule filter allows sterile fluid
transfer into pre-irradiated bag or system,
eliminating the need to autoclave, clean or
sterilize traditional stainless. The fluid, when
transferred through the capsule into the sterile
bag, is sterile, even when processed in a nonsterile environment.
Filter type is user defined and can be assembled
to either an open or closed system.
Traditional sampling via a fixed port on a vessel
through stainless steel diaphragm valves (or similar)
configured for SIP with sample device connected to a
Tri-Clamp connection and autoclave container or presterilized bag/manifold. Connection typically sterilized
prior to each sample. Valves require cleaning &
maintenance.
Single Use (NovaSeptum®, Three 60®, Sta-Pure
Fluid Sampling System®) – Single use sampling
methods differ with some systems having reusable
components requiring cleaning & maintenance to those
which are truly single use and disposable. The
commonality is the use of pre-sterilized tube & bag sets
(individual or manifolded) for sample collection &
storage.
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Sensors
Pole Star Technologies
Finesse
SciLog
Others
Pumping Technology
 Peristaltic
• Utilizing single use systems
eliminates the need to clean
assemble and sterilize
• Single use systems eliminates
cross-over contamination
• Maximize clean room footprint
• Reductions in labor and capital cost