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Procedure H — Flush with Buffer
Buffer flushing establishes the proper pH, ionic strength and temperature conditions to help
prevent product precipitation or denaturation when it is introduced into the system. The buffer
solution is normally the same solution used to prepare the product solution and should be at
a temperature similar to the product solution temperature.
Flush the Cadence ILC module with buffer:
1. Connect the feed line to a supply of buffer solution.
2. Direct the retentate and permeate lines to drain.
3. Open the feed, retentate, and permeate 2 lines, and close the permeate 1 line.
4. Start the feed pump and slowly increase the pump speed until the feed pressure reaches
1.4 – 4.1 barg (20 – 60 psig).
5. During buffer conditioning, open the permeate 1 line for 30 seconds. Repeat every
5 minutes.
6. Stop the feed pump after 15 L/m
2
of buffer passes through the module.
HELPFUL INFORMATION!
It is important to remove entrapped air during flushing. If excessive
air is observed exiting the module, increasing feed pressure and flow rates will assist in the air
removal method. Slight adjustments to the protocol may be necessary to optimize this step.
Part 1 — Pre-Use Conditioning
is now complete, and the user is ready to process the product
using SPTFF following the procedures in
Part 2 — Processing
.
5.3
Part 2 — Processing
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Procedure I — Process Product
Before initiating the processing step, review the recommended operating parameters below.
Follow these steps to process feed material with the Cadence ILC module:
1. Connect the feed line to the feed solution.
2. Place the retentate and permeate lines into separate collection vessels.
3. Fully open the feed, retentate, permeate 1, and permeate 2 lines.
4. Start the feed pump and increase the pump speed until the process design feed pressure
or feed flux is obtained.
6. After processing the protein solution, stop the feed pump.
Recommended Operating Pressures, Temperatures, and pH
The following list provides the recommended operating limit specifications for pressure,
temperature, and pH for Cadence ILC modules:
• Processing temperature range: 20 – 40 °C
• Operating pressure range: 1.4 – 4.1 barg (20 – 60 psig)
Maximum operating pressure: 4.1 barg (60 psig)
• pH range: 2 – 13
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Procedure J — Recover Product from the Cadence ILC Module
Follow these steps to recover product from the module:
1. Close both permeate lines.
2. Remove the retentate line from the collection vessel and place it in another collection vessel.
3. Connect the feed line to a buffer solution that is compatible with the product.
4. Start the feed pump on slow speed and adjust the speed to maintain a feed pressure of
less than 1.4 barg (20 psig). Do not exceed a feed pressure of 1.5 barg (22 psig) when the
permeate lines are fully closed.
