16
5. Pump one hold-up volume through the module and into a separate retentate vessel. Repeat
this step, each time pumping one hold-up volume into a separate retentate vessel. The
number of recovery flushes performed should be defined by the application and the targeted
recovery yield. This recovery step should be optimized for each application.
6. Stop the pump.
Table 4
Approximate minimum hold-up volumes for Cadence ILC modules
Module Size Minimum Module Hold-Up Volume*
T01 (0.065 m
2
) 20 mL
T02 (0.13 m
2
) 40 mL
T12 (0.7 m
2
) 200 mL
T06 (3.5 m
2
) 1,300 mL
* Actual total hold-up volume should be determined based on the setup. (See Procedure F)
Part 1 — Pre-Use Conditioning
and
Part 2 — Processing
are now complete. The user is ready
to begin
Part 3 — Post-Use Conditioning
which is optional and applicable only if the Cadence
ILC is to be reused. Otherwise, to proceed with
Part 4 – Post-Use Disposal
WARNING!
The Cadence ILC Module is a disposable device. It could potentially be used
several times. However, specific end-user studies should be conducted to identified the limited
re-use range and validate specific re-use requirements per application.
5.4 Part 3 — Post-Use Conditioning
After completing product recovery, clean, test, and prepare the Cadence ILC module for
storage or reuse in case the module would be utilized for multiple batches or for a specific
campaign. This section is optional and is not applicable when considering single-use processes.
Document and validate the cleaning process for biopharmaceutical applications.
u
Procedure K — Clean the Cadence ILC Module
If a sufficient amount of product has been removed from the module with buffer flushing during
product recovery, proceed directly to cleaning steps below.
If product must be flushed from the module with purified water or buffer before beginning
the cleaning step, follow Procedure B (Flush the Cadence ILC module). Then go to the
Cleaning Steps
below.
Cleaning Steps
Follow these steps to clean the Cadence ILC module and system:
1. Connect the feed line to a supply of cleaning solution (see Materials Section 5.1) at ambient
temperature.
2. Direct the retentate and permeate lines to drain.
3. Fully open the feed, retentate, and permeate 2 lines. Close the permeate 1 line.
4. Start the feed pump and adjust the feed pump speed to deliver a feed pressure of
1.4 – 4.1 barg (20 – 60 psig).
5. Open the permeate 1 line for 30 seconds and then close for the remainder of the
cleaning step.
6. – For Delta membranes: Stop the feed pump after 45 – 50 L/m
2
of cleaning solution
passes through the module.
– For Omega membranes: Stop the feed pump after 20 L/m
2
of cleaning solution passes
through the module. Then, introduce 30 L/m
2
of fresh cleaning solution and recirculate
at 1.4 – 4.1 barg (20 – 60 psig) for 1 hour with the permeate ports closed.