IF.PUG.003 R7
PRODUCT CONTENTS
Package includes the following:
1. TangenX™ PRO PD - 0.01 m
2
(0.1 ft
2
), 0.02 m
2
(0.2 ft
2
), 0.1 m
2
(1 ft
2
) membrane
filtration cassettes
2. Silicone* or EPDM** Gaskets (*A01,W01 / **AP1,AP2,WP1,WP2)
IMPORTANT INFORMATION BEFORE YOU BEGIN
CASSETTES
• Cassettes may be stacked to increase filtration surface area; however, use only
one type of membrane molecular weight cutoff at one time. Do not install a
mixture of cassettes with different pore sizes in the hardware.
• Cassettes must be flushed with deionized (DI) water or water for injection
(WFI) to ensure removal of storage agents and preservatives from the
membrane filter. It is critical to use the highest quality water possible to avoid
fouling the membrane or introducing contaminants into the system that could
affect membrane performance and product recovery.
GASKETS
• Gaskets lose their resiliency over time. Repligen recommends that you replace
gaskets a minimum of every six months. Repligen supplies two gaskets per
cassette. Installation of the first cassette requires two gaskets; stacking
additional cassettes requires only one gasket. Extra gaskets should be saved to
replace worn or damaged gaskets.
PUMP
• When using TangenX™ cassettes, select a pump with adequate capacity;
crossflow rate ranges (see Table 3) are feed channel type and process fluid
dependent.
MEMBRANE CASSETTE INSTALLATION
1. Lift the end plate off the manifold.
2. Rinse the silicone gaskets with deionized water or WFI. Place a rinsed gasket
flat against the bottom manifold; ensure that the holes in the gasket line up
with the holes in the manifold.
3. Using scissors carefully open the cassette bag to remove cassette.
WARNING: Each cassette is stored in an aqueous solution containing
15-20% glycerin and 0.1% sodium azide, pH 7 - 10. Follow standard
safety procedures for handling aqueous glycerin/sodium azide,
including the use of gloves, safety goggles, and lab coat.
4. Place the cassette into the holder flat against the gasket. Place another gasket
on top of the cassette. Ensure that the holes in the manifold, gaskets, and
cassette are completely aligned. If you are using multiple cassettes, continue
the same gasket/cassette/gasket pattern, ending with a gasket between the
last cassette and the end plate.
5. Place the end plate on top of the last gasket of the cassette or cassette stack
.
6. Install the tie-rod spacers (if used) and washers on each bolt leaving a
minimum of 18 mm (0.75 inch) of thread exposed on the rod. By hand, screw
the nut on each bolt and hand tighten evenly by alternating from one nut to
the other. Bolts must be further tightened to within the recommended torque
values shown in Table 1 using a calibrated manual torque wrench.
Table 1 Recommended Torque Values
Holder Type Torque Range (in-lbs)
Torque Range (nm)
TangenX™ PRO PD 120 – 180 14 – 20
7. Using the calibrated torque wrench with an 11/16” deep socket, tighten each
hex nut ¼ turn following the torque sequence illustrated in Figure 1. Tighten
the first nut ¼ turn, and then tighten the second nut ¼ turn alternating back
and forth until the torque wrench "clicks". Repeat this sequence until the
wrench "clicks" without turning the nut. The "click" of the torque wrench
indicates that the nut has reached the set point torque value.
CAUTION: Nuts must be tightened uniformly to avoid damaging the
cassette. Leakage may result from non-parallel plate alignment or
over compression of the cassettes at one end.
8. Wait 5-10 minutes and
allow the gaskets to relax
before re-torqueing.
Check each nut, per the
Figure 1 sequence, using
the torque wrench at its
set point torque value (see
step 7 above).
9. Re-torque to a maximum
of 180 inch-pounds, as
needed, to create a liquid-tight seal.
NOTE: Torque may change during processing as the cassettes may
compress, or as the cassettes expand or contract with temperature
changes. Periodically check the torque of the bolts and adjust torque
as needed.
FIRST TIME USE OF MEMBRANE CASSETTE
Cassettes should be flushed with DI water or WFI to ensure removal of storage and
preservative agents from the membrane filter and to minimize any possible
interaction with your particular application. The recommended volume of water to
flush the cassettes prior to use is 20 to 40 L/m². For some applications, further
sanitization is required.
CASSETTE INTEGRITY TEST
The integrity testing is a non-destructive method to verify the integrity of a
Tangential Flow Filtration (TFF) cassette. Each cassette manufactured by Repligen
undergoes strict release testing, including an air integrity test. This release test
verifies the integrity of the cassette prior to shipment; however it can't guarantee
the integrity of the cassette's installation in the holder at the time of use. In the
rare case there is an integrity issue, it can be a result of shipping damage or
improper installation.
Therefore, a pre-use integrity test should be conducted on site and can easily be
performed following the cassette installation and flush. Integrity test specifications
are shown in Table 5 of this guide. A detailed procedure (AN1002) for the
measurement of air integrity can be obtained by contacting Repligen or your local
sales representative.
CLEANING OF MEMBRANE CASSETTES
Cassettes can be reused if cleaned and stored properly. To clean, flush each
cassette (or cassette stack) with a recommended cleaning solution from Table 2.
Use 2 liters of cleaning solution per 1 m
2
of membrane area. Upon completion of
the cleaning cycle, flush each cassette (or stack) with buffer, WFI, or DI water prior
to storing.
Table 2 Recommended Cleaning Solutions
Cleaning Agent Cleaning Conditions
0.1n to 0.5N Sodium Hydroxide
Contact Time = 30 – 60 minutes
Temperature = 35°C (95°F)
1.5% Alconox® Detergent
Contact Time = 30 – 60 minutes
Temperature = 40°C (104°F)
STORAGE OF MEMBRANE CASSETTES
Membrane cassettes must be stored wet to maintain their characteristics and
integrity and prevent microbial growth. Below are critical factors to remember
when storing include the following:
• Cassettes stored greater than 2-4 weeks should be removed from the holder.
• Cassettes left in the holder should be flushed with fresh storage agent about
every 2 weeks. Contact the membrane manufacturer for a list of appropriate
storage agents.
• Recommended PH ranges:
o 2 - 13, long term (storage)
o 1 - 14, short term (cleaning)
• Recommended storage temperature:
o 4°C - 25°C long term (>7 Days)
o 50°C short term (<7 Days)
o Do not freeze cassettes
MEMBRANE OPERATING CHARACTERISTICS
Take care to use the membrane at the lowest pressure possible while still
producing consistent permeate flow. Although higher operating pressures initially
improve flow rate, they also promote increased concentration polarization and
membrane compaction, which ultimately limits flow. With very low NMWL
membranes, lower operating pressure may also reduce the retention of salts and
very low molecular weight species.
FIGURE 1
TORQUE SEQUENCE FOR TANGENX™ PRO PD
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