REPLIGEN TangenX PRO User manual

IF.PUG.014 R4
TANGENX™ PRO CASSETTE INSTALLATION
1. Lift the end plate off the manifold of the TangenX™ PRO cassette holder.
2. Remove the protective blue sheet and 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 using a calibrated manual torque wrench.
7. Proceed to step 8 for a four bolt hardware design or skip to step 9 for a two
bolt hardware design.
8. Using the calibrated torque wrench with a deep style socket, tighten each hex
nut ¼ turn following the torque sequence illustrated in Figure 2 for a four bolt
horizontal hardware. In ¼ turn increments, tighten the first (H1), second (H2),
third (H3), and fourth (H4) nut 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.
9. Using the calibrated torque wrench with a deep style socket, tighten each hex
nut ¼ turn following the torque sequence illustrated in Figure 3 for a two-bolt
vertical hardware. 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.
10. Wait 5-10 minutes and allow the gaskets to relax before re-torqueing. Check
each nut, per the Figure 2 or 3 sequences, using the torque wrench at its set
point torque value.
11. Re-torque 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.
TangenX™ PRO
Cassette Holder
COMPATIBILITY GUIDE
REPLIGEN TANGENX™ STANDARD WARRANTY
Repligen Corporation warrants its TangenX™ products will meet their
applicable published specifications when used in accordance with their
applicable instructions for a period of one year from shipment of the
products. REPLIGEN MAKES NO OTHER WARRANTY, EXPRESSED OR
IMPLIED. THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE. The warranty provided herein and the data,
specifications and descriptions of Repligen TangenX™ products appearing in
published catalogues and product literature may not be altered except by
express written agreement signed by an officer of Repligen.
Representations, oral or written, which are inconsistent with this warranty or
such publications are not authorized and if given, should not be relied upon.
In the event of a breach of the foregoing warranty, Repligen’s sole obligation
shall be to repair or replace, at its option, the applicable product or part
thereof, provided the customer notifies Repligen promptly of any such
breach. If after exercising reasonable efforts, Repligen is unable to repair or
replace the product or part, then Repligen shall refund to the customer all
monies paid for such applicable product or part. REPLIGEN SHALL NOT BE
LIABLE FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL OR ANY OTHER
DAMAGES RESULTING FROM ECONOMIC LOSS OR PROPERTY DAMAGE
SUSTAINED.
FIGURE 3
TORQUE SEQUENCE FOR
TANGENX™ PRO CASSETTES
(2 Bolt Design)
Phone [phone] | Fax [phone]
www.repligen.com/tangenx
[email protected]
FIGURE 2
TORQUE SEQUENCE FOR TANGENX™ PRO CASSETTES
(4 Bolt Design)

IF.PUG.014 R4
INTRODUCTION
Tangential flow filtration cassettes are typically installed in a stainless steel
cassette holder consisting of two steel plates, one acting as a flow distribution
manifold and the other as a mating solid flat surface. Repligen offers a complete
series of high performance stainless steel cassette holders and are designed for
optimal performance with TangenX™ PRO TFF cassettes. In addition to TangenX™
cassette holders, TangenX™ PRO cassettes have been designed to be compatible
with other types from alternative manufacturers. The following guide will outline
the compatibility of the TangenX™ PRO cassettes with these other cassette holders
and act as a supplement to the standard user guide.
TANGENX™ PRO TFF CASSETTES
•TangenX™ PRO cassettes are offered with several different membrane surface
areas that include 0.5m2, 1.5m2, and 2.5m2sizes. These cassettes have a
standard universal format are designed to fit a wide range of cassette holders
of various configurations. Figure 1 shows the dimensions for the alignment
notches for the TangenX™ PRO cassette.
Figure 1
•The following is a partial list of cassette holders that are compatible with the
TangenX™ PRO cassette.
Repligen TangenX™ PRO Cassette Holder (TX032)
Pall Centrasette Cassette Holder (FS001K05)
Millipore Pellicon Cassette Holder (XX42P0080)
Sartorius Sartocon Cassette Holder (17546-202)
GE Kvick Cassette Holder (KFHR0115TQE)
•Once the cassette holder has been identified continue to the next section for
the supplemental guide to the standard product use guide.
•Only use the gaskets provided by Repligen supplied with each TangenX™ PRO
cassette.
TANGENX™ PRO CASSETTE | SUPPLEMENTAL INSTALLATION
•Pall Centrasette Cassette Holder
Reference TangenX™ User Guide IF.PUG.004 for cassette installation
instructions, further details are below.
Pall Centrasette cassette holders are
offered in several different
configurations and are compatible with
TangenX™ PRO cassettes with the part
number xxxxxBxxx. Both a two bolt
vertical and a four bolt cassette holder
in the horizontal position are available.
The vertical two bolt design requires
greater torque to seal the cassette in
place. The four bolt design reduces the torque that is required to seal the
TangenX™ PRO cassette.
The TangenX™ PRO cassette must be placed in the cassette holder with
the cassette’s identification label facing “up” or away from the lower flow-
path manifold and towards the brass retaining nuts. Tighten the bolts in ¼
turn increments, as described on page 4 and page 5, until the recommended
torque is achieved. The suggested torque values are shown in Table 1
below.
Table 1 Recommended Torque Values | Pall Centrasette Holder
Holder Part Number
Torque Range
(in-lbs)
Torque Range
(Nm)
FS001K05 (4-Bolt)
300 – 450
35 – 50
FS004K05 (2-Bolt)
600 – 900
70 – 100
•Millipore Pellicon Cassette Holder
Reference TangenX™ User Guide
IF.PUG.004 for basic cassette installation
instructions. The Millipore Pellicon cassette
holders are offered in several different
configurations and are compatible with
TangenX™ PRO cassettes with the part
number xxxxxBxxx. Several four bolt
holders are available.
Millipore Pellicon pilot and process scale
holders utilize a series of permeate channels resembling a “star” shape on
the lower manifold. This type of holder requires a manifold support plate to
be installed when using TangenX™ PRO cassettes. The support plate is
available from Millipore and is identified with the part number XXPEL3MAP.
The TangenX™ PRO cassette must be placed in the cassette holder with the
cassette’s identification label facing “up” or away from the lower flow-path
manifold and towards the brass retaining nuts. Do not use the white
compression washers included with the Pellicon cassette holders. Only use
solid stainless steel spacers. Tighten the bolts in ¼ turn increments, as
described on page 4 and page 5, until the recommended torque is achieved.
The suggested torque values are shown in Table 2 below.
Table 2 Recommended Torque Values | Millipore Pellicon
Holder Part Number
Torque Range (in-
lbs)
Torque Range
(Nm)
XX42P0080 (4-Bolt)
300 – 450
35 – 50
•Sartorius Sartocon 2 Cassette Holder
Reference TangenX™ User Guide IF.PUG.004 for basic cassette installation
instructions, further details are as follows.
The Sartorius Sartocon 2 cassette holders are offered in many different
configurations and are compatible with
TangenX™ PRO cassettes with the part
number xxxxxBxxx. Several two bolt
holders in the vertical positions are
available. The TangenX™ PRO cassette
must be placed in the cassette holder with
the identification label facing away from
the feed/retentate ports and towards the
brass retaining nuts. Tighten the two bolts
in ¼ turn increments, as described on page
4 and page 5, until the recommended
torque is achieved. The suggested torque values are shown in Table 3 below.
Table 3 Recommended Torque Values | Sartorius Sartocon 2 (2-Bolt)
Holder Part Number
Torque Range (in-lbs)
Torque Range (Nm)
17546-202 (2-Bolt) 600 – 900 70 – 100
•GE Kvick Flow Cassette Holder
Reference TangenX™ User Guide IF.PUG.004
for basic cassette installation instructions. The
manual torque GE Kvick cassette holders are
compatible with TangenX™ PRO cassettes
with the part number xxxxxBxxx. Four bolt
holders in the vertical position are available.
The TangenX™ PRO cassette must be placed in
the cassette holder with the identification
label facing away from the feed/retentate
ports and towards the brass retaining nuts.
Tighten the four bolts in ¼ turn increments, as described on page 4 and page
5, until the recommended torque is achieved. The suggested torque values
are shown in Table 4 below.
Table 4 Recommended Torque Values | GE Kvick Holder
Holder Part Number Torque Range (in-lbs) Torque Range (Nm)
KFHR0115TQE (4 Bolt)
300 – 450
35 – 50
•TangenX™ PRO Cassette Holder (TX032)
Follow the instructions outlined in TangenX™
User Guide IF.PUG.004 for cassette installation
procedures. A copy is included in the box of
every TangenX™ PRO cassette. TangenX™
cassette holders are offered in several different
configurations, both horizontal and vertical
positions. The cassette holder is compatible with
all TangenX™ PRO cassettes with the part
number xxxxxBxxx.