REPLIGEN TangenX SIUS Cassette User manual

IF.PUG.006 R10
TangenX™ SIUS™ Cassette
USER GUIDE
Table 3 Recommended Crossflow Rates
Crossflow ∆P
LP Screen 4-8 L/min/m210 psi (0.7 bar)*
EP Screen 6-12 L/min/m25 psi (0.35 bar)*
J Channel 10-15 L/min/m2<1 psi (0.07 bar)
* Typical ∆P measured with water and permeate closed
Table 4 Maximum Recommended Operating Pressures
Maximum Operating Pressures at 30°C
Forward 100 psi (7 bar)
Reverse 7 psi (0.48 bar)
Table 5 Air Integrity Test Specification
Air Diffusion Rates
Ultrafiltration
1kD thru 5kD
≤ 323 sccm/m2@ 15 psi (1 bar)
Ultrafiltration
10kD thru 300kD
≤ 323 sccm/m2@ 7.3 psi (0.5 bar)
Microfiltration
≥ 0.1 um
≤ 323 sccm/m2@ 3 psi (0.2 bar)
Maximum Operating Temperature 50°C
CHEMICAL COMPATIBILITY
TangenX™ SIUS™ membrane cassettes are compatible with the following:
ACN (<15%)
DMF, DMSO (<40%)
DMAC (<15%)
Phosphoric acid (<1M)
Sodium Hypochlorite (<400ppm)
Sodium Hydroxide (<0.5M)
TangenX™ SIUS™ membrane cassettes are NOT compatible with the
following:
Pure aromatic and chlorinated hydrocarbons
Ketones
Polar aromatics
Aliphatic esters
A more comprehensive list is available in the cassette validation guide.
CAUTION
In the event that the cassette is subjected to any of the conditions listed
below, it is recommended that you perform both cassette integrity and water
flux tests to ensure your cassette is not damaged. Damage may occur as a
result of the following:
•Dropping on hard surfaces, or other mechanical shock.
•Poking with sharp objects on screened surfaces
•Excessive feed pressure.
•Excessive permeate backpressure, or pressurizing the filtrate port.
•Exposure to harsh chemicals.
•Freezing.
•Excessive heat.
•Drying out – ultrafiltration or microfiltration membrane that is allowed
to dry out can permanently damage the pore structure.
MEMBRANE CASSETTES MUST REMAIN WET AT ALL TIMES TO
MAINTAIN PRODUCT INTEGRITY AND PERFORMANCE.
FOR TECHNICAL SUPPORT OR ORDER ASSISTANCE PLEASE CALL YOUR
LOCAL SALES REPRESENTATIVE.
REPLIGEN TANGENX™ STANDARD WARRRANTY
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.
Phone [phone] | Fax [phone]
www.repligen.com/tangenx
[e-mail]

IF.PUG.006 R10
Figure 1
Torque Sequence for TangenX™ Sius™
Cassettes
PRODUCT CONTENTS
Package includes the following:
1. TangenX™ SIUS™ membrane filtration cassette: product consists of either a 0.5 m²
(5 ft²) cassette, 1.5 m² (15 ft²), or a 2.5 m² (25 ft²) single-use cassette
2. EPDM gaskets
IMPORTANT INFORMATION BEFORE YOU BEGIN
CASSETTES
•Product is packaged wet and must remain hydrated for optimal performance. Keep
bag sealed until cassette installation (step 3 below).
•TangenX™ SIUS™ Cassettes are compatible with the TangenX™ PRO cassette
holder. A list of other cassette holders is shown in the cassette holder compatibility
guide.
•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 equilibrated with an appropriate buffer (i.e., phosphate buffered
saline) to ensure the neutralization of the 0.2M sodium hydroxide storage agent in
the membrane filter. It is important to use pre-filtered buffer to avoid fouling the
membrane or introducing contaminants into the system that could affect membrane
performance and product recovery.
GASKETS
•Gaskets are intended to be single use; Repligen recommends that you replace
gaskets with each cassette changeover. 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.
TANGENX™ SIUS™ CASSETTE INSTALLATION
1. Lift the end plate off the manifold of the TangenX™ PRO cassette holder.
2. Rinse the EPDM 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 0.2M sodium hydroxide
solution as a preservative. Follow standard safety procedures for
handling 0.2M sodium hydroxide, 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.
7. Bolts must be further tightened to within the recommended torque values as 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 4-BOLT 300 – 450 35 – 50
TangenX™ PRO 2-BOLT 600 – 900 70 – 100
8. Figure 1 illustrates the bolt patterns for the two holder types: TangenX™ PRO 4-bolt
horizontal cassette holder is designated by letters H1 through H4; TangenX™ PRO
2-bolt vertical holder is designated by letters V1 and V2.
9. 4-bolt torque sequence:
Using the calibrated torque
wrench with a 1-¼" deep
style socket, place the socket
on bolt H1 and tighten the nut
¼ turn. Then move the wrench
diagonally to bolt H2 and
tighten the nut ¼ turn. Next
move the wrench to bolt H3
and tighten the nut ¼ turn.
Then move the wrench
diagonally to bolt H4 and
tighten the nut ¼ turn.
Alternate back and forth using this crisscross pattern until the torque wrench "clicks"
at each nut. 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.
10. 2-bolt torque sequence: Using the calibrated torque wrench with a 1-¼" deep
style socket, place the socket on bolt V1 and tighten the nut ¼ turn. Next move the
wrench across to bolt V2 and tighten the nut ¼ turn. Alternate back and forth until
the torque wrench "clicks" at each nut. 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.
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).
11. Re-torque as needed to create a liquid-tight seal, but do not exceed the maximum
torque limit for the TangenX™ PRO holder type used (see Table 1).
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.
EQUILIBRATION OF TANGENX™ SIUS™ CASSETTES
Cassettes must be equilibrated with an appropriate buffer (i.e., phosphate buffered
saline) to ensure the neutralization of the 0.2M sodium hydroxide storage agent in the
membrane filter. Verify the pH of the effluent from the cassette is neutralized to
minimize any possible interaction with your particular application. For most applications,
further sanitization is not required.
INTEGRITY TEST
The integrity test is a non-destructive method to verify the integrity of a 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 THE CASSETTE SYSTEM
TangenX™ SIUS™ cassettes are intended for single use only, post-use cleaning and re-
use is not recommended. To clean the TFF system following use, recirculate 0.5M sodium
hydroxide through the system with all valves open. Cassettes are left in place during the
system cleaning procedure to provide a flow path for the cleaning solution. Alternatively
the cassettes may be removed and a spacer gasket(1) is put in place of the used
cassettes. Upon completion of the cleaning cycle, flush the system with WFI, or DI water
prior to draining and discarding the cassettes. Table 2 lists possible recommended
cleaning solutions. (1) Spacer gaskets for flushing may be obtained by contacting
Repligen.
Table 2 Recommended Cleaning Solutions
Cleaning Agent Cleaning Conditions
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)
DISPOSAL OF USED TANGENX™ SIUS™ CASSETTES
TangenX™ SIUS™ cassettes are removed from the holder by reversing the cassette
installation procedure. If the cassettes are difficult to separate from the stainless steel
holder, a thin plastic spatula(2) can be slid under the edge of the cassette and break the
seal. Cassettes can then be disposed of in a similar fashion to other disposable process
equipment. (2) One cassette extractor is included with each shipment of TangenX™
SIUS™ cassettes.
STORAGE OF UNUSED TANGENX™ SIUS™ CASSETTES
Membrane cassettes must remain sealed in their original packaging prior to use to
maintain their characteristics, integrity, and prevent microbial growth. Below are critical
factors to remember when storing unused TangenX™ SIUS™ cassettes:
Recommended storage temperature:
o4°C - 25°C long term (> 7 days)
o50°C short term (< 7 days)
oDo 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.