REPLIGEN TangenX PRO PD User manual

IF.PUG.003 R7
TangenX™ PRO PD
Cassette
USER GUIDE
Table 3 Recommended Crossflow Rates
Crossflow ∆P*
HP Screen 5-8 L/min/m215 psi (1 bar)
LP Channel 5-8 L/min/m210 psi (0.7 bar)
S Channel 9-15 L/min/m21.5 psi (0.1 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™ 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™ 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 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 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.
Phone [phone] | Fax [phone]
www.repligen.com/tangenx.com
[email protected]

IF.PUG.003 R7
PRODUCT CONTENTS
Package includes the following:
1. TangenX™ PRO PD -0.01 m2(0.1 ft2), 0.02 m2(0.2 ft2), 0.1 m2(1 ft2) 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 m2of 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:
o2 - 13, long term (storage)
o1 - 14, short term (cleaning)
•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.
FIGURE 1
TORQUE SEQUENCE FOR TANGENX™ PRO PD
CASSETTES