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Page 11 of 12  

TangenX

TM

 SIUS

TM

 PD Filter Plate & 2-Bolt Clamp Assembly 

User Guide 

Identification  

IF.PUG.019

 

Revision  

R2

 

Approved  

20-DEC-2018 

 

Table 12.3     Air integrity test specifications 

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) 

 

13.

 

Chemical Restrictions 

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 

 

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.  

 
TangenX™ SIUS™ PD cassettes must remain wet at all times to maintain product integrity and 

performance. 

 

 

Summary of Contents for TangenX SIUS PD

Page 1: ...Page 1 of 12 Identification IF PUG 019 Revision R2 Approved 20 DEC 2018 TangenX SIUS PD Filter Plate and 2 Bolt Clamp Assembly USER GUIDE ...

Page 2: ...ed herein or for incidental or consequential damages in connection with the furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without the prior written consent of Repligen Corporation For further information please contact Repligen Corporation at www repligen com 2017 Repligen Corporation All rights reserved The ...

Page 3: ...ilibration 8 9 Cassette System Cleaning 8 10 Used TangenX SIUS PD Cassette Disposal 10 11 Unused TangenX SIUS PD Cassette Storage 10 12 Membrane Operating Characteristics 10 13 Chemical Restrictions 11 14 Repligen TangenX Standard Warranty 12 List of Tables Table 9 1 Recommended cleaning solutions 9 Table 12 1 Recommended crossflow rates 10 Table 12 2 Maximum operating pressures 10 Table 12 3 Air ...

Page 4: ...Stainless Steel Compatibility c TangenX SIUS Packet Cassette Torque Range b 120 180 in lbs 14 20 N m Hydraulic Option No Hex Socket 11 16 CONSUMABLES 8 Filter Plate TFPLS LVFL d TFPLS SA08 c Polypropylene 9 Isolation Plate Polypropylene 10 TangenX SIUS PD LP1L J or K e LP2L J or K e L01L J or K 11 Gasket EPDM a Not Shown b Always check and re torque if necessary your holder prior to use c NOT COMP...

Page 5: ...s Filter Plate Inserts are designed for single use Since Repligen does not recommend re use it is the responsibility of the end user to define a suitable cleaning protocol CASSETTE Product is packaged wet and must remain hydrated for optimal performance Keep bag sealed until cassette installation Section 6 Step 3 below TangenX SIUS PD cassettes are compatible with all TangenX cassette holders Cass...

Page 6: ...into base plate If loose place a 1 8 drive pin into thru hole on threaded rod and turn clockwise 6 Filter Plate Installation 1 The steps from CLAMP SETUP are complete 2 Remove Filter Plate Insert FPI and Isolation Plate from outer carton if not already removed WARNING Wear gloves to avoid contamination 3 Using scissors carefully open the FPI bag and remove the FPI 4 Again using scissors carefully ...

Page 7: ... Place a rinsed gasket flat against the bottom FPI 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 co...

Page 8: ...o create a liquid tight seal but do not exceed the maximum torque limit for the 4BMC clamp WARNING The hex nuts should be checked for adequate torque PRIOR to every run using the procedure described herein In addition torque may change during processing as the cassettes may expand or contract with temperature changes Periodically check the torque of each nut and adjust as needed 8 Repligen highly ...

Page 9: ... 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 replaced with a CIP spacer gasket see Figure 1 1 Upon completion of the cleaning cycle flush the system with WFI or DI water prior draining and discarding the cassettes Table 9 1 lists possible recommended cleaning solutio...

Page 10: ...egrity and prevent microbial growth Below are critical factors to remember when storing unused TangenX SIUS PD cassettes Recommended storage temperature 4 C to 25 C longer than 7 days long term 50 C less than 7 days short term Do not freeze cassettes 12 Membrane Operating Characteristics Take care to use the membrane at the lowest pressure possible while still producing consistent permeate flow Al...

Page 11: ... the following Pure aromatic and chlorinated hydrocarbons Ketones Polar aromatics Aliphatic esters 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 ...

Page 12: ...shed 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 optio...

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