REPLIGEN TangenX SC Series User manual

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are the property of Repligen Corporation and/or its affiliate(s) or their respective owners.
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TangenX® SC
TFF Device
User Guide

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The information contained in this document is subject to change without notice.
With respect to documentation accompanying Product Repligen makes no warranty, express or implied. Any and all warranties
related to the documentation accompanying Product are expressly disclaimed. Customer shall refer to the terms and conditions of
sale governing the transaction for any and all warranties for the Product.
Repligen Corporation shall not be liable for errors contained 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.
Products are not intended for diagnostic or therapeutic use or for use in vivo with humans or animals.
For further information, please contact Repligen Corporation at www.repligen.com.
©2023 Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property of Repligen Corporation and/or
its affiliate(s) or their respective owners.
Customer Support
[email protected]
781-250-0111
Repligen Corporation
41 Seyon Street
Building 1 Suite 100
Waltham, Massachusetts 02453
www.repligen.com

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Contents
1. About this document .................................................................................................................................................................5
2. Introduction...............................................................................................................................................................................6
2.1 Additional references................................................................................................................................................................6
3. Device components....................................................................................................................................................................8
3.1 Recommended device storage conditions ................................................................................................................................9
4. Pump requirements ...................................................................................................................................................................9
5. Preparing to use the TangenX SC TFF Device ..............................................................................................................................9
5.1 Required tools and components...............................................................................................................................................9
5.2 Unpackaging the device ..........................................................................................................................................................10
6. System set-up ..........................................................................................................................................................................10
6.1 Installing the TangenX SC TFF Device......................................................................................................................................10
6.1.1 Using AseptiQuik Genderless Connectors ......................................................................................................................11
6.2 TFF System flow path parts.....................................................................................................................................................11
6.3 Connecting the TangenX SC TFF Device ..................................................................................................................................13
6.4 Estimate hold-up volume........................................................................................................................................................14
6.5 Device flush.............................................................................................................................................................................15
6.5.1 Flush the TangenX SC TFF Device retentate flow path ...................................................................................................15
6.5.2 Flush the TangenX SC TFF Device permeate flow path ..................................................................................................17
6.6 Air integrity test ......................................................................................................................................................................18
7. Process execution ....................................................................................................................................................................18
7.1 Buffer equilibration.................................................................................................................................................................18
7.1.1 Equilibrate the TangenX SC TFF Device retentate flow path ..........................................................................................18
7.1.2 Equilibrate the TangenX SC TFF Device permeate flow path .........................................................................................19
7.2 Product introduction...............................................................................................................................................................20
7.3 Optimization ...........................................................................................................................................................................22
7.3.1 Optimization through flux excursion..............................................................................................................................22
7.3.2 Process optimization data plotting and analysis ............................................................................................................24
7.4 Concentration .........................................................................................................................................................................24
7.4.1 Determination of Concentration Factor (CF)..................................................................................................................24
7.4.2 Executing concentration step.........................................................................................................................................25
7.5 Diafiltration .............................................................................................................................................................................26
7.5.1 Prepare for diafiltration..................................................................................................................................................26
7.5.2 Execute diafiltration .......................................................................................................................................................26
7.5.3 Stop the diafiltration process .........................................................................................................................................27
7.6 Product recovery.....................................................................................................................................................................28
7.7 Inactivation and disposal ........................................................................................................................................................30
8. Index........................................................................................................................................................................................31
List of tables
Table 1. Explanation of user attention phrases .........................................................................................................................................5
Table 2. Safety precautions for TangenX SC TFF Devices...........................................................................................................................5
Table 3. Symbols used in flow diagrams ....................................................................................................................................................7
Table 4. Device Specifications....................................................................................................................................................................8
Table 5. Minimum recommended components for TangenX SC TFF System ............................................................................................9
Table 6. Recommended crossflow (CF) rates...........................................................................................................................................16
Table 7. Normalized TangenX SC TFF Device flush volumes ....................................................................................................................17
Table 8. TangenX SC TFF Device air integrity specifications.....................................................................................................................18

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List of figures
Figure 1. TangenX SC TFF Device (side view and top view)........................................................................................................................8
Figure 2. How to pick up the device.........................................................................................................................................................10
Figure 3. Using AseptiQuik Genderless Connectors.................................................................................................................................11
Figure 4. System configuration without TangenX SC TFF Device .............................................................................................................12
Figure 5. Connecting TangenX SC TFF Device to tube sets.......................................................................................................................13
Figure 6. System configuration with all pinch clamps closed...................................................................................................................14
Figure 7. System configuration showing flow path for hold-up volume..................................................................................................15
Figure 8. System configuration for retentate port WFI flush...................................................................................................................16
Figure 9. System configuration for permeate port WFI flush ..................................................................................................................17
Figure 10. System configuration for retentate outlet port buffer equilibration......................................................................................19
Figure 11. System configuration for filtration device permeate outlet port buffer equilibration ...........................................................20
Figure 12. System configuration for product introduction ......................................................................................................................21
Figure 13. System configuration for recirculation mode .........................................................................................................................22
Figure 14. System configuration for optimization studies .......................................................................................................................23
Figure 15. TMP vs LMH at 3 different crossflow rates .............................................................................................................................24
Figure 16. System configuration for product concentration....................................................................................................................25
Figure 17. Relationship between remaining contaminant and diavolumes ............................................................................................26
Figure 18. System configuration for diafiltration.....................................................................................................................................27
Figure 19. System configuration for stopping diafiltration ......................................................................................................................28
Figure 20. System configuration for product recovery, Step 2 ................................................................................................................29
Figure 21. System configuration for product recovery, Step 3 ................................................................................................................30
Abbreviations
ccm Cubic centimeter per minute
CF Crossflow
DF Diafiltration
ft2 Feet squared (square feet)
In Inches
kD Kilodalton
kg Kilogram
Lb Pounds
LMH Liters per minute per square meter
L/min Liters per minute
m2 Meter squared (square meter)
ml Milliliters
MWCO Molecular weight cut-off
N-m Newton meter
psig Pounds per square inch
RODI Reverse osmosis/Deionized water
TFF Tangential flow filtration
TMP Transmembrane pressure
UF Ultrafiltration
WFI Water for injection

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1. About this document
This manual uses several different phrases. Each phrase should draw the following level of attention:
Table 1. Explanation of user attention phrases
Phrase
Description
Note:
Points out useful information.
IMPORTANT
Indicates information necessary for proper instrument operation.
PRECAUTION
Cautions users of potential physical injury or equipment damage if the information is not heeded.
WARNING
Warns users that serious physical injury can result if warning precautions are not heeded.
Table 2. Safety precautions for TangenX SC TFF Devices
WARNING
Damage may occur as a result of the following:
Dropping on hard surfaces, or other mechanical shock
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
WARNING
Membrane devices must remain wet at all times to maintain product integrity and performance. Keep bag sealed until
device installation.
WARNING
All devices are stored in 0.2 M sodium hydroxide. Follow standard safety procedures for handling 0.2 M sodium
hydroxide, including the use of gloves, safety goggles, and lab coat.
Information
It is recommended that you perform a device integrity test (Section 6.6) and meet specifications (Table 8).
Information
Devices must be equilibrated with an appropriate buffer to ensure neutralization of the 0.2 M sodium hydroxide
storage agent in the membrane filter.
Information
It is important to pre-filter all liquids to avoid fouling the membrane or introducing contaminants into the system that
could affect membrane performance and product recovery.
Information
Select a pump with adequate capacity. Crossflow rate ranges (Table 6) depend upon feed channel type and process
fluid type.

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2. Introduction
The TangenX® SC TFF Device from Repligen is a holderless, flat sheet, gamma-irradiated, closed, single-use device for tangential flow
filtration (TFF). TangenX SC TFF Devices include:
A fully assembled, capsule-style, closed device with aseptic connectors.
Gamma irradiation to sterilze the device.
Closed system to reduce contamination risk and operator exposure to hazardous material.
All fluid path materials meet USP Class VI requirements.
Certificate of quality included.
Certificate of Processing — irradiation included.
Manufactured in an ISO 9001 certified ISO 8 clean room.
Validated manufacturing processes for consistent filter performance.
BioPhorum Operations Group (BPOG) leachables and extractables test data.
TangenX SC TFF Devices are available in five sizes with surface areas including 0.5, 1.5, 2.5, 5, and 10 m2. Designed and manufactured
for GMP environments, TangenX SC TFF Devices are accompanied by a detailed Regulatory Support File . A wide variety of molecular
weight cut-offs, surface areas, and membrane chemistries (ProStream and HyStream) support diverse process needs. Potential
applications include biomolecule concentration (ultrafiltration) and buffer exchange (diafiltration).
2.1 Additional references
www.repligen.com/resources
TangenX SC Unpacking Information: UG-3202
TangenX Device Preservative Sodium Hydroxide Solution Safety Data Sheet: Form-0498
TangenX SC TFF Device Regulatory Support File: RSF-4458

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Table 3. Symbols used in flow diagrams
Symbol
Description
Vessel
Pinch clamp
CPC AseptiQuik® aseptic genderless connector
Pump
- Diafiltration
- Feed
Pressure sensor
- Retentate
- Feed
- Permeate
Flow meter (optimization only)
Inactive/Standby flow path
On/Open flow path
Off/Closed flow path
Configuration change
Open valve action
Closed valve action
On/Open and Off/Closed valve action

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3. Device components
TangenX SC TFF Device consists of a flat sheet filter within a cylinder, connectors for feed, retentate, and permeate (filtrate), and
pinch clamps. The 10 m2device includes a handle for lifting and transport.
Figure 1. TangenX SC TFF Device (side view and top view)
1. TangenX SC Cassette/Filter
2. Feed input AseptiQuik connector
3. Retentate AseptiQuik connector
4. Permeate AseptiQuik connector
5. Pinch clamp (4)
6. Handle (10 m2device only)
Table 4. Device Specifications
Surface area
Module characteristics
0.5 m2
1.5 m2
2.5 m2
5.0 m2
10 m2
Channel path length
16 cm
Hold-up volume Feed/ Retentate
0.17 L
0.44 L
0.65 L
1.17 L
2.34 L
Hold-up volume Permeate
0.16 L
0.40 L
0.58 L
1.03 L
2.07 L
Working volume
1 – 50 L
3 – 150 L
5 – 250 L
10 – 500 L
20 – 1,000 L
Temperature
4 - 40° C
Maximum forward pressure
60 psi (4 bar)
Maximum reverse pressure
7 psi (0.48 bar)
Crossflow @ 10 psi / 0.7 bar
2 - 4 L/min
6 - 12 L/min
10 - 20 L/min
20 - 40 L/min
40 - 80 L/min
Air integrity test pressure
7.3 psi (0.50 bar)
Max air diffusion rate
323 ccm/m2
AseptiQuik connector
G
G
G
G
L
Height
5.9 in (15.0 cm)
7.7 in (19.7 cm)
9.3 in (23.6 cm)
13.1 in (33.3 cm)
20.6 in (52.3 cm)
Diameter
10.0 in (25.4 cm)
Tube stand-off length
7.5 in
6.75 in
6.75 in
6.75 in
7.25 in
Weight (in box)
20 lb (9 kg)
22 lb (10 kg)
24 lb (11 kg)
32 lb (14.5 kg)
47 lb (21.3 kg)
4
1
3
4
5
6
2
2
3
4
4

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Minimum Working Volume
Minimum working volume is influenced by the reservoir used in the TFF process. The user can calculate the minimum working
volume as the TangenX SC TFF device holdup volume plus the lowest volume achievable in the reservoir and system plumbing
without pulling air into the recirculation pump.
3.1 Recommended device storage conditions
TangenX SC TFF must remain sealed in their original packaging prior to use to maintain their characteristics and integrity and to
prevent microbial growth.
Recommended storage temperature:
• 15° C - 25° C (optimal)
• 40° C (maximum)
• Do not freeze devices
4. Pump requirements
The recommended cross flow rate is 4 - 8 LPM/m2. Optimal flow rate will be determined during process development and will
depend on both the solution being processed and equipment setup.
5. Preparing to use the TangenX SC TFF Device
5.1 Required tools and components
The following minimum components are recommended (Table 5); however, the exact system configuration and components will
vary according to user requirements.
Table 5. Minimum recommended components for TangenX SC TFF System
Item
Description
Feed vessel
Gamma-irradiated reservoir bag that holds the feed
Permeate vessel
Gamma-irradiated reservoir bag that collects the permeate
Waste vessel
Gamma-irradiated reservoir bag that collects waste
Water vessel
Gamma-irradiated reservoir bag that contains water that is pushed through the feed input port
Buffer vessel
Gamma-irradiated reservoir bag that contains buffer that is pushed through the feed import port
Collection vessel
Gamma-irradiated reservoir bag that will be used to recover the final product
Inlet port
Port delivering liquid to a vessel or the device
Outlet port
Port transporting liquid way from a vessel or the device
Flow path
Gamma-irradiated assembly of tubing, reservoirs, clamps etc. that connect the TangenX SC TFF Device to a vessel or
one vessel to a second vessel
Pinch clamps
Clamps at each port of the vessel and TangenX SC TFF Device that control the flow of liquid through the system
Pressure sensors
Sensors connected to the TangenX SC TFF Device feed input port, retentate output port, and permeate output port
KrosFlo® System
(or equivalent)
Controls pumps, records sensor data, and displays system status
Peristaltic pump (2)
(1) Delivers feed to the TangenX SC TFF Device feed input port.
(2) Delivers diafiltration buffer to the retentate vessel.
Scale
To determine the volume of water or feed material in a vessel
Flow meter
To measure the flow from the retentate when defining optimal operating conditions
Compressed air supply
Creates pressure during air integrity test

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5.2 Unpackaging the device
Product is double bagged under a partial vacuum. Depending on environmental conditions, the amount of air in the bags will vary. If
vacuum has been lost from the outer bag, the product remains sterile. Follow internal procedures for movement of product into the
production area.
Figure 2. How to pick up the device
6. System set-up
Record the following TangenX SC TFF Device details when setting up a system:
Part number
Serial number
Channel type
MWCO
Surface area
Membrane type
6.1 Installing the TangenX SC TFF Device
When integrating the TangenX SC TFF Device with a closed TFF system, several flow path options are available.
A custom ProConnex® Flow Path from the Repligen library of over 400 components
A pre-built, off-the-shelf ProConnex Flow Path
Genderless connectors to connect to an existing flow path.
WARNING: Do not lift device using fittings or connections. Lift from body of device or handle, if provided. Failure to do so
can result in permanent damage to the device.

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6.1.1 Using AseptiQuik Genderless Connectors
Aseptically connect the TangenX SC TFF Device to the TFF system using the genderless AseptiQuik® connectors from Colder Products
Company (Figure 3, CPC Worldwide Video).
Figure 3. Using AseptiQuik Genderless Connectors
a. Flip the blue pull-tab coxver down towards the hinge to expose the membrane that acts as an aseptic barrier.
Note: Do not remove the hinge or the membrane before the mating connection is made.
b. Align and push the two AseptiQuik connectors together until you hear two clicks.
c. Press the CPC logo on the two blue pull-tab covers to interlock them.
d. Pull on the two blue interlocked tabs to remove the membrane from the connectors.
6.2 TFF System flow path parts
The TangenX SC TFF Device is often used in a closed TFF system for ultrafiltration and diafiltration operations. While the exact flow
path used during these operations varies according to specific user requirements, a general example is outlined here. In this example
(Figure 4), the flow path contains the components included in Table 5.
Note: Retentate and upper filtrate tubing must be supported to prevent kinks and/or reduction in flow.

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Figure 4. System configuration without TangenX SC TFF Device
Legend:
Vessel
Pump
Pinch clamp
Pressure sensor
Genderless connector
Flow meter
For full list of symbols and descriptions, see Table 3.

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6.3 Connecting the TangenX SC TFF Device
Aseptically connect the TangenX SC TFF Device to the extended tube set (Figure 5).
Figure 5. Connecting TangenX SC TFF Device to tube sets
Legend:
Vessel
Pump
Open valve action
Pinch clamp
Pressure sensor
Genderless connector
Flow meter
For full list of symbols and descriptions see Table 3.
1. Connect feed inlet port on the TangenX SC TFF Device to the feed clamp on the extended flow path with the feed pressure
sensor.
2. Connect retentate outlet port on the TangenX SC TFF Device to the retentate clamp on the extended tube set with the
retentate pressure transducer.
3. Connect permeate outlet on the TangenX SC TFF Device to the permeate clamp on the extended flow path with permeate
pressure transducer.
4. Confirm that all the clamps are closed (Figure 6).

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Figure 6. System configuration with all pinch clamps closed
Legend:
Vessel
Pump
Off; Closed flow path
Pinch clamp
Pressure sensor
Genderless connector
Flow meter
For full list of symbols and descriptions see Table 3.
6.4 Estimate hold-up volume
Estimate the hold-up volume of the system based on user engineering diagrams. Sum the volume of the tubing and the hold-up
volume of the TangenX SC TFF Device (Table 4). The hold-up volume of the TangenX SC TFF Device includes the tubing that
terminates with AseptiQuik connectors. The appropriate flow path for hold-up volume estimation includes:
From the outlet of the retentate vessel to the feed inlet port of the TangenX SC TFF Device.
From the TangenX SC TFF Device retentate outlet port to the inlet port of the retentate vessel.

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Figure 7. System configuration showing flow path for hold-up volume
Legend:
Vessel
Pump
Off; Closed flow path
Pinch clamp
Pressure sensor
Hold-up volume
Genderless connector
Flow meter
For a full list of symbols and descriptions see Table 3.
6.5 Device flush
Flushing the TangenX SC TFF Device with water for injection (WFI) or reverse osmosis/deionized water (RODI) removes 0.2 M NaOH
present in the shipped product.
6.5.1 Flush the TangenX SC TFF Device retentate flow path
1. Tare the scale. Place the water vessel on the scale and record the weight.
2. Route tubing through the feed pump.
3. Open pinch clamps to create a path from water vessel to waste vessel (Figure 8).
a. Open clamps between the water vessel outlet port and TangenX SC TFF Device feed port.
b. Open clamps between TangenX SC TFF Device retentate port and the waste vessel inlet port.
c. Close all other clamps.

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Figure 8. System configuration for retentate port WFI flush
Legend
Vessel
Pump
Configuration change
Pinch clamp
Pressure sensor
On; Open flow path
Genderless connector
Flow meter
Off; Closed flow path
Scale
For full list of symbols and descriptions, see Table 3.
4. Start the pump using an appropriate crossflow rate (Table 6) to begin flushing water through the TangenX SC TFF Device
into the waste vessel.
Note: Do not exceed feed pressure of 30 psig (2 bar).
5. Stop the pump after 5 L/m2of water has been removed from the water vessel (Table 7).
6. If continuing directly to flushing permeate flow path, go to Section 6.5.2. If pausing for an extended period of time, close all
pinch valves.
Table 6. Recommended crossflow (CF) rates
Cross flow range
Low crossflow
Medium crossflow
High crossflow
ΔP
L screen
4 - 8 L/min/m2
4 L/min/m2
6 L/min/m2
8 L/min/m2
10 psig (0.7 bar)1
1Typical P measured with water and permeate closed.

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Table 7. Normalized TangenX SC TFF Device flush volumes
TFF filter surface area
Retentate to waste
Permeate to waste
0.5 m2
2.5 L
5 L
1.5 m2
7.5 L
15 L
2.5 m2
12.5 L
25 L
5 m2
25 L
50 L
10 m2
50 L
100 L
6.5.2 Flush the TangenX SC TFF Device permeate flow path
1. Tare the scale. Place the water vessel on the scale and record the weight.
2. Open pinch clamps to create a path from with water vessel to the waste vessel (Figure 9).
a. Open clamps between the water vessel outlet port and the TangenX SC TFF Device feed port.
b. Open clamps between the filtration device permeate port and the waste vessel inlet port.
c. Close all other clamps.
Figure 9. System configuration for permeate port WFI flush
Legend
Vessel
Pump
Configuration change
Pinch clamp
Pressure sensor
On; Open flow path
Genderless connector
Flow meter
Off; Closed flow path
Scale
For full list of symbols and descriptions, see Table 3.

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3. Start the pump with a low crossflow rate (approximately 10% of recommended crossflow rate (Table 6) to flush water
through the permeate path of the TangenX SC TFF Device into the waste vessel.
4. Increase crossflow rate slowly until the transmembrane pressure (TMP) reaches 10 - 15 psig (0.7 - 1 bar).
5. Stop the pump after 10 L/m2of water has been removed from the water vessel (Table 7).
6. If continuing directly to air integrity testing, go to Section 6.6. If pausing for an extended period of time, close all pinch
valves.
6.6 Air integrity test
The air integrity test non-destructively and quantitatively verifies the integrity of the TangenX SC TFF Device and confirms
performance meets the air integrity specifications (Table 8). Each TangenX SC TFF Device undergoes strict release testing, including a
constant pressure forward-flow air diffusion integrity test to verify the integrity of the device up to the point of shipment. However,
due to uncertainties associated with the shipping processes, this guarantee does not extend to point of receipt or time of use.
Therefore, Repligen recommends executing an integrity test immediately prior to running the process. A detailed procedure (UG-
3118 TangenX TFF Cassette Air Integrity Testing) for the measurement of air integrity can be obtained at repligen.com or by
contacting Repligen support.
Note: An air integrity test should be performed after device flushing as it measures air diffusion through a wetted membrane.
Table 8. TangenX SC TFF Device air integrity specifications
Surface area
Flow rate
(ccm1@ 0.5 bar/7.3 psig)
0.5 m2
≤161.5 ccm1
1.5 m2
≤484.5 ccm1
2.5 m2
≤807.5 ccm1
5 m2
≤1615 ccm1
ProStream and HyStream Membranes
10 kD - 300 kD MWCO
10 m2
≤3230 ccm1
11 ccm = 1 mL/min
Integrity specification: ≤323 ccm/m2
7. Process execution
7.1 Buffer equilibration
Equilibrating the TangenX SC TFF Device with buffer prepares the system for introduction of product.
7.1.1 Equilibrate the TangenX SC TFF Device retentate flow path
1. Tare the scale. Place the equilibration buffer vessel on the scale and record the weight.
2. Open pinch clamps to create a path from the equilibration buffer vessel to the waste vessel (Figure 10).
a. Open clamps between the equilibration buffer vessel outlet port and the filtration device feed port.
b. Open clamps from the filtration device retentate port to the waste vessel port.
c. Close all other clamps.

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Figure 10. System configuration for retentate outlet port buffer equilibration
Legend
Vessel
Pump
Configuration change
Pinch clamp
Pressure sensor
On; Open flow path
Genderless connector
Flow meter
Off; Closed flow path
Scale
For full list of symbols and descriptions, see Table 3.
3. Start the pump using an appropriate crossflow rate (Table 6) to begin flushing equilibration buffer through the filtration
device into the waste vessel.
Note: Do not exceed feed pressure of 30 psig (2 bar).
4. Stop the pump after 5 L/m2of equilibration buffer has been removed from the equilibration buffer vessel (Table 7).
5. If continuing directly to flushing the permeate flow path with equilibration buffer, go to Section 7.1.2 . If pausing for an
extended period of time, close all pinch valves.
7.1.2 Equilibrate the TangenX SC TFF Device permeate flow path
1. Tare the scale. Place the equilibration buffer vessel on the scale and record the weight.
2. Open pinch clamps to create a path from the equilibration buffer vessel to the waste vessel (Figure 11).
a. Open clamps between the equilibration buffer vessel port and the filtration device feed inlet port.
b. Open clamps between the filtration device permeate outlet port and the waste vessel inlet port.
c. Close all other clamps.

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Document Number:UG-4457 Revision: 1 Effective Date: 9/27/2023 Legacy Document #: N/A
Page 20 of 31
User Guide
TangenX® SC TFF Device
Figure 11. System configuration for filtration device permeate outlet port buffer equilibration
Legend
Vessel
Pump
Configuration change
Pinch clamp
Pressure sensor
On; Open flow path
Genderless connector
Flow meter
Off; Closed flow path
Scale
For full list of symbols and descriptions, see Table 3.
3. Start the pump with a low crossflow rate (10% of recommended crossflow rate; Table 6) to flush equilibration buffer
through the permeate path of the filtration device into the waste vessel.
4. Increase pump crossflow rate slowly until the TMP reaches 10 - 15 psig (0.7 - 1.0 bar).
5. Stop the pump after 10 L/m2of equilibration buffer has been removed from the equilibration buffer vessel (Table 7).
6. If continuing directly to product introduction, go to Section 7.2. If pausing for an extended period of time, close all pinch
valves.
7.2 Product introduction
Prior to initiating optimization, concentration, and/or diafiltration, the product is introduced to the system by filling the retentate
vessel and recirculating the product through the filter.
1. Tare the scale. Place the retentate vessel on the scale and record the weight.
2. Open pinch clamps to create a path from the product vessel, through the filtration device to the retentate vessel
(Figure 12).
a. Open clamps from the product vessel outlet port to the filtration device feed port.
b. Open clamps from the filtration device retentate port to the retentate vessel inlet port.
c. Close all other clamps.