Data Sheet

Mobius® FlexReady Solution

with Flexware® Assemblies for
Chromatography and TFF
For clinical development and manufacturing of
biopharmaceuticals and process-scale applications.
The Mobius® FlexReady Solution with Flexware®
Assemblies for Chromatography and TFF is now the
most flexible system available, allowing customers
to have a single, scalable system that can switch
between chromatography and tangential flow
filtration (TFF). The fully automated system is
designed to achieve separation and purification of
MAbs, vaccines, plasma and therapeutic proteins.

The Mobius® FlexReady Solution with Flexware®

Assemblies for Chromatography and TFF delivers
optimal operational flexibility. Unlike traditional
single-use technology, the system is quick and easy
to set-up, requiring only a minimum number of
components. And with our innovative single-use
flow paths, contamination is no longer a threat,
giving you the confidence you need to tackle any
chromatography and TFF challenge.

Benefits
• 
Standard hardware platform supports multi-unit
operation, multi-product and multi-scale production
maximizing the flexibility of high-value investments
• F lexware® single-use assemblies provide ease-
of-use, robust reproducibility and elimination of
carryover from previous batches
• 
Comprehensive services ensure rapid
implementation and optimized performance
• 
Supports industry leading resins and devices such as
Fractogel® resin, Eshmuno® resin, ProSep® Ultra Plus
resin, and Pellicon® cassettes

• 
Full process automation enables you to easily and
consistently produce clinical and preclinical scale
quantities of high-value drug products

EMD Millipore Corp. is a subsidiary of Merck KGaA, Darmstadt, Germany

 Flexware® Assemblies
The USP class VI and Animal Free or EMEA compliant Flexware® single-use assemblies deliver
equivalent performance to that of traditional stainless steel systems, while maximizing system
flexibility. Flexware® assemblies are clearly labeled, significantly reducing the risk of operator
error and the challenges typically associated with installing single-use flow paths. What’s more,
our groundbreaking flow path eliminates moving parts and minimizes dead space, decreasing
the risk of contamination to virtually zero.

To/from column top

Chromatography Flow Path To post-column instrumentation

From post-column instrumentation

From bubble trap vent
To fraction 1
Vent outlet
To fraction 2
From bubble trap
To fraction 3
To bubble trap
To waste

From/to column bottom

From pump 2 From pre-column instrumentation

From pump 1 To pre-column instrumentation

From prefilter

To drain

To prefilter

TF2S Flow Path

To filtrate collection

From transfer pump From membrane upper filtrate

To recycle bag
From membrane outlet

From feed pump

To membrane inlet

From membrane lower filtrate

Drain Lower filtrate drain

To product recovery
2
Benefits
• 
Gamma irradiated and ready to use, reducing
set-up time
• 
Highly automated system increases robustness and
consistency of production processes
• 
Reduced number of connections versus traditional
single-use, reducing risk of integrity failure
• 
The main flow paths are 100% Integrity Tested
during manufacturing ensuring robust performance
• 
Reduced dead legs maximizes product purity
& DF efficiency

3
 System Hardware
The Mobius® FlexReady Solution with Flexware® Assem-
blies for Chromatography and TFF are independent of
application or scale, allowing production facilities to
maximize the return on their investment.
Designed for maximum portability, the system’s Cart
does not exceed the standard height and width of a
door. In addition, the system has been designed to allow
a single technician to be able to manage, maintain and
switch applications via the use of accessories to lift
and store application components.
The Mobius® FlexReady Solution with Flexware® Assem-
blies for Chromatography and TFF also uses a combination
of keyed assemblies and clear labeling to ensure that carts
and Flexware® assemblies are easy to install, therefore
reducing the risk of leaks or loss of product.
Chromatography Configuration
Inlet Manifold
Pump Cart
4
Cart
The Cart is the heart of the system and houses the
clamshell and automation software for all applications.
The automation software, Common Control Platform®
(CCP®), allows central control of all pumps and valves on
the Cart and any connected carts. In addition, it permits
application recipes to be edited and stored for multiple
applications, reducing the need for multiple automation
systems. At the Administrator access level, recipes can
be shared from one Cart to another via a mass storage
device, which ensures outdated recipes are not used in
multi-system facilities.
This system, which is designed to operate in cGMP
facilities for clinical and commercial production
of therapeutic products, complies with GAMP 5
recommendations for automation software and
fulfills FDA guideline 21 CFR Part 11 requirements
for electronic records and signatures.
Pre and Post-Column
Sensors
Cart
Pre and Post-Column and TFF Filtrate
Sensor Instrumentation
The system gives production managers the option to
choose multi or single-use sensors without having to
sacrifice performance in favor of reducing cleaning or
risk of carryover. The performance characteristics of
single and multi-use sensors are the same giving you
the flexibility to develop processes with one approach,
and scale up with another sensor approach.
The hardware for receiving and transmitting data is
the same regardless of single or multi-use approach
increasing the flexibility of your facility. The system
enables production managers to balance economy,
TFF Configuration
Low Shear Mixer
Tank Cart
Inlet
Manifold Pump Cart
cleaning efforts and value of the product by choosing
between single-use or multi-use pre and post-column
sensors for chromatography and TFF filtrate instrumen-
tation. The UV and conductivity single-use sensors are
factory calibrated and supplied with the Flexware®
assemblies, reducing effort and risk of installation
error. The pH probe can be used in the multi-use and
single-use flow cell for maximum accuracy and flexibility.
The pH probe can be either cleaned or disposed of after
each batch as best suits the process.
TFF Filtrate Sensors
Cassette Holder
Cart
5

The clamshell lift enables
easy, safe and rapid clamshell
installation and removal
for application and scale
changeover.
Clamshells, Lift and Storage Rack
To maximize the value of the system, additional
clamshells to support both TFF and chromatography
applications and various flow rates can be purchased
to optimize system performance. An optional
clamshell lift and storage rack are also available,
which allows a single operator to safely change the
clamshell, minimizing any health and safety issues.
The clamshell rack can accommodate up to four
clamshells allowing for maximum flexibility of any
individual system while reducing the risk of damage.
6
Clamshell Lift Clamshell Storage Rack
TFF Cassette Holder
The TFF system includes a Pellicon® cassette holder
adapted to utilize single-use liner plates, which
isolates the process fluid from the holder endplates in
order to achieve robust membrane compression while
eliminating cleaning and validation effort.
QuikScale® Chromatography Columns
Designed to achieve ultra high throughput, our
robust QuikScale® columns are easily packed to
deliver optimal resolution across a wide range of
chromatographic applications, accommodating
all media types.
Chromabolt® Chromatography Columns
For further scale up in an easy prepacked column
format, EMD Millipore offers Chromabolt® columns
in different column diameters (10 cm, 20 cm, 32 cm)
all with a 20 cm bed height.
Chromabolt® Chromatography
Column (left)
QuikScale® Chromatography
Column (right)
 Mobius® FlexReady Solution with Flexware® Assemblies for
Chromatography and TFF
Featuring Industry Leading Chromatography Media
(Affinity and Ion Exchange) and TFF Cassettes
Eshmuno® Resin
Unique family of ion-exchange resins
specifically designed for highly productive
downstream purification
Fractogel® Resin
Tentacle modified synthetic polymer resins for
ion exchange, hydrophobic interaction, size
exclusion and metal chelate affinity
Chromatography System Performance
The pumps are rated from 0 - 20.0 L /min. with optimum
validated performance for Chromatography achieved
between 0.1- 8.0 L /min. With a flow rate range between
0.1 – 8.0 L /min. and a pressure rating of 4 bar (58 psi),
the Mobius® FlexReady Solution with Flexware® Assem-
blies for Chromatography is suited to a wide range of
chromatographic separation techniques and column
sizes. The system is also compatible with membrane
adsorbers adding to the overall flexibility required by
clinical development and manufacturing facilities. The
separation techniques include ion exchange, affinity,
hydrophobic interaction and gel filtration, in column
diameters ranging from 50 mm to 450 mm, depending
upon the application.
ProSep® Ultra Plus Resin
The highest dynamic binding capacity protein
A affinity chromatography media, designed for
cost effective, large-scale purification of today’s
higher titer therapeutic antibodies
Pellicon® Cassettes
These advanced, high-performance cassettes are
ideal for today’s higher titer therapeutic antibodies
as well as the more demanding filtration processes
that require higher operating pressures, temperatures
and caustic cleaning regimes.
The Mobius® FlexReady Solution with Flexware®
Assemblies for Chromatography performance is
documented in the system performance guide. The
following data highlights some examples of key
performance indicators.
The system is designed to deliver gradients using an
optional pump based mixing at an accuracy of +/- 2%
over a 10 - 90% gradient mix range (Figures 1, 2 and 3).
Figures 1 and 3 compare the actual and programmed
linear gradients at 0.1 and 8 L /min. The accuracy and
linearity of the actual gradients at both flow rates in the
10 - 90% range is clearly evident in the following figures
allowing application development, where separation and
recovery optimization is important, in a reproducible and
scalable way.
7
 0.5 1.2
7 8 1.2

Presssure Drop
Pressure
Error %
7 0 8 1
1 12
0.8
12 0.8
-.5
0.6 0.6
120-1.0 120
120 120 0.4 0.4
Figure 1. (left) 100-1.5 100 0.2 0.2

Gradient %
100 100
Comparison of actual

Gradient %
Gradient %
80 -2.0 80 0 0

Gradient %
and programmed linear 80 0 80 100 120 80 0 2 4 6 8 10
20 40 60 0
gradients at 0.1 L /min. 60
60 Gradient % 60 Flow Rate (LPM)
60
Figure 2. (right) 40
40
40
Comparison of actual and 40
20
programmed step gradients 20 20
20
at 0.1 LPM. 0
0 7 0 8
0 0 10 20 30 40 50 60 70
0 30 40 50 60 70 80 90 0 10 20 30 40 50 60 70 80 90 0 10 20 30 40 50 60 70
20 30 40 50 60 70 80 90 0 10 20 30 40 50 60 70 80 90 Time (minutes)
Time (minutes) Time (minutes) Time (minutes)
Time (minutes) Time (minutes) Actual Gradient Programmed Gradient
dient 1 Gradient
Programmed
120
Actual Gradient 1 2 Gradient
Programmed
120 Actual Gradient 25
Programmed Gradient 120
radient Programmed Gradient Actual Gradient Programmed Gradient
100 100 100

Gradient % Gradient %
Gradient %Gradient %

%Gradient %
120
80
120 120
80
120 80
120
Figure 3. (left) 60
100
60
100 100
60
100 100
Comparison of actual
Gradient %

16 17

Gradient %
40
and
16 programmed linear 4080
80 17 80
40
80 80

Gradient
gradients at 8 L /min. 20
460
20
60 20
60
60 60
4
3.5 0
Figure 4. (right) 03.5
40 400
40
3 40 40 0
Comparison of actual and 30 10 20 30 40 50 60 70 80 90 0 10 20 30 40 50 60 70 80 90
2.520
programmed step gradients 202.5
Time (minutes)
20
20
Time (minutes) 20
at 4 L /min.
UV

2 Ac
UV

2
1.50 0 Actual Gradient Programmed Gradient 00 Actual Gradient Programmed Gradient 0
20 30 40 50 60 70 80 90 1.5 0
1 0 1010 2020 3030 4040 5050 6060 7070 8080 9090 00 20 20 40 30 6040
10 80 60100 70 12080
50 140
90 0
Time (minutes) 1 Time(minutes)
(minutes) Time (minutes)
0.5 Time
0.5
radient Programmed Gradient 0 Actual
Actual Gradient Programmed
Gradient Programmed Gradient
Gradient Actual Gradient
Actual Gradient Programmed Gradient
Programmed Gradient Ac
0
20 30 40 50 60 70 0 10 20 30 40 50 60 70
20 30 40 50 60 70 0 10 20 30 40 50 60 70
Column Volumes Column16Volumes 17
Column Volumes Column Volumes
ale Bench Scale Process Scale Bench Scale
Scale Bench3Scale Process Scale Bench4Scale

3.5
42.5
4 3
Chromatography
4
3.5
Scalability
46
Figure 5. 2.0
2.5 2.0
3 2 3
Process performance 3 Figure 2 5 demonstrates loading and elution profiles
1.5 1.5
2.51.5 2.5
comparison with obtained
1.0 using a bench-scale system and the
1.5
bench scale 1.0
UV

UV

2 1 2
1
1.5 .5
Mobius®
1.5
FlexReady Solution with Flexware®
0.5
.5 0.5
1
Error%%

Assemblies for Chromatography.

Error %

Error %
Error %

1 0 10
0 0
Error

0-.5
0.5 0.5
-.5
-.5 -.5
0 Protein 0
-1 -1 -1 A chromatography was carried out using the
-1.0 -1.0
0
-1.5 10 20 30 40 50 60 70 -1.5 0 10 20 30 40 50 60 70
-2 -2 2.2 L-1.5
/min system to capture a monoclonal antibody
Column Volumes -2 Column Volumes -1.5
from a clarified cell culture harvest. A QuikScale®
-3-2.5 Process Scale Bench Scale -2.0
-2.5 Process Scale Bench Scale -2.0
40 60 80 100 120 0 0 20 20 40 40 60 60 80 80 100100 120120 100 mm00 column1020 was20 packed
30
40 40with
60 50ProSep®
80 Ultra
60 70 100Plus
80 120
90 0
Gradient % Gradient
Gradient %% media (bed height =Programmed
20 cm). TheGradient
Gradient capture
% %step was
100) Error (10-90) Error
Error (0-100)
(0-100) Error
Error (10-90)
(10-90) executed at a residence
Error (0-100) time(10-90)
Error of 3 minutes. Figure
5 illustrates the chromatograms obtained from the
9 9 10 process on both a bench scale10 11and 2.2 L/min system.
32.5 The alignment
2.5
2.5 of the chromatograms on the x-axis 2.5
2 demonstrates
22 that a bench-scale process can be 2
21.5 1.5
1.5 1.5
successfully scaled up using the 2.2 L/min system.
1 11 1
1
.5 .5
.5 .5
Error %

%
Error %

Error %
Error %

0 00 0
0
Error

Tangential
-1 -1
Flow Filtration System Performance
-.5
-1
-1
-.5
-.5 -.5
-1
-1.5 -1.5
-1.5 -1.5
The Mobius®
-2 FlexReady Solution with Flexware® Assem-
-2 addition
-2
-2
to the feed pump and retentate valve control -2
blies -3for
-2.5 Tangential Flow Filtration is optimized and loops,
-2.5
-2.5 the system also includes an automated flow -2.5
40 60 80 100 120 validated 0 for a20feed flow
0 20
40 capacity
40
60 up to 80
60 4080L /min.
100 and120
100 120 control valve on
0
0 20 the filtrate
20 40 line60
40 to enable
60 80open 100
80 UF and120
100 120 0
Gradient % a membrane holder that can Gradient %
accommodate
Gradient % from 0.5 to Gradient
Gradient %%
MF operations, increasing the overall flexibility for
100) Error (10-90) Error (0-100) Error (10-90) Error (0-100)
Error (0-100) Error (10-90)
Error (10-90) E
10.0 m2 ofError (0-100)
Pellicon® Error (10-90)
devices, making it suitable to a wide clinical development and manufacturing facilities.
range of concentration and diafiltration processes. In

13 1314 1514
8 2.0 2.0
2.0
1.8 1.8
1.51.8 1.61.8 1.6
Tangential Flow Filtration System Performance
The Mobius® FlexReady Solution with Flexware® Assem- The system includes several unique design features that
blies for Tangential Flow Filtration is optimized and make it especially suited to demanding final concentration
validated for a feed flow capacity up to 40 L /min. and and buffer exchange applications where the ability to
a membrane holder that can accommodate from 0.5 to accommodate elevated protein viscosity, low final volume,
2.5 m2 of Pellicon® devices, making it suitable to a wide and high purity requirements is key to process success.
range of concentration and diafiltration processes. In Feed pump capability and line pressure drop were tested
addition to the feed pump and retentate valve control with solutions up to 40 cP, giving you confidence in
loops, the system also includes an automated flow your operation as protein concentration increases. The
control valve on the filtrate line to enable open UF recycle container and flowpath were designed to enable
and MF operations, increasing the overall flexibility for recirculation at process flow rates with a minimum
clinical development and manufacturing facilities. product volume while maintaining adequate mixing and
avoiding vortexing or air entrainment (Figure 6).
A variety of recycle vessel configurations are available
with the Mobius® FlexReady Solution to provide
The Flexware® assembly includes innovative valving where
maximum process capability. In addition to different
the transfer and product recovery lines intersect with the
vessel volumes, users can select a plastic carrier or a
recirculation flowpath. By replicating the functionality
double-jacketed carrier, depending on whether or not
of traditional stainless steel zerostatic valves, deadlegs are
temperature control is required. All recycle vessels come
eliminated in the critical product path to maintain product
with integrated load cells, mixer, and temperature sensor,
purity and enable highly effective buffer exchange for
and have been designed such that the containers can be
demanding final UFDF operations (Figure 7).
easily and accurately installed by a single operator. For
even greater plant flexibility, the recycle vessel skids have
a built-in “stand-alone” setting where they can be used
as a mix container decoupled from the TFF system.

The Mobius® FlexReady Solution with Flexware®

Assemblies for TFF performance is documented in the
system performance guide. Some examples of key
performance data are highlighted on the right.

Figure 6.
Product Yield and Dilution versus Buffer Displacement Volume Minimum Working Protein YieldVolume and Mass Balance for two Produc
of TF-2SRecovery
versus Feed Flow
Recovery of 2 L of 50 g/L hlgG from TFF system after concentration with 1.1 m² 30kD Pellicon® 3 Cassettes with Ultracel® Membrane
of 2 L of 50 g/L hlgG from TFF system after concentration with 1.1 m² 30kD Pel
Minimum Woking Volume versus Feed Flow Rate
Data reflects working with no membranes installed - add 90mL per 0.5 m2 of membrane 100
100 100 Rate at 20 cP not including
Final Pool Concentration [% of target]

cassette
90 holdup volume (left)
2.5
95 95 80
Minimum Working Volume [L]

Product Yield [%]

2.0 70
90 90
Figure
60 7.
Yield [%]

1.5
85 85 Innovative
50 flowpath provides
Zero-Deadleg
40 Valving for
1.0
80 80
excellent Buffer Exchange
30
and Purity (right)
20
0.5
75 75
0 100 200 300 400 500 600 10
0.0 Buffer Displacement Volume [mL] 0
0 2 4 6 8 10 12 14 16 18 20 Yield Concentration Air Blowdown Buff
Feed Flow Rate [L/min] Recovery from Recycle Displacem
Bag and Feed Tubing Tubing an

9
 At the end of concentration and diafiltration operations, flowpath lines and membrane channels (Figures 8 and 9).
achieving maximum recovery of product from the This provides flexibility for users who can select a product
system is essential for process success. A straightforward recovery strategy that is most in line with their specific
sequence of steps has been developed to maximize process objectives, knowing that either choice will result
product yield during recovery. The method can be carried in success.
out using either air or buffer to displace product from the

d Dilution versus Buffer Displacement Volume Protein Yield and Mass Balance for two Product Recovery Methods
F system after concentration with 1.1 m² 30kD Pellicon® 3 Cassettes with Ultracel® Membrane
Recovery of 2 L of 50 g/L hlgG from TFF system after concentration with 1.1 m² 30kD Pellicon® 3 Cassettes with Ultracel® Membrane

100 Product Yield and Dilution versus Buffer Displacement Volume

100 Recovery of 2 L of 50 g/L hlgG from TFF system after concentration with 1.1 m² 30kD Pellicon® 3 Cassettes with Ultracel® Membrane
Recove
Minimum Woking Volume versus Feed Flow Rate
Final Pool Concentration [% of target]

90 Data reflects working with no membranes installed - add 90mL per 0.5 m2 of membrane 100
100 100

Final Pool Concentration [% of target]

95 80 90
2.5
70 95 95 80
[%] [L]

90

Product Yield [%]

60 2.0 70
Volume

90 90
50
Minimum WorkingYield

85 60

Yield [%]
40 1.5 50
85 85
80 30 40
1.0
20 80 80 30
75
200 300 400 500 600 10 20
0.5
75 75
uffer Displacement Volume [mL] 0 0 100 200 300 400 500 600 10
Yield Concentration Air Blowdown Buffer Displacement
0.0 Buffer Displacement Volume [mL] 0
0 Recovery
2 4
from 6
Recycle 8 10 Displacement
12 14 from
16 Retentate
18 20 Yield Concentration
Bag and Feed Tubing Tubing and Membrane Channels
Feed Flow Rate [L/min]

Figure 8. Figure 9.
Proven Methodology for High Product Recovery Product Dilution during Recovery with Buffer can be
Using Air or Buffer Displacement using TF-2S Minimized while Achieving High Product Yield

10
The Provantage® implementation
service approach
Our approach revolves around your specific needs and
requirements so that we can best address your concerns.
The Provantage® Implementation services for Mobius®
FlexReady Solution with Flexware® assemblies for
Chromatography and TFF are tailored to solving your
challenges, saving you significant time.
To help us understand your specific needs, we will
send you an application questionnaire that will inquire
about your process requirements. Once we receive
the completed questionnaire, we will send you the
appropriate protocols for your qualifications service.
Our team of experts will meet your team so that
together we can determine who will be servicing
your product onsite.
In addition, we will send you a letter prior to the service,
listing all of the tools, materials and expendables you
will need to prepare before our engineer arrives.
Once the implementation service has been performed,
our engineer will create an intervention report for
your approval and signature.
Comprehensive range of
value-added services
All of our Provantage® services include a team of
experienced engineers who are personally committed to
ensuring your processing success and will partner with
you to overcome any challenge.
Site acceptance test, installation and
operational qualification (SAT, IQ/OQ)
Our pre-written service protocols contain procedure and
acceptance criteria to ensure your Mobius® FlexReady
system with Flexware® assemblies is fully operational
and easily validated on site. Completing IQ/OQ with our
service protocols ensures your system will function as
specified in cGMP environments.
The support includes one on-site visit by a qualified field
service engineer to perform the Site Acceptance Test,
Installation and Operational Qualification Protocol in
compliance with cGMP regulations, and verification of:
• System documentation and identification
• Instrument and component installation
• Electrical and pneumatic specifications
• Instrument transmitter and converter settings
• Software and pump frequency drivers
In addition, all of the controllers, alarms, graphical
interfaces, bubble trap level switches, critical alarms,
minimum/maximum flow rates of the pumps and
valves are verified and tested.
As a pre-requisite to the SAT, IQ/OQ service, our field
service engineers can install and start the system, as
well as run tests.
Operator training
While we have some of the most knowledgeable Service
Engineers in the industry, our most beneficial service
may be training your people. This is especially true if
you experience high turnover or a rapid ramp-up.
Designed for pharmaceutical, biotechnology, and
medical device manufacturing personnel who operate
downstream processing equipment, our interactive
course provides an overview of the Mobius® FlexReady
system with Flexware® assemblies. Installation of
Flexware® assemblies and Common Control Platform®
(CCP®) use are also described and practiced in hands-on
sessions. To satisfy cGMP requirements, course graduates
will receive a certificate upon completion.
With us as your guide, your operators will be better
prepared to operate and manage your Mobius®
FlexReady system with Flexware® assemblies with
greater confidence.
11
 CCP® Recipe design Support for performance qualification
Every process is unique and to ensure that your system Performing the qualification of your whole process
is optimised to deliver the best seperation or recovery with new equipment can be challenging. To help with
performance, our biomanufacturing engineers will trans- this step, our biomanufacturing engineers can assist
late your process into your own CCP® recipe in order to you with targeted advice, in order to allow you to
maximise the performance of your Mobius® FlexReady focus on your own process.
system with Flexware® assemblies to your process
The support includes one on-site visit by a trained
biomanufacturing engineer to assist you while you
perform your qualification, preparation of the equipment,
CCP® Training
dry run your process recipe, and support
If your system will be used in process development
for real run during the qualification, for which you
or support many different moleculesand and need to
will remain the owner.
rapidly adapt your Mobius® FlexReady system with
Flexware® assemblies to new process characteristics,
our biomanufacturing engineers can also provide you
with a specific training, including a hands-on session
so that you are able to create and manage your own
recipes and system.

Services packages
We offer a wide range of comprehensive packages to meet your unique manufacturing requirements,
resulting in peace of mind and maximum operational flexibility.

CCP® Recipe
SAT IQ/OQ Operator training Design CCP® Training Support for PQ
Qualification package
non-cGMP
• •
Qualification package GMP
• • • •
Single molecule non cGMP
package
• • • •
Multi Molecule cGMP package
• • • •
Single Molecule cGMP package
• • • • •
Full cGMP package
• • • • • •
Full cGMP Package is designed for 2 to 4 attendees at manufacturing site and delivered by a Qualified Field Service Engineer and/or a Biomanufacturing
Science Engineer. Upon completion a Certificate of Achievement will be delivered.

12
General Specifications
Pressure Rating Up to 4 bar (58 psi)

Environmental Temperature Range 2 – 30 °C (TF3S 20 - 30 °C)

Process Connection Type Colder CPC and TC connections

Humidity 10-90 % (non-condensing)

Utility Requirements Compressed air: 6 bar minimum (oil free). Maximum consumption: 4 L/min
Electrical supply1; 110/240 @ 50/60 Hz., 1 phase (TF3S Pump Cart requires
additional 3 Phase supply)
Power consumption: 1.1 kVA (TF3S 3.7 kVA)
Electrical cable with CN, EU, JP, NA or UK plugs delivered with
the system
Wetted Materials PureFlex™ film, Platinum cured silicone tubing, PE fittings and Inline
*Not on TFF Sampler**, Polysulfone flow cell (SUC) and TFF cassette/ Liner**, PP TC con-
**TFF Only nections, Polysulfone connections, SS316 L (flowmeters* and conductivity
pins on SUC), PP pump body, Santoprene® pump diaphragms, EPDM pump
non-return valve, quartz UV cell windows , PFA* (flow meter body), USP
Class VI, Animal Free or EMEA/410/01 compliant.
Electrical Enclosure IP 65

Electrical Compliance CE (2006/95, 2004/108, 2006/42/EEC) Certified

UL508A Compliant
PSE Exempt

Chromatography Specifications
Flow Rate 0.1 - 2.2 L/min & 1.6 – 8.0 L/min

Process Fluid Temperature Range 2 – 30 °C

Buffer/Solvent Inlets 2 times 5 inlets

Column Connectivity 3/4 in. TC connection

Pipe Work Inside Diameter 1/4 in. and 3/8 in. ID

Gradient Capability 10 – 90 % accuracy : +/- 2%

Fraction Ports 3 + 1 waste

Holdup Volume Chromatography buffer to waste:

(Bubble trap bypass, filter by pass and column bypass)
Sample to column: 300 mL (2.2 L/min) and 550 mL (8.0 L/min)
Bubble trap (full): 1.1 — 1.9 L small scale and large scale
Dimensions Height: 175 cm (69 in.)
Width: 172 cm (68 in.)
Depth: 88 cm (34 in.)
Uncrated Weight 649 kg (1433 lb)

13
 TFF Specifications
Membrane Holder Capacity 0.5 to 5.0 m² & 2.0 to 10.0 m²

Feed Flow Rate 2.0 – 20 L/min & 4.0 - 40.0 L/min

Feed Flow Measurement Flow is calculated to an accuracy of +/- 10% MV

Filtrate Flow Measurement Flow is calculated to an accuracy of +/- 5% MV (between

0.5-8.0 LPM) using the optional external 0-600 kg floor weigh
scale, optional flowmeter or custom weigh scale.
Process Fluid Temperature Range 2 – 45 °C

Inlets 5 inlets (air plus 4 fluids)

Pipe Work Inside Diameter
Outlet Ports
TF - 2S 3/4 in. (Inlet Manifold), 5/8 in.
(recirculation loop), ½ in. (Filtrate & Diafiltration lines), 3/8 in.
(Product Recovery & Drains) ID
TF - 3S 3/4 in. (Inlet Manifold), 3/4 in. (recirculation loop), 5/8
in. (Filtrate & Diafiltration lines), 1/2 in. (Product Recovery &
Drains) ID
1 drain, 1 Recovery, 1 Filtrate

Minimum Working Volume TF - 2S - 2.0 L with 2.5 m2 Pellicon® Cassette at 10 .0 L /min

feed flow rate
TF - 3S <6.0 L with 8.0 m2 Pellicon® Cassette at 10 .0 L/min
feed flow rate

Dimensions Height: 200 cm (79 in.)

Width: 216 cm (85 in.)
Depth: 97 cm (38 in.)
TF3S Depth: 105 cm (41 in.)
Uncrated Weight TF - 2S - 980 kg (2160 lb)
TF - 3S - 1010 kg (2227 lb)

TFF Sensor Performance

Sensor Type Range Accuracy
Pressure Sensors 0 - 4 bar +/- 0.2 bar

Optional Filtrate 0 – 200 µS/cm +/- 2% FS

Conductivity default range is
0 - 100 µS/cm
Tank Temperature 2 - 45 °C +/- 2 °C
Optional Filtrate UV 0 – 2 AU +/- 2% FS
(wavelengths
280/300 nm)
Tank Weight 0 - 50 kg +/- 0.3% FS
0 – 100 kg
0 - 200 kg

Chromatography Sensor Performance

Sensor Type Range Accuracy
Pressure Sensors 0 - 4 bar +/- 0.2 bar

Flowmeter 2.2 L/min: 0.1 – 2.2 L/min +/- 1% MV

8.0 L/min: 1.6 – 8 L/min +/- 1% MV

Multi-use conductivity 0 – 200 mS/cm +/- 2% FS

default range is
0 - 50 mS/cm
Single-use conductivity 0 – 150 mS/cm +/- 2% FS
default range is
0 - 50 mS/cm
Pre and post column temperature 2 -30 °C +/- 1 °C
pH 1 - 14 +/- 0.1 (between pH
3 - 9)
Multi-use and 0 – 2 AU +/- 2% FS
Single-use (wavelengths 280/300 nm)
Post-column UV

14
Ordering Information
Description Catalogue No.
Mobius® FlexReady Core Hardware
Please contact your sales representative
Flexware® Assemblies
Please contact your sales representative
Accessories
Clamshell Lift for Clamshell Exchange CLAMLIFT
Clamshell Storage Rack for up to 4 Clamshells CLAMST0R
Chromatography 2.2 L /min Clamshell CLAMXM1
Chromatography 8.0 L /min Clamshell CLAMXM3
TFF 2.5 m2 Clamshell CLAMTF2S
TFF 5.0m2 Clamshell CLAMTF3S
Single Pass TFF Diverter Plate XXSPTFFPLATE
Chromatography Media
All resins and membrane adsorbers must be purchased separately.
See data sheets for ordering information.

Chromatography system
Services Packages Catalogue No.
Mobius® FlexReady Solution with Flexware® assemblies for SSASCIMP1
Chromatography Qualification package non-GMP
Mobius® FlexReady Solution with Flexware® assemblies for SSASCIMP2
Chromatography Qualification package GMP
Mobius® FlexReady Solution with Flexware® assemblies for SSASCIMP5
Chromatography Single molecule non cGMP package
Mobius® FlexReady Solution with Flexware® assemblies for SSASCIMP6
Chromatography Multi molecule non cGMP package
Mobius® FlexReady Solution with Flexware® assemblies for SSASCIMP7
Chromatography Single molecule cGMP package
Mobius® FlexReady Solution with Flexware® assemblies for SSASCIMP8
Chromatography Full cGMP package

TFF system
Services Packages Catalogue No.
Mobius® FlexReady Solution with Flexware® assemblies for SSASTIMP1
TFF Qualification package non-cGMP
Mobius® FlexReady Solution with Flexware® assemblies for SSASTIMP2
TFF Qualification package cGMP
Mobius® FlexReady Solution with Flexware® assemblies for SSASTIMP5
TFF Single molecule non cGMP package
Mobius® FlexReady Solution with Flexware® assemblies for SSASTIMP6
TFF Multi molecule non cGMP package
Mobius® FlexReady Solution with Flexware® assemblies for SSASTIMP7
TFF Single molecule cGMP package
Mobius® FlexReady Solution with Flexware® assemblies for SSASTIMP8
TFF Full cGMP package

Stand alone services can be ordered on request.

Contact your sales representative.

15
References
FDA Guidance for Industry Process Validation:
General Principles and Practices - January 2011

Annex 15 to the EU Guide to Good Manufacturing

Practice Qualification and Validation - July 2001

To place an order or receive

technical assistance
In the U.S. and Canada, call toll-free:
1(800)-645-5476
For other countries across Europe, call:
+44 (0) 115 943 0840
For other countries across Europe and the world,
please visit www.emdmillipore.com/offices
For Technical Service, please visit
www.emdmillipore.com/techservice

www.emdmillipore.com

EMD Millipore, the M mark, Mobius, Common Control Platform, CCP, Flexware, Eshmuno, Fractogel,
ProSep, Pellicon, and QuikScale are registered trademarks of Merck KGaA, Darmstadt, Germany.
PureFlex is a trademark of Merck KGaA, Darmstadt, Germany. Santoprene is a registered trademark of
Advanced Elastomer Systems, L.P. Lit No. DS2251EN00 Version 6.0 PS-SBU-12-06693 02/2016
© 2016 EMD Millipore Corporation, Billerica, MA USA. All rights reserved.