GE Healthcare

Life Sciences
Data file 29-0432-61 AB

Filtration hardware

VERSAflux
VERSAflux is an easy-to-use, manual cross flow filtration
system suitable for applications ranging from process
development to large-scale biopharmaceutical production.
VERSAflux is available in three versions: VERSAflux 13, for
bench-top use, and VERSAflux 120 and VERSAflux 400, for
larger-scale filtration applications (Fig 1).
As a high-quality, durable system, VERSAflux is optimized for
GE Healthcare Life Sciences hollow fiber cartridges. Because
of their open channel structure, hollow fiber filter cartridges
are well-suited for both microfiltration applications, such
as cell harvesting and clarification, as well as for protein
concentration and purification. The advanced system can
also be configured to support ultrafiltration cassettes through
an optional cassette holder for ultrafiltration and diafiltration
applications.
Benefits with VERSAflux filtration system

Fig 1. VERSAflux systems.

Effective performance
Convenient usage
Robust design for reliable operations
Increased return on investment (ROI)

Effective performance
Designed to meet the demanding requirements of real-world
process development, VERSAflux 13 consists of a four-piston
diaphragm pump, which provides a continuous and uniform
fluid flow. The system also incorporates an optimized flow
path, resulting in low void volume. VERSAflux13 uses silicone
hoses and polypropylene tubing that resist pressures up
to 3bar, enabling users to perform in-line integrity tests of
hollow fiber cartridges.
For cost-efficient filtration at production-scale , the VERSAflux
120 and 400 system versions strike an optimized balance
between basic system and advanced systems features,
delivering effective process performance. Base system
comprises rotary lobe pump, feed pressure sensor, retentate
pressure sensor, feed drain, retentate drain, and cartridge

drain. Optional functions include temperature sensor,

permeate pressure sensor, retentate flowmeter, permeate
flowmeter, and a pneumatic pressure control valve.
In addition, GE Healthcares hollow fiber cartridges provide
robust processing across a wide range of cross flow filtration
applications, enabling consistent productivity over a long
period of time.

Convenient usage
To facilitates monitoring of process parameters and control
pump speed, the VERSAflux system includes an intuitive
display and touch screen interface.

Robust design for reliable operations

VERSAflux comprises high-quality components that allow for
reliability and productivity in operations. With a robust design,
the system can be used within a wide range of operating
conditions, with the added benefit of reduced facility
expenditure compared with traditional manual cross flow
filtration systems.

VERSAflux also incorporates comprehensive safety features,

such as a two-level alarm monitor: one level to give a
warning message and the other to give a critical alarm to
enable immediate suspension of the filtration process.
Industrially designed with a software reset button,
indicator, and E-stop switch (one for VERSAflux 13, two
for VERSAflux120 and 400) for handling emergencies,
the system embodies GEHealthcares uncompromising
commitment to quality.

Increased ROI
The focused functionality of VERSAflux, its effective
performance, convenient usage, and a high degree of
reliability can enable users to experience optimized asset
utilization and productivity, which can translate into an
increased ROI in comparison to traditional manual cross flow
filtration systems.

System specifications
System specifications are listed in Table 1. Piping and
instrument diagrams are shown in Figures 2 to 4.

Table 1. System specifications

General specifications

VERSAflux 13

VERSAflux 120

VERSAflux 400

Hollow fiber cartridges

3M, 3 x 2M, 4M, 4 x 2M, 5, 6, 8, 9 35, 55, 75

45, 65, 85

Maximum operating flow rate,

feed pump (L/min)

13*

120

400

Minimum operating flow rate,

feed pump (L/min)

0.15*

12

40

Hold-up volume (L)

0.05 (with size 5 cartridge)

3.60 (estimated)

12.9

Ambient temperature range (C)

2 to 25

2 to 30

2 to 30

Process temperature range (C)

2 to 60

2 to 60

2 to 60

Footprint W H D (mm)

697 1013 440

1442 2059 800

1970 2357 950

Weight (kg)

40

400

500

Piping

Polypropylene

316L stainless steel

316L stainless steel

Gaskets

EPDM rubber

EPDM rubber

EPDM rubber

Frame, cabinet and supports

304 stainless steel

304 stainless steel

304 stainless steel

Materials of construction

Other specifications
Protection class IP
Cabinet

IP 54

IP 54

IP 54

Field mounted instruments

IP 54

IP 54

IP 54

Power supply system

L-N-PE, 115/230 VAC,

50 to 60 Hz

L-N-PE, 110/230 VAC,

50-60 Hz

L-N-PE, 110/230 VAC,

50-60 Hz

Power supply pump

L1-L2-L3-N-PE, 400/480 VAC,

50-60 Hz

L1-L2-L3-N-PE, 400/480 VAC,

50-60 Hz

* At 3 barg back pressure.

At 4 barg back pressure.

Hold up volume is defined as the internal volume in the complete system (tubing, valves, sensors, etc.).

229-0432-61 AB

Fig 2. Piping and instrument diagrams for VERSAflux 13.

Fig 3. Piping and instrument diagrams for VERSAflux 120. Dashed boxes = optional configuration.

29-0432-61 AB3

Fig 4. Piping and instrument diagrams for VERSAflux 400. Dashed boxes = optional configuration.

429-0432-61 AB

 Advanced: includes input/output list, layout and

interconnection, electrical schematics, wiring table, cable
diagram, functional test records, calibration certificates,
configuration of programmable devices record,
material certificates, and installation test records. These
documents can be purchased at an additional cost.

Flux (L/m2/h)

0.2

50

0.1
0
3

10
15
Time (min)

21

26

29

(B)Experiment 2: 9 concentration using NMWC 5000,

size 4X2M hollow fiber cartridge

40

1.0

30

0.8
0.6

20

0.4

10

0.2

0
1

5
10
Time (min)

13

18

(C)Experiment 3: 5 concentration and 4-fold diafiltration using 0.1 m,

size 4Mhollow fiber cartridge
Diafiltration
100
0.20

80

0.15

60

0.10

40

0.05

20
0

0
1

10 15 20 26 31 36 41 44 49
Time (min)

(D)Experiment 4: 4.3 concentration using NMWC 5000,

Kvick Lab SCU cassette

40

1.2
1.0

30

0.8

20

0.6

10

0.4

TMP (bar)

Validation documentation, such as installation and

operational qualification (IQ/OQ) documents, as well as a
service to perform actual qualification of the system on-site
upon installation, can be ordered separately. These services
help towards satisfying the increasingly strict demands
posed by regulatory authorities who expect manufacturers
of pharmaceuticals to qualify equipment before using in
production.

0.3

100

TMP (bar)

Basic: includes product specification, assembly drawing,

general specification, bill of material (equipment list),
piping and instrument diagram, spare part list, user
manual, and certificate of conformity. These documents
come standard with the purchase of the system.

0.4

150

Flux (L/m2/h)

As with all GE Healthcare equipment, the VERSAflux system

is designed to fulfill high quality expectations. The wetted
materials used in the system fulfill FDA 21 CFR Part 177
guidelines. Additionally, two levels of documentation are
available to help fulfill the requirements set by the regulatory
authorities:

0.5

200

TMP (bar)

Quality and regulatory considerations

0.6

Diafiltration

Flux (L/m2/h)

Target yield and purity were achieved in all four experiments.

The cross flow filtration performance (flux decay and
maintenance of process transmembrane pressure) was
shown to be in accordance with expectations.

250

TMP (bar)

The systems cross flow filtration performance was verified

using VERSAflux 13 with GE Healthcare hollow fiber cartridges
and ultrafiltration cassettes in several microfiltration,
ultrafiltration, and diafiltration experiments on both a
fermentation broth of E. coli, expressing green fluorescent
protein (GFP), as well as a GFP solution. The results from the
experiments are presented in Figures 5 A to D.

(A)Experiment 1: 9.3 concentration and 3-fold diafiltration using

NMWC750 000, size 5hollow fiber cartridge

Flux (L/m2/h)

System performance

0.2

0
1

10
7
Time (min)

12

14

Fig 5. The VERSAflux cross flow filtration performance was verified using
VERSAflux 13. NMWC = nominal molecular weight cut-off.

29-0432-61 AB5

Typical applications where the system

can be used
Monoclonal antibody clarification and concentration
Mammalian cell harvesting, washing, and clarification
Bacterial cell harvesting and clarification
Yeast cell harvesting and clarification
Hybridoma cell culture clarification
Protein concentration and diafiltration
Vaccine concentration and diafiltration
Plasmid concentration and diafiltration
Virus clarification, concentration, and purification
Purification of blood substitutes
Lysate clarification

Ordering information
To order the VERSAflux filtration system, please contact your
regional sales representative.

629-0432-61 AB

29-0432-61 AB7

For local office contact information, visit

www.gelifesciences.com/contact
www.gelifesciences.com
GE Healthcare Bio-Sciences AB
Bjrkgatan 30
751 84 Uppsala
Sweden

GE, imagination at work, and GE monogram are trademarks of General

Electric Company.
20132014 General Electric CompanyAll rights reserved.
First published Feb. 2013
All goods and services are sold subject to the terms and conditions of
sale of the company within GE Healthcare which supplies them. Acopy
of these terms and conditions is available on request. Contact your local
GE Healthcare representative for the most current information.
GE Healthcare UK Limited
Amersham Place
Little Chalfont
Buckinghamshire, HP7 9NA
UK
GE Healthcare Europe, GmbH
Munzinger Strasse 5
D-79111 Freiburg
Germany
GE Healthcare Bio-Sciences Corp.
800 Centennial Avenue, P.O. Box 1327
Piscataway, NJ 08855-1327
USA
GE Healthcare Japan Corporation
Sanken Bldg., 3-25-1, Hyakunincho
Shinjuku-ku, Tokyo 169-0073
Japan

imagination at work
29-0432-61 AB 03/2014