Page 1
Zeta Plus
VR Series
Depth Filter Cartridges & Capsules
Application
The removal and/or inactivation of contaminating viruses from biotherapeutics is a
requisite for ensuring final product safety . Zeta Plus VR Series cartridge depth filters
remove significant levels of viruses from biological fluids. They provide validatable viral
titer reduction, high flow rates, scalability, economy , disposability and ease-of-use in the
biological manufacturing environment. The Zeta Plus VR Series includes specific filter
media recommendations for virus removal from blood plasma proteins and bioprocessderived cell culture fluids.
Virus Removal Applications for Zeta Plus VR Media:
■
Processing of human plasma-derived proteins
■
Recombinant proteins from cell culture and fermentation
■
Monoclonal antibodies
■
Serum and other raw materials derived from animal sources
Zeta Plus depth filtration offers an attractive and economical alternative to other available
technologies for reduction of viral burden. Zeta Plus VR Series depth filters can be used
as a bolt-on processing step to existing in-process viral clearance methodologies, providing an added measure of end-product safety .
™
Zeta Plus VR Series For
Enhanced Log Reduction
Features & Benefi ts
Combined ion exchange & physical entrapment virus removal mechanisms.
■
Validatable viral log reduction.
■
Provides added level of viral safety.
Economical “bolt-on” separation technology as adjunct or pre-fi lter to other viral clearance steps.
■
Provides added level of validatable viral clearance.
■
Can replace or augment chromatography columns or function as prefi lter to fi nal virus removal membrane fi lter.
Quality Control tested for media ion exchange capacity.
■
Assurance of fi lter media consistency & performance.
Self-contained, single-use disposable capsules & cartridge modules
■
Single-use, disposable design eliminates validation concerns associated with reusable clearance options
(chromatography column sanitization & regeneration).
Range of cartridge sizes, sanitary design cartridge housings & disposable capsules.
■
Facilitates scaleup from small volume feasibility trials & validation studies to production scale operations.
of Viruses From Biological
Fluids
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a
ecommended Fo
a
ChoicePlasma
s
Ce
s
on
(
μ
m
0
C Wate
@
)
Ste
e
t
(ppb)
VR 01
8
2
VR 02
8.9
Yes
VR 03
8
2
Yes
VR
45.9
VR 05
2.4
Yes
VR 06
2.6
Yes
VR
2.4
Yes
Zeta Plus VR Series filter media is available in a
wide range of cartridge sizes including 8-, 12- and
16-inch diameter filter cartridges for varying flow rates
and batch volumes. 3M Purification Inc.’s sanitary
design ZPB Zeta Plus filter housings are designed
for pharmaceutical and biological manufacturing
environments. For more information on Zeta Plus
sanitary filter housings, request 3M Purification Inc.
literature numbers 70-0201-8857-2 and
70-0201-8762-4.
Zeta Plus VR Series filter media is a family of cellulosic depth filtration media
designed to retain contaminants by both physical entrapment and ion exchange
adsorption. It is composed of high-area process filter aids embedded in a cellulose fiber
depth matrix. During the manufacturing process, a cationic charge modifier is chemically
bound to the matrix components, forming a permanent, interconnected, rigid depth
filter with positively-charged electrokinetic capture sites. The resulting poro us d e p th fil t er
structure is a tortuous network of adsorptive flow channels capable of retaining contaminating
viruses through a combination of anion exchange adsorption and mechanical entrapment.
Cumulative viral titer reduction may also be attainable through a staged two-step Zeta
Plus system.
Zeta Plus depth filtration is a key component in biopharmaceutical production schemes for
clarifying cell culture fluids (cell separation) and is utilized world wide in the fractionation of human and animal plasma proteins.
Zeta Plus VR Series Filter Selection
A range of cartridge sizes is available for varying batch size, so scale-up is easy and
predictable from lab-scale, to pilot plant, to full production scale. Three different cartridge
sizes (8, 12 and 1 6-inch diameter) make scale-up straight forward and predictable. Zeta
Plus cartridges are used in a flow-through mode, enabling the process stream to be passed
through the filter cartridge while viruses are retained within the depth filter matrix.
Small, low area disposable BC capsules are available for laboratory scale and process
development work and are ideal for scaled down viral validation studies.
Table 1: Selection of Zeta Plus VR Series Filter Medi
R
Filter Medi
04 •
07 •
Protein
•
•
•
r:
ll Culture
Protein
Zeta Plus VR Series Disposable Capsules, Filter Cartridges, and Filter Sheets–
Confi gured to Suit Your Every Need
Zeta Plus VR Series filter products are highly scaleable and can be used for applications
ranging from milliliter lab volumes to production scale cGMP operations. Filter media is
available in the following configurations:
Zeta Plus VR Series Filter Sheets: VR filter media is available in a range of filter sheet
sizes to fit plate-and-frame filter presses (contact 3M Purification Inc. for specific sheet
sizes and part numbers) .
Zeta Plus VR Series BC Disposable Filter Capsules: VR filter media is available in
three different sizes of BC disposable capsules for bench scale and pilot scale filtration.
Zeta Plus VR Series Filter Cartridges and Sanitary Housings: VR filter media is
available in 8-inch, 12-inch and 16-inch diameter, easy-to-use, disposable cartridges. A
range of sanitary design Zeta Plus filter housings is available for VR Series cartridges.
Nominal Retenti
Rating
.
.
.
.
.
.
.
)
2
5 psid (gpm/ft
r Flow
.
.
Autoclavable or
In-situ Steam
rilizabl
o
o
Al3+] in 20°C water @
L/f
2
Page 3
e
(25 cm
)
e
(650 cm
)
e
(1300 cm
)
109
ll)
(0.26 m
)
167
(0.23 m
)
NPX
(650 cm
)
NPX2
(1300 cm
)
264
(12-inch diameter cartridge, 7-cell bodyfeed)
t
(0.67 m
)
245
ll)
t
(1.5 m
)
(16-inch, 14-cell, netted)
(3.2 m
)
Recommended Operating Parameters
s
a
g
essure
:
g
i
idg
e
.
.
.
d
g
t
at 0.5 gpm/ ft
m
at 20 L/m
/min.
n
s
steam sterilized, except VR 01 &
).
ilized
).
d
s
/
/min.
s
g
0
)
p
D
C
V
t
3.37.3
4
3.1
7
8
8.5
eductio
8.1.416.6
,
Nominal
Retention Rating
M
ximum
Operatin
Pr
Maximum
Operating
Tem per atur
Recommende
Pre-use Rinse
terilizatio
rameter
ecommende
ow Rate
0.2 to 0.8 micron
VR Cartridges: 35 psi maximum cartridge pressure drop.
BC25 Capsules
BC1000/2000 Series Capsules: 80 psi
35 ps
max. cartr
Zeta Plus VR 02, 03, 05, 06, & 07 Cartridges: 82° C
Zeta Plus VR 01 & 04 Cartridges: 60° C
BC25 Capsules: 40° C.
BC1000 / 2000 Capsules: 60° C
al/f
1.3
All media grades can be autoclaved or
VR 04 (refer to Table 1
Zeta Plus VR Series Cartridges: In-situ steam ster
for 30 minutes at 121°C (1 cycle).
BC25: Autoclave for 30 minutes at 121°C (1 cycle).
BC1000/2000: Autoclave for 30 minutes at 121°C (up to 3 cycles
BC25: 3 - 30 ml/min.
BC1000/2000 & VR Cartridges: 0.065 gpm
40 psig max. inlet pressure, 35 psi max. media pressure drop.
at 25° C, 40psig at 60° C, max. inlet pressure;
e pressure drop.
50 L/
ft
2.5 L/m
or autoclaved,
Viral Reduction Validation
Many factors influence the choice of process steps to be studied
when performing viral clearance evaluation and validation.
Viral clearance validation studies are performed with a select panel
of model viruses. Different model viruses are chosen to validate
blood and plasma products, and separately, cell-culture derived
products.
Virus removal efficiency may be dependent on fluid and processing conditions and is best determined during qualification
and validation studies using suitable virus model systems in a controlled laboratory study. Contact 3M Purification Inc. Scientific
Applications Support Services (SASS ) f or further technical advice
concerning validation of viral reduction with Zeta Plus VR Series
depth filters.
Data is available which confirms the ability of Zeta Plus VR Series depth filter media to function as an effective and validatable
viral log reduction filter. T ab le 2 illustrates results for a reported viral
clearance study utilizing Zeta Plus VR depth filters.
Quality Control of Zeta Plus VR Series Filters
3M Purification Inc. applies rigorous Quality Control testing and
standar ds both during in-process manufacturing and during final
lot release. This testing ensures consistent filter media performance
in critical virus removal applications. A Certificate of Quality is
provided with each Zeta Plus VR Series filter cartridge and disposable BC capsule.
Each grade of Zeta Plus VR Series filter media is Quality Control
tested on a lot release basis for the presence and magnitude of
positiv e c harge .
Zeta Plus™
Gasket Materials
Separator
I
4.
.9 in
0.7 ft
.4 ft
2.8 ft
7.2 f
6.4 f
4.7 ft
Various
Edge
Seal
Cell
PV PRV
.
.7
Edge
Tab s
VR Series
Depth Filter Cartridges & Capsules
Cartridge Construction
Gasket
Protected
V
.
Retainer
Internal
Separator
Cell
Weldments
1
M
.
.
.5.
Filter
Media
Flow Channels
Table 2: Viral Clearance In An Immunoglobulin Production Proces
umulative Virus Titer Reduction (Lo
rocess Ste
olvent detergen
upernatant III
eta Plus VR 03 Depth Filtration 4.
tal Cumulative R
ource: D. Revie
mmunoglobulin Production Process, IBC 2nd International Symposium on Viral Clearance,
ective Filtration Area
25 Capsul
1000 Capsul
2000 Capsul
5
5
8FA2
8FA4
5
5
ovel Validation Approaches to Obtain Maximum Viral Clearance from an
(8-inch diameter cartridge, 8-ce
(8-inch diameter cartridge, 7-cell, o-ring plug-in)2.5 ft
2 (8-inch diameter cartridge, 2-cell plug-in)0.7 ft
(8-inch diameter cartridge, 4-cell plug-in).4 ft
(12-inch diameter cartridge, 16-ce
n
.
.4
3
Page 4
Zeta Plus™ VR Series Ordering Guide
Important Notice:
The information described in this literature is accurate to the best of our knowledge. A variety of factors, however, can affect the performance of the Product(s) in a particular application, some of
which are uniquely within your knowledge and control.
INFORMATION IS SUPPLIED UPON THE CONDITION THAT THE PERSONS RECEIVING THE SAME WILL MAKE THEIR OWN DETERMINATION AS TO
ITS SUITABILITY FOR THEIR USE. IN NO EVENT WILL 3M PURIFICATION INC. BE RESPONSIBLE FOR DAMAGES OF ANY NATURE WHATSOEVER RESULTING FROM THE USE OF OR RELIANCE UPON
INFORMATION.
It is your responsibility to determine if additional testing or information is required and if this product is fi t for a particular purpose and suitable in your specifi c application.
3M PURIFICATION INC. MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR OF ANY OTHER NATURE HEREUNDER WITH RESPECT TO INFORMATION OR THE PRODUCT TO WHICH INFORMATION REFERS
Limitation of Liability:
3M Purifi cation Inc. will not be liable for any loss or damage arising from the use of the Product(s), whether direct, indirect, special, incidental, or consequential, regardless of the legal theory as-
serted, including warranty, contract, negligence or strict liability. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you.
8” Diameter Cartridges
Catalog Number Confi guration VR Series
45109 (8" 8-cell)
45167
(8" 7-cell, O-ring plug-in)
11 - Nitrile
13 - Fluorocarbon
14 - EPR
22 - Silicone
23 - Expanded PTF E
01 - Nitrile
02 - EPR
03 - Fluorocarbon
04 - Silicone
VR01 VR05
VR02 VR06
VR03 VR07
VR04
VR01 VR05
VR02 VR06
VR03 VR07
VR04
16” Diameter Cartridges
Catalog Number Gasket Material VR Series
Z16P (16" 14-cell)
BC Capsules
Catalog Number VR Series
Pkg
Z8FA2NP
(8" 2-cell, plug-in)
Z8FA4NP
(8” 4-cell, plug-in)
01 - Nitrile
02 - EPR
03 - Fluorocarbon
04 - Silicone
Code
2
VR01 VR05
VR02 VR06
VR03 VR07
VR04
BC0025L (Luer)
BC0025S (Sanitary)
BC1000A (Single pack)
BC1000B (3 pack)
BC2000A (Single pack)
BC2000B (3 pack)
12” Diameter Cartridges
Catalog Number Geometric Variation Gasket Material VR Series
45264 (12" 7-cell, Bodyfeed)
45245 (12" 16-cell)
01 - Standard
Polypropylene
A - Silicone
B - Fluorocarbon
C - EPR
D - Nitrile
VR01 VR05
VR02 VR06
VR03 VR07
VR04
A - Silicone
B - Fluorocarbon
C - EPR
D - Nitrile
VR01 VR05
VR02 VR06
VR03 VR07
VR04
VR01 VR05
VR02 VR06
VR03 VR07
VR04
Important Notice:
which are uniquely within your knowledge and control.
ITS SUI TABILITY FOR THEIR USE. IN NO EVENT WILL 3M PURIFICATION INC. BE RESPONSIBLE FOR DAMAGES OF ANY NATURE WHATSOEVER RESULTING FROM THE USE OF OR RELIANCE UPON
INFORMATION.
It is your responsibility to determine if additional testing or information is required and if this product is fi t for a particular purpose and suitable in your specifi c application.
3M PURIFICATION INC. MAKE S NO REPRESENTATIONS OR WARR ANTIE S, EITHE R EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHAN TABILIT Y, FITNESS FOR A
PARTICULAR PURPOSE OR OF ANY OTHER NATURE HEREUNDER WITH RESPECT TO INFORMATION OR THE PRODUCT TO WHICH INFORMATION REFERS
Limitation of Liability:
serted, including warranty, contract, negligence or strict liability. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you.
The information described in this literature is accurate to the best of our knowledge. A variety of factors, however, can affect the performance of the Product(s) in a particular application, some of
3M Purifi cation Inc. will not be liable for any loss or damage arising from the use of the Product(s), whether direct, indirect, special, incidental, or consequential, regardless of the legal theor y as-
INFORMATION IS SUPPLIED UPON THE CONDITION THAT THE PERSONS RECEIVING THE SAME WILL MAKE THEIR OWN DETERMINATION AS TO
Your Local 3M Purifi cation Inc. Distributor:
3M Purifi cation Inc.
400 Research Parkway
Meriden, CT 06450
U.S.A.
(800) 243-6894
(203) 237-5541
Fax (203) 630-4530
www.3Mpurifi cation.com
3M is a trademark of 3M Company.
Zeta Plus is a trademark of 3M Company used under license.
© 2011 3M Company. All rights reserved.
70-0201-8875-4
REV 0411pb
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