3M VR01 User Manual
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
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
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