3M EXT User Manual
Zeta Plus
EXT Series
Featuring Dual Zone ZA Filter Media
The Zeta Plus™ EXT filter media extends depth filtration capacity and extends protection of downstream memb ranes there by
extending filter life and lowering overall filtration costs. Zeta Plus
EXT series is a family of advanced dual zone depth filters designed
to provide optimal clarification of bioprocess, biological and pharmaceutic al fluids. Ze ta P l us EXT series media consist of two distinct
layers, or “zones” of filter media with the upstream zone more open
than the downstream zone. This structure enhances the contaminant ho lding capacity of the filter media, since larger particles are
trapped in the upper zone of the filter media and smaller particles are
trapped in the lower zone, reducing premature plugging and extending service life. The two filter “zones” can be independently
selected and combined to optimize performance.
■
Increased throughput with high turbidimetric efficiency
■
Lower processing costs
■
Smaller filter assemblies
■
Consolidation of multiple filter stages
■
Enhanced protection of downstream membrane filters
Applications
Zeta Plus EXT filters with ZA series media are optimized for clarification of mammalian cell
harvest fluids and for protection of downstream sterilizing grade membrane filters. In
addition, their strong positive charge provides enhanced reduction of negatively charged
contaminants. In solution, cells and cellular debris, endotoxins and contaminating nucleic
acids (DNA, RNA) carry a negative charge. 3M's application of positive zeta potential
to ZA filter media creates a filter matrix that enhances the capture of negatively charged
contaminants for maximum filtration performance. The strong positive charge over a
broad pH range makes these filters ideal for cell broth clarification and for protection of
downstream membrane filters.
Applications
Clarifi cation of mammalian cell culture process fl uids (cell separation)
Protection of downstream processes including membrane
(0.2, 0.1 micron) fi lters and chromatography columns
Clarifi cation of bacteria and yeast cell lysates
Endotoxin and nucleic acid reduction
Clarifi cation of colloidal and haze forming contaminants
™
Superior Performance
Zeta Plus EXT series filters with ZA series media offer unique advantages in contaminant reduction because of their strong electrokinetic properties. In addition to the mechanical exclusion of particles by its depth loading feature, the filter medium adsorbs contaminants
too small for reduction by mechanical straining. Because most particles in suspension are
negatively charged, virtually all contaminants can be reduced with proper media grade
selection.
Zeta Plus™ BC25 & Scale-Up Capsule fi lters are ideal
for feasibility, sizing, small volume, and pilot scale trials.
s
Appli
n
R
s
n
60ZA05A
120ZA08A,
A
n
60ZA05A
A
TFF
n
60ZA05A
A
End
n
90ZA05A
A
G
n
60ZA05A
A
Figure 1: EXT Series with ZA Media Throughput
120 0
600
Throughput (l/m²)
93.7%
92.1%
0
3M
Flux = 5.0 lpm /m²
Competitor A
30
15
Throughput (gal/ft²)
0
Figures 1 through 3 illustrate the superior Zeta Plus™ EXT series performance, tested
using mammalian cell culture fluids, when compared to competitive product. Zeta Plus
EXT series outperform competitive product in each scenario providing both superior
throughput and turbidimetric efficiency. To the end user, this superior performance
translates into lower processing costs, smaller filter assemblies, and enhanced protection
of downstream membrane filters.
Regulatory Support
Zeta Plus EXT series with ZA series media are documented in a Drug Master File (DMF)
on record with the US Food and Drug Administration (FDA ). Contact 3M to request the
fi le number. The product is also supported with a regulatory support fi le and certifi cate of
quality in order to ease validation and regulatory submissions.
Figure 2: EXT Series with ZA Media Throughput
120
60
Throughput (l/m²)
98.6%
99.2%
0
3M
Flux = 2.7 lpm/m²
Competitor B
3
1.5
0
% = Turbidimetric Efficiency
Turbidimetric Efficiency % =
[(Inlet Turbidity - Outlet Turbidity) / Inlet Turbidity] * 100
For example, the efficiency of the first bar
shown on the graph:
Turbidimetric Efficiency = [(37 - 2.34) / 37] * 100 = 93.7%
EXT filters with ZA series media provide up to
2.5 times the throughput with better or equivalent
turbidimetric efficiency.
Figure 3: EXT Series with ZA Media Throughput
2.67 NTU
B
20
10
0
800
400
2.27 NTU
Throughput (l/m²)
0
3M
Competitor
High Turbidity
96 NTU
4.27 NTU
2.88 NTU
Competitor
3M
A
Low Turbidity
17.5 N TU
Even with the varying extremes of inlet turbidity, the
EXT filter media maintains superior throughput and
effluent turbidity when compared to competitive product.
2
Cartridge Construction
Individual cells of Zeta Plus EXT with ZA series media are assembled together with
polypropylene separators under predetermined compression and unitized by three, 316
stainless steel bands.* Each cell is constructed using thermoplastic elastomer molded edge
seals and polypropylene separators for high performance. F ilter cartridges are available
in 8", 1 2", and 1 6 " diameters, with surface area ranging from 0.1 6 m² (1 .8 ft²) to 2. 7 7 m²
(29.8 ft²) per cartridge.
Throughput (gal/ft²)
Capsule Construction
Zeta Plus EXT series is available in autoclavabl e and fully disposable BC25 and Zeta Plus
Encapsulated System capsules. With 25 cm² ( 3 . 9 in²) of fi ltration area, the ready to use
BC fi lter capsule is ideal for feasibility and sizing trials. The Zeta Plus Encapsulated
System includes capsule filters with effective filtration areas at 170 cm² (0.18 ft²), 340 cm²
(0.37 ft²), 1020 cm² (1.10 ft²), 0.23 m² (2.4 ft²), and 1.6 m² (17.1 ft²). They are ideal for both
the scale-up studies as well as large scale production. F or more information on the Zeta
Plus Encapsulated System, please refer to 3M literature 70-0202- 3967 -2.
Pilot Scale and Small Volume
For pilot scale and small volume trials, the Zeta Plus EXT series is available in 8" diameter cartridges or the Zeta Plus Scale-Up Capsule filters. Other units available are 1 - and
2-cell 16" diameter cartridges and the 0.23 m² Zeta Plus Encapsulated filters. Small scale
pilot runs are recommended to confirm grade selection prior to scale-up.
Grade Selection
The Zeta Plus EXT series with ZA filter media are available in six grades. Figure 4
provide a guide to proper grade selection based on nominal retention ratings and can be
used in conjunction with the recommendations in Tab le 1 to determine the appropriate
filter grade for your application. Operating conditions and the fluid being filtered impact
Throughput (gal/ft²)
retention performance. 3M recommends small-scale pilot runs to confirm grade selection
prior to scale-up. 3M's Scientific Applications Support Services ( SASS ) staff can assist in
grade selection as well as assist in on-site evaluatio ns . F i lt er sy st em op timiza ti on c an a ls o
be conducted at 3M Purification's laboratory facilities.
Table 1: Application Recommendation
catio
Mammalian cell broth clarificatio
Bacterial, insect, yeast cell/cell lysate
clarificatio
, membrane protectio
otoxin, nucleic acid reductio
eneral clarificatio
Table 1 is intended as a guide. Grade selection and per formance should be confirmed with small-scale pilot trials.
*Except Z08E05, 8" plug-in style cartridge, which is unitized by a polypropylene post.
ecommended Grade
, 90ZA05A, 90ZA08A,12 0ZA05A,
120ZA10
, 90ZA05A,12 0ZA05A,12 0ZA08
, 90ZA08A,12 0ZA05A,12 0ZA08A, 120ZA10
, 90ZA08A,12 0ZA05A,12 0ZA08A, 120ZA10
, 90ZA05A,12 0ZA05A,12 0ZA08
Loading...