Page 1
Zeta Plus™
DELI and DELP
Zeta Plus™ DELI and DELP series comprise a family of depth filter media which incorporates lipid-specific adsorbents for sel ective reduction of lipids, surfactants and biological
hydrophobes from human blood plasma, serum-based products, recombinant proteins and
other biological fluids. These media types provide a range of lipid reduction capacity and
functionality.
Applications
During protein purification processes, lipid contamination can cause an assortment of processing problems. Lipids can foul and plug expensive chromatography columns and membrane filters. Prior reduction of lipids via depth filtration promotes column and membrane
performance and extends their useful life. Lipid contamination can also cause solution
instability of intermediate and final protein products leading to a problematic lipoprotein
haze. Zeta Plus DELI and DELP series products can replace bulk silica operations which
are labor-intensive, messy and difficult to prepare.
Series Filter Media
Zeta Plus DELI and DELP series filter media may be used to separate lipids within the
following lipid classes: mono-, di-, and triglycerides, fatty acids, cholesterol, phospholipids, and lipoproteins. Enhanced reduction of lipid contaminants from protein solutions is
therefore highly desirable, leading to improved processing economies (extended column
and membrane life), improved product purity, and enhanced final protein product stability
for longer product shelf life.
Features & Benefi ts
Two different media formulations available for varying degrees of lipid reduction.
■
Effi cient reduction of undesirable lipids, lipoprotein haze, and microbial and
particulate contaminants.
Depth fi lter media with hydrophobe and lipid specifi c adsorbents.
■
Provides effective protection and extended life for chromatography columns and
reusable membranes.
Variety of cartridge sizes, disposable capsules and fi lter sheets.
■
Highly scaleable.
■
Flexible options for all fl ow and batch volume requirements.
Totally-enclosed, sanitary-design systems and cartridge housings.
■
Easily cleanable, no external contamination, offers rapid assembly and take down.
Tested and optimized for pharmaceutical and biological service.
■
Safe for critical pharmaceutical, bioprocessing and biological applications.
■
Components meet USP Class VI Biological Safety Tests and requirements of CFR 21.
Applications
Lipid reduction from human blood plasma
proteins such as albumin, coagulation factors,
fi brinogen, and immunoglobulins
Provide protection, enhanced performance and
extended life for chromatographic columns and
ultrafi lters
Reduction of residual lipids from serum, fermentation broths and cell culture fl uids
Reduction of detergents and surfactants from
biologicals
Separation of hydrophobic bioprocess contaminants
from aqueous solutions
Page 2
Filter
)
DELI
DELP
M
17.9
0
9
0
5
0
Media
Protected
Flow Channels
Gasket
Retainer
Internal
Separator
Cell
Weldments
Various
Gasket Materials
Edge
Edge
Seal
Tab s
Cell
Separator
Zeta Plus ™ Products: The Benchmark for Pharmaceutical & Biological Depth
Filtration
Filters using Zeta Plus™ DELI and DELP series media are part of the Zeta Plus family
of depth filtration pr oducts, which provide highly efficient, cost-effective clarification
of turbid, difficult-to-filter biological fluids and pharmaceutical products. Zeta Plus
cellulose-based depth filtration media are designed to retain contaminants by both size
exclusion and adsorption. It is composed of high surface area filter aids embedded in a
cellulose fiber matrix.
Zeta Plus DELI and DELP filter media incorporate added silica adsorbents, which are the
active components for lipid reduction. During the manufacturing process, mol ecules
carrying a positive charge are chemically bonded to the matrix components, forming a
permanent, interconnected, rigid filter sheet with positive ly -charged electrokinetic capture
sites. The resulting porous depth filter structure is a tortuous network of adsorptive flow
channels capable of retaining bacteria, endotoxin, cell debris and su bmicron con taminants
to a level which mechanical screening alone cannot achieve. Zeta Plus depth filters provide
high-efficiency submicron filtration, often surpassing the performance of pleated prefilters
and competitive depth filters.
Zeta Plus Delipid Media Choices
T w o different types of delipid filter media are available to suit varying application requirements. The chart below serves as a guideline for selecting the appropriate delipid media
type:
Type Lipid Reduction Capacity
DELI Intermediate No No
DELP High Yes Yes
*
Limulus
Amoebocyte Lysate
Optimized for Low Aluminum
Extractable Levels
Optimized for Sensitive
LAL* Test Procedures
All DELI and DELP fi lter media are available in totallydisposable BC fi lter capsules for lab-scale, process
development or small-volume fi ltration. Shown are
BC25 and BC1000/2000 capsule units with DELI
fi l t e r m e d i a .
2
Media Selection
3M differentiates its DELI and DELP media offerings by varying the materials of construction used in their manufacture. Choice of silica type confers upon the media either a
medium or a high capacity for lipids based upon the specific surface area (m²/g) of the silica
incorporated into the filter matrix. Choice of cellulose type affects the level o f apparent
endoto xin or Limulus Amoebocyte Lysate-R eacti v e Material (LAL-RM) extractables .
LAL Reactive Material
Trace levels of cellulosi c impurities (ß-glucans ) from several of the more useful types of
cellulose interfere with some (but not all) FDA-approv ed LAL reagent systems designed
to test for USP Bacterial Endotoxins. DELP media has been purposely formulated to alleviate this sort of interference.
Table 1: LAL Reactive Material (EU/ml
Rinse Volume l/m
EU/ml including LAL-R
35.
3.8
0.50
.25 0.01
.25 0.01
.02
Page 3
Table 2: Recommended Operating Parameter
s
y
0
g
e
)
8
)
Recommended
e
5
5
C Clea
e
50 l/m²/
m
/
)
In situ
Steam
S
n
121
Table 3: Surface Area for Zeta Plus
DELI
DELP
s
C
n
S
B
e
B
e
650 cm
(0.7 ft
)
B
e
130 0
m
²
ft
)
45109
ll)
0.26 m
(2.8 ft
)
45167
)
0.23
(2.4 ft
)
Z8FA2NPX
(2-cell plug-in)
650 cm
(0.7 ft
)
Z8FA4NPX
(4-cell plug-in)
130 0
m
²
t
)
45805
²
(
t
)
45211
)
1
(
1
t
)
45245
)
1
(
1
)
Z16P
(16 diameter cartridge, 14-cell netted)
3
)
Nominal Porosit
Maximum
Operatin
Maximum
Operating Temperature
Rins
2
Flow Rat
Pressur
n Water
terilizatio
.5 to 0.8 micron
2.4 bar (35 psid
2˚C (180F
4 L/m² (1.3 gal/ft²)
min/bar (0.09 gp
C (250°F) for 30 minutes-1 cycle
ft²/psid
Cartridges and Capsule
artridge Confi guratio
C25 Capsul
C1000 Capsul
C2000 Capsul
(8 diameter cartridge, 8-ce
(8 diameter cartridge, 7-cell, o-ring plug-in
(12 diameter cartridge, 9-cell bodyfeed netted)0.9 m
(12 diameter cartridge, 15-cell netted
(12 diameter cartridge, 16-cell
Single-Use Capsules, Filter Cartridges & Sanitary Housings and Filter Sheets
Zeta Plus™ DELI and DELP series filter products are highly scaleable and can be used
for a pplic a ti o n s ranging from milliliter laboratory volumes to production-scale cGMP
manufacturing operations. Filter media are available in the following configurations:
Single-Use Capsule Filters: Zeta Plus DELI and DELP filter media are available
in three different sizes of BC disposable capsules for bench and pilot scale filtration:
BC25, BC 1000 and BC2000. 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), 1.6 m² (17.1 ft²)*, and 2.5 m² (27.0 ft²)*. They are ideal for
both the scale-up studies as well as large scale production. For more information on the
Zeta Plus Encapsulated System, please refer to 3M literature 70-0202-3 96 7-2.
Filter Cartridges & Sanitary Housings: Filter cartridges are available in 8" , 1 2",
and 16 " diameters, easy-to-use, disposable cartridges, providing effective filtration area
from 0.06 m² to 3.2 m² (0.7 ft² to 34.7 ft²). A range of sanitary design Zeta Plus filter
housings is available for all sizes of DELI and DELP series filter cartridges. For more
information on Zeta Plus sanitary filter housings, request 3M literature numbers
70-0201-8857-2 and 70-0201 -8762-4.
Filter Sheets: Zeta Plus DELI and DELP series filter media are available in a range of
filter sheet sizes to fit plate-and-frame filter presses (contact 3M for specific sheet sizes
and part numbers).
DELI and DELP Media Lipid Capacity Estimation
Using Non-Ionic Surfactants
T o demonstrate the ability of DELI and DELP media to reduce biological hydrophobes
such as lipids, lipoproteins, and detergents, two non-ionic surfactants (T w een 80 and
Triton X-1 00 ) were chosen as models to characterize adsorptive binding capacities
under dynamic flow -through conditions (Fi gures 1 and 2). Dynamic challenge conditions: media initially rinsed with 54 L/m² ( 1.32 gal/ft²) water and then challenged with
surfactant solution at 20°C. Methods of analysis: Isocratic RP-HPLC with UV-VIS
detection.
Zeta Plus™
DELI and DELP
Series Filter Media
and
Figure 1: DELI & DELP Plus Media
Tween® 80 Capacity
02154315748611076
100
80
60
40
20
Tween out/Tween in (percent)
0
05.2810.5715.8521.1326.42
Throughput (l/m² )
DELP media breakthrough
@ 269 L /m² (6.63 gal /ft²)
Throughput (gal/ft²)
Tween in = 0.05%, Flux = 1 ml/min/cm²
Figure 2: DELI & DELP Media
Tri ton® X-100 Capacity
054108161215270323
100
80
60
40
20
Triton out/Triton in (percent)
0
0 1.32 2.64 3.96 5.28 6.60 7.93
Throughput (l/m² )
Throughput (gal/ft²)
Triton in = 0.01%, Flux = 0.25 ml/min/cm²
urface Area
25 cm² (3.9 in)
c
(1.4
m
c
(1.4 f
9.2 f
.4 m²
5.4 f
.5 m²
6.4 ft
.2 m² (34.7 ft
DELI media breakthrough
@ 75 L/m² (1.84 gal/ft²)
DELI media breakthrough
@ 32 L/m² (0.79 gal/f t²)
DELP media breakthrough
@ 97 L/m² (2.38 gal/ft²)
* 1.6 m² double layer and 2.5 m² for single layer.
3
Page 4
Zeta Plus™ DELI and DELP Series Product Ordering Guide
8" Cartridges
Catalog Number Gasket Media Formulation
45109 (8" 8-cell)
45167
(8" 7-cell, O-ring plug-in)
Z8FA2NP (2-cell plug-in)
Z8FA4NP (4-cell plug-in)
11 - Nitrile
13 - Fluorocarbon
14 - EPR
22 - Silicone
01 - Nitrile
02 - EPR
03 - Fluorocarbon
04 - Silicone
A - Silicone
B - Fluorocarbon
C - EPR
D - Nitrile
DELI
DELP
16" Diameter Cartridges
Catalog Number Gasket Media Formulation
Z16P (16" 14-cell)
A - Silicone
B - Fluorocarbon
C - EPR
D - Nitrile
DELI
DELP
12" Diameter Cartridges
Catalog Number
45805 (12" 9-cell)
45211 (12" 15-cell)
Netted Cartridges
45245 (12" 16-cell)
Geometric
Variation
01 - Stan dard
polypropylene
01 - Stan dard
polypropylene
BC Capsules
Catalog Number Media Formulation
BC0025L (Luer)
BC0025S (Sanitary)
BC1000A (single pack)
DELI
DELP
Gasket
A - Silicone
B - Fluorocarbon
C - EPR
D - Nitrile
A - Silicone
B - Fluorocarbon
C - EPR
D - Nitrile
Media
Formulation
DELI
DELP
DELP
BC1000B (3 pack)
BC2000A (single pack)
BC2000B (3 pack)
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 asserted, 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.
Your Local 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.
All other trademarks are the property of their respective owners.
© 2012 3M Company. All rights reserved.
70-0201-8854-9
REV 0312
Loading...