The System of Choice for Single-Use Depth Filtration
High Performance
Filter Media
The 3M™ Zeta Plus™ Encapsulated
System utilizes the high performing
Zeta Plus depth lter series
media, including the single and
dual layer.
• Positive charge is capable of
reducing negatively charged
DNA, endotoxins and other host
cell proteins
™
• The 3M
media enhances the contaminant
holding capacity of the lter media.
This allows for larger particles to
be trapped in the upstream zone
of the more open lter media and
smaller particles to be trapped in
the downstream zone, reducing
premature plugging and helping
extend service life of the media.
• Can be used for post fermentation
cell culture clarication or
downstream impurity removal
• Can be employed independently or
in conjunction with centrifugation or
tangential ow ltration (TFF)
Zeta Plus™ dual layer
3M™ Zeta Plus™ Depth Filter Quick Start Guide
Application Stage / Product
First StageSecond Stage
Two Stage
Operations
Single Stage
Operations
Post Centrifuge
Operations
05SP01
10SP02
60SP02
90ZB08
90SP08
60ZB05
60SP05
90ZB08
90SP08
60ZB05
60SP05
Media Series
SP MediaLA MediaZB Media
Widest RangeCleanestHighly Charged
SP has the widest nominal
pore size range relative to
other 3M Zeta Plus media
oerings, including a
greater number of grades
as well as grades with
larger nominal pore sizes
than LA or ZB media.
LA is the cleanest
3M Zeta Plus media family
offered. 3M
series low aluminum (LA)
filter media are designed
to provide low levels of
extractables, especially
aluminum.
™
Zeta Plus™ LA
ZB media offers a higher
charge level than SP or LA
media, and offers single
layer and dual layer grades
with a smaller nominal
pore size than either the
SP media family or the LA
media family.
The System of Choice for Single-Use Depth Filtration
Ergonomically Designed
Large Filter Holders
Traditional depth ltration systems utilize lenticular style
cartridge lters and a vertical ltration ow path to allow
easy access to process liquids and ecient utilization of
lter media. However, stacking cartridges from bottom
to top can be cumbersome, and dismantling the spent
cartridges is often labor intensive.
Features & Benets
Ergonomically Designed Holder System
3M™ Encapsulated System
Holder, Large (Model
#16EZB): holder is pivoted
between horizontal and
vertical positions
Vertical flow path
• Enables loading and unloading at
waist height.
• Central inlets and outlets minimize
fluid spills during post use handing.
• Holder and capsule design
allows the combination of multiple
3M Zeta Plus media types or even
multiple 3M filtration products
in a single holder.
Recognizing the need for a depth ltration system that is fast, easy and clean, 3M designed lter holders
(Model# 16EZB) that can be pivoted between the horizontal position for loading and unloading the
capsules and manifolds, and the vertical position for ltration. Allowing loading and unloading at waist
height eliminates the need for operators to lift capsules above their heads and reduces the risk of uid
spills when handling spent capsules. The use of the vertical ow path allows for full media utilization and
a small system footprint during ltration.
3M™ Encapsulated System Holders, Small
(Model# 16EZA)
The small holder is available for laboratory and pilot scale-up
studies, in addition to low volume production ltration. The
1-high holder can accommodate from one to four 0.23 m²
capsules, or one 1.6 m² (dual layer) or 2.5 m² (single layer)
capsule. The 2-high holder can accommodate up to two 1.6 m²
(dual layer) or 2.5 m² (single layer) capsules. The 3 high holder
can accommodate up to three 1.6 m² (dual layer) or 2.5 m²
(single layer) capsules. Either single stage or two-stage depth
ltration can be performed within the same holder. The 1-high
small holder has a built-in torque limiter that will signal the
operator when the holder assembly is properly sealed. All
small holders have been designed to be fully autoclavable for
applications where that may be required.
3M™ Encapsulated System Holders, Large
(Model# 16EZB)
The large holder can accommodate up seven 1.6 m² (dual layer)
or 2.5 m² (single layer) capsules. This holder is best suited for
use in small to large production scale purication processes.
However, this holder can also accommodate a single 1.6 m²
(dual layer) or 2.5 m² (single layer) capsule should choose to use
it for scale up studies.
Two Stage Operations
For two stage purication operations a
second pair of manifolds is required between
each stage of multistage operations.
Manifold and capsule materials should
always be the same.
Edge Seal OvermoldGlass Fiber Filled Polypropylene
Luer Cap & Luer-barb ConnectorPolypropylene
Volume
Capsule Fill Volume¹ - Single Layer≈ 17 mL
Capsule Fill Volume¹ - Dual Layer≈ 25 mL
Post Blow-Down Hold-up Volume² - Single Layer≈ 11 mL
Post Blow-Down Hold-up Volume² - Dual Layer≈ 17 mL
Miscellaneous
Effective Filtration Area25 cm²25 cm²
ConnectorLuer
1
Volume of liquid required to fill capsule (experimentally measured).
2
Capsule Post blow-down hold-up volume. Estimated volume of residual preconditioning flush liquid after air/gas blow-down, using water as the flush
fluid and calculated by post-blow-down weight and flush fluid density. Actual amount depends upon exact blow-down conditions, media type in
capsule, the number of capsules in the system, the process fluid, and loading level of the capsule.
Volume of liquid required to fill capsule (experimentally measured).
2
Capsule Post blow-down hold-up volume. Estimated volume of residual preconditioning flush liquid after air/gas blow-down, using water as the flush
fluid and calculated by post-blow-down weight and flush fluid density. Actual amount depends upon exact blow-down conditions, media type in
capsule, the number of capsules in the system, the process fluid, and loading level of the capsule.
IMPORTANT NOTICE: Always operate the filter system within the maximum differential pressure of 2.4 bar (35 psig).
4.1" × 8.5" (10.3 cm × 21.6 cm)6.0" × 8.5" (15.2 cm × 21.6 cm)
Single LayerE16E01 & E16R01: ≈ 3.8 L (≈ 1.0 gal)E16E11 & E16R11: ≈ 18.8 L (≈ 5.0 gal)
Capsule Fill Volume
Post Blow-Down
Hold-up Volume³
2
Dual LayerE16E01 & E16R01: ≈ 3.4 L (≈ 0.9 gal)E16E07 & E16R07: ≈ 18.1 L (≈ 4.8 gal)
Single LayerE16E01 & E16R01: ≈ 0.7 L (≈ 0.2 gal)E16E11 & E16R11: ≈ 7.5 L (≈ 2.0 gal)
Dual LayerE16E01 & E16R01: ≈ 1.3 L (≈ 0.4 gal)E16E07 & E16R07: ≈ 9.0 L (≈ 2.4 gal)
Maximum Operating Line Pressure3.4 bar (50 psig)3.4 bar (50 psig)
Maximum Differential Pressure
Forward2.4 bar (35 psid)2.4 bar (35 psid)
Effective Filtration Area0.23 m² (2.4 ft²)
1
Based on testing with 1M NaOH and 5% NaClO (Bleach).
² Volume of liquid required to fill capsule (experimentally measured).
³ Capsule Post blow-down hold-up volume. Estimated volume of residual preconditioning flush liquid after air/gas blow-down, using water as the
flush fluid and calculated by post-blow-down weight and flush fluid density. Actual amount depends upon exact blow-down conditions, media type
in capsule, the number of capsules in the system, the process fluid, and loading level of the capsule.
1
StandardAlkaline Resistant
Polycarbonate
Polyphenylene oxide /
Polystyrene
Double layer: 1.6 m² (17.2 ft²)
Single layer: 2.5 m² (27.0 ft²)
* Number of 3M production capsules which will fit in a 3M holder along with two sets of 3M manifolds. For example, 2 single cell production
capsules in the first stage followed by 1 single cell production capsule in the second stage meets the maximum of 3 single cell production capsules
for Part Number 4552601.
Figure 9. Small Holder Family (Model# 16EZA) Dimensions
121 cm
(47.48”)
Max
98 cm
(38.48”)
Min
Depth (z)
64.5 cm (25.4”)
65.6 cm
(25.81”)
3M™ Encapsulated System Holder,
Small, One-High Part #4552601
148 cm
(58.38”)
Max
120 cm
(47.38”)
Min
Depth (z)
64.5 cm (25.4”)
65.6 cm
(25.81”)
3M™ Encapsulated System Holder,
Small, Two-High Part #4552603
169 cm
(65.38”)
Max
141 cm
(55.38”)
Min
Depth (z)
64.5 cm (25.4”)
65.6 cm
(25.81”)
3M™ Encapsulated System Holder,
Small, Three-High Part #4552604
Intended Use: 3M™ Zeta Plus™ single-use lter products are intended for use in biopharmaceutical processing applications of aqueous and chemical
based pharmaceuticals (drugs) and vaccines in accordance with the product instructions and specications, and cGMP requirements, where applicable.
Since there are many factors that can aect a product’s use, the customer and user remain responsible for determining whether the 3M product is
suitable and appropriate for the user’s specic application, including user conducting an appropriate risk assessment and evaluating the 3M product in
user’s application.
Restricted Use: 3M advises against the use of these 3M products in any application other than the stated intended use(s), since other applications have
not been evaluated by 3M and may result in an unsafe or unintended condition. Do not use in any manner whereby the 3M product, or any leachable
from the 3M product, may become part of or remains in a medical device that is regulated by any agency, and/or globally exemplary agencies, including
but not limited to: a) FDA, b) European Medical Device Directive (MDD), c) Japan Pharmaceuticals and Medical Devices Agency (PMDA) or in
applications involving permanent implantation into the body; Life-sustaining medical applications; Applications requiring food contact compliance.
Product Selection and Use: Many factors beyond 3M’s control and uniquely within user’s knowledge and control can aect the use and performance of
a 3M product in a particular application. As a result, end-user is solely responsible for evaluating the product and determining whether it is appropriate
and suitable for end-user’s application, including completing a risk assessment that considers the product leachable characteristics and its impact on
drug safety conducting a workplace hazard assessment and reviewing all applicable regulations and standards (e.g., OSHA, ANSI, etc.). Failure to
properly evaluate, select, and use a 3M product and appropriate safety products, or to meet all applicable safety regulations, may result in injury,
sickness, death, and/or harm to property.
Warranty, Limited Remedy, and Disclaimer: Unless a dierent warranty is specically stated on the applicable 3M product packaging or product
literature (in which case such warranty governs), 3M warrants that each 3M product meets the applicable 3M product specication at the time 3M ships
the product. 3M MAKES NO OTHER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTY OR CONDITION OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING OUT OF A COURSE OF DEALING,
CUSTOM, OR USAGE OF TRADE. If a 3M product does not conform to this warranty, then the sole and exclusive remedy is, at 3M’s option, replacement
of the 3M product or refund of the purchase price.
Limitation of Liability: Except for the limited remedy stated above, and except to the extent prohibited by law, 3M will not be liable for any loss or damage
arising from or related to the 3M product, whether direct, indirect, special, incidental, or consequential (including, but not limited to, lost prots or
business opportunity), regardless of the legal or equitable theory asserted, including, but not limited to, warranty, contract, negligence, or strict liability.