3M Zeta Plus SP Series Filters RSF REV 0321

3M Separation and Puriﬁcation Sciences Division
3M Zeta Plus
™ ™
SP Series Filters
Regulatory Support File

Table of Contents
I. Regulatory Support Information .................................................................................................... 2
II. Drug Master File Reference ........................................................................................................... 3
III. Product Descriptions ....................................................................................................................... 3
8” Diameter Cartridges ..................................................................................................................... 4
12” Diameter Cartridges .................................................................................................................. 5
Laboratory Capsules ......................................................................................................................... 6
Scale-Up Capsules ............................................................................................................................ 7
Production Capsules ......................................................................................................................... 7
3M Manifolds .................................................................................................................................... 8
IV. Product Design ................................................................................................................................. 8
A. Media ........................................................................................................................................ 8
B. Cartridges ................................................................................................................................. 8
C. Capsules ................................................................................................................................. 10
D. Materials of Construction ..................................................................................................... 12
E. Capsule and Manifold Design Characteristics ................................................................... 14
F. Wetted Surface Areas........................................................................................................... 16
V. Product Specifications and Operation Parameters .................................................................. 18
A. Product Release Specifications ........................................................................................... 18
B. Installation and Operation Instructions ............................................................................... 19
C. Minimum Required Preconditioning Flush ......................................................................... 19
D. Operating Conditions ............................................................................................................ 21
E. Pre-Use Sterilization .............................................................................................................. 21
F. Post-Use Sanitization ............................................................................................................ 21
VI. Performance Verification .............................................................................................................. 22
A. Media Pressure Drop vs. Water Flow Rate ........................................................................ 22
VII. Effluent Quality ............................................................................................................................... 22
A. USP <643> Total Organic Carbon (TOC) and Total Nitrogen (TN) ................................ 23
B. USP <645> Conductivity ...................................................................................................... 27
C. USP <791> pH ....................................................................................................................... 28
D. USP <232>/<233> and ICH Q3D Elemental Impurities ................................................... 30
E. USP <788> Particulate Matter in Injections ....................................................................... 32
F. USP <85> Bacterial Endotoxin ............................................................................................. 33
VIII. Shelf Life .......................................................................................................................................... 34
IX. Regulatory Compliance................................................................................................................. 34
A. USP <88> Class VI - 70Cminimum Biological Reactivity Tests, In Vivo .............................. 34
B. BSE/TSE (animal derived materials) .................................................................................... 34
X. Quality Assurance .......................................................................................................................... 34
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I. Regulatory Support Information
3M Separation and Purification Sciences Division is a leader in advanced filtration and purification solutions, offering a
wide range of products and services for various stages of pharmaceutical and biologics manufacturing.
3M, a U.S. based multinational high technology company, has operations in more than 65 countries. Facilities that
participate in the manufacturing of 3M™ Zeta Plus™ SP Series filter products as shown below, have quality systems
registered to quality system standards as noted below.
Stafford Springs, CT, USA Wroclaw, Poland Columbia, MO, USA

Registered to: Registered to: Registered to:
ISO 9001 ISO 9001 ISO 13485
ISO 13485
This Regulatory Support File provides information pertinent to the 3M™ Zeta Plus™ SP Series filter products. Contained
herein are detailed test methods, product specifications, product performance information and regulatory documentation
related to pharmaceutical and biologics manufacturing processes. 3M supplied documentation can be used to support
risk assessments and regulatory submissions, prepare standard operating procedures, and streamline testing
requirements, all of which save time and cost for the manufacturer. The manufacturer of a pharmaceutical or biologic
product is ultimately responsible for registration through regulatory authorities in each country or region where their
product will be produced or used.
The U.S. Federal Food, Drug, and Cosmetics Act designated the United States Pharmacopeia (USP) and the National
Formulary (NF) as official compendia for drugs marketed in the United States. USP-NF is a combination of two public
compendia of pharmacopeia standards. The International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and pharmaceutical
industry to discuss various aspects of drug registration and to achieve greater international harmonization. These
standards form the primary basis for technical information provided in this product support document. 3M routinely
completes a thorough review of the USP and ICH standards and this regulatory support file to ensure that the claims and
data package are current.
Complementary product information, use and operating instructions and guidelines, and technical data can be found in
the 3M™ Zeta Plus™ SP Series filter product literature and product quality certifications. Further information can be
obtained by contacting your local 3M representative.
The intended use(s), restrictions on use, and production selection and use for 3M™ Zeta Plus™ SP Series filter products
are stated below.
Intended Use(s): 3M™ Zeta Plus™ single-use filter 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 specifications, and cGMP requirements, where applicable.
Since there are many factors that can affect a product’s use, the customer and user remain responsible for determining
whether the 3M product is suitable and appropriate for the user’s specific application, including user conducting an
appropriate risk assessment and evaluating the 3M product in user’s application.
Restrictions on 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
affect 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.
2
II. Drug Master File Reference
3M™ Zeta Plus™ SP Series filters are listed in a Drug Master File (DMF) registered with the United States Food and Drug
Administration (FDA).
The information contained in the DMF may be utilized by regulatory reviewers to support a New Drug Application (NDA),
Investigational New Drug Application (INDA), Abbreviated New Drug Application (ANDA), another DMF, an Export
Application, or supplements to any of these.
Permission by 3M for review of a DMF is granted only to appropriate United States Food and Drug Administration (FDA)
or similar regulatory agency personnel as the document contains 3M proprietary information. Following the FDA Code of
Federal Regulations (CFR) Title 21 Section 314.420, before FDA may review the DMF in support of an application, 3M
Purification Inc. must provide a letter of authorization permitting FDA to reference the DMF. The applicant is required to
include a copy of the letter of authorization in their application. Contact 3M Separation and Purification Sciences Division
to initiate a review of the DMF. 3M will update this Regulatory Support File as a routine aspect of product maintenance.
III. Product Descriptions
3M™ Zeta Plus™ SP Series filter products are a family of advanced depth filters designed for clarification of various
bioprocess, biological and pharmaceutical fluids. 3M™ Zeta Plus™ SP Series filter media has the widest nominal pore
size range relative to 3M™ Zeta Plus™ LA and ZB Series filter media offerings, including grades with larger nominal pore
sizes. 3M™ Zeta Plus™ SP Series filter media has a lower charge level than 3M™ Zeta Plus™ ZB filter media, which may
reduce the likelihood of removing (binding) product along with contaminants.
3M™ Zeta Plus™ SP Series filter media contains a mixture of inorganic filter aids, cellulose, and a crosslinking polymer
binder resin. The polymer resin has a mixed amine structure including a quaternary amine, which imparts the anion
exchange functionality of the media.
The 3M™ Zeta Plus™ SP Series filter media exhibits a combination of mechanical and electrokinetic mechanisms for
particulate removal as a result of its physical and chemical attributes. The 3M™ Zeta Plus™ SP Series porous depth filter
media is a tortuous network of charge-enhanced flow channels capable of reducing negatively charged DNA, endotoxins,
and other host cell proteins to a level which mechanical screening alone cannot achieve. Whole cells and cell debris can
be removed by mechanical entrapment within the 3M™ Zeta Plus™ SP depth filter matrix. Note that the charge capacity
of the 3M™ Zeta Plus™ SP Series filter media is a general attribute but not a controlled qualification or release
specification. Therefore formal process validation of charged contaminant removal must be fully assessed as part of the
customer’s rigorous risk management process.
3M™ Zeta Plus™ dual layer versions of SP Series filter media consist of two distinct layers, or “zones,” of filter media with
the upstream zone more open than the downstream zone. The media used for each layer is a standard grade. The
structure of the 3M™ Zeta Plus™ SP dual layer media enhances the contaminant holding capacity of the filter media. The
dual layer structure allows larger particles to be trapped in the upstream zone of the more open filter media and smaller
particles to be trapped in the downstream zone, reducing premature plugging and helping extend service life of the
media. The structure of 3M™ Zeta Plus™ SP dual layer media can provide enhanced contaminant holding capacity when
the challenge process stream has a wide particle distribution, compared to that of a single layer, single zone product.
A wide range of product configurations are available including converted media sheets, lenticular cartridges and single-
use capsules.
3M has global manufacturing and supply chain capabilities. The products described below may be produced at multiple
global locations. 3M assigns a unique ID number to each product specific to its source of supply to enable traceability.
Note that special configurations for current customers may not be covered by this RSF. Contact 3M to determine if a
specific 3M™ Zeta Plus™ SP Series filter configuration not listed below is covered by an RSF Supplement.
3
8” Diameter Cartridges
Table 1a. 8” Cartridge Product Descriptions: Single Layer Media
Manufacturing
Product Description Examples: 451092260SP, Z8FA4NPA230SP, Z08P2A05SP, Z08DA60SP
Facility
Diameter Designation Gasket Material Grade
13 – Fluorocarbon (FPM) 05SP
45109 - 8 cell 22 – Silicone (VMQ) 10SP
23 – Fluoropolymer (PTFE) 30SP
03 – Fluorocarbon (FPM) 50SP
45167 - 7 cell Plug-in 04 – Silicone (VMQ) 60SP
United States 09 –PTFE-Encapsulated Fluorocarbon 90SP
Diameter Number Configuration Material O-Ring Material Package Grade
Designation of Cells
05SP
A – Silicone (VMQ) 10SP
2 - 2 cell P- B – Fluorocarbon (FPM) 30SP
Z8FA -Plug-in N - None 2 - Standard
4 - 4 cell Polypropylene K – PTFE-Encapsulated 50SP
Fluorocarbon 60SP
90SP
Diameter Designation Cartridge Construction O-Ring Material Grade
P - Plug-in 7 cells 05SP
P2 - Plug-in 2 cells A – Silicone (VMQ) 10SP
Poland Z08 P4 - Plug-in 4 cells 30SP
50SP
A - Silicone (VMQ) 60SP
D - Standard 8 cells
B – Fluorocarbon (FPM) 90SP
Table 1b. 8” Cartridge Product Descriptions: Dual Layer Media

Manufacturing
Product Description Examples: Z08E05PA60SP05A, Z08E07AA60SP02A
Facility
Diameter Media Number of Cartridge Construction Gasket Material¹ Grade
Designation Configuration Cells
05SP01A (5 & 6 cell)
10SP01A (5 & 6 cell)
10SP02A (5 & 6 cell)
30SP02A (5 & 6 cell)
United States 05 – 5 cell A - Stainless Steel Bands 30SP03A (5 & 6 cell)
A – Silicone
Z08 E 06 – 6 cell B - Hastelloy® Bands 60SP01A (5 & 6 cell)
(VMQ)
07 – 7 cell P – Polypropylene Plug-in 60SP02A (5 & 6 cell)
60SP03A (5 & 6 cell)
60SP05A (5 & 7 cell)
90SP05A (5 & 7 cell)
90SP08A (5 & 7 cell)
Diameter Media Number of Cartridge Construction Gasket Material¹ Grade
Designation Configuration Cells
A – Silicone
Z08 E 06 – 6 cell A - Stainless Steel Bands
(VMQ)
05SP01A (6 cell)
Poland
30SP02A (7 cell)
60SP02A (7 cell)
A - Stainless Steel Bands A – Silicone

Z08 E 07 – 7 cell
B - Hastelloy® Bands (VMQ)
1 Dual layer media configurations are designed for biopharmaceutical applications, where gasket material is Silicone (VMQ)
4
12” Diameter Cartridges
Manufacturing
Product Description Examples: 4523702A90SP, Z12DA90SP
Facility
Diameter Designation Material Gasket Material Grade
05SP
United States 10SP
45244 - 9 cell DOE 01 - Polypropylene (PP) A – Silicone (VMQ)
30SP
45237 - 12 cell DOE 02 – Mineral-filled PP B – Fluorocarbon (FPM)
50SP
45245 - 16 cell DOE 03 – PP, Hastelloy® Bands E – Fluoropolymer (PTFE)
60SP
90SP
Diameter Cartridge Optional Lifting Gasket Material Grade Optional
Designation Construction Handle Material
C – 9 cells /small 05SP
Poland B – 12 cells 10SP
A – Silicone (VMQ) H³ –
D – 16 cells¹ H² – with Handle 30SP
Z12 B – Fluorocarbon (FPM) Hastelloy
M – 15 cells, 50SP
Bands
Netting 60SP
S – 7 cells 90SP
1 15 cells for 05SP media
2 Omit “H” from product description if lifting handle is not required.
3 “H” for Hastelloy® bands. Omit “H” for Stainless Steel Bands.

Manufacturing
Product Description Example: Z12E11AA60SP05A
Facility
Diameter Cartridge Number Cartridge Gasket Material¹ Grade
Designation Construction of Cells Construction
05SP01A
Poland A - Stainless Steel
11 – 11 30SP02A
Z12 E Bands A – Silicone (VMQ)
cell 60SP05A
B - Hastelloy® Bands
90SP05A
1 Dual layer media configurations are designed for biopharmaceutical applications, where gasket material is Silicone (VMQ).
16” Cartridges
Manufacturing
Product Description Examples: Z16PA90SP, Z16DA90SP
Facility
Diameter Configuration Gasket Material Grade Lifting
Designation Handle
05SP
P – 14 cell 10SP
United States A – Silicone (VMQ)
H – High Area¹ 30SP H – with
Z16 B – Fluorocarbon (FPM)
R – 14 cell (Hastelloy® Bands) 50SP Handle²
E – Fluoropolymer (PTFE)
T – High Area (Hastelloy® Bands) 60SP
90SP
Diameter Cartridge Construction Gasket Material Grade Lifting
Designation Handle
M – 14 cell, Netting
P – 14 cell, Netting
05SP
Poland D – 15 cell
10SP
S – 9 cell A – Silicone (VMQ)
30SP H – with
Z16 H – High Area³, Netting, Stainless Steel B – Fluorocarbon (FPM)
50SP Handle²
Bands E – Fluoropolymer (PTFE)
60SP
T – High Area³, Netting, Hastelloy®
90SP
Bands
R – 14 cell, Netting, Hastelloy® Bands
1 High Area Cell Count – 16 cells for grades 30SP & 50SP; 17 cells for grades 60SP & 90SP; not available for 05SP. Bodyfeed cartridge available, please order 45802 (16”, 9 cell).
2 Omit “H” from product description if film lifting handle is not required.
3 16 cells for grades 30SP and 50SP, 17 cells for grades 60SP and 90SP.
5
Manufacturing
Product Description Example: Z16E08AA60SP05A, Z16E08AA90SP05A
Facility
Diameter Media Number Cartridge Gasket Material¹ Grade
Designation Configuration of Cells Construction
05SP01A
10SP01A
10SP02A
01 - 1 cell 30SP02A
United States 02 - 2 cell 30SP03A
A - Stainless Steel
Z16 E 08 - 8 cell A – Silicone (VMQ) 60SP01A
Bands
12 - 12 60SP02A
cell 60SP03A
60SP05A
90SP05A
90SP08A
Diameter Cartridge Number Cartridge Gasket Material¹ Grade
Designation Construction of Cells Construction
05SP01A
10SP01A
10SP02A
01 - 1 cell 30SP02A
Poland 02 - 2 cell A - Stainless Steel 30SP03A
Z16 E 08 - 8 cell Bands A – Silicone (VMQ) 60SP01A
12 - 12 B - Hastelloy® Bands 60SP02A
cell 60SP03A
60SP05A
90SP05A
90SP08A
1 Dual layer media configurations are designed for biopharmaceutical applications, where gasket material is Silicone (VMQ).
Laboratory Capsules
Table 4a. Laboratory Capsule Product Descriptions: Single Layer Media
Manufacturing
Product Description Example: BC0025L90SP
Facility
Diameter Designation Configuration Grade
05SP
United States and 10SP
Poland L - Luer 30SP
BC0025
S - Sanitary 50SP
60SP
90SP
Table 4b. Laboratory Capsule Product Descriptions: Dual Layer Media

Manufacturing
Product Description Example: BC0025L90SP08A
Facility
Diameter Designation Configuration Grade
05SP01A
10SP01A
10SP02A
30SP01A
United States and 30SP02A
Poland L - Luer 30SP03A
BC0025
S - Sanitary 60SP01A
60SP02A
60SP03A
60SP05A
90SP05A
90SP08A
6
Scale-Up Capsules
Table 5a. Scale-Up Capsule Product Descriptions: Single Layer Media
Manufacturing
Product Description Example: E0340FSA90SP
Facility
Diameter Designation EFA (cm²) Capsule Material Grade
05SP
0170
Poland 30SP
E 0340 FSA - Polysulfone
50SP
1020
60SP
90SP
Table 5b. Scale-Up Capsule Product Descriptions: Dual Layer Media

Manufacturing
Product Description Example: E0340FSA90SP08A
Facility
Diameter Designation EFA (cm²) Capsule Material Grade
05SP01A
10SP01A
10SP02A
30SP02A
United States and
0170 30SP03A
Poland
E 0340 FSA - Polysulfone 60SP01A
1020 60SP02A
60SP03A
60SP05A
90SP05A
90SP08A
Production Capsules
Table 6a. Production Capsule Product Descriptions: Single Layer Media
Manufacturing
Product Description Example: E16E01A90SP
Facility
Diameter Designation Configuration Number of Cells Gasket Material Grade
05SP
Poland E - Standard 01 - 1 cell A – Silicone 30SP
E16
R - Alkaline Resistant¹ 11 - 11 cell (VMQ) 50SP
60SP
90SP
1 Alkaline resistance is based on testing with 1M NaOH and 5% NaClO (Bleach).
Table 6b. Production Capsule Product Descriptions: Dual Layer Media

Manufacturing
Product Description Example: E16E07A05SP01A
Facility
Diameter Designation Configuration Number of Cells Gasket Material Grade
05SP01A
10SP01A
10SP02A
30SP02A
United States and 30SP03A
Poland E - Standard 01 - 1 cell A – Silicone
E16 60SP01A
R - Alkaline Resistant¹ 07 - 7 cell (VMQ)
60SP02A
60SP03A
60SP05A
90SP05A
90SP08A
7
3M Manifolds
Table 7. 3M Manifold Product Descriptions
Manufacturing
Product Description Example: 6128901
Facility
Product Description
United States and
Poland 6128901 – Standard Set
6129001 – R - Alkaline Resistant Set¹
IV. Product Design

All components used in the manufacture of 3M™ Zeta Plus™ SP Series products are traceable. Intermediate products
are packaged and labeled throughout the manufacturing process to provide complete traceability from the raw materials
to media batch to finished product.
All grades of the 3M™ Zeta Plus™ SP Series filter media are composed of the same materials of construction at varying
ratios. Therefore, the test results reported herein are generally applicable to all grades and product configurations.
Multiple manufacturing facilities in various global locations produce 3M™ Zeta Plus™ SP Series products. Raw materials
are purchased consistent with global specifications.
A. Media
3M™ Zeta Plus™ SP Series filter media contains a mixture of inorganic filter aid, cellulose, and a crosslinking polymer
binder resin. The polymer binding resin used in 3M™ Zeta Plus™ SP depth filtration media is a polyamide
epichlorohydrin (PAE) polymer that contains a mixture of secondary, tertiary, and quaternary amines. The media is
produced by a wetlaid process.
Media or filter sheets may be die cut to various shapes and dimensions per customer specifications. Converted filter
sheets are generally used in commercially available filter presses. Each distinct pattern is assigned a unique stock
number.
Dual layer versions of 3M™ Zeta Plus™ SP Series filter media consist of two distinct layers, or “zones,” of filter media
with the upstream zone more open than the downstream zone. Smaller numbers indicate more open grades; for
example, 30SP is more open than 90SP. The media used for each layer is a standard grade.
B. Cartridges
The lenticular cells of cartridges are comprised of single or dual opposing layers of the filter media and an inner cell
separator with a polymeric molded edge seal. The lenticular cells are sealed to one another by ring seals that are
aligned to the inner fluid effluent core and rest on the media under predetermined compression by three 316
stainless steel or Hastelloy® binder bands or, in the case of certain 8’’ cartridges that are designated as Plug-in, by a
plug-in post and a connector. Netting is added to selected model numbers to maintain flow path between lenticles.
Each cartridge has two gaskets, one at the top and one at the bottom. Depending on the cartridge configuration,
three standard gasket materials may be offered: silicone (VMQ), fluorocarbon (FPM) or fluoropolymer (PTFE).
Filter cartridges are available in 8", 12" and 16" nominal diameters, with surface areas ranging from 0.26 m² to 3.9 m²
per cartridge. The cartridge lenticles have an outside-to-in flow path. The flow passes through the filter media and is
directed to a central exit flow path along the separators.
8
Figure 1a. 3M™ Zeta Plus™ cartridge lenticle Figure 1b. 3M™ Zeta Plus™ cartridge lenticle
configuration with single media layer configuration with dual media layers
Figure 1c. 3M™ Zeta Plus™ cartridge and Figure 1d. 3M™ Zeta Plus™ cartridges shown with
components housings
Figure 1e. 3M™ Zeta Plus™ 8” plug-in cartridge Figure 1f. 3M™ Zeta Plus™ plug-in cartridge housing
Figure 1g. Optional Molded Lifting Handle on Figure 1h. Optional Film Lifting Handle for 16”
Gasket Retainer for 12” cartridges cartridges
9
C. Capsules
There are three capsule categories for the 3M™ Zeta Plus™ filters: Laboratory, Scale-up and Production Capsules.
The Laboratory capsule (BC0025) is constructed by compressing the single or dual layer filter media between the
inlet and outlet capsule components, then overmolding this entire unit with a glass fiber filled polypropylene. The
Laboratory capsule is available with either luer lock or 1/2” mini sanitary matched inlet and outlet connections. The
Laboratory capsule has a nominal surface area of 25 cm².
Scale-up capsules are constructed from a lenticular media cell design having a diameter of 8”. The lenticle comprises
single or dual opposing layers of the filter media and an inner separator with a polymeric molded edge seal. This
lenticle is first compressed and then held together by injection molding at the outer and inner diameter by a
thermoplastic resin, which simultaneously seals all edges and forms the inner fluid outlet manifold. A polypropylene
spacer is placed between the lenticles in 3-cell design capsule. The lenticles have an outside-to-in flow path. The
flow passes through the filter media and is directed to a central exit flow path along the separators. Scale-up
capsules have three configurations with nominal surface areas of 170 cm², 340 cm² and 1020 cm² per capsule. For
the 170 cm² lenticle, one of the opposing filter media layers is replaced with an injection molded polypropylene disk,
thereby, reducing the accessible surface area by a factor of two. The 1020 cm² capsules contain three stacked and
sealed lenticles. The lenticles, or lenticle stack, are sealed to the outlet side of the capsule with a polypropylene
support ring and fluorocarbon o-ring. The top and bottom pieces of the capsule are sealed together by a thermal
bond. The Scale-up capsules have mini sanitary connections on the inlet and outlet.
Production capsules are also constructed from a lenticular media cell design having a diameter of 16". Each lenticle
has two opposing layers of the filter media and an inner separator with a polymeric molded edge seal. The lenticle is
first compressed and then held together by injection molding at the outer and inner diameter by a thermoplastic
resin, which simultaneously seals all edges and forms the inner fluid outlet manifold. A polypropylene spacer is
placed between the lenticles in 7-cell and 11-cell capsules. The lenticles have an outside-to-in flow path. The flow
passes through the filter media and is directed to a central exit flow path along the separator. The production
capsules have three single-use capsule configurations. The 0.23 m² capsule has one lenticle of single or dual layer
media. The 1.6 m² capsule has seven (7) lenticles of dual layer media. The 2.5 m² capsule has eleven (11) lenticles of
single layer media.
The outermost lenticles of the lenticle stack have respective male and female connectors thermally attached to
provide connection to adjacent capsules or manifolds. The connectors use silicone o-rings. The top and bottom
capsule shells are sealed together by a thermal bond. The multicell production capsule has a self-guiding locking
mechanism for a robust capsule-to-capsule connection. The standard production capsule material is translucent
polycarbonate. An opaque, alkaline-resistant, polyphenylene/oxide polystyrene capsule material option is available,
enabling exposure to strong bases. The multicell production capsules have two handles for convenient loading and
unloading.
A set of 3M manifolds is required for connecting the production capsules to external components of the purification
train. The 3M manifolds have 1.5” sanitary connections on the inlet and outlet. Manifold and capsule materials should
always be the same; materials of construction should not be mixed. For example, polycarbonate capsules should only
be used with polycarbonate manifolds.
The 3M Zeta Plus™ Production capsules may be used in a multi-stage filtration or purification train with a single 3M
Encapsulated System holder. Production capsules of the same or different media configurations can be installed in a
single 3M™ Encapsulated System holder. Additionally, one of the stages may include 3M™ Emphaze™ AEX Hybrid
Purifier. An extra pair of manifolds is required between each stage of the multi-stage train within the 3M
Encapsulated System holder.
Figure 2. Laboratory Capsules
Figure 2a. BC0025 Capsule – Luer Style Figure 2b. BC0025 Capsule – Sanitary Style
10
Figure 3. Scale-Up Capsules
Figure 3a. 170 cm² & 340 cm² Capsules Figure 3b. 1020 cm² Capsule
Luer Cap Scale-up Capsule

Shell Top
Lenticle
Edge Seal
Fluid
Fluid Inlet
Outlet
Downstream
Scale-up Capsule
Shell Bottom
Separator Media-Top
Upstream
Figure 3c. Scale-up Capsule cross-section
Figure 4. Production Capsules
Figure 4a. 0.23 m² Capsule Figure 4b. 1.6 m² & 2.5 m² Capsules
Figure 4c. Production Capsule cross-section

11
Figure 4d. 3M Manifolds – Top manifold Figure 4e. 3M Manifolds – Bottom manifold
Figure 4f. Production capsules installed in 3M holders
D. Materials of Construction
Table 8. Materials of Construction – Filter Cartridges

Part Type Materials
Filter Media Natural Silica, Cellulose, Polymer Resin
Separators Polypropylene or Mineral-filled Polypropylene
Netting¹ Polypropylene
Polypropylene or Mineral-filled Polypropylene (single layer media) or
Edge Seal
Thermoplastic Elastomer (dual layer media)
Ring Seal Polypropylene
Gasket Retainers Polypropylene or Mineral-filled Polypropylene
Optional Molded Lifting Handle on
Polypropylene or Mineral-filled Polypropylene
Gasket Retainer
Gaskets Silicone, Fluorocarbon or PTFE
Optional Film Lifting Handle Polypropylene
Binder Bands 316 Stainless Steel or Hastelloy®
8" Cartridge Plug-in Unitizing Post Polypropylene
1 Specific 12” and 16” cartridges
12
Table 9. Materials of Construction – Laboratory Capsule
Materials
Part Type
BC0025
Nominal Surface Area 25 cm2
Shells Polypropylene
Ring Seal (dual layer media) Polypropylene
Edge Seal Overmold Glass Fiber Filled Polypropylene
Luer cap & luer-barb connector Polypropylene
Table 10. Materials of Construction – Scale-Up Capsules

Materials
Part Type
E0170 Capsule E0340 Capsule E1020 Capsule
Nominal Surface Area 170 cm2 340 cm2 1020 cm2
Separators Polypropylene
Spacers N/A Polypropylene
Flow Inhibitor Disc Polypropylene N/A
Edge Seal Thermoplastic Elastomer
Inner Seal Thermoplastic Elastomer
Endcap Thermoplastic Elastomer
Shells Polysulfone
Back-up O-ring Polypropylene
O-ring Fluorocarbon (FKM)
Luer Cap Polypropylene
Table 11. Materials of Construction – Production Capsules

Materials
Part Type E16E01, E16R01 E16E07, E16R07 E16E11, E16R11
Capsules Capsules Capsules
Nominal Surface Area 0.23 m2 1.6 m2 2.5 m2
Separators, Spacers Polypropylene
Edge Seal Thermoplastic Elastomer
Ring Seal Thermoplastic Elastomer
Connectors (Male & Female) Polypropylene
Shells Either Polycarbonate or Polyphenylene Oxide/Polystyrene
O-ring Retainer Either Polycarbonate or Polyphenylene Oxide/Polystyrene
O-rings Silicone
Handles N/A Nylon
Manifold Polycarbonate or Polyphenylene Oxide/Polystyrene
13
E. Capsule and Manifold Design Characteristics
Weights and Volumes shown in Tables 12-15 below were experimentally determined from samples of various
representative grades and families of 3M™ Zeta Plus™ media. Please note that these values are presented for
guidance only and are not specifications; actual amounts depend upon individual capsule variability, 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) Dry Weight – Weight of capsule prior to use.

2) Wet, Post Blow-down Weight - Liquid retained in the system, as measured by the differential between the
capsule dry weight and the capsule weight after blow-down. This predominantly reflects the liquid left in the
filter media. 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.
3) Capsule Fill Volume - Amount of liquid necessary to fill the capsule from inlet to outlet, including media,
calculated using the filled capsule weight and flush fluid density.
4) 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.
Table 12. Capsule Design Characteristics – Laboratory Capsules

Product Name BC25, Luer BC25, Sanitary
Nominal Surface Area 25 cm² 25 cm²
Inlet/Outlet Luer ½” - ¾” Sanitary Style
Nominal Dimensions
6.5 cm x 7.6 cm 7.9 cm x 7.6 cm
Single Layer (height by diameter)
(2.6 inches x 3 inches) (3.1 inches x 3 inches)
6.9 cm x 7.6 cm 8.3 cm x 7.6 cm
Dual Layer (height by diameter)
(2.7 inches x 3 inches) (3.3 inches x 3 inches)
Weight
Dry – Single Layer ≈ 60 g ≈ 64 g
Dry – Dual Layer ≈ 69 g ≈ 75 g
Wet, post blow-down¹ – Single Layer ≈ 70 g ≈ 75 g
Wet, post blow-down¹ – Dual Layer ≈ 86 g ≈ 93 g
Volume
Capsule Fill Volume² – Single Layer ≈ 17 mL
Capsule Fill Volume² – Dual Layer ≈ 25 mL
Post blow-down Hold-Up Volume³ – Single Layer ≈ 11 mL
Post blow-down Hold-Up Volume³ – Dual Layer ≈ 17 mL
1 Post blow-down wet weight is defined as the experimentally measured weight of the capsule after air/gas blow-down using water as the flush fluid. 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.
2 Capsule Fill Volume is defined as the volume of liquid required to fill the capsule (experimentally measured).
3 Post blow-down hold-up volume is defined as the estimated volume of the residual 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.
14
Table 13. Capsule Design Characteristics – Scale-Up Capsules
Product Name E170 E340 E1020
Nominal Surface Area 170 cm² 340 cm² 1020 cm²
Inlet/Outlet ½” Sanitary Style
Nominal Dimensions
10.3 cm x 21.6 cm 15.2 cm x 21.6 cm
Height by Diameter
(4.1 inches x 8.5 inches) (6.0 inches x 8.5 inches)
Weight
Dry – Single Layer 1.0 kg (2.2 lb) 1.0 kg (2.2 lb) 1.4 kg (3.0 lb)
Dry – Dual Layer 1.0 kg (2.2 lb) 1.0 kg (2.3 lb) 1.6 kg (3.5 lb)
Wet, post blow-down¹ – Single Layer 1.1 kg (2.4 lb) 1.1 kg (2.5 lb) 1.8 kg (4.0 lb)
Wet, post blow-down¹ – Dual Layer 1.2 kg (2.6 lb) 1.3 kg (2.9 lb) 2.4 kg (5.2 lb)
Volume
Capsule Fill Volume² – Single Layer ≈ 0.67 L (≈ 1.5 gal) ≈ 0.69 L (≈ 1.5 gal) ≈ 1.7 L (≈ 3.7 gal)
Capsule Fill Volume² – Dual Layer ≈ 0.63 L (≈ 1.4 gal) ≈ 0.65 L (≈ 1.4 gal) ≈ 1.6 L (≈ 3.5 gal)
Post blow-down Hold-Up Volume³ – Single Layer ≈ 0.12 L (≈ 0.26 gal) ≈ 0.16 L (≈ 0.35 gal) ≈ 0.46 L (≈ 1.0 gal)
Post blow-down Hold-Up Volume³ – Dual Layer ≈ 0.15 L (≈ 0.34 gal) ≈ 0.26 L (≈ 0.58 gal) ≈ 0.80 L (≈ 1.8 gal)
Table 14. Capsule Design Characteristics – Production Capsules, Single Cell

Single Layer Media Dual Layer Media
Alkaline Alkaline
Standard Resistant¹ Standard Resistant¹
Product Name Production Production Production Production
Capsule Capsule Capsule Capsule
E16E01 E16R01 E16E01 E16R01
Nominal Surface Area 0.23 m²
Nominal Dimensions
5.7 cm x 45.2 cm
Height by Diameter
(2.2 inches x 17.8 inches)
Weight
3.0 kg 3.1 kg 3.3 kg 3.4 kg
Dry
(6.6 lbs) (6.8 lbs) (7.3 lbs) (7.5 lbs)
3.8 kg 3.9 kg 4.6 kg 4.8 kg
Wet (post Blow-Down)²
(8.3 lbs) (8.5 lbs) (10 lbs) (11 lbs)
Volume
≈ 3.8 L ≈ 3.4 L
Capsule Fill Volume³
(≈ 1.0 gal) (≈ 0.89 gal)
≈ 0.7 L ≈ 1.3 L
Capsule Post Blow-Down Hold-up Volume⁴
(≈ 0.20 gal) (≈ 0.35 gal)
15
Table 15. Capsule Design Characteristics – Production Capsules, Multi-Cell
Alkaline Alkaline
Standard Resistant¹ Standard Resistant¹
Product Name Production Production Production Production
Capsule Capsule Capsule Capsule
E16E11 E16R11 E16E07 E16R07
Nominal Surface Area 2.5 m² 1.6 m²
Nominal Dimensions
20.3 cm x 45.2 cm
Height by Diameter
Weight
10.2 kg 10.4 kg 10.5 kg 10.7 kg
Dry
(23 lbs) (23 lbs) (23 lbs) (24 lbs)
17.6 kg 18 kg 19.3 kg 19.7 kg
Wet (post Blow-Down)²
(39 lbs) (40 lbs) (43 lbs) (43 lbs)
Volume
≈ 18.1 L ≈ 18.8 L
Capsule Fill Volume³
(≈ 4.8 gal) (≈ 5.0 gal)
≈ 7.5 L ≈ 9.0 L
Capsule Post Blow-Down Hold-up Volume⁴
(≈ 2.0 gal) (≈ 2.4 gal)
Weights and Volumes shown in Table 16 below for standard and alkaline resistant manifolds were experimentally
determined. Please note that these values are presented for guidance only and are not specifications.
Table 16. 3M Manifold Design Characteristics

Standard Manifold, Alkaline Resistant¹ Manifold,
Component
Top or Bottom Top or Bottom
5.2 cm x 45.2 cm
Nominal Dimensions, Height by Diameter
Connector 1½” Sanitary Style
4.4 kg per set 4.7 kg per set
Dry Weight
(10 lbs per set) (10 lbs per set)
Hold-up Volume² <250 mL per set
post-blow-down weight and flush fluid density.
F. Wetted Surface Areas

The wetted surface areas of components in 3M™ Zeta Plus™ filter cartridges and capsules are listed in Tables 17-20.
For O-rings, it is estimated that 50% of the surface area is wetted. Nominal media surface areas for capsules and
cartridges are listed in Table 23.
Wetted surface area calculations are based on 3D models where all geometries are represented by a finely spaced
discrete set of points; curves are approximated by linear interpolation between these points. A numerical quadrature
algorithm is used to estimate the surface area and volume. The listed wetted surface areas represent the nominal
values with tolerances allowed in component dimensions.
16
Table 17. Wetted Surface Areas of Cartridge Components
Wetted Surface Area [cm2]
Components
8” Cartridge 12” Cartridge 16” Cartridge
Separator (per lenticle) 415 1373 4361
Netting¹ (per lenticle) - 5970 12900
Edge Seal (per lenticle) 174 312 426
Ring Seal (per lenticle) 23 12 22
Gasket Retainer (each) 46 57 57
Molded Lifting Handle² on Gasket Retainer - 181 -
Gasket (each) 28 37 37
Film Handle³ - - 1245
Binder Bands 19 28 28
8” Plug-in Unitizing Post 397 -- --
1 Specific 12” and 16” cartridges
2 Specific 12” cartridges
3 Specific 16” cartridges
Table 18. Wetted Surface Areas of Laboratory Capsule Components

Components
BC0025
Shell (Inlet – Luer) 41
Shell (Inlet – Sanitary) 48
Shell (Outlet - Luer) 54
Shell (Outlet – Sanitary) 58
Ring Seal (dual layer media) 36
Edge Seal Non-wetted Surface
Table 19. Wetted Surface Areas of Scale-Up Capsule Components

Components
E0170 Capsule E0340 Capsule E1020 Capsule
Separator (per lenticle) 324
Spacer - - 3.7
Flow Inhibitor Disc 439 - -
Edge Seal (per lenticle) 250 208
Inner Seal (per lenticle) 47
End Cap 14.7
Shell Top 388 679
Shell Bottom 420
Back-up O-ring 2.5
O-ring 1.4
17
Table 20. Wetted Surface Areas of Production Capsule Components
Components E16E01, E16R01 E16E07, E16R07 E16E11, E16R11
Capsules Capsules Capsules
Number of Cells 1 cell 7 cells 11 cells
Separator Assembly 2,178
Spacer 825
Edge Seal (per lenticle) 592 516 592
Inner Seal (per lenticle) 68 79 68
Connectors (Male and Female) 377
Capsule Shells (2) 3,554 5,477
O-ring large retainer 28
O-ring large 14
O-ring small 4
Manifold (Total Top and Bottom) 1,047
V. Product Specifications and Operation Parameters
A. Product Release Specifications

The product specifications verified during filter manufacturing and prior to the release of media lots include but are
not limited to the following.
1) Pressure Drop at constant air flow – Determined by testing a 5-inch diameter disc of media sheet when
challenged at a specific air flow rate.
2) Wet Tensile Strength - Determined by soaking a media coupon in water for two minutes then measuring the
peak force (in kilograms) to break the sample. The result is normalised for the cross-sectional width and length.
3) Calcium Extraction - Determined by soaking media in deionized (DI) water at a ratio of 1 gram of media to 10
mL of water for 24 hours at ambient temperature and analysing the water for soluble calcium. The result is
normalised as mg of calcium per gram of media.
4) Iron Extraction - Determined by soaking media in DI water at a ratio of 1 gram of media to 10 mL of water for 24
hours at ambient temperature and analysing the water for soluble iron. The result is normalised as mg of iron per
gram of media.
5) Aluminum Extraction - Determined by flushing media with DI water followed by a flush of lactic acid solution.
After flushing the media is allowed to sit in the lactic acid solution for 1hr. After 1hr the housing is drained of
fluid and the solution is analyzed for soluble aluminum.
6) Color Extraction - Determined by flushing a media sample with 100 mL of 0.4% w/v 180° F sodium citrate
solution through a 45 mm disc sample of the media. The pooled effluent is analysed for percent transmittance
at 420 nm.
7) Total Nitrogen (TN) - Determined by autoclaving media in deionized (DI) water at a ratio of 1 gram of media to
12 mL of water for 1 hour at 121 °C. The extract is analyzed for Total Nitrogen content.
8) Endotoxin Extraction - Limulus Amebocyte Lysate (LAL) bacterial endotoxin reactivity - Determined by filtering
sterile water through a 45 mm disc of media at a flow rate of 18-20 mL/min then collecting a 2 mL effluent
sample after 49 mL. The effluent sample is tested for endotoxins using a Kinetic Turbidimetric LAL Assay.
The above specification limits for each 3M™ Zeta Plus™ SP media grade are presented in Table 21. The dual layer
media specifications represent the specifications of the tighter media layer. The tighter media layer has the smaller
nominal pore size of the two layers; the larger the grade number, the tighter or smaller the nominal media pore size.
In the Dual Layer Media section of Table 21, the dual layer configuration is shown in parentheses beneath the media
grade; the upstream layer is shown first, followed by the downstream layer. Each layer is released according to the
single layer media specification, and then assembled into dual layer products.
18
Table 21. Product Release Properties for 3M™ Zeta Plus™ SP Series Filters
Single Layer Media Specifications¹
Product Release
01SP 05SP 10SP 30SP 50SP 60SP 90SP
Properties Units
50.0 – 81.0 – 148.0 -
Pressure Drop at Air Flow ≤ 2.8 2.7 – 5.0 8.5 – 13.0 16.0 – 26.0 Inch H₂O
68.0 107.0 202.0
Wet Tensile Strength ≥ 1.5 ≥ 3.0 ≥ 3.0 ≥ 4.0 ≥ 5.0 ≥ 5.5 ≥ 6.5 Kg/in
≤ 0.040
Ca Extraction (PL ≤ ≤ 0.040 ≤ 0.040 ≤ 0.040 ≤ 0.040 ≤ 0.040 ≤ 0.040 mg/g
0.080)
Fe Extraction ≤ 0.010 ≤ 0.010 ≤ 0.010 ≤ 0.010 ≤ 0.010 ≤ 0.010 ≤ 0.010 mg/g
Color Extraction ≤ 8.0 ≤ 8.0 ≤ 8.0 ≤ 8.0 ≤ 8.0 ≤ 8.0 ≤ 8.0 Color Units
Total Nitrogen ≤ 60 ≤ 60 ≤ 60 ≤ 60 ≤ 60 ≤ 60 ≤ 60 ppm
Endotoxin Extraction < 0.25 < 0.25 < 0.25 < 0.25 < 0.25 < 0.25 < 0.25 EU/mL
Dual Layer Media¹
(Specification of Tighter Media Layer)
Product Release 30SP02,
60SP02, 60SP03,
90SP05,
60SP05
Properties 05SP01 10SP01 10SP02 30SP03 90SP08
(01SP/05SP) (01SP/10SP) (05SP/10SP) (05SP/30SP,
(05SP/60SP,
(30SP/90SP,
Units
10SP/60SP,
10SP/30SP) 60SP/90SP)
30SP/60SP)
148.0 -
Pressure Drop at Air Flow 2.7 – 5.0 8.5 – 13.0 8.5 – 13.0 16.0 – 26.0 81.0 – 107.0 Inch H₂O
202.0
Wet Tensile Strength ≥ 3.0 ≥ 3.0 ≥ 3.0 ≥ 4.0 ≥ 5.5 ≥ 6.5 Kg/in
Ca Extraction ≤ 0.040 ≤ 0.040 ≤ 0.040 ≤ 0.040 ≤ 0.040 ≤ 0.040 mg/g
Fe Extraction ≤ 0.010 ≤ 0.010 ≤ 0.010 ≤ 0.010 ≤ 0.010 ≤ 0.010 mg/g
Color Extraction ≤ 8.0 ≤ 8.0 ≤ 8.0 ≤ 8.0 ≤ 8.0 ≤ 8.0 Color Units
Total Nitrogen ≤ 60 ≤ 60 ≤ 60 ≤ 60 ≤ 60 ≤ 60 ppm
Endotoxin Extraction < 0.25 < 0.25 < 0.25 < 0.25 < 0.25 < 0.25 EU/mL
1 Manufacturing facilities have the same specification except as noted in parentheses. (US: USA; PL: Poland)
B. Installation and Operation Instructions

The installation and operation of the 3M™ Zeta Plus™ SP Series filter products should follow the appropriate use
instruction for each filter configuration. Always operate within the specified pressure and temperature limits.
Note: Installation and Operation Instructions are available upon request from your local representative.
Prior to filtration operation, end-user should verify that the housing for filter cartridges is integral and filter cartridges
or capsules have been properly installed and sealed. Therefore, a pre-use Installation Qualification test (IQ) should
be performed per recommended test procedure contained in 3M's Installation and Operating Procedures manuals
(70-0201-8802-8 for cartridges, 70-0202-6945-5 for capsules).
C. Minimum Required Preconditioning Flush

3M™ Zeta Plus™ depth filters made with SP media are comprised primarily of natural products and are considered
fiber-releasing filters. Trace amounts of polymer resin, cellulosic fibers and natural extractables such as endotoxin,
beta glucan, and inorganic ions, are released by these filters during use. Therefore, customers must flush the filters
before exposure to their product. 3M™ Zeta Plus™ SP media depth filters can be flushed with water or buffer at
temperature and pressure not to exceed the maximum product specification. The required minimum preconditioning
flush volume for all products is 54 L/m². Pressure drop across the filter should not exceed 2.4 bar [35 psid]. The
maximum recommended preconditioning flush flux for the required preconditioning flush is 1200 L/m²/hour (LMH)
for cartridges. The maximum recommended preconditioning flush flux for the required preconditioning flush is 210
LMH for capsules.
If the filter is autoclaved or steam sterilized in-situ prior to use, the product must be flushed after sterilization using
the required preconditioning flush.
Detailed preconditioning flush protocols are provided in 3M Installation and Operating Instructions (see Section V.B.).
Based on the required minimum preconditioning flush of 54 L/m² and the nominal surface area for each filter, flush
volumes for each filter configuration are provided in Table 23.
19
The data package of effluent quality presented in this Regulatory Support File is developed based on the maximum
recommended flux of the required preconditioning flush for cartridges.
Table 22. Minimum Required Preconditioning Flush Volume and Maximum Recommended Flux
Minimum Required Preconditioning Flush Volume All Products 54 L/m²
Cartridges 1200 LMH
Maximum Recommended Flux of Required Preconditioning Flush
Capsules 210 LMH
Table 23. Minimum Required Preconditioning Flush Volume & Nominal Surface Area
Minimum Required
Nominal Surface
Cartridge Configuration Preconditioning Flush
Area
Volume [L]
45109 (8" diameter cartridge, 8-cell) 0.26 m2 14
45167 (8" diameter cartridge, 7-cell O-ring plug-in) 0.23 m2 12
Z8FA2NPx2 (8" diameter, 2-cell plug-in) 0.065 m2 3.5
Z8FA4NPx2 (8" diameter, 4-cell plug-in) 0.13 m2 7.0
Z08E05 (8” diameter cartridge, 5-cell plug-in) 0.16 m2 8.6
Z08E07 (8” diameter cartridge, 7-cell) 0.23 m2 12
Z16D (16" diameter cartridge, 15-cell) 3.5 m2 189
Z16P (16" diameter cartridge, 14-cell) 3.2 m2 173
Z16H (16" diameter cartridge, 16-cell) 30SP & 50SP only 3.7 m2 200
Z16H (16" diameter cartridge, 17-cell) 60SP & 90SP only 3.9 m2 211
Minimum Required
Nominal Surface
Capsule Configuration Preconditioning Flush
Area
Volume [L]
BC0025 Laboratory Capsule 25 cm2 0.14
E0170 (Scale-Up capsule) 0.017 m2 0.9
E16E01 & E16R01 (Production capsule) 0.23 m2 12
20
D. Operating Conditions
Table 24. Operating Conditions
Laboratory Capsule 2.8 bar (40 psig) maximum inlet pressure
Maximum Operating Pressure Scale-Up Capsule 3.1 bar (45 psig)
Production Capsule 3.4 bar @40 °C (50 psig @104 °F)
Maximum Differential Pressure Forward All Products 2.4 bar (35 psig)
Cartridge 82 °C (180 °F)
Maximum Operating Temperature
Capsules 40 °C (104 °F)
Minimum Required Preconditioning Flush Volume All Products
Maximum Recommended Flux of Required Cartridges See Section V. C.

Preconditioning Flush Capsules
Cartridges
Pre-Use Sterilization See Section V. E.
Capsules
E. Pre-Use Sterilization
3M Zeta Plus™ SP Series products are not bioburden controlled. They can be autoclaved or in-situ steam sterilized
per recommended conditions listed in Table 25. The filter cartridges can be steam sterilized per 3M procedure 70-
0201-8840-8. Studies were conducted to ensure sterility after autoclave or in situ steam sterilization. If the filter is
autoclaved or steam sterilized in-situ prior to use, it must be flushed after sterilization using the required
preconditioning flush.
Table 25. Pre-Use Sterilization Conditions

Product Class Autoclave / Steam-in-Place Parameters¹
Cartridges in situ steam sterilization, 30 minutes @ 126 °C (259 °F) maximum (3 cycles Max)
Laboratory Capsules Autoclave only, 30 minutes @ 121 °C (250 °F) maximum (1 cycle)
Scale-Up Capsules Autoclave only, Pre-vac cycle, 30 minutes @ 126 °C (259 °F) maximum (1 cycle)
Production Capsules Autoclave only, Pre-vac cycle, 30 minutes @ 126 °C (259 °F) maximum (1 cycle)
1 Do not exceed maximum pressure and temperature ratings during sterilization.
F. Post-Use Sanitization
3M™ Zeta Plus™ SP Series products may be sanitized by the procedure in Table 26 prior to disposal, if necessary, to
comply with local regulations or customer requirements.
Note that the Standard Production Capsules (E16E01, E16E07, E16E11) have a polycarbonate shell and
CANNOT be exposed to NaOH or NaClO (Bleach).
Table 26. Post-Use Sanitization Conditions¹

Autoclave / Steam-in-Place
Product Class Caustic Sanitization
Parameters
Cartridges Can be treated with 1M NaOH or 5% NaClO post-use.
Laboratory Capsules Capsule soak for 1 hour with 1M NaOH or 5% NaClO
Scale-Up Capsules (bleach)² post-use. Same as Pre-Use Sterilization
Conditions
Alkaline-Resistant³ Production Capsules can be treated
(See Table 25)
with 1M NaOH or 5% NaClO (bleach)² post-use.
Production Capsules
Not applicable to polycarbonate Standard
Production Capsules.
1. Do not exceed maximum pressure and temperature ratings during sanitization.
2. Do not use NaClO (bleach) for pre-use sanitization.
3. Alkaline resistance is based on testing with 1M NaOH and 5% NaClO (Bleach).
21
VI. Performance Verification
A. Media Pressure Drop vs. Water Flow Rate

The 90-mm discs of 3M™ Zeta Plus™ media 30SP, 60SP and 60SP05A produced at different global plants were
tested for pressure drop as a function of water flow rate in liters/m²/hour (LMH) with 18 Megohm water (25°C), as
shown in Table 27 and Figure 5.
3M™ Zeta Plus™ SP media has variations within each manufacturing lot and from lot-to-lot. The chart is based on
test data for representative manufacturing lots from each global facility and should be considered typical values.
The water flow rate differentiation by grade of 3M™ Zeta Plus™ SP media indicated here is for guidance only.
Factors that influence actual customer flow rates include fluid viscosity, density, flow restriction due to fluid path,
and normal fouling of media by contaminant load.
Table 27. Pressure Drop vs. Water Flow Rate of 3M™ Zeta Plus™ Media 30SP, 60SP and 60SP05A
at 25°C
30SP 60SP 60SP05A
Number of Manufacturing Lots: 3 Number of Manufacturing Lots: 4 Number of Manufacturing Lots: 4
Flow Rate Differential Pressure (PSID)
LMH Average Max Min Average Max Min Average Max Min
0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
304 0.4 0.3 0.5 0.9 0.7 0.9 2.3 2.1 2.6
542 0.6 0.5 0.8 1.5 1.3 1.7 3.8 3.6 4.4
794 1.0 0.8 1.3 2.4 2.2 2.6 5.0 4.6 5.5
992 1.3 1.1 1.6 3.0 2.8 3.2 5.5 5.2 5.7
1204 1.6 1.3 1.9 3.6 3.4 3.8 6.2 5.6 6.9
VII. Effluent Quality

Various regulatory organizations require that equipment used in pharmaceutical manufacturing that is in direct contact
with the drug product should not add to or change the drug in any way other than what is intended by the manufacturer.
22
Distribution of Responsibility
3M Separation and Purification Sciences Division has adopted the following supplier collaborative model (D. Jenke,
Pharma Ed Conference on Extractables & Leachables, keynote address Oct 2011) relative to Extractable and Leachable
evaluation.
Shared Responsibility of Supplier and Producer

1. It is the responsibility of suppliers of plastic materials or systems to provide users with a full and complete composition
of their material or system.
2. It is the responsibility of the producer to supply regulators with a full and complete leachables assessment for their
finished therapeutic product.
3. It is the shared responsibility of the producer and supplier to collaborate on obtaining extractables information and in so
doing increases the effectiveness and efficiency of extractables studies.
In this Regulatory Support File, 3M provides effluent quality data relating to the required preconditioning flush based on
the requirements listed in Table 29. As of August 2020, the USP chapter <665> outlining guidance for
extractables/leachables of polymers in pharmaceutical manufacturing is still in draft form. It is 3M’s commitment to
comply with all regulatory requirements, as well as provide data for our customers to make appropriate risk assessments.
To this end, an Extractable Profile Report is available upon request that follows current USP draft guidance for reporting
extractables/leachables.
Table 28. Reference Industry Standards

USP Standards Applicable Methods
<643> Total Organic Carbon
<645> Conductivity
<791> pH
<232>, <233>, ICH* Q3D Elemental Impurities
<788> Particulate Matter in Injections
<85> Bacterial Endotoxin
<88> Biological Reactivity
* ICH – International Conference for Harmonisation, Guideline for Elemental Impurities, Q3D
A. USP <643> Total Organic Carbon (TOC) and Total Nitrogen (TN)
challenged with 18 Megohm water (25°C) at a constant flux of 1200 LMH to a total volume of two times the
minimum required preconditioning flush volume of 54 L/m². Effluent samples were collected at 10%, 20%, 30%, 40%,
and so on at 10% increments to 200% of the preconditioning flush volume. The effluent samples were then analyzed
for TOC and TN. The TOC data at selected preconditioning flush volume percentages is shown in Table 29 and
Figure 6. The TN data at selected preconditioning flush volume percentages is shown in Table 30 and Figure 7.
Table 29. Effluent TOC [ppm] vs. Preconditioning Flush Volume % of 3M™ Zeta Plus™ Media 30SP,
60SP and 60SP05A – No Treatment
30SP 60SP 60SP05A
Flush Vol % Number of Manufacturing Lots: 5 Number of Manufacturing Lots: 7 Number of Manufacturing Lots: 4
[%] Average Max Min Average Max Min Average Max Min
10% 150.1 201.6 115.5 237.7 443.3 83.0 314.6 548.7 190.2
20% 22.5 37.6 13.7 25.4 40.7 10.2 55.0 90.5 29.3
30% 13.0 22.5 8.5 13.4 21.9 5.6 26.6 34.4 19.1
40% 9.6 15.3 6.5 9.6 15.6 4.3 17.3 18.0 16.9
50% 7.8 11.8 5.4 7.6 12.6 4.0 12.5 15.9 10.2
60% 6.5 10.0 4.6 6.3 9.8 3.7 10.5 13.9 7.8
100% 4.2 7.0 3.2 3.2 4.6 2.4 6.3 7.0 5.3
150% 2.8 4.1 1.9 2.0 2.7 1.4 4.1 4.3 3.8
200% 2.1 3.3 1.6 1.5 2.0 0.9 2.9 3.2 2.5
23
Table 30. Effluent TN [ppm] vs. Preconditioning Flush Volume % of 3M™ Zeta Plus™ Media 30SP,
60SP and 60SP05A – No Treatment
30SP 60SP 60SP05A
10% 28.3 36.0 23.8 46.0 73.7 19.66 76.3 109.8 42.7
20% 4.24 6.77 3.03 4.93 7.94 2.08 12.58 18.74 6.25
30% 2.51 4.09 1.88 2.65 4.45 1.05 5.33 6.73 3.82
40% 1.89 2.88 1.24 1.99 2.93 0.73 3.35 3.63 3.09
50% 1.58 2.31 0.95 1.64 2.11 0.71 2.33 3.18 1.77
60% 1.36 2.02 0.71 1.38 1.78 0.53 1.92 2.75 1.33
100% 0.97 1.45 0.43 0.84 0.97 0.35 1.05 1.18 0.93
150% 0.77 1.00 0.35 0.66 0.81 0.31 0.49 0.58 0.43
200% 0.68 0.81 0.35 0.59 0.72 0.25 1.01 3.05 0.32
24
Additional 90-mm discs of 3M™ Zeta Plus™ media 60SP were autoclaved using a pre-vac cycle at 126°C for 60
minutes prior to the preconditioning flush. The same preconditioning flush sampling and test procedures which were
used for the non-autoclaved samples were followed for the autoclaved samples. The TOC data for autoclaved
samples is shown in Table 31 and Figure 8. The TN data for autoclaved samples is shown in Table 32 and Figure 9.
Table 31. Effluent TOC [ppm] vs. Preconditioning Flush Volume % of

3M™ Zeta Plus™ Media 60SP – Post Autoclave
Single Layer Media
60SP
Flush Volume Number of Manufacturing Lots: 2
[%] Average Max Min
10% 417 505 329
20% 40.2 43.5 36.9
30% 16.4 18.0 14.8
40% 11.1 12.8 9.4
50% 9.0 10.5 7.5
60% 7.6 8.6 6.6
100% 4.5 5.3 3.7
150% 2.8 3.1 2.4
200% 2.1 2.3 1.9
25
Table 32. Effluent TN [ppm] vs. Preconditioning Flush Volume % of 3M™
Zeta Plus™ Media 60SP – Post Autoclave
Single Layer Media
60SP
Flush Volume Number of Manufacturing Lots: 2
[%] Average Max Min
10% 89.0 107 71.3
20% 8.8 9.5 8.1
30% 3.2 3.5 2.9
40% 2.0 2.3 1.7
50% 1.5 1.8 1.2
60% 1.2 1.3 1.1
100% 0.6 0.7 0.5
150% 0.3 0.4 0.3
200% 0.2 0.2 0.2
26
B. USP <645> Conductivity
and so on at 10% increments to 200% of the minimum required preconditioning flush volume. The effluent samples
were then measured for conductivity. The conductivity at selected preconditioning flush volume percentages are
shown in Table 33 and Figure 10.
Additional 90-mm discs of 3M™ Zeta Plus™ media 30SP, 60SP and 60SP05A were autoclaved using a pre-vac cycle
at 121°C for 60 minutes prior to the preconditioning flush. The same preconditioning flush sampling and test
procedures which were used for the non-autoclaved samples were followed for the autoclaved samples. The
conductivity at selected preconditioning flush volume percentages are shown in Table 34 and Figure 11.
Table 33. Effluent Conductivity [µS/cm] vs. Preconditioning Flush Volume % of 3M™ Zeta Plus™
Media 30SP, 60SP and 60SP05A – No Treatment
30SP 60SP 60SP05A
10% 149 184 134 212 261 140 307 386 242
20% 29.2 35.1 25.2 42.2 52.6 33.5 67.8 80.8 53.5
30% 17.8 23.5 15.7 28.0 33.9 23.0 40.3 47.1 36.0
40% 13.7 18.7 11.3 22.2 24.8 19.5 31.2 35.0 28.9
50% 12.0 14.8 10.1 18.5 20.4 16.4 26.2 29.4 22.9
60% 10.5 12.3 9.4 15.6 17.8 14.0 23.1 25.2 19.7
100% 7.6 8.5 6.7 9.1 12.0 7.5 13.0 13.9 11.0
150% 6.3 6.5 6.1 6.2 7.7 5.4 8.6 9.3 8.2
200% 5.3 6.1 4.4 5.2 5.7 4.5 6.8 7.5 6.3
27
Table 34. Effluent Conductivity [µS/cm] vs. Preconditioning Flush Volume % of 3M™ Zeta Plus™
Media 30SP, 60SP and 60SP05A – Post-Autoclave
30SP 60SP 60SP05A
10% 274 296 264 369 442 310 621 714 510
20% 39.0 41.9 34.7 53.7 65.6 43.5 114.4 137.9 76.5
30% 17.5 18.3 17.0 27.4 32.4 20.3 62.5 75.8 49.5
40% 12.0 12.7 11.4 20.4 25.1 14.7 46.6 52.9 41.9
50% 9.5 10.1 8.9 17.6 21.9 13.2 38.1 43.6 30.6
60% 8.2 8.5 7.8 15.3 19.1 11.7 32.0 40.6 23.1
100% 5.4 5.8 4.9 10.4 12.5 8.1 13.5 20.4 9.3
150% 4.2 4.6 3.7 7.1 8.2 6.0 7.0 7.9 6.4
200% 3.8 4.1 3.4 5.6 6.2 5.4 5.9 6.3 5.6
C. USP <791> pH
and so on at 10% increments to 200% of the minimum required preconditioning flush volume. The effluent samples
were then measured for pH.
The effluent pH at selected preconditioning flush volume percentages, along with pH of DI water controls, are shown
in Table 35 and Figure 12. Note that the DI water used as the flush solution is not buffered. Its low resistance to pH
change due to small amount of acid or base is reflected in the extract pH difference shown here.
procedures which were used for the non-autoclaved samples were followed for the autoclaved samples. The
effluent pH for autoclaved samples at selected preconditioning flush volume percentages, along with pH of DI water
controls, are shown in Table 36 and Figure 13.
28
Table 35. Effluent pH vs. Preconditioning Flush Volume % of 3M™ Zeta Plus™ Media 30SP, 60SP and
60SP05A – No Treatment
30SP 60SP 60SP05A
DI Water Control 5.1 5.4 5.0 5.3 5.4 5.0 5.2 5.3 5.0
10% 5.7 5.9 5.2 5.7 5.9 5.5 5.5 5.7 5.5
20% 5.5 5.7 4.7 5.1 5.6 4.8 5.4 5.6 5.3
30% 5.3 5.6 4.6 4.9 5.1 4.6 5.2 5.5 5.1
40% 5.4 5.6 4.7 4.8 5.0 4.6 5.2 5.4 5.0
50% 5.3 5.5 4.8 4.8 4.9 4.5 5.2 5.4 5.0
60% 5.4 5.7 4.9 4.8 5.0 4.6 5.1 5.2 5.0
100% 5.4 5.6 5.3 5.0 5.2 4.7 5.2 5.3 5.0
150% 5.3 5.4 5.3 5.1 5.2 4.9 5.3 5.4 5.2
200% 5.4 5.6 5.3 5.2 5.3 5.0 5.4 5.5 5.3
29
Table 36. Effluent pH vs. Preconditioning Flush Volume % of 3M™ Zeta Plus™ Media 30SP, 60SP and
60SP05A – Post-Autoclave
30SP 60SP 60SP05A
DI Water Control 5.4 5.5 5.4 5.3 5.4 5.2 5.3 5.5 5.2
10% 6.6 6.7 6.3 6.4 6.5 5.8 6.6 7.2 6.4
20% 6.5 6.7 6.2 6.1 6.3 5.8 6.3 6.7 6.1
30% 6.4 6.6 6.1 5.9 6.1 5.7 6.3 6.5 6.2
40% 6.3 6.5 6.0 5.9 6.1 5.6 6.3 6.4 6.2
50% 6.2 6.4 6.0 5.8 5.9 5.5 6.2 6.3 6.0
60% 6.2 6.4 6.0 5.8 5.8 5.6 6.2 6.4 6.0
100% 6.1 6.3 5.9 5.7 5.7 5.5 6.0 6.2 5.7
150% 6.1 6.2 5.8 5.5 5.5 5.4 5.7 5.8 5.6
200% 6.0 6.2 5.7 5.5 5.5 5.4 5.5 5.5 5.4
D. USP <232>/<233> and ICH Q3D Elemental Impurities

challenged with 18 Megohm DI water (25°C) at a constant flux of 1200 LMH to a total volume of two times the
and so on at 10% increments to 200% of the preconditioning flush volume. The 10%, 100% and 200% effluent samples
were then analyzed for extractable elements.
procedures which were used for the non-autoclaved samples were followed for the autoclaved samples.
Elemental profiles for effluent from both autoclaved and non-autoclaved samples are shown in Tables 37 and 38.
The designation “<LOQ“ indicates that the measured value is below the Limit of Quantification (LOQ). 3M™ Zeta
Plus™ SP media contains natural silica; naturally occurring differences are anticipated, and the values below should
be taken as representative.
30
Table 37. Flush Effluent Elemental Impurities for 3M™ Zeta Plus™ Media 30SP, 60SP and 60SP05A (ppb)
ICH LOQ
Element 30SP 60SP 60SP05A
Class [ppb]
At % of Flush Volume 10% 100% 200% 10% 100% 200% 10% 100% 200%
As 0.01 2.00 0.41 <LOQ 1.08 1.37 0.48 <LOQ <LOQ <LOQ
Cd 0.01 0.04 <LOQ <LOQ 0.21 <LOQ <LOQ 0.20 <LOQ <LOQ
1
Hg 0.2 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Pb 0.3 0.41 0.02 <LOQ 0.43 <LOQ <LOQ 0.20 <LOQ <LOQ
Co 0.01 0.28 <LOQ <LOQ 0.90 <LOQ <LOQ 0.80 <LOQ <LOQ
2A Ni 1.8 4.7 <LOQ <LOQ 11.5 <LOQ <LOQ 12.0 <LOQ <LOQ
V 0.4 6.5 1.6 1.1 162.5 4.3 4.3 105.5 5.71 5.56
Ag 0.02 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Au 0.071 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Ir 0.002 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Os 0.275 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Pd 0.017 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
2B
Pt 0.002 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Rh 0.001 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Ru 0.002 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Se 0.6 <LOQ <LOQ <LOQ 0.23 0.11 0.05 0.24 <LOQ <LOQ
Tl 0.01 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Ba 0.3 23.7 1.6 1.1 21.3 2.7 2.8 31.5 3.3 1.8
Cr 0.6 0.9 <LOQ <LOQ 0.9 <LOQ <LOQ 2.1 <LOQ <LOQ
Cu 4 5 0.2 0.3 12 1 0.2 21 0.94 0.43
3 Li 0.2 4.2 <LOQ <LOQ 19.0 1.0 <LOQ 11.8 0.6 0.4
Mo 0.01 <LOQ <LOQ <LOQ 5.47 <LOQ <LOQ 4.53 1.40 1.22
Sb 0.02 0.07 0.01 <LOQ 0.14 0.09 0.05 0.13 0.08 0.06
Sn 0.2 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Al 0.2 535.5 12.2 9.3 784.1 82.2 19.2 1328.9 130.9 29.7
B 0.6 12.4 <LOQ <LOQ 60.4 <LOQ <LOQ 24.6 <LOQ <LOQ
Ca 17 986 41 37 1877 54 21 4219 92 45
Fe 4 429 <LOQ <LOQ 753 <LOQ <LOQ 1177 <LOQ <LOQ
K 65 1397 112 82 5442 315 111 3565 381 224
Other Elements
Mg 2 196 7 10 1425 13 4 1500 18 7

Mn 0.3 141 2.5 1.4 101.9 1.6 0.8 159.3 5.9 1.8
Na 3 16144.4 864 556 20863 666 292 20107 1701 837
Si 10 535 25 29 673 52 33 1036 81 48
Sr 0.2 5 0.3 0.2 12.0 0.6 0.3 12.3 0.5 0.3
W 0.01 <LOQ <LOQ <LOQ 0.70 <LOQ <LOQ <LOQ <LOQ <LOQ
Zn 20 14.91 3.19 4.32 34 3 3 32 2.33 2.88
Zr 0.01 1.86 0.05 <LOQ 0.07 0.04 <LOQ <LOQ <LOQ <LOQ
31
Table 38. Flush Effluent Elemental Impurities for 3M™ Zeta Plus™ Media 30SP, 60SP and 60SP05A (ppb) –
Post-Autoclave
ICH LOQ
Element 30SP 60SP 60SP05A
Class [ppb]
At % of Flush Volume 10% 100% 200% 10% 100% 200% 10% 100% 200%
As 0.01 0.16 <LOQ <LOQ 0.14 <LOQ <LOQ <LOQ <LOQ <LOQ
Cd 0.01 <LOQ <LOQ <LOQ 1.43 <LOQ <LOQ 1.54 <LOQ <LOQ
1
Hg 0.2 10.5 <LOQ <LOQ 17.44 1.01 <LOQ 18.4 <LOQ <LOQ
Pb 0.3 3.06 <LOQ <LOQ 297.6 46.39 24.2 304.02 47.64 41.02
Co 0.01 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
2A Ni 1.8 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
V 0.4 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Ag 0.02 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Au 0.071 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Ir 0.002 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Os 0.275 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Pd 0.017 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
2B
Pt 0.002 <LOQ <LOQ <LOQ 1.06 <LOQ <LOQ 1.07 0.27 <LOQ
Rh 0.001 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Ru 0.002 24.78 2.08 1.2 26.68 23.95 12.08 38.05 19.52 10.38
Se 0.6 17.98 <LOQ 3.25 14.37 <LOQ <LOQ 14.89 <LOQ <LOQ
Tl 0.01 3.39 1.41 <LOQ 12.84 5.9 1.96 14.21 8.32 3.89
Ba 0.3 35.32 0.93 <LOQ 79.27 1.25 0.84 76.07 2.07 <LOQ
Cr 0.6 5.5 <LOQ <LOQ 58.05 5.83 4.04 67.92 8.98 4.77
Cu 4 0.22 0.01 <LOQ 1.22 0.16 0.09 1.14 0.16 0.08
3 Li 0.2 0.12 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ 0.01 <LOQ
Mo 0.01 94.16 7.73 5.86 722.04 42.14 18.39 634.52 39.74 20.76
Sb 0.02 28.76 2.59 <LOQ 89.88 4.51 <LOQ 86.58 5.04 <LOQ
Sn 0.2 1914.4 95.84 60.9 7540.55 228.27 101.06 5920.07 166.45 71.15
Al 0.2 463.84 <LOQ <LOQ 540.67 <LOQ <LOQ 725.09 <LOQ <LOQ
B 0.6 4245.5 155.74 57.89 10679.08 338.84 219.69 8351.86 321.92 143.55
Ca 17 1178.74 35.43 25.21 6520.6 183.54 47.2 6031.61 155.53 48.66
Fe 4 170.92 5.28 3.73 387.13 11.03 4.83 336.48 8.55 3.54
K 65 44956.84 1098.95 780.47 72066.67 1638.21 783.32 73799.8 3493.33 940.19
Other Elements
Mg 2 2425.42 58.21 40.13 2554.42 85.14 50.32 2619.63 139.52 39.71

Mn 0.3 9.86 0.68 0.5 33.2 4.04 1.65 35.37 3.11 1.37
Na 3 1.89 0.07 0.04 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
Si 10 6.04 0.7 0.7 20.01 3.12 5.19 23.63 2.12 0.98
Sr 0.2 <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ <LOQ
W 0.01 0.16 <LOQ <LOQ 0.14 <LOQ <LOQ <LOQ <LOQ <LOQ
Zn 20 <LOQ <LOQ <LOQ 1.43 <LOQ <LOQ 1.54 <LOQ <LOQ
Zr 0.01 10.5 <LOQ <LOQ 17.44 1.01 <LOQ 18.4 <LOQ <LOQ
E. USP <788> Particulate Matter in Injections

90-mm discs of Zeta Plus media 30SP, 60SP and 60SP05A produced at different global plants were challenged with
18 Megohm water (25°C) at a constant flux of 1200 LMH to a total volume of two times the minimum required
preconditioning flush volume of 54 L/m². Effluent samples were collected at 33%, 66%, 100% and 200% of the
preconditioning flush volume. After the 200% extract sample was collected, the remaining extract was left to soak in
the housing. After one hour, the static soak extract was then pushed through the filter and collected. For dual layer
products, media discs were stacked in the housing with the tighter grade media downstream of the more open
grade.
32
Additional 90-mm discs of 3M™ Zeta Plus™ media 30SP and 60SP were autoclaved using a pre-vac cycle at 121°C
for 60 minutes prior to the preconditioning flush. The same preconditioning flush sampling and test procedures
which were used for the non-autoclaved samples were followed for the autoclaved samples.
Samples were analyzed following USP <788> Method 1 (Light Obscuration Particle Count Test) for particulate
release. Three to four aliquots of 5 mL each were measured from each sample, with particles counted and measured
at the size ranges specified in the USP chapter: particles greater than 10 μm but less than 25 μm; and particles > 25
μm. The solution meets the USP <788> requirement if it contains less than 25 particles/mL >10 μm and less than 3
particles/mL >25 μm.
The results of this analysis including results of control water samples are shown in Tables 39-41. The tests showed
that minimum required preconditioning flush of the untreated and autoclaved 3M™ Zeta Plus™ SP filter media
reduced the particulate matter of effluent.
Table 39. Particulate Matter of 3M™ Zeta Plus™ Media 30SP and 60SP
Single Layer Media
30SP 60SP
Number of Manufacturing Lots: 3 Number of Manufacturing Lots: 3

Flush Volume Flush Volume
Particulate 18 Megohm Static 18 Megohm Static
Size Water (25°C) 33% 66% 100% 200% Soak Water (25°C) 33% 66% 100% 200% Soak
>10 μm 4.1 3.1 3.0 3.1 2.6 267.4 4.1 26.1 21.5 13.7 3.0 24.2
>25 μm 0.1 0.1 0.1 0.1 0.1 4.2 0.1 0.2 0.2 0.2 0.2 0.3
Table 40. Particulate Matter of 3M™ Zeta Plus™ Media

60SP05A
Dual Layer Media
60SP05A
Number of Manufacturing Lots: 2
Flush Volume
Particulate 18 Megohm Static
Size Water (25°C) 33% 66% 100% 200% Soak
>10 μm 4.1 86.1 70.2 28.7 14.1 84.9

>25 μm 0.1 1.4 1.6 0.6 0.6 1.4
Table 41. Particulate Matter of 3M™ Zeta Plus™ Media 30SP and 60SP – Post-Autoclave
Single Layer Media
30SP 60SP
Number of Manufacturing Lots: 1 Number of Manufacturing Lots: 1

Flush Volume Flush Volume
Particulate 18 Megohm Static 18 Megohm Static
Size Water (25°C) 33% 66% 100% 200% Soak Water (25°C) 33% 66% 100% 200% Soak
>10 μm 4.1 79.0 59.9 158 164 1558 4.1 9.9 36.6 11.8 4.3 20.7
>25 μm 0.1 3.2 1.1 4.7 4.3 60.0 0.1 0.5 1.2 0.5 0.3 1.4
F. USP <85> Bacterial Endotoxin

As part of the product release tests for every media lot at each global plant, a 45-mm disc of 3M™ Zeta Plus™ SP
media produced is challenged with Sterile Water For Injection (SWFI) at a constant flux of 1200 LMH to a total
volume equivalent to the minimum required preconditioning flush volume of 54 L/m2. A 2 mL effluent sample
33
collected at the end of flush is analyzed per USP <85> for extractable endotoxin concentration by a Limulus
Amebocyte Lysate (LAL) reactivity method. The extractable endotoxin release specification for all grades of 3M™
Zeta Plus™ SP media is < 0.25 EU/mL. The specification is based on a flush of single layer media, even for dual layer
media products. Therefore, the SP media flush effluent as prepared per above conditions meets the bacterial
endotoxin limits for WFI of <0.25 EU/mL.
Note the release specification is based on a dynamic flush protocol that does not necessarily reflect the total
endotoxin amount in the media. Therefore, the extractable endotoxin amount may be impacted if using a different
challenge fluid under different test conditions (i.e., pH, conductivity, protein, etc.).
Cellulose is a raw material used in 3M™ Zeta Plus™ media. Cellulose may contain β-Glucan, which is a non-
endotoxin LAL-reactive material. The presence of β-Glucan in any 3M™ Zeta Plus™ media flush effluent may cause
an interference or enhancement of endotoxin measurement. Thus, a β-Glucan blocking buffer or LAL reagent may
be used to minimize interference in the product release test. USP <85> “Bacterial Endotoxins Tests” supports these
strategies during extractable endotoxin measurement in the presence of β-Glucan.
VIII. Shelf Life

Shelf Life of 3M™ Zeta Plus™ SP Converted Media Sheets, Cartridges, and Capsules:
3 years at a recommended storage temperature of 5⁰C - 30⁰C, stored in original package
Shelf Life of 3M Manifolds:

3 years at a recommended storage temperature of 5⁰C - 30⁰C, stored in original package
All 3M™ Zeta Plus™ SP products and 3M manifolds should be stored in a controlled environment with an average
temperature between 5 and 30°C with short term excursions to 50°C, and relative humidity less than 90%. All 3M™ Zeta
Plus™ SP products and 3M manifolds should be inspected before use to determine if any unanticipated damage has
occurred during shipping and storage. This includes an inspection of the O-rings to confirm that they have no nicks or
cuts, are not cracked or do not exhibit a loss of elasticity that would prevent a normal sealing operation.
IX. Regulatory Compliance

The following Regulatory Compliance items apply to 3M™ Zeta Plus™ SP products and 3M manifolds.
A. USP <88> Class VI - 70Cminimum Biological Reactivity Tests, In Vivo

Representative media grade samples and wetted components or wetted component materials were tested and met
the requirements of USP <88> Class VI, Biological Reactivity Tests, In Vivo at either 121˚C or 70˚C extraction
temperature.
B. BSE/TSE (animal derived materials)

3M understands the continued public interest and the increased regulatory scrutiny concerning the transmission of
bovine spongiform encephalopathy (BSE) and other transmissible spongiform encephalopathies (TSE).
In order to address these issues, the following statement is offered: In order to assess the BSE/TSE risk associated
with the above products, we have contacted our suppliers of raw materials and performed an evaluation of our
production processes to determine if any of the materials used are of animal origin. The result of our survey and
inquiries of our raw material suppliers has revealed that the resins used in the molded parts and over-molds may
contain tallow derivatives and certain elastomer gaskets could contain a stearic acid that is used as an activator in the
vulcanization process. We can state, however, that our suppliers have indicated that these parts which use tallow
derivatives and stearic acid are processed at conditions conforming to the requirements of the European Medicines
Agency note for guidance EMEA/410/01 rev.3.
X. Quality Assurance
Pharmaceutical and Biological products manufacturers routinely visit 3M manufacturing sites to audit production quality
management systems and documentation. The ISO certifications for 3M Separation and Purification Sciences Division
global plants are available on request.
Certificates are provided in support of the release of the 3M™ Zeta Plus™ SP Series filter products.
34
The 3M™ Zeta Plus™ SP Series filter products are defined as non-hazardous articles under REACH and do not require a
Safety Data Sheet under Article 31 of Regulation (EC) No. 1907/2006.
The 3M™ Zeta Plus™ SP Series filter products are not regulated under the OSHA Hazard Communication Standard (CFR
Title 29 1910.1200). A Safety Data Sheet (SDS) is not required for these products.
Article Information Sheets for 3M™ Zeta Plus™ SP Series filter products are available in the US as courtesy.
35
Intended Use(s): 3M™ Zeta Plus™ single-use filter 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 specifications, and cGMP requirements, where applicable.
Restrictions on 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.
Technical Information: The technical information, guidance, and other statements contained in this document or otherwise provided by 3M are based upon
records, tests, or experience that 3M believes to be reliable, but the accuracy, completeness, and representative nature of such information is not guaranteed.
Such information is intended for people with knowledge and technical skills sufficient to assess and apply their own informed judgment to the information. No
license under any 3M or third party intellectual property rights is granted or implied with this information.
Product Selection and Use: Many factors beyond 3M’s control and uniquely within user’s knowledge and control can affect 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 different warranty is specifically 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 specification 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 profits or business
opportunity), regardless of the legal or equitable theory asserted, including, but not limited to, warranty, contract, negligence, or strict liability.
3M Purification Inc. 3M, Emphaze and Zeta Plus are trademarks of 3M

3M Separation and Purification Sciences Division Company. All other trademarks are the property of
400 Research Parkway, Meriden, CT 06450 USA their respective owners.
Phone 1-800-243-6894 1-203-237-5541 Please recycle. Printed in USA © 3M 2021.
Web 3M.com/bioprocessing All rights reserved.
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III. Product Descriptions

Table 1b. 8” Cartridge Product Descriptions: Dual Layer Media

A - Stainless Steel Bands A – Silicone

Table 2b. 12” Cartridge Product Descriptions: Dual Layer Media

Table 4b. Laboratory Capsule Product Descriptions: Dual Layer Media

Table 5b. Scale-Up Capsule Product Descriptions: Dual Layer Media

Table 6b. Production Capsule Product Descriptions: Dual Layer Media

IV. Product Design

Figure 2. Laboratory Capsules

Luer Cap Scale-up Capsule

Figure 3c. Scale-up Capsule cross-section

Figure 4. Production Capsules

Figure 4c. Production Capsule cross-section

Figure 4f. Production capsules installed in 3M holders

Table 8. Materials of Construction – Filter Cartridges

Table 10. Materials of Construction – Scale-Up Capsules

Table 11. Materials of Construction – Production Capsules

1) Dry Weight – Weight of capsule prior to use.

Table 12. Capsule Design Characteristics – Laboratory Capsules

Table 14. Capsule Design Characteristics – Production Capsules, Single Cell

Table 16. 3M Manifold Design Characteristics

F. Wetted Surface Areas

Table 18. Wetted Surface Areas of Laboratory Capsule Components

Table 19. Wetted Surface Areas of Scale-Up Capsule Components

V. Product Specifications and Operation Parameters

A. Product Release Specifications

B. Installation and Operation Instructions

C. Minimum Required Preconditioning Flush

Maximum Recommended Flux of Required Cartridges See Section V. C.

Table 25. Pre-Use Sterilization Conditions

Table 26. Post-Use Sanitization Conditions¹

A. Media Pressure Drop vs. Water Flow Rate

VII. Effluent Quality

Shared Responsibility of Supplier and Producer

Table 28. Reference Industry Standards

Table 31. Effluent TOC [ppm] vs. Preconditioning Flush Volume % of

D. USP <232>/<233> and ICH Q3D Elemental Impurities

Mg 2 196 7 10 1425 13 4 1500 18 7

Mg 2 2425.42 58.21 40.13 2554.42 85.14 50.32 2619.63 139.52 39.71

E. USP <788> Particulate Matter in Injections

Number of Manufacturing Lots: 3 Number of Manufacturing Lots: 3

Table 40. Particulate Matter of 3M™ Zeta Plus™ Media

>10 μm 4.1 86.1 70.2 28.7 14.1 84.9

Number of Manufacturing Lots: 1 Number of Manufacturing Lots: 1

F. USP <85> Bacterial Endotoxin

VIII. Shelf Life

Shelf Life of 3M Manifolds:

IX. Regulatory Compliance

A. USP <88> Class VI - 70Cminimum Biological Reactivity Tests, In Vivo

B. BSE/TSE (animal derived materials)

3M Purification Inc. 3M, Emphaze and Zeta Plus are trademarks of 3M

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