3M Purification Inc.

Filter Systems
for Small Molecule
Pharmaceutical
Purification
2 Filter Systems for Pharmaceutical Separations

3M Purification Inc.
Core Filtration Applications

3M Purification Inc. is a leader in Page:

advanced depth filter systems and
membrane-based separations,
offering a wide range of products
3 Adsorptive Depth Filtration
• Optimized color reduction
for all stages of pharmaceutical • Precipitate control
processing and sterile filtration • Streamlined process
from bench-top to pilot-scale to
manufacturing-scale operations.
5 Solids Removal, Recovery & Reclaim
Active Pharmaceutical Ingredients • Effective removal of bulk catalyst
(API’s) refer to the active chemicals • Reduced exposure concerns
used in the manufacture of drugs. • Efficient operation
API’s are purified by a series of unit
operations that include key filtration
steps to the purity required in a final 6 Solvent & Bulk Chemical Filtration
drug formulation. • Broad chemical compatibility
• High throughputs
3M Purification’s core filtration • Variety of filter options
technologies address the demanding
applications in pharmaceutical
processing for small molecule
7 Endotoxin & Bioburden Reduction
• Effective prefiltration
and API applications. Regulatory • Bacteria control
requirements demand the highest • Downstream unit operation protection
quality product standards along
with documented evidence of
manufacturing processes. 3M 8 Sterilizing Grade Filtration (liquid & gas)
Purification products in the • High capacity
pharmaceutical industry meet the • Low cost of ownership
demands of regulatory agencies
throughout the world and are
used by some of the largest and 9 Utilities & Plant Services
• High efficiency
most respected pharmaceutical
• High throughputs
manufacturers in the industry.
• Few change-outs

10 Filter Validation
• Products and services
• Full documentation
 3
Filter Systems for Pharmaceutical Separations

Adsorptive Depth Filtration

Color Reduction Figure 1. Grades of Zeta Plus Activated Carbon Media
Activated carbon is used in the Zeta Plus Activated Carbon media are
pharmaceutical industry to remove impurities Viscosity of
available in different filtration ratings in
from active ingredient manufacturing. These R1X order to deal with products of different
60 to 80 cp
impurities are typically derived from chemical viscosity. The figure to the left is used
reactions that produce colored by-products. Viscosity of to determine optimum filter selection.
R3X
These colored by-products must be removed 20 to 60 cp Different types of carbon can be specified
to maintain drug purity and produce high- as required.
quality, on-spec intermediate compounds. R5X Viscosity of
Activated carbon use in powdered form 1 to 20 cp
presents three primary areas of concern to
the pharmaceutical manufacturer, namely 10 4 2 1 .5 .1
operator exposure to carbon dust, the quality Microns
of the process and the operating costs
associated with the use and handling of bulk
activated carbon. 3M Purification’s Zeta
Plus Activated Carbon media incorporates
immobilized activated carbon in our depth
filtration technology to decolorize and
remove contaminants from pharmaceutical
process streams.

Zeta Plus Activated Carbon Media Benefits

Optimized Process Reduced Operator Exposure to
Carbon type is selected based on
Carbon Dust
contaminant removal efficiency; activated
Carbon dust is virtually eliminated due to
carbon is fixed in filter matrix and the flow
carbon incorporated into depth filtration
is forced through the matrix at constant
media.
flux, increasing process efficiency.

Cleanliness Shorter Batch Times

Cleaning and handling concerns with bulk Batch times are reduced as contaminant
activated carbon are minimized; cleaning removal takes place at constant rate; bulk
validation between batches is streamlined. activated carbon filtration step eliminated.

Figure 2. Zeta Plus Activated Carbon Color & Dissolved Solids Reduction

API Synthesis Zeta Plus™ Activated Carbon

Bulk Catalyst Depth Filter Housings
Reactor Filtration & Reclaim
4 Filter Systems for Pharmaceutical Separations

Reduction of Dissolved Solids

Most synthetic drug products utilize a
variety of intermediates during processing. Zeta Plus™ Depth Filter Benefits
These intermediates can include active drug
components, solvents or fine chemicals used Improved Process Efficiency
in processing, excipients and as precursors to A variety of Zeta Plus media formulations allows for product
final drug formulation. Dissolved contaminants selection to maximize contaminant removal and throughput, and
in various forms in these intermediates must be improve process efficiency.
reduced to ensure product quality and safety
requirements. Sources of contamination can Scalable
include catalysts used in synthesis, process A large range of available product sizes enables pilot testing and
tanks, valves and piping, raw materials and scale-up with the same filter media materials that will be used in
by-products produced as a result of multi-step full-scale systems.
synthesis reactions. 3M Purification’s positively
charged Zeta Plus™ depth filters may represent
an efficient method for dissolved contaminant Product Validation
reduction in pharmaceutical active ingredient A Regulatory Support File is available to ease validation and
manufacturing. Zeta Plus depth filters consist regulatory submissions by providing important documentation.
of a cellulose matrix, inorganic filter aid and
a cationic resin. The resin component binds
the cellulose and the filter aid and imparts a
positive charge to the filter medium. Negatively
charged contaminants and complexes can be
adsorbed to the Zeta Plus media by electrostatic
Figure 3. Nominal Retention Capacity
attraction. In addition, contaminants of sufficient
size can be removed by mechanical entrapment of Zeta Plus™ SP Series Filters
within the Zeta Plus depth filter matrix. Zeta
Plus depth filters are provided in a wide range 05SP
of formulations and grades in order to provide
effective contaminant removal properties. Please 10SP
reference Table 1 below. 30SP

Zeta Plus™ depth filters are available in a variety 50SP

of configurations including filter sheets and
cartridges ranging in size from laboratory to full- 60SP
scale production. Zeta Plus™ filter cartridges are 90SP
the most convenient form for efficient filtration.
10 6 4 2 1 0.5 0.1
Microns

Table 1. Zeta Plus Depth Filter Media

Media Series Description Applications Grades Available
Small & large volume parenterals, blood
LA Series Low extractable levels 30, 50, 60, 90
fractions
SP Series Solids recovery & clarification API solutions, blood products 05, 10, 30, 50, 60, 90
DELP Series Lipid-specific adsorbent formula Removal of lipids & surfactants DELP08
 5
Filter Systems for Pharmaceutical Separations

Solids Removal, Recovery & Reclaim

Solids removal and catalyst recovery is a common application in pharmaceutical production
at various stages in the operation. Heavy-metal catalysts are used to promote hydrogenation
reactions in active pharmaceutical ingredient manufacture. A variety of carriers or supports
are used for the precious metals, including alumina, zeolites and carbon. These precious metal
catalyst supports must be removed from the batch prior to downstream processing. Their high
cost along with environmental regulations requires these solids to be captured and reclaimed
at high yields. An effective filtration system is needed that effectively removes these particles
from the process stream and helps protect the operator from contacting these hazardous
materials. 3M Purification offers various filtration options for solids removal and recovery
applications. Please reference Table 2 below.

Table 2. Solids Removal & Recovery Filtration Options

3M Purification
Media Available/Type Micron Rating
Product

CUNO™ CTG-Klean Betapure™ NT-P, multi-layer

0.5–70 μm
enclosed packs polypropylene depth

Figure 4. Solids Removal & Recovery Application

Active Ingredient,
Catalyst & Solvent

Catalyst
Removal/Recovery
Guard Filter
6 Filter Systems for Pharmaceutical Separations

Solvent & Bulk Chemical Filtration

Chemicals and solvents used in pharmaceutical manufacturing include alcohol, acetone,
methylene chloride and numerous other bulk chemicals for raw materials. Active
pharmaceutical ingredients are synthesized through chemical reactions that use solvents
together with other ingredients including catalysts. These bulk chemicals should be free
of particulate matter and contaminants prior to their use in manufacturing processes in
order to maintain process integrity and overall product quality. Filtration ratings range
from coarse to fine and include filter cartridges for tank venting. Please reference Table
3 below.

Table 3. Solvent & Bulk Chemical Filtration Options

Application 3M Purification Filter Material Micron Rating
Coarse filtration -
cartridges Betapure™ NT-P Multi-layer polypropylene 0.5–70 μm
( > 5 μm)
Fine filtration
Betafine™ PPG Series Pleated polypropylene, graded porosity 0.2–10 μm
( < 5 μm)
Tank venting LifeASSURE™ PFS Series Hydrophobic PTFE 0.2 μm, sterilizing grade

Product Benefits
Fine Filtration Course Filtration - Cartridges Tank Venting
Betafine™ series cartridges feature absolute 3M Purification cartridge filters for LifeASSURE™ PFS series filter cartridges
rated, polypropylene media that provides coarse particle (>5 μm) reduction provide and capsules combine high flow with a liquid
a wide range of chemical compatibility. exceptionally high flow rates with low validated, bacteria retentive, hydrophobic
Betafine™ PPG series filters feature differential pressures, extending filtration life PTFE filter membrane. Structural components
graded porosity polypropylene media that and reducing the number of filter change- are polypropylene, optimized for long on-
offers excellent capacity and throughput. outs. stream air service.
Filters provided with validation support
documentation for implementation into
existing processes.

Figure 5. Solvent & Bulk Chemical Filtration Application

1. Course Filtration
2. Fine Filtration
3. Tank Vent
4. Membrane Prefilter (page 7)
5. Final Sterile Filter (page 8)

Point-of-Use
 7
Filter Systems for Pharmaceutical Separations

Endotoxin & Bioburden Reduction

Bioburden reduction is a common application used in Product Benefits
the pharmaceutical industry to provide clarification of
pharmaceutical process streams. Control of bioburden in LifeASSURE™ SP Series Filters
pharmaceutical processing is critical in order to maintain product A single-layer charge modified Nylon 6,6
quality and to improve overall process economics. Prefilters are membrane, these filters offers enhanced
typically used in line with sterilizing grade filters to help protect particle and endotoxin reduction via
and prolong the life of downstream sterile filters. In some non- electrostatic charge on the membrane.
sterilizing grade applications, prefilters are used as stand alone
filters to help protect downstream equipment or as a safety Betafine™ PPG Series Filters
filtration step in the process flow. A polypropylene media, absolute-rated,
graded porosity high-flow filter cartridge,
Effective bioburden reduction/prefilters exhibit the following Betafine PPG series filters offer good
performance characteristics: chemical resistance and durability in
• High throughput and product yield demanding applications.
• Long service life
• Effective protection of downstream sterilizing grade filters
• Chemically compatible with process fluids

Please reference Table 4 below for 3M Purification’s product

portfolio for bioburden reduction and prefiltration.

Table 4. Bioburden Reduction/Prefiltration Options

Application 3M Purification Filter Material Micron Rating
Endotoxin reduction LifeASSURE™ 020SP Series Pleated charge-modified Nylon 6,6 0.2 μm
Prefiltration Betafine™ PPG Series Pleated polypropylene, graded porosity 0.2–10 μm
Bioburden reduction LifeASSURE™ PNA Series Pleated polyethersulfone (PES) 0.45 μm

Figure 6. Bioburden Reduction/Prefiltration Application

Re-dissolution Re-crystallization
8 Filter Systems for Pharmaceutical Separations

Sterilizing Grade Filtration (liquid & gas)

Sterilizing grade filtration requires robust filters designed for
performance certification to standards established by regulatory
agencies, including absolute retention of certain microorganisms
and certification of filter integrity by the manufacturer.
3M Purification supplies a variety of filter options for use in
sterilizing grade filtration applications.

The applications for these products include:

• Nitrogen filtration and tank venting
• Parenterals (SVP, LVP)
• Biologicals
• High Purity DI water and WFI systems
• Ophthalmics
Figure 7. Sterile Filtration Application

1. Purge nitrogen Air/N2

2. WFI water
3. Prefilter (page 7)
4. Sterile filter
5. Tank vent
6. Sterile filter
7. WFI filter
8. Air/nitrogen filter

Table 5. Sterilizing Grade Filtration Options

Application 3M Purification Filter Material Micron Rating
Purge nitrogen/sterile
LifeASSURE™ PFS Series Hydrophobic PTFE membrane 0.2 μm
tank venting (1, 5, 8)
DI/WFI water (2, 7) LifeASSURE™ SP Series Charge-modified, Nylon 6,6 0.2 μm
Ophthalmic/LVP, SVP
LifeASSURE™ PDA Series Dual-layer, asymmetric polyethersulfone (PES) 0.1 or 0.2 μm
(4, 6)

Product Benefits
LifeASSURE™ PFS Series Filters LifeASSURE™ SP Series Filters LifeASSURE™ PDA Series Filters
Combining high flow with a liquid validated, Utilizing a charge-modified Nylon 6,6 media Incorporating two layers of graded porosity
bacteria retentive hydrophobic PTFE to retain negatively charged biological polyethersulfone (PES) membrane that
membrane for long on-stream service in vent and particulate contaminants including provide high contaminant capacity, fast
filtration and purge nitrogen applications. endotoxins. flow rates and reliable sterilizing filtration
performance.
 9
Filter Systems for Pharmaceutical Separations

Utilities & Plant Services

The water, steam and utilities used in pharmaceutical production is
typically filtered to remove particles, scale and impurities prior to
its use. 3M Purification offers a variety of filter options to meet the
needs of these utility applications.

Water filtration is perhaps the most common application in the

pharmaceutical industry. Different standards for water quality exist in
the pharmaceutical industry depending on the application.
• USP Water for Injection (WFI)—for product formulation,
equipment and container cleaning and WFI steam production.
• USP Purified Water—for equipment and container cleaning,
fermenter make-up water (sterile filtered) and clean steam
production.
• Utilities water—for heating/cooling process equipment.

Figure 8. Water Filtration Options

City Feed
Water

To Points of Use To Points of Use

Steam Parenterals
Container Cleaning Container Washing
CIP/SIP Operations
WFI Steam

Table 6. Water Filtration Options

Application 3M Purification Filter Options Material Micron Rating

1. Removal of silica
particles Betapure™ NT-P Multi-layer polypropylene 0.5–70 μm
2. Carbon fine removal Betafine™ PPG Graded porosity pleated polypropylene 0.2–10 μm
3. Resin trap filter
4. Sterile tank vent LifeASSURE™ PFS Series Hydrophobic PTFE membrane 0.2 μm
5. Sterile filtration, LifeASSURE™ SP Series Charge-modified Nylon 6,6 0.2 μm
point-of-use LifeASSURE™ PDA Series Polyethersulfone (PES) 0.2 μm
10 Filter Systems for Pharmaceutical Separations

Filter Validation
3M Purification supplies products and services to help
pharmaceutical manufacturers ease regulatory compliance and
meet the exacting demands of the industry. 3M Purification
Validation Services streamlines filter regulatory compliance, saving
our customers time. Our goal is to provide well-designed, properly
executed and completely documented test protocols on 3M
Purification filter products in their intended applications.

Validation Services
Our scope of services in validation support consulting includes:
• Integrity testing: provides product specific integrity test
parameters for the fluids being used in the application.
• Bacterial retention, chemical compatibility and extractable
testing: execution of these tests to confirm a given filter’s
performance under actual process conditions.

Validation Products
3M Purification offers a variety of products
that support customer validation to help meet
regulatory requirements:
• Filter Validation Guides: provide
extensive regulatory information for
sterilizing grade filters.
• Regulatory Support Files: Provided for
filters upstream of sterile filters.

Global Locations
3M Purification can provide on-site validation
support around the world or in one of our
state-of-the-art laboratories located in
Europe, USA, China, India and Brazil.
 11
Filter Systems for Pharmaceutical Separations

Lenticular Style Depth Filter Products

3M Purification offers an extensive range of Zeta Plus™ depth

filter capsules and cartridges to meet virtually any process flow
requirement. Lenticular style depth filter capsules are designed
to facilitate the scale-up of processes between the laboratory
bench and the plant floor. Process-scale cartridges come in a
variety of sizes to accommodate a wide range of application
conditions to handle the most critical clarification and depth
filter applications in pharmaceutical manufacturing.

BC25 Capsules
The BC25 capsule configuration is used for laboratory evaluation
and small volume filtration. The BC25 capsule is supplied with
25 cm² of most 3M Purification depth filter media offerings, for
simple laboratory evaluation of the media in your application. The
BC25 capsule is available in two connection options, luer and
sanitary. BC1000/2000 capsules are available with the Zeta Plus
Activated Carbon media.

Table 7. Lenticular Style Depth Filtration Options

Effective Filtration
Lenticular Filtration Unit
Surface Area/Unit
BC25 capsule 3.9 in² (25 cm²)
8” dia., 2-cell plug-in style 0.7 ft² (650 cm²)
8” dia., 5-cell plug-in style 1.8 ft² (0.16 m²)
8” dia., 7-cell plug-in style 2.5 ft² (0.23 m²)
8” dia., 6-cell 2.1 ft² (0.20 m²)
8” dia., 7-cell 2.5 ft² (0.23 m²)
8” dia, 8-cell 2.8 ft² (0.26 m²)
12” dia., 9-cell 9.2 ft² (0.85 m²)
12” dia., 12-cell 12.3 ft² (1.1 m²)
12” dia., 16-cell 16.4 ft² (1.5 m²)
16” dia., 1-cell 2.5 ft² (0.23 m²)
16” dia., 2-cell 5.0 ft² (0.46 m²)
16” dia., 8-cell 19.8 ft² (1.8 m²)
16” dia., 12-cell 29.8 ft² (2.8 m²)

8”, 12” & 16” Diameter Zeta Plus™ 16” dia., 16-cell 39.7 ft² (3.7 m²)

Cartridges Note: The table above is for reference

Zeta Plus™ cartridges utilize the same media as the BC disposable only; not all Zeta Plus filter grades are
capsule products, enabling linear and predictable scale-up as batch available in the lenticular types listed in the
volumes increase. The range of diameters and lenticular filter cells table. Contact 3M Purification for specific
per cartridge provides a flexible product family that can be information and product availability.
designed to accommodate almost any process flow rate.
12 Filter Systems for Pharmaceutical Separations

Membrane Filter, Capsules,

& Cartridges
3M Purification supplies filter membrane and sheet
media filter products in wide variety of formats
including disposable capsules and full-scale
cartridges. The wide range of product formats allows
for simple scale-up from the laboratory bench to full-
scale production.

50 mm Disposable Filter Capsules

50 mm disposable filter capsules are ideal for laboratory scale
filtration or for evaluating 3M Purification filter media prior to
pilot-scale work. Containing the same filter media as full size 3M
Purification capsules and filter cartridges, the 50 mm capsules are
a convenient, low hold-up volume method to determine various
filtration parameters such as retention, compatibility and filtrate
attributes.

The 50 mm capsule is available with our polyethersulfone (PES) and

PTFE 0.2 micron rated medias.

Filter Capsules*
Disposable filter capsules are designed for critical small volume
filter applications and are available in a variety of filter media
options.

“C” style capsules available in 2.5” and 5” lengths

“J” style capsules available in 10,” 20” and 30” lengths

Standard Filter Cartridges*

Standard filter cartridges are available in a variety of lengths, end
connections and O-ring sealing options to tailor filter cartridges to
the needs of your specific application.

Filter cartridges are available in 5”, 10”, 20”, 30” and 40” lengths as
well as a variety of end modifications.

* Contact 3M Purification for specific product availability information in desired format.

 13
Filter Systems for Pharmaceutical Separations

Filter Housings &

Engineered Systems
3M Purification offers an extensive range of
cartridge filter housings to meet almost any process
flow requirement. Designed for the production
environment, 3M Purification sanitary design cartridge
housings are available for laboratory bench to pilot
plant to full-scale production.

Lenticular Style Zeta Plus™ Depth Filter

Housings
These housings are designed to accommodate our line of Zeta Plus™
lenticular depth filters. This range of housings includes:
• Models 8ZP1P and 12ZP1P: designed for one 8” (8ZP1P) or one 12”
(12ZP1P) filter cartridge.
• Model ZPB: ZPB bolt-style enclosure housings accept from one
to four 8”, 12” or 16” diameter standard Zeta Plus filter cartridges.

3M™ Series Filter Housings

These housings are designed to accommodate our full range of
filter cartridge products:
• 3M™ ZMS series Mini-cartridge: small volume, critical
filtration and sterile filtration applications.
• 3M™ ZVS series (in line) and ZMS (“T” line): Designed to
accept a single 10”, 20”, 30” or 40” filter cartridge.
• 3M™ ZWB series: multi-cartridge housings designed for three,
five, seven or 12 cartridges in 10”, 20,” 30” and 40” lengths.

Custom Engineered Systems

3M Purification’s capabilities include a full-service Engineering
Department that provides custom engineered filter housings.
Custom engineered filter housings can be provided with pumps,
gauges, piping, optional feed loops and other options to meet your
specific needs.
14 Filter Systems for Pharmaceutical Separations

Product Reference Guide

These tables list the products that are mentioned in this brochure

Zeta Plus™ Adsorptive Depth Filter products*

Activated Carbon Carbon-based adsorptive Various carbon grades &
Color & odor reduction 70-0201-8733-5
Series depth filter porosities
Low extractable level depth
LA Series 30, 50, 60, 90 grade SVP & LVP, blood fractions 70-0201-8860-6
media grade
Solids recovery & API solutions, blood
SP Series 05, 10, 30, 50, 60, 90 grade 70-0201-8869-7
clarification grade products
Lipid-specific adsorbent Selective removal of lipids
DEL Series DELP08 70-0201-8854-9
formula & surfactants

* All lenticular depth filter products available in BC25 capsule, BC1000/2000 capsule (Activated Carbon only), 8”, 12” and
16” lenticular cartridges.

Cartridge filters for particulate removal

PP media w/flow Coarse/fine particle
Betapure™ NT-P 0.5–70 μm 70-0201-8721-0
distribution channels reduction
Betafine™ PPG Pleated PP, graded porosity 0.2–10 μm Fine particle reduction 70-0202-1001-2

Application Development & Engineering 3M Purification - Solutions

3M works closely with customers to solve difficult filtration When looking for pharmaceutical filtration solutions, the industry
challenges and recommend the most efficient, economical filter has turned to 3M Purification for performance. 3M Purification has
systems. Application Engineering specialists perform on-site achieved a leadership position by striving to be the best supplier of
testing and utilize filtration application expertise to partner with high-quality products designed to provide cost effective solutions.
customers. 3M Purification understands that each application is unique and there
is always an alternative. 3M Purification has both the experience and
advanced material technology throughout its products to provide quality
improvements and dramatic cost savings for the customer.
 15
Filter Systems for Pharmaceutical Separations

Literature
Product Description Ratings/Grades Available Applications
Reference
Cartridge filters for bioburden reduction & prefiltration
LifeASSURE™ SP Series Pleated charged Nylon 6,6 0.2 μm Endotoxin reduction 70-0201-8891-1
Betafine™ PPG Series Pleated PP, graded porosity 0.2–10 μm Prefiltration 70-0202-1001-2
LifeASSURE™ PNA Series Polyethersulfone (PES) 0.45 μm Bioburden reduction 70-0202-6776-4

Sterilizing grade cartridge filters

Hydrophobic PTFE Purge nitrogen, sterile vent
LifeASSURE™ PFS Series 0.2 μm 70-0201-8715-2
membrane filtration, gases
Charge-modified,
LifeASSURE™ SP Series 0.2 μm WFI, DI water 70-0201-8738-4
Nylon 6,6 membrane
Dual-layer, asymmetric
Biologicals, protein
LifeASSURE™ PDA Series polyethersulfone (PES) 0.2 μm 70-0201-8687-3
purification
membrane

3M™ Filter housings for lenticular cartridges

8ZP1P for plug-in style, 8”
8ZP1P & 12ZP1P 304 & 316L SS housing cartridge Lab use, small volumes 70-0201-8857-2
12ZP1P for 12” cartridge
316L SS housing for
ZPB Swing bolt closure Production depth filtration 70-0201-8762-4
lenticular depth filters

3M™ Cartridge filter housings

316L SS housings for single,
ZVS: In-line inlet/outlet Intermediate, critical &
ZVS & ZMS 10”, 20”, 30” or 40” 70-0201-8883-8
ZMS: “T”-line inlet/outlet sterilizing grade filtration
cartridge
316L multi-cartridge filter
Production-scale critical
ZWB housings are available in Swing bolt closure 70-0201-8884-6
& sterilizing grade filtration
3, 5, 7 and 12-around

The 3M Purification products listed in this table represent a chosen sample of products available for sale; please contact
your local 3M Purification sales representative for information on additional products not listed in this table.

Quality Management & ISO Standards

3M Purification works to provide high 3M Purification has established a global quality management program which encompasses
quality fluid purification and filtration all facets of its operations. An essential part of the 3M Purification program is the creation
products and consistent technical support. of multi-function teams whose combined expertise is devoted to continuous improvement
3M Purification filtration systems are of processes, procedures and quality systems. In addition, the 3M Purification system
designed and manufactured to the most ensures the active support and participation of senior management. 3M Purification is
stringent industry standards to assure the fully committed to the tenets of the quality management program and provides a support
reliability of 3M Purification systems that system for the quality process. The media, cartridges, and capsules are manufactured
our customers have come to expect. globally in facilities with quality management systems registered to ISO Standards to ensure
consistency in meeting product specifications. The manufacturing process, quality controls,
and regulatory oriented compliance reports are documented in a Drug Master File on
record with the FDA.
 Product Use
Intended uses: Manufacturing of pharmaceutical (drug) products, including active pharmaceutical ingredients and
vaccines.
Prohibited uses: As a component 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); Applications involving permanent implantation into the body; Life-sustaining
medical applications; Applications requiring FDA Food Contact compliance without use restrictions.

Disclaimer
Information is correct to the best of our knowledge at the date of the publication. Before using a product sold by
3M, users are solely responsible for making their own independent determination that the product is suitable for the
intended use and can be used safely and legally. 3M MAKES NO WARRANTY; EXPRESS OR IMPLIED INCLUDING,
BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OR CONDITION OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR ANY IMPLIED WARRANTY OR CONDITION ARISING OUT OF A COURSE OF DEALING,
CUSTOM OR USAGE OF TRADE.

Limitation of Liability
Except where prohibited by law, 3M will not be liable for any loss or damage arising from the 3M product, whether
direct, indirect, special, incidental or consequential, regardless of the legal theory asserted, including warranty,
contract, negligence or strict liability.

3M Purification Inc.
400 Research Parkway
Meriden, CT 06450 USA

Phone 1-800-243-6894 Please recycle. Printed in USA © 3M 2017.

1-203-237-5541 3M, Betafine, Betapure, LifeASSURE, CUNO,
Fax 1-203-630-4530 and Zeta Plus are trademarks of 3M Company.
Web 3Mpurification.com All rights reserved. 70-0202-6429-0 REV 0217