3M MICROFLUOR II Specifications

Microfluor®II Critical Sterilizing Grade PTFE
Cartridge and Capsule Membrane Filters
Microfluor II PTFE membrane filters offer the ultimate in
microorganism retention for air and gas streams while
CUNO’S Microfluor II filters with flow enhanced
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construction allow use of smaller, more economical air
filter assemblies compared to competitive air filters.
Microfluor II filters provide absolute retention based on
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liquid bacteria challenge and aerosol bacteriophage
challenge.
Microfluor II filters are available in a wide range of
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cartridge and capsule configurations to provide the most
New flow enhanced cartridge and capsule filter construction
provides lower differential pressure than competitive filters
economical solution to air, gas and aggressive liquid
filtration applications.
Cartridge and Capsule Configurations to Meet Any Process Requirement
Microfluor II membrane filters are available in 5 through 40 inch cartridges, 2.5 and 5 inch Mini Cartridges and
2.5, 5, 10, 20 and 30 inch capsules. With the exceptionally high Microfluor II flow rates, smaller and more economical assemblies can provide the same air flow as larger, more costly competitive PTFE filters.
Feature Benefit
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Unique flow enhancing layer construction
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Liquid validation of B. diminuta retention
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Hydrophobic PTFE membrane
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21 CFR Materials of Construction, USP Biological Safety Test, Validation Guide and Drug Master File Listing
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Higher air flow for fermenter aeration and smaller, more economical vent filter assemblies
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Reliable sterilizing performance in wet or dry conditions
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Membrane will not become blocked with moisture
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Eases validation and regulatory submissions
2
Microfluor®II Cartridge and Capsule Filter Applications
(
)
(
)
Microfluor II filters are optimized for applications requiring sterilization of air, gas, or aggressive solvents and chemicals. The hydrophobic PTFE filter membrane prevents wetting with aqueous liquids or moisture that can block free air flow. Some applications, however, may require filtration of aggressive fluids such as acids or bases. Depending on compatibility, Microfluor II filters can be used to provide sterile filtration of these fluids by prewetting the membrane with a low surface tension fluid such as alcohol. A list of Microfluor II filter applications includes:
Sterile venting of process tanks
>
Sterile filtration of process air and aseptic filling lines
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Sterile venting of lyophilizers
>
Sterile venting of autoclaves
>
Sterile air filtration on blow, fill, and seal machines
>
Sterilizing filtration of fermentation inlet and exhaust air
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Sterile filtration of aggressive liquids
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Microfluor II filters have been designed to provide exceptionally high flow rates with low differential pressures (Figure 1). Microfluor II filters are available in a range of cartridge and capsule filter configurations to meet any process requirement. Shown in Figure 1 are flow curves for cartridge and capsule filter assemblies at atmospheric (vent) and compressed air conditions. For details of sizing vent and compressed air assemblies, please ask for CUNO Automated Sizing Program assistance.
Figure 1. - Microfluor II Air Flow vs. Diffferential Pressure*
Microfluor II Filter
Air Flow @ Vent Conditions
4.0
3.5
3.0
2.5
2.0
1.5
2.5” Mini Cartridge & Capsules
Differential Pressure (psid)
1.0
0.5
0
0 20406080100
5” Mini Cartridge
5” Capsule
5” Cartridge
10” Capsule
10” Cartridge
20” Cartridge
Air Flow (SCFM)
40 60 80 100 120 140 160
20
0
0.25
0.20
0.15
0.10
0.05
0
Differential Pressure (bar)
Microfluor II Filter
4.0
3.5
3.0
2.5
2.0
1.5
Differential Pressure (psid)
1.0
0.5
0
0 20406080100
Air Flow @ 30 psi
2.5” Mini Cartridge
5” Mini Cartridge
5” Cartridge
10” Cartridge
20” Cartridge
Air Flow (SCFM)
40 60 80 100 120 140 160
20
0
0.25
0.20
0.15
0.10
0.05
0
Differential Pressure (bar)
3
Air Flow
* Cartridge airflow values with housing pressure loss subtracted (excluding capsules).
Nm /hr
3
Air Flow
3
Nm /hr
The Microfluor®II Membrane Advantage
Microfluor II filter cartridges and capsules combine high flow with a liquid validated, bacteria retentive, hydrophobic PTFE filter membrane. Capsule and cartridge filter structural components are polypropylene, optimized for long on-stream air service. The most important characteristics for a sterilizing grade air filter include:
Validated PTFE Membrane
Microfluor II filters are validated by liquid bacteria challenge for complete retention. Liquid bacteria challenge represents the most severe test of filter performance and provides the highest assurance level of reliable sterilizing performance. In addition, Microfluor II filters have demonstrated complete
aerosol retention of the bacteriophage ΦX-174. For complete details, request the Microfluor II Validation Guide (LITVGMR2). The scanning electron micrograph (Photo 1) shows the structure of the PTFE membrane with a tortuous pore pathway of flow channels.
Photo 1. - SEM of Microfluor II PTFE membrane
Hydrophobicity
Free air flow with little resistance requires that the filter membrane not wet with water or moisture. Membrane wetting can result in filter pore blockage, which in turn prevents free air flow and can cause filter failure. In order to prevent pore blockage, an extremely hydrophobic PTFE membrane is used which prevents wetting with water or moisture. Graph 1 shows the relative hydrophobicity of filter media used in air filters. As can be seen, PTFE offers the highest level of hydrophobicity ensuring optimum air flow service.
High Air Flow
Efficient performance requires maximum air flow at minimum pressure drop. Microfluor II air filters utilize a patent pending construction to achieve higher air flow vs. pressure drop compared to competitive air filters. This unique CUNO development involves the use of specially designed PTFE filter membrane and polypropylene flow enhancing layers. This construction is applied to Microfluor II cartridge and capsule filters. Photo 2 shows how each layer is positioned within the cartridge and capsule filters.
Photo 2. - Microfluor II Filter Construction
Graph 1. - Comparative Hydrophobicity
0.06
0.05
0.04
0.03
0.02
0.01
1/Critical Surface Tension (dynes/cm)
0
Air Filter Hydrophobicity
PTFE PVDF Polypropylene
Flow Distribution
Layer
Downstream Support
Layer
PTFE Media
Upstream Support
Layer
4
Superior Flow Rate Performance
f
Microfluor II filter cartridges and capsules offer outstanding flow rate performance at low differential pressures. Whether used for tank venting, lyophilizer or autoclave vacuum breaking, blow, fill, seal machines or fermentation air sterilization, filter flow rate is a critical parameter. Using the design enhancements described, Microfluor II filters provide maximum flow performance. Graph 2 presents the comparison of Microfluor II cartridge and capsule filter performance to competitive air filters.
Graph 2. - Air Flow Rate Comparisons
luor II 20”Cartridges
Micro
Microfluor II Cartridges
Outperform Competitive
Cartridge Filters
Provide Comparable
Performance to Domnick
Hunter 30” Cartridge Filters
Microfluor II Capsules
Significantly Outperform
Competitive Capsule Filters
Microfluor II 5 Inch Capsule
Microfluor II 2.5 Inch Capsule
Domnick Hunter Tetpor 5 Inch Capsule
Pall Kleenpak™ Emflon KA3 Capsule
Millipore Opticap 4 Inch Capsule
®
®
®
100
SCFM/0.5psid @ 30 psig
80
60
40
20
Microfluor II 10 Inch Cartridge
Microfluor II 5 Inch Cartridge
Domnick Hunter ZCHT 10 Inch Cartridge
®
Pall Emflon PFR10 Inch Cartridge
Millipore Aervent™ 10 Inch Cartridge
200
160
120
80
SCFM/0.5psid @ 30 psig
40
0
0
Microfluor II 20 Inch Cartridge
Domnick Hunter 30 Inch Cartridge
25
20
15
10
SCFM/0.5psid @ Vent
5
0
Reliable Microorganism Retention Performance.
Microfluor II filters are validated for sterilizing performance using a liquid bacteria (B.diminuta) challenge test method. Liquid bacteria retention testing is the most critical test of sterilizing filter performance and provides the user with the utmost assurance that critical product or fermentation broth will be protected from contamination. In addition to demonstrating sterilizing performance in liquid, Microfluor II filters were tested for complete bacteriophage retention using aerosol challenge test methods. Aerosol retention performance assures users that Microfluor II filters will provide reliable air and gas sterilization. Aerosol challenge testing was performed using
ΦX-174 bacteriophage which are small organisms that infect bacteria cells and can ruin bacteria fermentation processes. Complete retention of bacteriophage was observed as shown in Table 1. For complete details request the CUNO Microfluor II Validation Guide (LITVGMR2).
Table 1. - Microfluor II Retention Performance
Test Method Test Organism Test Result
Liquid Bacteria Challenge B. diminuta Sterile
Aerosol Virus Test
Emflon and Kleenpak are trademarks of Pall Corporation, Aervent and Opticap are trademarks of Millipore Incorporated, and Tetpor is a trademark of Domnick
Hunter Group plc
.
ΦX-174 Bacteriophage
5
0 Plaque Forming Units
Robust Filter Construction
Mini Cartridge End Cap
Inner Core & Outer Cage
Support Layers
Microfluor II PTFE Filter Media
Mini Cartridge
Microfluor II PTFE Filter Media
Flow Distribution Layer
Inlet
Vent Valve
Support Layers
Outlet
Capsule
Microfluor PTFE Filter Media
Flow Distribution Layer
Flow Distribution Layer
End Cap Adapter
Various O-Ring Materials
316 Stainless Steel Reinforcing Ring
Support Layers
Inner Core & Outer Cage
Standard Cartridge
Many applications for air filtration require steam sterilization of filter cartridges. In vent or fermentation air service applications, filters may be steam sterilized multiple times. For fermentation processes, air sterilizing filters may be used for up to two years, and if sterilization is performed weekly, this results in exposure to over 100 steam cycles. Microfluor II air filters were tested for ability to withstand multiple forward and reverse steam cycles and were demonstrated to retain integrity for 200 steam cycles at 145°C. For complete details, request the Microfluor II Validation Guide (LITVGMR2).
Microfluor II Cartridge and Capsule Filter Configurations
Cartridge Filters
Microfluor II filters are available in 5 through 40 inch cartridge filters with a variety of end fittings and o-ring options to meet hardware and process requirements.
Mini-Cartridges
CUNO 2.5” and 5” Microfluor II Mini Cartridges can be installed in existing Pall Sealkleen™ housings or CUNO Mini Cartridge housing (LITZRMCH).
Capsule Filters
Microfluor II filters are available in 2.5, 5, 10, 20 and 30-inch capsule filter configurations. Capsule filters may be autoclave sterilized and offer a convenient, easy to use format for air sterilization. As with Microfluor II cartridge filters, the capsule filters have been specially designed to provide optimum air flow. Capsules are not
recommended for continuous compressed gas service.
Quality and Reliability
Microfluor II filters are manufactured to an ISO 9000 registered quality system and are 100% diffusion flow tested prior to shipment. All materials of construction are 21 CFR listed and cartridge and capsule filter components have been tested in accordance with United States Pharmacopoeia (USP) Class VI Biological Safety. All Microfluor II cartridge and capsule filters are shipped with a Certificate of Quality affirming compliance with rigid manufacturing quality specifications. Supporting Drug Master File (DMF) documentation is on file with the United States Food and Drug Administration (FDA). A complete Microfluor II Validation Guide is available upon request (LITVGMR2).
Integrity Testing
Microfluor II cartridge and capsule filters can be easily and automatically tested to verify filter integrity pre and post use using the CUNOCheck
®
2 integrity test instrument. Filters can be tested using diffusive flow, pressure hold, bubble point or water intrusion test (WIT) methods. Refer to CUNO publication LITTDMR2INTG - Integrity Testing Microfluor II Cartridge and Capsule Filters.
Sealkleen is a trademark of Pall Corporation
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Operating Parameters and Specifications
Filter Configuration
Filter Rating
Materials of Construction
Membrane
Membrane Support Layer
Core, cage, end caps, and adaptors
Adapter Reinforcing Ring
Filtration Surface Area -ft
Cartridge Operating Parameters
Maximum Differential Pressure
Forward Pressure
Reverse Pressure
Maximum Operating Temperature Integrity Test Parameters - Diffusion Flow Test - @ 25°C and 1 atm.***
25%/75% TBA/Water @ 16 psig (1.11 bar)
55%/45% IPA/Water @ 16 psig (1.11 bar)
Autoclave Conditions
In-situ Steam Conditions
* per 10 inch element **not for continuous compressed gas service. *** Consult factory for other methods
2(m2
)
Cartridge Mini Cartridge Capsules**
5to40"
Stainless Steel NA
11 (1.02)* 1.8 (0.17) 3.7 (0.34) 2.8 (0.26) 5.5 (0.51) 11 (1.02) 22 (2.04) 33 (3.06)
80 psid (5.5 bar) @ 75°F (25°C)
25 psid (1.7 bar) @ 180°F (80°C)
65 psid (4.5 bar) @ 75°F (25°C)
8.7 cc/min.* 1.4 cc/min. 2.9 cc/min. 2.2 cc/min. 4.4 cc/min. 8.7 cc/min. 17.5 cc/min. 26.2 cc/min.
14.7 cc/min.* 2.4 cc/min. 5.0 cc/min. 3.8 cc/min. 7.4 cc/min. 14.7 cc/min. 29.5 cc/min. 44.2 cc/min.
2.5" 5" 2.5" 5" 10" 20" 30"
180°F (80°C) 104°F (40°C)
Up to 259°F (126°C)
Up to 293°F (145°C)
CUNO Filter Housings
0.2 µm
PTFE
Polypropylene
Polypropylene
75 psid (5.2 bar) @ 104°F (40°C)
65 psid (4.5 bar) @ 75°F (25°C)
Do not In-situ steam
A complete line of sanitary design, stainless steel filter housings is available for Microfluor II cartridge filters. Options are available for heat traced (electrical and steam jacketed) housings where condensate is a concern. Specialized configurations and housing designs are also available for high flow, fermentation air filtration applications.
Housing Model Mini ZMS ZMS ZWC ZWB ZVS Mini Cartridge Housing
For 5 inch Cartridge
Basic Part Number / Cartridge Capacity
Housing Style T-line Sanitary type connection Sanitary type in-line
Equivalent Cartridge Lengths
Materials of Construction
Pressure & Temperature Ratings
Literature # LITZRHZMS2 LITZRH.104 LITZRH.106 LITZRH.104 LITZRHMCH
70236 / 1
5 inch 10, 20, 30, and 40 inches 2.5 inches 5 inches
150 psi (10 bar) @ 300°F (149°C)
70220-01 / 1 70180 / 4 70192 / 4 70221-01 / 1
70220-02 / 1 70189 / 8 70193 / 8 70221-02 / 1
70220-03 / 1 70190 / 11 70194 / 11 70221-03 / 1
70220-04 / 1 70191 / 21 70195 / 21 70221-04 / 1
For 10, 20. 30, and 40 inch cartridges For 2.5 inch Mini Cartridges For 5 inch Mini Cartridges
7023502 / 1 7023501 / 1
316L Stainless Steel
75 psi (5 bar) @ 200°F (90°C)
150 psi (10 bar) @ 200°F (90°C)
150 psi (10 bar) @ 300°F (149°C)
150 psi (10 bar) @ 300°F (149°C)
150 psi (10 bar) @ 300°F (149°C)
Scientific Applications Support Services (SASS)
CUNO's 90 years of experience are synonymous with quality, performance and high-level technical support. The cornerstone of CUNO's philosophy is service to customers, not only in product quality and prompt delivery, but also in validation assistance, applications support and in the sharing of scientific information. CUNO's Scientific Applications Support Services group works closely with customers to solve difficult separations problems and to recommend the most economical and efficient filter system. SASS Specialists are skilled in performing on-site testing and relating test results to full-scale manufacturing operations.
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Microfluor II Cartridge Ordering Guide
Grade Designation
PFS020 A
Configuration
Height (Inches)
01 -10 B - 226 O-ring & Spear A - Silicone
02 -20 C - 222 O-ring & Spear B - Fluorocarbon
03 -30 F - 222 O-ring & Flat Cap C - EPR
04 -40 J - 226 O-ring & Flat Cap D - Nitrile
50 -5 K - Teflon Encapsulated Viton
Microfluor II Mini Cartridge Ordering Guide
Grade Designation
PFS020 R
Configuration
Height (Inches)
01 - 2.5
02 -5
Microfluor II Capsule Ordering Guide
Grade Designation
PFS020 J
Configuration
Height (Inches)
01 -10
02 -20 B - Fluorocarbon
03 -30 C - EPR
25 - 2.5
50 -5
End Modification O-Ring Material
End Modification Package Quantity
AN 06 - 6 Pack
End Modification
A - Sanitary Fitting
Vent O-Ring
Option
A - Silicone
Package Quantity
01 -1 Pack
CUNO: A World Leader in Fluid
Purification
CUNO's manufacturing sites have ISO 9000 registered quality systems. Global manufacturing together with trained stocking distributors and state-of-the-art laboratory support bring quality solutions to existing and challenging new filtration applications.
CUNO Filtration Asia Pte Ltd
18 Tuas Link 1 (3 Floor)
Singapore 638599
Cuno Filtration Shanghai Co, Ltd
No. 2 Xin Miao San Rd,
Song Jiang District,
Shanghai. China. 201612
rd
Xin Miao Town,
CUNO Pacific Pty Ltd
140 Sunnyholt Road
Blacktown, NSW 2148
CUNO K.K.
Hodogaya Station
Building 6F
1-7 Iwai-cho, Hodogaya-ku
Yokohama 240 Japan
Australia
WARRANTY
Seller warrants its equipment against defects in workmanship and material for a period of 12 months from date of shipment from the factory under normal use and service and otherwise when such equipment is used in accordance with instructions furnished by Seller and for purposes disclosed in writing at the time of purchase, if any. Any unauthorized alteration or modification of the equipment byBuyer will void thiswarranty. Seller's liability under this warranty shall be limited to the replacement or repair, F.O.B. point of manufacture,of any defective equipment or part which, having been returned to the factory, transportation charges prepaid, has been inspected and determined by the Seller to be defective. THIS WARRANTY IS IN LIEU OF ANY OTHER WARRANTY, EITHER EXPRESSED OR IMPLIED, AS TO DESCRIPTION, QUALITY, MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE OR USE, OR ANY OTHER MATTER. Under no circumstances shall Seller be liable to Buyer or any third party for any loss of profits or other direct or indirect costs, expenses, losses or consequential damages arising out of or as a result ofany defects inor failure of its products or any part or partsthereof or arising out of or as a result of parts or components incorporated in Seller's equipment but not supplied by the Seller.
a 3M company
CUNO Latina Ltda
Rua Amf Do Brasil 251
18120 Mairinque-Sp
Brazil
CUNO Ltd
21 Woking Business Park
Albert Drive
Woking, Surrey GU215JY
United Kingdom
CunoIncorporated
400 Research Parkway
Meriden, CT 06450, U.S.A.
Tel: (800) 243-6894
(203) 237-5541
Fax: (203) 630-4530
www.cuno.com
© CUNO Incorporated, 2002 - ALL RIGHTS RESERVED LITCMR2.1202
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