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Sterilizing-Grade Aervent Filters: Superior Filters For The Sterile Filtration of Gases

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Hao Nguyen Phuc
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0% found this document useful (0 votes)
143 views6 pages

Sterilizing-Grade Aervent Filters: Superior Filters For The Sterile Filtration of Gases

Uploaded by

Hao Nguyen Phuc
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Data

Data Sheet
Sheet

Sterilizing-grade Aervent® Filters


Superior filters for the sterile filtration of gases

The 0.2 µm hydrophobic Aervent polytetrafluoroethylene


(PTFE) membrane provides sterility assurance high flow
rates and throughput. The Aervent membrane contributes
to clean processes due its non-fiber releasing properties.

Benefits
• Ideal membrane for removing particles and
microorganisms from gases

• Unparalleled thermal and hydraulic stress


resistance

• Validated to withstand multiple sterilization


cycles

Membrane Types Filter Formats

Aervent 0.2 µm hydrophobic • Aervent-50


cartridge filters
• Opticap® XL 2 disposable
capsule filters
Typical Applications Aervent-50 Cartridge Filters
The Aervent hydrophobic filter will remove particles and
microorganisms greater than 0.2 μm from gases and liquids. Aervent-50 filters are sterilizing

Aervent filters will sterilize air or gas streams in: grade devices manufactured with
hydrophobic PTFE membrane and
Venting polypropylene hardware. These filters
• Bioreactor inlet and outlet filtration are 100% integrity tested during
• Filling vessels manufacturing to guarantee filter
integrity and sterility assurance.
• Carboys
• Autoclaves Opticap XL 2
• Transfer vessels Disposable Capsule Filters
Gas Filtration Opticap XL 2 disposable capsule filters with
hydrophobic Aervent membrane are
• Filling Machines
available in multiple filtration areas,
• Utilities
providing an optimal choice for
• Fermentation every application. Each Opticap XL 2
• Moisture-free gas supply lines capsule is integrity tested during the
• Particulate removal manufacturing process.
The patented Opticap XL 2 capsule
design allows unparalleled thermal and
hydraulic stress resistance in a disposable
Regulatory Compliance filter, resulting in reliability, high
confidence in the sterility process and improved cleanliness.
Filters with hydrophobic Aervent membrane are
designed, developed, and manufactured in accordance
with a Quality Management System approved by an
Convenient and Easy to Use
accredited registering body to an ISO® 9000 Quality Opticap XL 2 capsule filters eliminate the time and the
Systems Standard. Each filter is shipped with a expense associated with assembling, cleaning, and validating
Certificate of Quality. Each Opticap XL 2 is integrity stainless steel housings. Adjustable, easy-to-turn, upstream
tested during manufacturing and is supported with a vents and drain valves with O-ring seals and hose barb
comprehensive Validation Guide for compliance with
connections allow for easy process control. Other ease-
regulatory requirements.
of-use features include flow directional arrows and ribbed
For traceability and easy identification, each filter is
edges for easy gripping even with gloved hands.
labeled with the product name, lot number and serial
number.
The Right Size
The Opticap capsule product family provides a wide range
of sizes for scale-up of your small volume filtration steps to
larger, full-scale filtration processes.

The Right Connections


Self-contained and disposable, Opticap XL 2 capsule filters
are supplied with a choice of inlet and outlet connections to
optimize your filtration process, including fractional sanitary
flange, hose barb, and sanitary flanges which provide a
higher flow rate.

2
Specifications (Aervent-50 and Opticap XL 2 Capsule Filters)
Aervent-50 Opticap XL 2
Nominal Dimensions
Maximum length: — 14.3 cm (5.6 in.)
Body diameter: — 8.4 cm (3.3 in.)
Vent to vent diameter: — 12.5 cm (4.9 in.)
Filtration Area 19.6 cm2 0.10 m2 (1.1 ft2)
Materials of Construction
Filter media: Hydrophobic PTFE Hydrophobic PTFE
Supports: Polypropylene Polypropylene
Structural components: — Polypropylene
Vent O-rings: — Silicone
Vent/Drain ­— 1/4 in. hose barb with double O-ring seal
Maximum Inlet Pressure 4.1 bar (60 psi) at 25 °C 5.5 bar (80 psi) at 23 °C
— 2.8 bar (40 psi) at 60 °C
— 1.0 bar (15 psi) at 80 °C
Maximum Differential Pressure
Forward: 2 bar (30 psi) at 25 °C 5.5 bar (80 psid) at ambient temperature,
1.0 bar (15 psid) at 80 °C
Reverse: — 4.1 bar (60 psid) intermittent
Bubble Point at 23 °C ≥ 1100 mbar (16 psig) in 60/40 IPA/water ≥ 1100 mbar (16 psig) in 70/30 IPA/water
at 25 °C
HydroCorr™ Test At 2600 mbar (38 psig):
≤ 0.03 mL/min. ≤ 0.12 mL/min.
Gravimetric Extractables After autoclaving and a 24 hour soak
in 70/30 IPA/water at controlled room
temperature:
≤ 1 mg per 10 units ≤ 15 mg
Bacterial Endotoxin Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM®
methodology.
Sterilization May be autoclaved for 10 cycles of 30 May be autoclaved for 30 cycles of 30 minutes
minutes at 130 °C. at 135 °C.
Good Manufacturing Practices These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing
Practices.
Non-Fiber Releasing Millipore Aervent membrane meets the criteria for a “non-fiber releasing” filter as defined in 21
CFR 210.3 (b) (6).
Component Material Toxicity Component materials were tested and meet the criteria of USP <88> Reactivity Tests for Class VI
Plastics. Aervent filters are non-toxic per the USP <88> Safety Test.
European Pressure Equipment Millipore Corporation certifies that this product complies with the European Pressure Equipment
Directive Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the
Pressure Vessel Directive. It has been designed and manufactured in accordance with sound
engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure
Equipment Directive, this product does not bear the CE mark.
Viral Retention — Rated for aerosol retention of a total challenge
of 108–1010 plaque forming units of fx–174
virus particles at 50 SCFM per cartridge.
Bacterial Aerosol Growth — Retains B. diminuta liquid aerosol for 21 days at
a minimum challenge of 107 CFU/cm2.

3
Air Flow Rate and Pressure Drop

Aervent-50 Cartridge Filter Opticap XL 2 Capsule with 0.2 µm


Aervent Membrane — FF Fitting*
scfm
2,5 0 4 8 12 16
0.2 5
3.5
Differential Pressure Drop (bar)

2 0 PSIG Outlet
15 PSIG Inlet 3.0
0.2 0
30 PSIG Inlet
2.5

Pressure Drop (bar)


1,5
0.1 5
2.0
1
0.1 0 1.5

0,5 1.0
0.0 5
0.5
0

psid
0 20 40 60 80 100 0.0 0 0.0
Air Flow Rate at 25°C - Litre/min for MTGR 050 00 Unit 0 5 10 15 20 25 30
Flow Rate (Nm3/h)

Opticap XL 2 Capsule W ith 0.2 m


Aervent Membrane — FF Fitting

Opticap XL 2 Capsule with 0.2 µm Opticap XL 2 Capsule with 0.2 µm


Aervent Membrane — HH Fitting* Aervent Membrane — TT Fitting*
scfm scfm
0 4 8 12 16 0 4 8 12 16
0.40 0.2 5
3.5
0.35 0 PSIG Outlet 5 0 PSIG Outlet
15 PSIG Inlet 15 PSIG Inlet 3.0
0.2 0
0.30 30 PSIG Inlet 30 PSIG Inlet
4 2.5
Pressure Drop (bar)

Pressure Drop (bar)

0.25
0.1 5
2.0
0.20 3

0.1 0 1.5
0.15
2
0.10 1.0
0.0 5
1
0.05 0.5

psid
psid

0.00 0 0.0 0 0.0


0 5 10 15 20 25 30 0 5 10 15 20 25 30
Flow Rate (Nm3/h) Flow Rate (Nm3/h)

Opticap XL 2 Capsule W ith 0.2 m


Aervent Membrane — HH Fitting Opticap XL 2 Capsule W ith 0.2 m
*Opticap XL Capsule Connection Types Aervent Membrane — TT Fitting
TT = 38 mm (11/2 in.) Sanitary Flange Inlet & Outlet
FF = 19 mm (3/4 in.) Sanitary Flange Inlet & Outlet
HH = 14 mm (9/16 in.) Hose Barb Inlet & Outlet

4
Ordering Information

Aervent-50 0.2 µm filters (100/pack)

Diameter Length Connections Catalogue No.

62 mm 71 mm Both sides: Hose connection for MTGR 050 00


1/4” - 1/2” latex tubing and female luer slip
62mm 55 mm Both sides: 3/4” sanitary flange MTGR 150 00
62 mm 63 mm One side: 3/4” sanitary flange MTGR 250 00
Other side: hose connection
62 mm 65 mm One side: 1/8” NPTM connection MTGR 650 00
Other side: Hose connection
for 1/4” - 1/2” silicone tubing
62 mm 57 mm Both sides: 1/8” NPTM connection MTGR 750 00
62 mm 72 mm Both sides: Hose connection MTGR 850 00
for 1/4” - 1/2” silicone tubing

Accessories
Description Qty/pk Catalogue No.
®
ClickClamps Clamps 2 3538200WB

Opticap XL 2 Capsule Filters

K T G R A 0 2 3

Opticap XL May be Length Quantity per


Capsule Filter Autoclaved 02 = Opticap XL 2 Package
3 = 3/pk
Media Type Pore Size Connection Type
T = Aervent GR = 0.2 µm TT = 38 mm (11/2 in.) Sanitary Flange Inlet and Outlet
FF = 19 mm (3/4 in.) Sanitary Flange Inlet and Outlet
HH = 14 mm (9/16 in.) Hose Barb Inlet and Outlet
For technical assistance, contact Millipore:
1-800-MILLIPORE (1-800-645-5476)
E-mail: [email protected]

Millipore, Aervent, Opticap, and ClickClamps are registered trademarks of Millipore


Corporation. The M mark, Advancing Life Science Together, and HydroCorr are trademarks
of Millipore Corporation. ISO is a registered trademark of the International Organization
for Standardization. ASTM is a registered trademark of American Society for Testing and
Materials. ATCC is a registered trademark of American Type Culture Collection.
Lit. No. DS2895EN00 BN03240912 Rev. A 4/09 Printed in U.S.A. DP SBU-09-01728
© 2009 Millipore Corporation, Billerica, MA 01821 U.S.A. All rights reserved.

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