Millex®-GV Sterilizing Filter Unit - Biocenter
Millex®-GV Sterilizing Filter Unit - Biocenter
Millex®-GV Sterilizing Filter Unit - Biocenter
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User Guide<br />
Millex ® -<strong>GV</strong><br />
<strong>Sterilizing</strong> <strong>Filter</strong> <strong>Unit</strong><br />
(For Low-Binding Sterilization)<br />
■ Single use only<br />
■ Sterile<br />
■ Non-pyrogenic<br />
■ Do not use this product as an in-line filter for intravenous administration<br />
HCM0 518 01 (1000/box)
Notice<br />
The information in this document is subject to change without notice and should not be<br />
construed as a commitment by Millipore Corporation. Millipore Corporation assumes no<br />
responsibility for any errors that may appear in this document. This manual is believed to be<br />
complete and accurate at the time of publication. In no event shall Millipore Corporation be<br />
liable for incidental or consequential damages in connection with or arising from the use of<br />
this manual.<br />
Copyright 2005. Millipore Corporation. Printed in Ireland. All rights reserved.<br />
Millipore, Durapore and Millex are registered trademarks of Millipore Corporation.<br />
Luer Lok is a trademark of Becton-Dickinson and Company.<br />
Freon is a trademark of E.I. du Pont de Nemours & Co., Inc.<br />
P36381, Rev. A, 10/05<br />
0459<br />
This product is manufactured by:<br />
Millipore Ireland BV<br />
Carrigtwohill<br />
Co. Cork
Introduction<br />
This document provides compatibility information, operating steps, and specifications<br />
for the Millex-<strong>GV</strong> sterilizing filter. This bi-directionally supported, low-binding sterilizing<br />
unit is designed to filter aqueous, proteinaceous substances where minimal sample loss<br />
is desired. It removes microorganisms, particles, precipitates, and undissolved powders<br />
larger than 0.22 micron (µm). This single-use product consists of a 0.22 µm Durapore ®<br />
membrane filter sealed in a PVC housing. It is sterile, non-pyrogenic, and non-toxic.<br />
Typical applications include the sterile filtration of tissue culture media, media additives,<br />
protein solutions,virus suspensions, monoclonal antibodies, DNA solutions, antibiotics,<br />
and lymphokines.
2 www.millipore.com/millex<br />
Chemical Compatibility<br />
The Millex-<strong>GV</strong> filter is compatible with most aqueous solutions. You may use it to filter<br />
the agents listed in the following chart. This information was developed from technical<br />
publications, materials suppliers, laboratory tests, and field evaluations, etc., and is believed<br />
to be reliable. However, because of variability in temperature, concentrations,<br />
duration of exposure, and other factors outside of our control that may affect the use of<br />
the unit, Millipore does not provide or imply a warranty with respect to such information.<br />
You should test the agents that are not listed with the Millex-<strong>GV</strong> filter prior to use.<br />
Chemical<br />
Acetic acid (glacial)<br />
Acetic acid (5%)<br />
Aliphatic ethers<br />
Ammonium hydroxide (6N)<br />
Amyl acetate<br />
Amyl alcohol<br />
Benzyl alcohol (1%)<br />
Boric acid<br />
Brine (sea water)<br />
Butyl alcohol<br />
Carbon tetrachloride<br />
Ethyl alcohol<br />
Ethylene glycol<br />
Formaldehyde<br />
Freon ® solvent, TF or PCA<br />
Glycerine (glycerol)<br />
Helium<br />
Hexane<br />
Hydroflouric acid<br />
Hydrogen (gas)<br />
Hydrogen peroxide (3%)<br />
Hypo (photo)<br />
Isobutyl alcohol<br />
Isopropyl acetate<br />
Methyl alcohol<br />
Mineral spirits<br />
Nitrogen<br />
Paraldehyde<br />
Pentane<br />
Pet base oils<br />
Petroleum ether<br />
Phenol (0.5%)<br />
Pyridine
Millex-<strong>GV</strong> <strong>Sterilizing</strong> <strong>Filter</strong> 3<br />
How to Use the Millex-<strong>GV</strong> <strong>Filter</strong> <strong>Unit</strong><br />
This section lists warnings and cautions and provides steps to use the Millex-<strong>GV</strong> filter unit.<br />
WARNINGS:<br />
■ To ensure sterility, do not use this product if the package is damaged.<br />
■ Do not use this product as an in-line filter for intravenous administration; it<br />
was not designed for that purpose.<br />
■ Do not use with syringes smaller than 10 cc because pressures in excess of<br />
the maximum pressure rating may be reached, potentially causing damage to<br />
the filter unit and/or personal injury.<br />
CAUTIONS:<br />
■ Do not resterilize or reuse the Millex-<strong>GV</strong> filter unit.<br />
■ Do not use the Millex-<strong>GV</strong> unit at temperatures above 45 °C (113 °F).<br />
■ Do not use the same Millex-<strong>GV</strong> unit to filter solutions in both directions.<br />
■ Do not use the Millex-<strong>GV</strong> unit to filter emulsions or suspensions.<br />
■ Do not use the Millex-<strong>GV</strong> unit to filter 5 milligrams (mg) or less of active drug materials<br />
unless you have performed binding studies.
4 www.millipore.com/millex<br />
Directions for the Millex-<strong>GV</strong> <strong>Sterilizing</strong> <strong>Filter</strong> <strong>Unit</strong><br />
1<br />
2 3<br />
Fill the syringe with the<br />
solution you want to filter.<br />
4<br />
Aseptically remove the<br />
cover from the package<br />
that contains the<br />
Millex-<strong>GV</strong> filter.<br />
5<br />
Attach the syringe to the<br />
Millex-<strong>GV</strong> filter and remove<br />
the assembly from the package.<br />
(Attach needle to Luer<br />
Slip outlet if necessary.)<br />
Hold the syringe with the filter (and<br />
needle if attached) pointing up and top<br />
it off by pushing a few drops through it.<br />
(Make sure you do not contaminate the<br />
underside of the Millex-<strong>GV</strong> filter with<br />
your fingers.)<br />
Insert the needle (if attached) and push<br />
the plunger to deliver the filtered solution.
Millex-<strong>GV</strong> <strong>Sterilizing</strong> <strong>Filter</strong> 5<br />
Specifications<br />
Materials<br />
Dimensions<br />
Temperature limit<br />
Pressure limit at 25 °C<br />
Filtration volume<br />
Hold-up volume<br />
Connections<br />
Sterilization method<br />
Flow rate at 25 °C<br />
Hydrophilic Durapore (PVDF) membrane, type <strong>GV</strong>;<br />
Polyvinyl Chloride (PVC) housing<br />
inlet to outlet 25 millimeters (mm) (1.0 in.)<br />
diameter 29 mm (1.13 in.)<br />
filtration area 4 centimeters 2 (cm 2 ) (0.62 in 2 )<br />
pore size 0.22 µm<br />
45 °C (113 °F) maximum<br />
75 psig (5 bar) inlet and differential maximum<br />
1.0 milliliter (mL) to 100 mL<br />
≤ 0.1 mL after air purge<br />
Female, Luer Lok ® inlet; male, Luer slip outlet<br />
Ethylene Oxide Gas<br />
Typical initial average flow rate for water at 30 psig: 40 mL/min
Technical Assistance<br />
For more information, contact the Millipore office nearest you. In the U.S., call 1-800-<br />
MILLIPORE (1-800-645-5476). Outside the U.S., see your Millipore catalogue for the<br />
phone number of the office nearest you or go to our web site at www.millipore.com/<br />
offices for up-to-date worldwide contact information. You can also visit the tech service<br />
page on our web site at www.millipore.com/techservice.<br />
Warranty<br />
This product is covered by Millipore’s standard limited warranty, as set forth in<br />
Millipore’s Bioscience Catalogue.