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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.

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