Millex -GV Sterilizing Filter Unit

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1 User Guide Millex -GV Sterilizing Filter Unit (For Low-Binding Sterilization) Single use only Sterile Non-pyrogenic Do not use this product as an in-line filter for intravenous administration HCM (1000/box)

2 Notice The information in this document is subject to change without notice and should not be construed as a commitment by Millipore Corporation. Millipore Corporation assumes no responsibility for any errors that may appear in this document. This manual is believed to be complete and accurate at the time of publication. In no event shall Millipore Corporation be liable for incidental or consequential damages in connection with or arising from the use of this manual. Copyright Millipore Corporation. Printed in Ireland. All rights reserved. Millipore, Durapore and Millex are registered trademarks of Millipore Corporation. Luer Lok is a trademark of Becton-Dickinson and Company. Freon is a trademark of E.I. du Pont de Nemours & Co., Inc. P36381, Rev. A, 10/ This product is manufactured by: Millipore Ireland BV Carrigtwohill Co. Cork

3 Introduction This document provides compatibility information, operating steps, and specifications for the Millex-GV sterilizing filter. This bi-directionally supported, low-binding sterilizing unit is designed to filter aqueous, proteinaceous substances where minimal sample loss is desired. It removes microorganisms, particles, precipitates, and undissolved powders larger than 0.22 micron (µm). This single-use product consists of a 0.22 µm Durapore membrane filter sealed in a PVC housing. It is sterile, non-pyrogenic, and non-toxic. Typical applications include the sterile filtration of tissue culture media, media additives, protein solutions,virus suspensions, monoclonal antibodies, DNA solutions, antibiotics, and lymphokines.

4 2 Chemical Compatibility The Millex-GV filter is compatible with most aqueous solutions. You may use it to filter the agents listed in the following chart. This information was developed from technical publications, materials suppliers, laboratory tests, and field evaluations, etc., and is believed to be reliable. However, because of variability in temperature, concentrations, duration of exposure, and other factors outside of our control that may affect the use of the unit, Millipore does not provide or imply a warranty with respect to such information. You should test the agents that are not listed with the Millex-GV filter prior to use. Chemical Acetic acid (glacial) Acetic acid (5%) Aliphatic ethers Ammonium hydroxide (6N) Amyl acetate Amyl alcohol Benzyl alcohol (1%) Boric acid Brine (sea water) Butyl alcohol Carbon tetrachloride Ethyl alcohol Ethylene glycol Formaldehyde Freon solvent, TF or PCA Glycerine (glycerol) Helium Hexane Hydroflouric acid Hydrogen (gas) Hydrogen peroxide (3%) Hypo (photo) Isobutyl alcohol Isopropyl acetate Methyl alcohol Mineral spirits Nitrogen Paraldehyde Pentane Pet base oils Petroleum ether Phenol (0.5%) Pyridine

5 Millex-GV Sterilizing Filter 3 How to Use the Millex-GV Filter Unit This section lists warnings and cautions and provides steps to use the Millex-GV filter unit. WARNINGS: To ensure sterility, do not use this product if the package is damaged. Do not use this product as an in-line filter for intravenous administration; it was not designed for that purpose. Do not use with syringes smaller than 10 cc because pressures in excess of the maximum pressure rating may be reached, potentially causing damage to the filter unit and/or personal injury. CAUTIONS: Do not resterilize or reuse the Millex-GV filter unit. Do not use the Millex-GV unit at temperatures above 45 C (113 F). Do not use the same Millex-GV unit to filter solutions in both directions. Do not use the Millex-GV unit to filter emulsions or suspensions. Do not use the Millex-GV unit to filter 5 milligrams (mg) or less of active drug materials unless you have performed binding studies.

6 4 Directions for the Millex-GV Sterilizing Filter Unit Fill the syringe with the solution you want to filter. 4 Aseptically remove the cover from the package that contains the Millex-GV filter. 5 Attach the syringe to the Millex-GV filter and remove the assembly from the package. (Attach needle to Luer Slip outlet if necessary.) Hold the syringe with the filter (and needle if attached) pointing up and top it off by pushing a few drops through it. (Make sure you do not contaminate the underside of the Millex-GV filter with your fingers.) Insert the needle (if attached) and push the plunger to deliver the filtered solution.

7 Millex-GV Sterilizing Filter 5 Specifications Materials Dimensions Temperature limit Pressure limit at 25 C Filtration volume Hold-up volume Connections Sterilization method Flow rate at 25 C Hydrophilic Durapore (PVDF) membrane, type GV; Polyvinyl Chloride (PVC) housing inlet to outlet 25 millimeters (mm) (1.0 in.) diameter 29 mm (1.13 in.) filtration area 4 centimeters 2 (cm 2 ) (0.62 in 2 ) pore size 0.22 µm 45 C (113 F) maximum 75 psig (5 bar) inlet and differential maximum 1.0 milliliter (ml) to 100 ml 0.1 ml after air purge Female, Luer Lok inlet; male, Luer slip outlet Ethylene Oxide Gas Typical initial average flow rate for water at 30 psig: 40 ml/min

8 Technical Assistance For more information, contact the Millipore office nearest you. In the U.S., call MILLIPORE ( ). Outside the U.S., see your Millipore catalogue for the phone number of the office nearest you or go to our web site at offices for up-to-date worldwide contact information. You can also visit the tech service page on our web site at Warranty This product is covered by Millipore s standard limited warranty, as set forth in Millipore s Bioscience Catalogue.

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