TEST SUMMARY Biological Testing...18 Bacterial Retention...18 Viral Removal Validation...18 Toxicity...19 Chemical Testing...18 Compatibility...

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2 Table of Contents CONTENTS PRODUCT SUMMARY Introduction Typical Applications Oxygen Removal Carbon Dioxide Removal Oxygen Absorption Carbon Dioxide Absorption Lumen and Shell Side Flow Curves Air Flow Rate Curves Catalogue Numbers Installation Instructions Product Specifications Materials of Construction Connections Effective Filtration Area Maximum Differential Pressure Integrity Testing Sanitization Summary of Results Bacterial Challenge Testing Viral Removal Toxicity Chemical Compatibility TEST SUMMARY Biological Testing Bacterial Retention Viral Removal Validation Toxicity Chemical Testing Compatibility TEST METHODS Biological Testing Bacterial Retention Viral Removal Toxicity Testing Physical and Performance Testing Diffusive Flow Test Pressure Decay Test SANITIZATION USING MINNCARE FiberFlo Capsule Filters, Page 1

3 PRODUCT SUMMARY The FiberFlo Hydrophobic Capsule Filter Validation Guide has been prepared to help you assess the filtration characteristics of the capsule filters and relate them to your individual applications. Fibercor s technical group is prepared to assist you with any specific needs not covered in this Validation Guide FiberFlo hydrophobic capsule filters are manufactured using a unique, polypropylene hollow fiber providing a wide range of chemical compatibility. The asymmetric hollow fiber provides absolute micron removal ratings making them ideally suited for high value added applications. FiberFlo capsule filters have easy-to-use, dual upstream vents that allow sanitization of the filter using Minncare. FiberFlo capsule filters are provided with a variety of inlet and outlet connections and three different capsule sizes allowing optimum flexibility for easy scale-up and system sizing. For easy identification and traceability each capsule is labeled with a lot number, catalog number, pore size and serial number. FiberFlo capsule filters are designed and manufactured in accordance with an ISO 9000 Quality Management Systems Standard. FiberFlo hydrophobic capsule filters are 100% integrity tested during manufacturing to guarantee integrity. The products described in this guide have been tested according to ISO guidelines for biocompatibility and have been found to be acceptable. All Fibercor filter devices are manufactured and tested non-pyrogenic by Limulus Amebocyte Lysate (LAL). TYPICAL APPLICATIONS FiberFlo capsule filters are available in both an inline and cross flow configuration. They have been designed for use in almost any application of interest. Some suggestions for usage are the following: Inline Capsule Filter Applications: Filtration of gases, sparging with gases and tank venting. Cross Flow Capsule Filter Applications: Degassing of solutions and sparging solutions with gases. Product Summary Typical Applications FiberFlo Capsule Filters, Page 2

4 Oxygen Removal Oxygen Removal (700 mmhg Vacuum) FiberFlo Capsule Filters, Page 3

5 Carbon Dioxide Removal (700 mmhg Vacuum) Carbon Dioxide Removal FiberFlo Capsule Filters, Page 4

6 Oxygen Absorption Oxygen Absorption FiberFlo Capsule Filters, Page 5

7 Carbon Dioxide Absorption Carbon Dioxide Absorption FiberFlo Capsule Filters, Page 6

8 Flow Curves Lumen Side Flow Curves Shell Side Flow Curves FiberFlo Capsule Filters, Page 7

9 Air Flow Rate Curves Air Flow Rate Curves FiberFlo Capsule Filters, Page 8

10 Catalog Numbers FiberFlo 30 Pore Size mm 0.03 absolute 1 Membrane hydrophobic polypropylene Maximum Differential 40 PSI (2.7 Bar) Pressure Surface Area Large (L): 6300 cm2 (6.5 ft2) Medium (M): 2500 cm2 (2.5 ft2) Small (S): 840 cm2 (1.0 ft2) Diameter Large (L): 2" Medium (M): 1" Small (S): 0.75" Nominal Length Large (L), Medium (M) and Small (S): 6.5"" Case and Polycarbonate End Caps End Seals Polyurethane Extractables Passes U.S.P. tests for oxidizable substances and total solids for purified water. Fiber meets all USP-XXIII Class VI criteria as well as test standards for tissue cytoxicity. 1. As determined by latex bead challenge. Procedure available upon request. 2. As determined by HIMA challenge and latex bead challenge. End-fitting options: Code Inlet Description Outlet Description Filter Type A /4 inch NPT /4 inch NPT Inline, Cross Flow B /8 inch NPT /8 inch NPT Inline, Cross Flow C /2 inch hose barb /2 inch hose barb......inline, Cross Flow D /8 inch hose barb /8 inch hose barb inline E /4 inch NPT /2 inch hose barb inline F /4 inch NPT /8 inch hose barb inline G /8 inch NPT /2 inch hose barb inline H......Sanitary Sanitary Inline, Cross Flow I ISO ISO Inline J......Luer Luer Inline K /4 inch NPT Luer Cross Flow L /8 inch hose barb luer cross Flow O......ISO ISO Cross Flow P......Luer Luer Cross Flow How to determine ordering codes: Catalog Number MV-C-030-K is a 2.5 square foot capsule filter with cross flow design, a 0.03 micron rating, a quarter inch NPT inlet and a Luer outlet. MV - C K Capsule Size (Membrane Surface Area) L = 6.5 ft 2 M = 2.5 ft 2 S = 1.0 ft 2 Inline/Cross Flow C = Cross Flow I = Inline Micron Rating 030 = 0.03µM* End-Fitting Option (see chart) * available with hydrophobic polypropylene hollow fibers only FiberFlo Capsule Filters, Page 9

11 Installation Instructions Crossflow Models: Partially open valve V 1 to fill the inside of the fibers with solution open valve V 2 and adjust valve V 1 for desired flowrate. Initiate gas or vacuum to port cap C 3 or C 4 Note: Follow steps 5 through 8 ONLY if the fiber is to be wet out. (Inline Models) 5. To purge downstream air from the system, partially open valve V 5, then slowly open valve V 1 until the inlet pressure gauge reads between psi. Throttle valves V 1 and V 5 until the inlet gauge reads between psi (Caution: The difference between the inlet pressure and the outlet pressure should not exceed 30 psi) and there is approximately ml/min flow of 55 wt. % IPA/H 2 O out of the valve V Allow the system to run under these conditions for 10 minutes. This will fully wet out the filter as well as provide a brief rinse of the filter. 7. Close valve V 1, then close valve V The filter is now ready for integrity testing or to be placed into wet service. (Wet Out Crossflow Models) Install a 2-way valve with a female luer connection to the port on the case that is C 3. Repeat all the above steps and in step 5 this 2-way valve will serve as V 5. When finished cap C 3 may be replaced. Air/N2 Supply Pressure Regulator FiberFlo Capsule Filters, Page 10 Hydrophobic V1 Pressure Gauge V6 C4 C3 V5 V2 Housing Installation The FiberFlo capsule filter should be installed as shown in Diagram 1, with the appropriate isolation valves and pressure gauges. Diagram 1 is an example of a single capsule filter element. If the filter and assembly are to be integrity tested, each assembly should have the additional valves and fittings as shown in Diagram 2. V1 Process Fluid Pressure Gauge C4 C3 Diagram 1 - Capsule Filter Filter Cartridge Installation Note: Inline or crossflow models will only flow process fluid across the fiber if previously wet out with 55 wt. % IPA/H 2 O. 1. Shut off flow by closing valves V 1 and V 2. To release pressure open port caps C 3 or C 4. Do not attempt to remove an existing filter capsule until pressure gauges read 0 psi. 2. Remove the old filter. 3. Open the new capsule filter s plastic bag and install the new capsule filter. Inline Models: 4. Partially open port cap C 3 and valve V 1 to fill the housing while bleeding off the air through cap C 3. When a steady stream of solution or gas is exiting port cap C 3, close valve V 1, then close port cap C 3 and open valve V 2. V5 V2 Integrity Testing by Diffusive Flow (Diagram 2) CAUTION: DO NOT BUBBLE POINT THE FIBERFLOW CAPSULE FILTERS. BUBBLE POINT PRESSURES WILL DAMAGE THE MEM- BRANE FIBERS. A DIFFUSIVE FLOW MEA- SUREMENT IS RECOMMENDED TO VERIFY FILTER INTEGRITY. Process Fluid Diagram 2 - Diffusive Flow Integrity Test 1. Install and wet the capsule filter per instructions. 2. Close all valves and drain housing by opening caps C 3 and C 4. Tilt the capsule filter to allow it to drain. Draining the capsule filter reduces the time required for the diffusive air flow to come to equilibrium conditions. When drained, close cap C 3 and connect tubing from V 6 to port C Attach flexible tubing to valve V 5. Plug the inlet to the filter. Slowly open valve V 5 and V 6, then slowly regulate the air pressure to 30 psig. Wait until a steady stream of bubbles is coming through the flexible tubing before proceeding. 4. Fill a 100 ml graduated cylinder with water and invert it in a filled collection container. Place the tubing into the submerged opening of the graduated cylinder. Measure the amount of water displaced by the air in one minute. 5. Close valve V 5 and V 6, then slowly open C 3 to vent the pressurized air. Install cap on port C The maximum diffusive flow for the capsule filter is 80 ml/min. Diffusive flow in excess of 80 ml/capsule filter indicates that either the filters are not fully wetted or that a mechanical leak exists in the filters/housing system. If the system fails the integrity test, wet the filters again and retest. Note: If the filter is to be used for wet filtration, it can be put into service. If the filter is to be used for gas filtration or as a degasser, it must be dried using a convection oven at 70 C for 24 hrs. or compressed air at ambient temperature for the same time period.

12 FiberFlo Capsule Filters, Page 11 An alternative integrity test for filters used in degassing would be as follows: Reference Diagram 1. Close valve V 2. Open valve V 1 and adjust the process solution pressure to 400 mm Hg. Close valve V 1. The pressure decay should be less than or equal to 18 mm Hg in one minute. Open valves V 1 and V 2. Unit is now in service. Note: Be assured there are no leaks in the system which may lead to a failed pressure decay test. Filter Sanitization The following chemicals are approved as compatible with the FiberFlo capsule filter and can be used for sanitizing. Any other chemical may damage the filter. Approved Sanitizers and Contact: (liquid and degasser service) Minncare 1% for maximum 96 hours Hydrogen Peroxide 1% for 6 hours Sodium Hypochlorite 200 ppm 6 hours Formaldehyde 2% for 6 hours Sanitizing Recommendations These guidelines are provided to support the chosen sanitizer s specific directions for use. Reference each sanitizer s material data sheet for special handling procedures. 1. Make sure the system is free from other chemicals that may react with the solution being used. 2. Mix the appropriate concentration of chemical in purified water from a reverse osmosis or deionization system. Then verify the concentration with appropriate test strips. 3. The diluted solution should be injected through the capsule filter's white colored port cap C 3. See Validation Guide Alternately, the filter may be removed from the housing and soaked in the solution. If the filters are removed from the system and soaked, it is important that the entire filter be submerged and the contact time doubled. Sterile gloves should be worn when handling the filter. 4. After the desired contact time, the filter should be thoroughly rinsed to drain. The time required to rinse the filter will vary from system to system. Residual test strips or some other appropriate means of testing the residual concentration should be used to verify when the filter has adequately rinsed prior to placing in service. Note: Minncare is the recommended sanitizer because of its greater biocidal activity, ease of disposal, and the ability to measure residual concentrations with test strips. Process or Solution Treatment Applications The particular placement of FiberFlo capsule filter's in gas systems depends on the desired performance. One suggested location would be directly downstream of the gas treatment equipment as final filtration. The FiberFlo capsule filter will remove pyrogens, bacteria, and fine particulates that might be shed by gas systems, small storage tanks, filters, or by other equipment located upstream. The FiberFlo capsule filter also can be installed at the point of use. Here the filter will remove contaminants from the process equipment and from the distribution piping. CAUTION: THIS DEVICE DOES NOT TREAT GASES; IT WILL ONLY REMOVE CONTAMI- NANTS BY FILTRATION. TO OBTAIN CHEMICAL- LY PURE GASES, IT IS NECESSARY TO USE THIS FILTER IN CONJUNCTION WITH OTHER GAS TREATMENT DEVICES SUCH AS DEIONIZA- TION BEDS. THIS FILTER SHOULD NORMALLY BE PLACED FOLLOWING THESE OTHER TREAT- MENT DEVICES. CAUTION: THIS FILTER SHOULD BE SANITIZED WITH THE REST OF THE GAS SYSTEM OR WHEN BACTERIAL COUNTS EXCEED THE USERS ESTABLISHED LEVELS. UNDER NORMAL USAGE, IT IS RECOMMENDED THAT THE SYSTEM BE SANITIZED AT LEAST WEEKLY UNTIL THE APPROPRIATE SANITIZATION PAT- TERN CAN BE ESTABLISHED. CAUTION: THIS FILTER SHOULD BE REMOVED FROM SERVICE IF THE PRESSURE DROP ACROSS IT IS 30 PSI OR GREATER. This filter should be integrity tested following sanitization/ rinse or steam sterilization. Other Applications For assistance on other applications, contact Fibercor s Technical Service Department. Minntech Corporation th Avenue North Minntech B.V. Sourethweg 11 Minntech Japan Corporation 4F Sumitomo Seimei Yochomachi Bldg. Minneapolis, MN PC Heerlen Yochomachi, Shinjuku-ku U.S.A. Tel: (612) The Netherlands Tel: (31) Tokyo Japan Toll Free: (800) Fax: (31) Tel: (81) 03 (3225) 8680 Fax: (612) Kvk No.: Fax: (81) 03 (3225) 8681 Installation Instructions /B

13 PRODUCT SPECIFICATIONS MATERIALS OF CONSTRUCTION Hollow Fiber Membrane:..Polypropylene Casing: Polycarbonate End Caps: Polycarbonate End Seals: Polyurethane Luer Caps: Polypropylene Sealing Method: Ultrasonic Welding Product Specifications CONNECTIONS Large (L) Capsule: /4"NPT, 3/8"NPT, 1/2" Hose Barb, 1-1/2" Sanitary, ISO. Medium (M) Capsule:....1/4"NPT, 3/8" Hose Barb, Luer. Small (S) Capsule: /4"NPT, 3/8" Hose Barb, Luer. EFFECTIVE FILTRATION AREA Large (L) Capsule: cm2 Medium (M) Capsule: cm2 Small (S) Capsule: cm2 (6.5 ft2) (2.5 ft2) (1.0 ft2) MAXIMUM DIFFERENTIAL PRESSURE 40 PSI (2.7 Bar) INTEGRITY TEST All FiberFlo capsule filters are 100% integrity tested. Capsule filters may be integrity tested by the quantitative diffusive flow method. See the section entitled "Test Methods" for further information. SANITIZATION FiberFlo capsule filters can be sanitized using Minncare Cold Sterilant. See the section entitled "Sanitization using Minncare " for further information. Minntech Corporation Part Numbers: Minncare Solution (4 quarts per Case): P.N Minncare Solution (4 gallons per Case): P.N Minncare 15 Test Strips: P.N Minncare Residual Test Strips: P.N FiberFlo Capsule Filters, Page 12

14 Summary of Results Viral Removal Toxicity SUMMARY OF RESULTS BACTERIAL CHALLENGE TESTING An outside laboratory conducted testing in order to determine the filtration efficiency of the FiberFlo hydrophobic filters to remove bacteria from the input gases. When challenged with an aerosol containing approximately 106 Pseudomonas diminuta bacteria/cm2 the FiberFlo hydrophobic filters blocked all bacteria. VIRAL REMOVAL An outside laboratory conducted testing in order to determine the filtration efficiency of the FiberFlo hydrophobic capsule filters to remove viruses from the input gases. When challenged with an aerosol challenge containing approximately 107 bacteriophage stock culture (ATCC #13706-B1) the FiberFlo hydrophobic filters blocked all the viruses. TOXICITY The FiberFlo capsule filter components have been tested according to ISO guidelines for biocompatibility and have been found to be acceptable. FiberFlo Capsule Filters, Page 13

15 CHEMICAL COMPATIBILITY KEY 1 = Compatible 2 = Limited compatibility 3 = Not Recommended = Insufficient Data The following chemical compatibility charts are provided as a guide only. Fibercor recommends that the users verify compatibility with a specific chemical under actual use conditions. Chemical compatibility can be affected by many variables, including concentration, viscosity, temperature, time and pressure. Acids Rating Acetic Acid, glacial Acetic Acid, 90% Acetic Acid, 20% Acetic Acid, 10% Acetic Acid, 3% Chromic Acid, conc Hydrochloric Acid, conc Hydrochloric Acid, 6N Hydrofluoric Acid, 6N Nitric Acid, conc Nitric Acid, 6N Phosphoric Acid, conc Sulfuric Acid, conc Sulfuric Acid, 6N Minncare, 1% Renalin, 1% Chemical Compatibility Acids Alcohols Rating Amyl Alcohol Benzyl Alcohol, 100% Benzyl Alcohol, 3% Butanol Ethanol Isopropanol Methanol Propanol Alcohols FiberFlo Capsule Filters, Page 14

16 Chemical Compatibility Bases Bases Rating Ammonium Hydroxide, 3N Ammonium Hydroxide, 6N Potassium Hydroxide, 3N Sodium Hydroxide, 3N Sodium Hydroxide, 6N Esters 100% Esters 100% Rating Amyl Acetate Butyl Acetate Cellosolve Acetate Ethyl Acetate Isopropyl Acetate Methyl Acetate Esters Ethers Rating Ethyl Ether Isopropyl Ether Dioxane Tetrahydrofuran Glycols Aromatic Hydrocarbons Glycols Rating Ethylene Glycol Glycerol Propylene Glycol Aromatic Hydrocarbons Rating Benzene Toluene Xylene Halogenated Hydrocarbons Halogenated Hydrocarbons Rating Carbon Tetrachloride Chloroform Chlorothene NU Ethylene Dichloride Freon TF Freon-M TMC Genosolv D Methylene Chloride Perchloroethylene Trichloroethylene FiberFlo Capsule Filters, Page 15

17 Ketones Rating Acetone Cyclohexanone Methyl Ethyl Ketone Methyl Isobutyl Ketone Oils Rating Cottonseed Oil Lubrication Oil MIL-L Peanut Oil Sesame Oil Chemical Compatibility Keytones Oils Photoresists Rating Positive Negative Photoresists Miscellaneous Photoresists Rating Acetonitrile Aniline Dimethyl Formamide Dimethyl Sulfoxide Formaldehyde, 37% Formaldehyde, 4% Gasoline Hexane JP Kerosene Nickel Sulfate Solution Phenol, liquefied Pyridine Skydol Turpentine High Purity Water Miscellaneous Photoresists FiberFlo Capsule Filters, Page 16

18 Biological Testing Bacterial Retention TEST SUMMARY BIOLOGICAL TESTING BACTERIAL RETENTION An outside laboratory conducted testing in order to determine the filtration efficiency of the FiberFlo hydrophobic filters to remove bacteria from the input gases. An aerosol challenge containing approximately 10 6 Pseudomonas diminuta bacteria/cm 2 was filtered through FiberFlo hydrophobic filters. The filtrate from the air was collected in sterile containers and then assayed. The results show 0 (none) CFU s of bacteria, demonstrating the ability of the FiberFlo hydrophobic capsule filters to block all of the bacteria. Filter Number Challenge Total CFU Log Filtration Level (CFU) Recovered Reduction Efficiency #1 4.5 x 106 < 1* > 6.7 > % #2 4.5 x 106 < 1* > 6.7 > % #3 5.7 x 106 < 1* > 6.8 > % #4 5.7 x 106 < 1* > 6.8 > % #5 7.2 x 106 < 1* > 6.9 > % * There were no detectable CFU recovered on the assay membrane. VIRAL REMOVAL VALIDATION An outside laboratory conducted testing in order to determine the filtration efficiency of the FiberFlo hydrophobic capsule filters to remove viruses the input gases. An aerosol challenge containing approximately 107 bacteriophage stock culture (ATCC #13706-B1) was filtered through FiberFlo hydrophobic filters. (The 0X174 bacteriophage was selected because it has a diameter of 27nm providing a severe challenge to the test filters.) The filtrate from the air was collected in sterile containers and then assayed. The results show 0 (none) detectable PFU s, demonstrating the ability of the FiberFlo hydrophobic capsule filters to block viruses. Filter Number Challenge Total CFU Filtration Level (CFU) Recovered Efficiency #1 > 4.6 x 107 PFU < 1* > % #2 > 4.6 x 107 PFU < 1* > % #3 > 4.6 x 107 PFU < 1* > % * There were no detectable PFU on the assay plates for this sample. FiberFlo Capsule Filters, Page 17

19 TOXICITY The FiberFlo capsule filter components have been tested according to ISO guidelines for biocompatibility and have been found to be acceptable. The following studies have been preformed and are on file at Minntech Corporation: Cytotoxicity, Hemolysis, Systemic Toxicity, Intracutaneous Toxicity, Sensitization, Muscle Implantation, Subchronic Intravenous Toxicity, and Mutagenicity. CHEMICAL TESTING The chemical compatibility is based on the materials used in construction of the capsule filter. Fibercor has generated these results based on in house testing or on data accumulated by outside sources. Chemical compatibility can be affected by many variables, including concentration, viscosity, temperature, time and pressure. The following chemical compatibility charts are provided as a guide only. Fibercor recommends that the users verify compatibility with a specific chemical under actual use conditions. BACTERIAL RETENTION Testing was performed at Nelson Laboratories, Inc. located in Salt Lake City, Utah. A complete protocol is available upon request. VIRAL REMOVAL Testing was performed at Nelson Laboratories, Inc. located in Salt Lake City, Utah. A complete protocol is available upon request. TOXICITY TESTING Testing was performed according to USP Class VI standards at ViroMED Laboratories, Inc., located in Minneapolis, Minnesota. A complete protocol is available upon request. Biological Testing Toxicity Chemical Testing Compatibility FiberFlo Capsule Filters, Page 18

20 Physical and Performance Testing Diffusive Flow Test PHYSICAL AND PERFORMANCE TESTING DIFFUSIVE FLOW TEST A. Install and wet filter as described in the Directions for Use. B. Close all valves and drain housing by opening valves V3 and V4. Draining the housing reduces the time required for the diffusive airflow to reach equilibrium conditions. When drained, close valves V3 and V4. C. Attach flexible tubing to valve V5. Open valve V5 and V6, then slowly regulate the air pressure to 30 psig. Wait until a steady stream of bubbles is coming through the flexible tubing before proceeding. D. Fill a 100 ml graduated cylinder with water and invert it in a filled collection container. Place the tubing into the submerged opening of the graduated cylinder. Measure the amount of water displaced by air in one minute. E. Close valve V5 and V6, then slowly open V3 to vent the pressurized air. F. The diffusive flow is equal to the amount of water displaced. Diffusive flow in excess of 80 ml indicates that either the filter is not fully wetted of that a mechanical leak exists in the filter. If the filter fails the integrity test, wet and test the filter again. Pressure Decay Test PRESSURE DECAY TEST A. Install and wet filter according to the Directions for Use. B. After the filter has been thoroughly wetted, stop the water supply and drain the filter. Connect an air supply to the inlet of the filter and pressurize to 7.7 psig (400 mmhg) using an accurate pressure monitor device. C. Open a valve to drain from the outlet side of the filter housing. Close the air supply valve. Ensure that the pressure monitor device is between this valve and the filter. D. Observe the pressure decay over a one-minute period. The decay should be between 2-15 mmhg or psig for a properly wetted, undamaged filter. Note: The volume of the system (filter and the distance from isolation valves) affects the results of this test. Generally, a use history will have to be developed for a given filter/system being used. FiberFlo Capsule Filters, Page 19

21 SANITIZATION USING MINNCARE A. System Requirements (Refer to Figure 4) 1. An isolation valve should be located on the inlet side of the filter as close to the filter as possible. 2. A reverse osmosis water supply should be connected to the system (including isolation valve) on the inlet side of the filter and down stream of the inlet isolation valve. 3. An outlet isolation valve should be located on the outlet of the filter, this valve should divert the outlet flow to the drain. B. Sanitization NOTE: Always were gloves and eye protection when handling Minncare. Failure to do so may result in injury. 1. Cross Flows Capsule Filters: a. Isolate the filter from the system by closing the inlet valve and opening the outlet valve to drain. b. Rinsing the capsule filter of the process solution with reverse osmosis water before sanitization is recommended. c. Fill a luer syringe (new) with Minncare, refer to Table 4 for the volume required for filter size being used. Sanitation Using Minncare Capsule Filter Size (both Inline and Cross Flow) Minncare Volume* Small (S) 0.5 ml Medium (M) 1.0 ml Large (L) 2.5 ml Table 4 * - If the volume of solution contained in the outlet tubing exceeds 50 ml, it needs to be accounted for when adding Minncare. The additional volume of solution will dilute the Minncare added to the capsule filter. Table 4 contains the amount of Minncare required for the capsule filter only, to calculate the additional amount of Minncare required to maintain the concentration at the required 1%, the following method can be used. Sample Calculations: Volume of Outlet Tubing: 80ml Additional Volume of Minncare: 80 ml x 0.01 = 0.8 ml To maintain the concentration of Minncare at 1% in the filter and outlet tubing (Example: 80ml volume), 0.8ml of Minncare should be added to the volume indicated in Table 4. d. Remove the inlet side of the filter s white luer port cap. Take care not to release much of the volume of solution in the capsule. e. Immediately connect the syringe filled with Minncare to the port of the capsule filter case. FiberFlo Capsule Filters, Page 20

22 f. Slowly inject the Minncare into filter housing. This should displace an equivalent amount of liquid to the drain. Verify the Minncare concentration by using a Minncare 1% Test Strip (Refer to Minncare Test Strip DFU). If necessary add additional Minncare solution. g. After the Minncare concentration has been verified, carefully remove and discard the syringe. h. Replace the luer cap and tighten. Close the outlet isolation valve. i. Allow the Minncare to dwell in the filter for a minimum of 36 minutes (96 hours maximum). 2. Inline Capsule Filters: a. Isolate the filter from the system by closing the inlet valve and removing both of the filter s white luer caps. b. Rinsing the capsule filter of the process solution with reverse osmosis water before sanitization is recommended. c. Fill a luer syringe (new) with Minncare, refer to Table 4 for the volume required for filter size being used. d. Take care not to release much of the volume of solution in the capsule. e. Immediately connect the syringe filled with Minncare to the inlet side luer port of the capsule filter case. f. Slowly inject the Minncare into filter housing. This should displace an equivalent amount of liquid to the drain via the other open luer port. Verify the Minncare concentration by using a Minncare 1% Test Strip (Refer to Minncare Test Strip DFU). If necessary add additional Minncare solution. g. After the Minncare concentration has been verified, carefully remove and discard the syringe. h. Replace both the white luer caps and tighten. Close the outlet isolation valve. i. Allow the Minncare to dwell in the filter for a minimum of 36 minutes (96 hours maximum). C. Flush Filter After the Minncare has dwelled and before the filter is put back into service the Minncare should be flushed from the filter and outlet tubing. 1. Cross Flow Capsule Filter: a. Open the outlet isolation valve to drain. b. Slowly open the reverse osmosis isolation valve. c. Flush the filter until the Minncare Residual Test Strips indicate that the Minncare solution has been flushed from system (Refer to Minncare Residual Test Strip DFU). d. Following the verification that the filter has been flushed, stop the flow of the reverse osmosis water and initiate the process solution flow. NOTE: You may wish to flush the system with process fluid to drain for a short period, as it will be diluted with reverse osmosis water. e. Reconnect the outlet tubing of the capsule filter to the process system. FiberFlo Capsule Filters, Page 21

23 2. Inline Capsule Filter: a. Slowly open one of the white luer caps to drain. b. Slowly open the reverse osmosis isolation valve. c. Flush the filter until the Minncare Residual Test Strips indicate that the Minncare solution has been flushed from system (Refer to Minncare Residual Test Strip DFU). d. Following the verification that the filter has been flushed, stop the flow of the reverse osmosis water and initiate the process solution flow. Install the white luer cap. NOTE: You may wish to flush the system with process fluid to drain for a short period, as it will be diluted with reverse osmosis water. e. Reconnect the outlet tubing of the capsule filter to the process system. Minntech Corporation Part Numbers: Minncare Cold Sterilant (4 quarts per Case): Minncare Cold Sterilant (4 gallons per Case): Minncare 1% Test Strips: Minncare Residual Test Strips: P.N P.N P.N P.N Minncare Part Numbers FiberFlo Capsule Filters, Page 22

24 1999 Minntech Corp. P/N: /A