50090740B Cart 200 Valid HF HF200VG
User Manual: HF-200
Open the PDF directly: View PDF 
.
Page Count: 26
| Download | |
| Open PDF In Browser | View PDF |
FiberFlo® Hollow Fiber Cartridge Filters Validation Guide: HF-200 0.2 µm For use in Pharmaceutical, Medical, Electronic and Dialysis applications. CONTENTS PRODUCT SUMMARY INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Catalog Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 FDA 510K CLEARANCE LETTER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 INSTALLATION INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 PRODUCT SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Materials of Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Effective Filtration Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Maximum Differential Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Integrity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 SUMMARY OF RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Bacterial Challenge Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Extractables/Solids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Chemical Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 TEST SUMMARY BIOLOGICAL TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Bacterial Retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 CHEMICAL TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Gravimetric Extractables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 PHYSICAL AND PERFORMANCE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Latex Bead Challenge Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Autoclave/Live Steam Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Diffusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Pressure Decay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 TEST METHODS BIOLOGICAL TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 Bacterial Retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 Toxicity Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 CHEMICAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 Gravimetric Extractables Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 PHYSICAL AND PERFORMANCE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Latex Bead Challenge Protocol and Sample Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Equipment and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 In-Line Steam Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 Diffusive Flow Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26 Pressure Decay Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26 Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 3 ® PRODUCT SUMMARY Introduction INTRODUCTION This validation guide has been prepared to help you assess the filtration characteristics of the FiberFlo® Hollow Fiber Cartridge Filters and relate those characteristics to your individual filtration needs. Fibercor's technical group is prepared to assist you with any specific needs not covered in this Validation Guide. The FiberFlo Hollow Fiber Cartridge Filters have been engineered to meet the filtration needs for precise particle and bacterial removal from high purity fluids. The cartridge is manufactured by the Filtration Technologies Group of Minntech which as a manufacturer, meets or exceeds FDA Device Good Manufacturing Practice standards. In addition the manufacturing facility is ISO-9001 registered. The FiberFlo HF-200 cartridge filter has been cleared for marketing as a medical device by the FDA. The Polyphen® polysulfone used in the FiberFlo HF cartridge filter devices is manufactured by Filtration Technologies Group under U.S. patent number 5,762,798. The asymmetric hollow fiber provides for absolute micron removal ratings, large surface area, superior flow rates and a wide range of chemical compatibility. Polysulfone Hollow Fiber Filtered Unfiltered Validation Guide: Page 4, FiberFlo® HF-200 Cartridge Filters The FiberFlo HF Cartridge line has been tested to produce a sterile effluent when challenged with bacteria according to Health Industry Manufacturer's Association (HIMA) standards. FiberFlo 200 Flow Rates at 25O ±1O C Flow Rate 0 2 3 4 6 Average Delta P Standard Deviation 0 0 1.06 0.107 1.59 0.16 2.16 0.234 3.4 0.347 FiberFlo 200 Flow Rates at 32O ±1O C Flow Rate 0 2 3 4 6 Average Delta P Standard Deviation 0 0 0.92 0.111 1.39 0.129 1.88 0.193 3.07 0.359 Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 5 ® CATALOG NUMBERS Catalog Number Size End Cap Configuration 200-103 10 inch (25.4 cm) 222 O-Ring 200-104 10 inch (25.4 cm) 222 O-Ring w/ fin 200-105 10 inch (25.4 cm) 226 O-Ring w/ fin 200-107 10 inch (25.4 cm) 119 O-Ring Internal O-Ring 200-203 20 inch (50.8 cm) 222 O-Ring 200-204 20 inch (50.8 cm) 222 O-Ring w/ fin 200-205 20 inch (50.8 cm) 226 O-Ring w/ fin 200-208 20 inch (50.8 cm) 119 O-Ring Internal O-Ring 200-303 30 inch (76.2 cm) 222 O-Ring 200-304 30 inch (76.2 cm) 222 O-Ring w/ fin 200-305 30 inch (76.2 cm) 226 O-Ring w/ fin 200-403 40 inch (101.6 cm) 222 O-Ring 200-404 40 inch (101.6 cm) 222 O-Ring w/ fin 200-405 40 inch (101.6 cm) 226 O-Ring w/ fin Validation Guide: Page 6, FiberFlo® HF-200 Cartridge Filters Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 7 ® Validation Guide: Page 8, FiberFlo® HF-200 Cartridge Filters Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 9 ® PRODUCT SPECIFICATIONS MATERIALS OF CONSTRUCTION Materials of Construction Polyphen® Polysulfone Polypropylene Polypropylene Polypropylene Polyurethane Silicone (others available upon request) Welding Hollow Fiber Membrane Casing End Caps Inner Support Core End Seals Standard O-rings Sealing Method Effective Filtration Area 1.5 m2 (16ft2) per 3.0 m2 (32ft2) per 4.5 m2 (48ft2) per 6.0 m2 (64ft2) per 10 20 30 40 in. in. in. in, cartridge. cartridge. cartridge. cartridge. Maximum Differential Pressure 30 PSI (2 Bar) Integrity Test Each cartridge is 100% integrity tested. Each cartridge may be integrity tested by the quantitative diffusive flow method. See the section entitled "Test Methods" for further information. Cartridge Length 10 20 30 40 Validation Guide: Page 10, FiberFlo® HF-200 Cartridge Filters inch inch inch inch @ 30 psi <80 ml/min <160 ml/min <240 ml/min <320 ml/min SUMMARY OF RESULTS Bacterial Challenge Testing FiberFlo HF cartridge filters meet all absolute bacterial rated tests at 0.05 pore size as outlined by the Health Industry Manufacturers Association (HIMA) standard method for "Microbiological Evaluation of Filters for Sterilizing Liquids." HIMA document #3, Vol. 4, 1982. BACTERIAL CHALLENGE TESTING Extractables/Solids Passes USP standards for oxidizable substances and total solids for purified water. Toxicity Passes all current USP Class VI Plastics and Mouse Safety Tests Sterilization FiberFlo HF cartridges may be autoclaved dry or wet (121°C, 30 min.) up to 6 cycles, or steam sterilized (190°F, 100 min.) up to 30 cycles. Certification All Filtration Technologies Group hydrophilic 0.2 µm cartridges have a Certificate of Analysis available upon request, which assures that each cartridge is manufactured and tested to the specifications designated in this guide. This certificate provides the part number, lot number, performance testing (water flux, diffusive flow, and endotoxin removal), latex bead challenge, biocompatibility and solids/extractables. Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 11 ® Validation Guide: Page 12, FiberFlo® HF-200 Cartridge Filters Chemical Compatibility KEY 1 = Fully Compatible 2 = Limited Compatibility 3 = Not Recommended = Insufficient Data Ratings are defined as follows: Acids Acetic Acid, glacial Acetic Acid, 90% Acetic Acid, 30% Acetic Acid, 10% 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% Alcohols Amyl Alcohol Benzyl Alcohol, 100% Benzyl Alcohol, 3% Butanol Ethanol Isopropanol Methanol Propanol FiberFlo Silicone Rubber HF 200 Filter O-Ring 3 2 2 1 2 3 1 3 3 3 3 2 2 3 3 3 3 1 1 1 1 FiberFlo Silicone Rubber HF 200 Filter O-Ring 1 3 1 2 3 1 1 3 1 1 1 1 1 1 1 1 Bases FiberFlo Silicone Rubber HF 200 Filter O-Ring Ammonium Hydroxide, 3N 1 1 Ammonium Hydroxide, 6N 1 1 Potassium Hydroxide, 3N 1 2 Sodium Hydroxide, 3N 1 1 Sodium Hydroxide, 6N 1 1 Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 13 ® Esters 100% Amyl Acetate Butyl Acetate Cellosolve Acetate Ethyl Acetate Isopropyl Acetate Methyl Acetate Ethers FiberFlo Ethyl Ether Isopropyl Ether Dioxane Tetrahydrofuran Glycols Ethylene Glycol Glycerol Propylene Glycol Aromatic Hydrocarbons FiberFlo Silicone Rubber HF 200 Filter O-Ring 1 1 1 1 2 1 1 2 3 Silicone HF 200 Filter 1 3 Rubber O-Ring 3 3 3 3 FiberFlo Silicone Rubber HF 200 Filter O-Ring 1 1 1 1 3 1 Benzene Toluene Xylene FiberFlo Silicone Rubber HF 200 Filter O-Ring 2 3 2 3 2 3 Halogenated Hydrocarbons Carbon Tetrachloride Chloroform Chlorothene® NU Ethylene Dichloride Freon® TF Freon-M TMC Genosolv® D Methylene Chloride Perchloroethylene Trichloroethylene FiberFlo Silicone Rubber HF 200 Filter O-Ring 2 3 3 3 3 3 3 1 3 3 3 1 3 3 3 2 3 2 3 Validation Guide: Page 14, FiberFlo® HF-200 Cartridge Filters Ketones Acetone Cyclohexanone Methyl Ethyl Ketone Methyl Isobutyl Ketone FIberFlo Silicone Rubber HF 200 Filter O-Ring 3 3 3 3 3 3 3 Oils FiberFlo Silicone Rubber HF 200 Filter O-Ring Cottonseed Oil 1 Lubrication Oil MIL-L-7808 3 1 Peanut Oil 1 Sesame Oil 3 1 Photoresists Positive Negative FiberFlo Silicone Rubber HF 200 Filter O-Ring 3 3 3 Miscellaneous Photoresists Acetonitrile Aniline Dimethyl Formamide Dimethyl Sulfoxide Formaldehyde, 37% Formaldehyde, 4% Gasoline Hexane, dry JP-4 Kerosene Nickel Sulfate Solution Phenol, liquefied Pyridine Skydol® 500 Turpentine High Purity Water FiberFlo Silicone Rubber HF 200 Filter O-Ring 1 3 3 3 1 3 3 1 1 1 1 1 3 2 3 1 3 1 3 1 3 3 3 3 1 2 1 3 1 1 Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 15 ® TEST SUMMARY BIOLOGICAL TESTING Bacterial Retention In order to show that FiberFlo water filters remove bacteria from the input water, testing was conducted by an outside lab. The challenge suspension contained approximately 107 Brevundimonas diminuta ATCC 19146* bacteria/cm2 filtered through a FiberFlo water filter with a 0.2 µm pore size. B. diminuta was selected because of its small size. The filtrate from the water filter was collected in a sterile container and then assayed. The results showed 0 (none) CFU of bacteria in the filtrate. This demonstrated that the FiberFlo cartridge water filter blocked all of the bacteria. Filter Number Challenge Flow Rate Pressure Total Challenge Challenge / sq. ran Filtrate Count Rinse Log Count Reduction FF 200 Cartridge 20 sq. cm., 0.2 µm Lot 6323-02-19 #1 30 PSIG 220 mL/57 sec. 2.40E+09 1.2E+08 None detected None detected > 9.4 FF 200 Cartridge 20 sq. cm., 0.2 µm Lot 6323-02-19 #2 30 PSIG 220 mL/59 sec. 2.40E+09 1.2E+08 None detected None detected > 9.4 FF 200 Cartridge 20 sq. cm., 0.2 µm Lot 6330-02-07 #1 30 PSIG 220 mL/76 sec. 2.40E+09 1.2E+08 None detected None detected > 9.4 FF 200 Cartridge 20 sq. cm., 0.2 µm Lot 6330-02-07 #2 30 PSIG 220 mL/75 sec. 2.40E+09 1.2E+08 None detected None detected > 9.4 FF 200 Cartridge 20 sq. cm., 0.2 µm Lot 6330-02-07 #3 30 PSIG 220 mL/81 sec. 2.40E+09 1.2E+08 None detected None detected > 9.4 *Brevundimonas diminuta ATCC 19146 is now preferred over Pseudomonas diminuta in the filtration industry. Validation Guide: Page 16, FiberFlo® HF-200 Cartridge Filters Toxicity USP Class VI Plastic and Mouse Safety Tests were used to confirm the suitability of FiberFlo HF cartridge construction materials and assembled cartridges for contact with parenterals. Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 17 ® Validation Guide: Page 18, FiberFlo® HF-200 Cartridge Filters CHEMICAL TESTING Gravimetric Extractables Testing was performed to determine the amount of non-volatile extractables in a 10 inch FiberFlo filter. Refer to the section entitled "Test Methods" for a full description of the test performed. Product FiberFlo 200 Extractables mg/cartridge 3.6 Compatibility The chemical compatibility is based on the materials used in construction of the cartridge filter as well as any and all components used in the test. Filtration Technologies Group has generated results based on in house testing and on data accumulated by outside sources. Temperature, viscosity and other components can affect the testing differently. Filtration Technologies Group recommends that each customer test before hand the chemical in question before use in the system. Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 19 ® PHYSICAL AND PERFORMANCE TESTING Latex Bead Challenge Test The latex bead challenge test was used to determine the absolute pore size of the FiberFlo 200 filter. Fifteen polysulfone fibers were potted in a polycarbonate module. The module was then fully wetted. A latex bead solution containing beads of the appropriate size (0.2 µm) for the filter was forced through the filter at a pressure between 300 to 400 mmHg. The outlet fluid was passed through an analytical filter disk and into a vacuum flask. Spectraphotometric analysis was performed to detect beads in either the collected effluent or on the outlet filter. Additionally, scanning electron microscopy was performed on the analytical filter disk. No beads were found on the disk using either method, nor were any found in the effluent. The protocol used for this test is included in the test protocol section. Autoclave/Live Steam Sterilization FiberFlo Hollow Fiber Cartridge Water Filters were tested for their ability to withstand autoclave sterilization. The procedure autoclaved filters at 121°C for 30 minutes. The filters were tested dry (out of the box) and wetted (as described in the instruction for use.) The results are summarized in the table below. Flow Rate GPM Specification D P After A/C, Dry D P After A/C, Wet 1 0.6 0.7 0.8 2 1.1 1.1 1.2 3 1.6 1.6 1.8 4 2.2 2.2 2.4 5 2.8 2.9 3.2 6 3.4 3.4 3.7 Diffusive Flow (ml/min) Less than 80 Less than 80 Less than 80 Tests were also performed to indicate the tolerance of the Validation Guide: Page 20, FiberFlo® HF-200 Cartridge Filters FiberFlo water filters to steam sterilization. A full description of the in-line steam test is located in the section entitled "Test Methods." The results of this testing is shown in the table below. Flow Rate GPM Specification 2 1.1 3 1.6 4 2.2 5 2.8 6 3.4 Diffusive Flow (ml/min) Less than 80 D P After A/C, Dry 1.1 1.5 2.3 2.9 3.4 Less than 80 D P After A/C, Wet 1.2 1.6 2.4 3.0 3.5 Less than 80 The autoclave/steam sterilization test results demonstrate that all units met the factory specification for maximum pressure drop. Pressure drops measurements are the most often used criteria when using heated methods of sterilization. The units passed all other functional release testing as well. Diffusion FiberFlo Hollow Fiber Cartridge Filters are integrity tested by the quantitative diffusive flow method. Diffusive flow less than 80 ml per 10 inch equivalent indicates that all fibers are intact. A complete description of the Diffusive Flow test method is located in the section entitled "Test Methods." Pressure Decay Pressure decays were observed over a 1 minute time period. All values were within 2 - 15 mmHg (0.039 - 0.290 PSIG). Results are shown in the table below. Product FiberFlo 200 FiberFlo 200 FiberFlo 200 Pin (mmHg) 0 minutes 423 407 411 Pout (mmHg) 0 minutes 417 404 408 ∆P (mmHg) 6 3 A complete description of the pressure decay test appears in the section entitled "Test Methods." Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 21 ® TEST METHODS BIOLOGICAL TESTING Bacterial Retention 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. CHEMICAL Gravimetric Extractables Test Purpose To determine the amount of non-volatile extractables in a 10” FiberFlo® 100 filter. Materials Aluminum Foil Oven, 80°C ±0.5°C Desiccator Analytical Balance Beakers, Acid Washed Hot Plate Reagent Grade Water Glass Cylinder Procedure Place the cartridge in a glass cylinder. Add a known amount of pure water to the cylinder, sufficient to cover the cartridge. Cover with aluminum foil and let stand undisturbed for 24 hours. Remove Cartridge. Transfer 250 ml of the extraction water to a clean desiccated, tared beaker (±0.5mg). Boil almost to dryness. Place beaker in a 80°C oven until water is evaporated. When dry, place in a desiccator to cool. Weigh the cooled beaker and residue (±0.05mg). Repeat the above steps starting with "transfer 250ml" using pure water. This will serve as a control. Calculations A. Sample Weight of beaker and residue)-(Weight of beaker) = Cartridge extractables B. Control (Weight of beaker and residue)-(Weight of beaker) = Control extractables C. Result [(Cartridge extractables)-Control extractables)] x [Extraction volume/250] = Extractables/cartridge. Validation Guide: Page 22, FiberFlo® HF-200 Cartridge Filters PHYSICAL AND PERFORMANCE TESTING Latex Bead Challenge Protocol and Sample Data OBJECTIVE: The objective of this test procedure is to verify the pore size rating of fiber that is produced for the FiberFlo water filter at 0.2 microns. Equipment and Supplies QUANTITY 300 ml 1.25 ml 2 1 1 2 1 1 1 1 1 2 2 2 1 a/r a/r 1 5 1 a/r 1 a/r 1 1 1 DESCRIPTION 0.10 Reagent Grade Water 0.09 diameter polystyrene beads Luer stopcocks Digidyne® pressure monitor 500 ml beaker 60 cc luer lock syringe 13 mm stainless filter holder 0.05 Nucleopore polycarbonate filter Rubber stopper with hole Vacuum Source 15 fiber test mat Headers for 250 case Header nuts for 250 case O-rings for 250 case + inch dead end + inch blood tubing + inch vacuum tubing Teflon® stir bar Cuvettes Spectrophotometer (Beckman) D. I. Water Stand Disposable Pipettes Petri dish 10 ml polypropylene cup + inch tube X luer adapter Procedure A. Cleaning 1. Where possible use new component / supplies that are disposable. Any components that contact the water or bead solution that are not disposable, must be thoroughly cleaned. 2. The cleaning procedure for all components other than the filter holder is through washing with detergent, followed by complete rinsing in DI water, then air dried at 70-100°F. 3. The cleaning procedure for the filter holder is to disassemble and soak submerged in Methylene Chloride for 20 minutes, followed by air or convection oven drying at 70-150°F. Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 23 ® B. Test Mat Preparation 1. The test mat should be fully wetted out per procedure titled "WETTING OUT OF 15 FIBER TEST MATS". (available upon request) 2. The test amt should be tested for integrity per procedure titled "LEAK TESTING OF 15 FIBER TEST MATS". (available upon request) C. Bead Solution Preparation The bead solution is prepared by combining 1.25 grams of Duke Scientific 0.2 mm concentrated beads to 125 ml of reagent grade water in the 500 ml beaker. The mixture is then stirred on a stir plate or other suitable means for 20 minutes. A sample of the bead solution is to be read on the spectrophotometer at 90-110 ppm. D. Assembly The test mat should be assembled per figure #1 with the luer stopcocks, headers, header nuts, O-Rings, one end sealed with the + "dead end," and collection syringe installed. Insure that the Digi-Dyne is connected. E. Priming of the Test Mat Aspirate 60 cc of the bead solution into the feed syringe, and connect the syringe to stopcock #1. Open stopcock #1. Open stopcock #2 to vent the air. Slowly inject the bead solution while purging the air from the system. Close both stopcocks. Repeat this procedure until all air is purged form the casing around the fibers. Verify that the Digi-Dyne is connected and stopcock #2 is positioned such that the Digi-Dyne will display the pressure inside the case. F. Conducting the Challenge 1. Aspirate 30 cc of bead solution into the syringe and connect the syringe to stopcock #1. Open the stopcock to position B. 2. Insure that the Digi-Dyne is connected and that stopcock is positioned such that the Digi-Dyne is reading the pressure inside the case. 3. Depress the piston of feed syringe to force the bead solution across the membrane in the test mat. Depress the piston at a rate such that the DigiDyne reads 500-550 mmHg. Continue depressing the piston until all 30 cc of bead solution have been dispensed. This will take up to 10 minutes. 4. Remove the collection syringe from the assembly and dispense approximately 2 ml of filtrate into a Cuvette for analysis. Cap the syringe with its original stopper. 5. Read the collected sample on the spectrophotometer. Validation Guide: Page 24, FiberFlo® HF-200 Cartridge Filters In-line Steam Sterilization Objective: Determine the capability of FiberFlo filters to withstand in-line steam sterilization. Procedure: Assemble a test apparatus as shown in the accompanying schematic diagram. Adjust the steam pressure regulator to 20 psi. 3. With all valves in their closed position, install the filter into the housing and secure with a clamp. 4. Open Valves V3, V4 and V5 to vent the incoming steam. 5. Slowly open Valve V2 to let steam enter the system. (Note: this valve must be throttled to prevent the differential pressure from exceeding 3 psi.) 6. Drain any condensate until the system heats up. Close valves V3, V4 and V5 when a steady flow of steam is observed. 7. Slowly open Valve V2 until the downstream pressure gauge reads 20 psi. Maintain differential pressure at < 3 psi. When necessary, adjust the pressure via the steam regulator valve. 8. Maintain the system at 121O C and 20 psi for 30 minutes. 9. Close Valve V2 and cool the system to room temperature. 10. Perform flow vs. pressure drop and diffusive flow integrity tests on each filter. Validation Guide: FiberFlo HF-200 Cartridge Filters, Page 25 ® Diffusive Flow Test 1. Install and wet filter as described in the Directions for Use. 2. Close all valves and drain housing by opening valves V3 and V4. Draining the housing reduces the time required for the diffusive air flow to reach equilibrium conditions. When drained, close valves V3 and V4. 3. 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. 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 V5 and V6, then slowly open V3 to vent the pressurized air. 6. Multiply the number of ten inch equivalent filters in the housing by 80 ml/min to obtain the maximum diffusive flow for the housing. 7. Example: a housing containing a single 30 inch filter should have a diffusive flow of less than 240 ml/min (i.e. 80 x 3 = 240). Diffusive flow in excess of 80 ml/ten inch equivalent 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 and test the filters again. Pressure Decay Test 1. Install the filter in the filter housing according to the Directions for Use. 2. Wet the filter using a minimum of 0.5 gpm water flowrate and back pressure the cartridge by partially closing the discharge valve to a pressure of 30 to 40 psig for at least ten minutes. Note: do not create a pressure drop greater than 30 psig from the inlet to the outlet. Pressure drops greater than 30 psig may damage the filter cartridge. 3. After the filter cartridge has been thoroughly wet, stop the water supply and drain the filter housing. Connect an air supply to the inlet of the filter cartridge and pressurize to 7.7 psig or 400mmHg using an accurate pressure monitor device. 4. 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 housing. 5. Observe the pressure decay over a one minute period. The decay should be between 2 - 15 mmHg or 0.039 - 0.290 psig for a properly wetted, undamaged filter. Note: The volume of the system (the filter housing and the distance of the isolation valves from the filter housing) affects the results of this test. Generally, a use history will have to be developed for the given filter/housing system being used. Validation Guide: Page 26, FiberFlo® HF-200 Cartridge Filters ©2003 Minntech Corporation. P/N 50090-740/B
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.5 Linearized : Yes XMP Toolkit : 3.1-701 Producer : Acrobat Distiller 5.00 for Macintosh Create Date : 2003:04:29 11:02:14-05:00 Modify Date : 2006:07:20 12:30:53-07:00 Metadata Date : 2006:07:20 12:30:53-07:00 Creator Tool : QuarkXPressª: AdobePS 8.8.0 (301) Format : application/pdf Creator : g4 Title : 50090740B cart 200 valid Document ID : uuid:056ea276-fa40-4190-a42c-7df39f70d82c Instance ID : uuid:3db32038-49b9-46b6-a784-e9d6c1b68071 Page Count : 26 Author : g4EXIF Metadata provided by EXIF.tools