50090740B Cart 200 Valid HF HF200VG
User Manual: HF-200
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Page Count: 26
FiberFlo®
Hollow Fiber Cartridge Filters
Validation Guide: HF-200
0.2 µm
For use in Pharmaceutical, Medical,
Electronic and Dialysis applications.
Validation Guide:
FiberFlo®HF-200 Cartridge Filters, Page 3
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:
Page 4, FiberFlo®HF-200 Cartridge Filters
PRODUCT SUMMARY
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.
Introduction
Polysulfone
Hollow Fiber
Unfiltered
Filtered
Validation Guide:
FiberFlo®HF-200 Cartridge Filters, Page 5
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±1OC
Flow Rate 02 3 4 6
Average Delta P 01.06 1.59 2.16 3.4
Standard Deviation 00.107 0.16 0.234 0.347
FiberFlo 200 Flow Rates at 32O±1OC
Flow Rate 02 3 4 6
Average Delta P 00.92 1.39 1.88 3.07
Standard Deviation 00.111 0.129 0.193 0.359
CATALOG NUMBERS
Catalog Size End Cap
Number 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
Validation Guide:
Page 10, FiberFlo®HF-200 Cartridge Filters
PRODUCT SPECIFICATIONS
Materials of Construction
Hollow Fiber Membrane Polyphen®Polysulfone
Casing Polypropylene
End Caps Polypropylene
Inner Support Core Polypropylene
End Seals Polyurethane
Standard O-rings Silicone (others available upon request)
Sealing Method Welding
Effective Filtration Area
1.5 m2(16ft2) per 10 in. cartridge.
3.0 m2(32ft2) per 20 in. cartridge.
4.5 m2(48ft2) per 30 in. cartridge.
6.0 m2(64ft2) per 40 in, 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 @ 30 psi
10 inch <80 ml/min
20 inch <160 ml/min
30 inch <240 ml/min
40 inch <320 ml/min
MATERIALS OF
CONSTRUCTION
Validation Guide:
FiberFlo®HF-200 Cartridge Filters, Page 11
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.
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.
BACTERIAL
CHALLENGE
TESTING
Validation Guide:
Page 12, FiberFlo®HF-200 Cartridge Filters
Validation Guide:
FiberFlo®HF-200 Cartridge Filters, Page 13
Chemical Compatibility
KEY
1= Fully Compatible
2= Limited Compatibility
3= Not Recommended
-= Insufficient Data
Ratings are defined as follows:
Acids FiberFlo Silicone Rubber
HF 200 Filter O-Ring
Acetic Acid, glacial 3 2
Acetic Acid, 90% - 2
Acetic Acid, 30% - 1
Acetic Acid, 10% - 2
Chromic Acid, conc. - 3
Hydrochloric Acid, conc. 1 3
Hydrochloric Acid, 6N - 3
Hydrofluoric Acid, 6N - 3
Nitric Acid, conc. 3 2
Nitric Acid, 6N - 2
Phosphoric Acid, conc. - 3
Sulfuric Acid, conc. 3 3
Sulfuric Acid, 6N - 3
Minncare, 1% 1 1
Renalin, 1% 1 1
Alcohols FiberFlo Silicone Rubber
HF 200 Filter O-Ring
Amyl Alcohol 1 3
Benzyl Alcohol, 100% 1 2
Benzyl Alcohol, 3% 3 1
Butanol 1 3
Ethanol 1 1
Isopropanol 1 1
Methanol 1 1
Propanol 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:
Page 14, FiberFlo®HF-200 Cartridge Filters
Esters 100% FiberFlo Silicone Rubber
HF 200 Filter O-Ring
Amyl Acetate - 1
Butyl Acetate - 1
Cellosolve Acetate 1 1
Ethyl Acetate 2 1
Isopropyl Acetate 1 2
Methyl Acetate 3 -
Ethers FiberFlo Silicone Rubber
HF 200 Filter O-Ring
Ethyl Ether 1 3
Isopropyl Ether - 3
Dioxane - 3
Tetrahydrofuran 3 3
Glycols FiberFlo Silicone Rubber
HF 200 Filter O-Ring
Ethylene Glycol 1 1
Glycerol 1 1
Propylene Glycol 3 1
Aromatic Hydrocarbons FiberFlo Silicone Rubber
HF 200 Filter O-Ring
Benzene 2 3
Toluene 2 3
Xylene 2 3
Halogenated FiberFlo Silicone Rubber
Hydrocarbons HF 200 Filter O-Ring
Carbon Tetrachloride 2 3
Chloroform 3 3
Chlorothene®NU - 3
Ethylene Dichloride 3 3
Freon®TF 1 3
Freon-M TMC 3 3
Genosolv®D13
Methylene Chloride 3 3
Perchloroethylene 2 3
Trichloroethylene 2 3
Validation Guide:
FiberFlo®HF-200 Cartridge Filters, Page 15
Ketones FIberFlo Silicone Rubber
HF 200 Filter O-Ring
Acetone 3 3
Cyclohexanone 3 3
Methyl Ethyl Ketone - 3
Methyl Isobutyl Ketone 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 FiberFlo Silicone Rubber
HF 200 Filter O-Ring
Positive 3 3
Negative - 3
Miscellaneous FiberFlo Silicone Rubber
Photoresists HF 200 Filter O-Ring
Acetonitrile 1 -
Aniline 3 3
Dimethyl Formamide 3 1
Dimethyl Sulfoxide 3 3
Formaldehyde, 37% 1 1
Formaldehyde, 4% 1 1
Gasoline 1 3
Hexane, dry 2 3
JP-4 1 3
Kerosene 1 3
Nickel Sulfate Solution - 1
Phenol, liquefied 3 3
Pyridine 3 3
Skydol®500 1 2
Turpentine 1 3
High Purity Water 1 1
Validation Guide:
Page 16, FiberFlo®HF-200 Cartridge Filters
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 107Brevundimonas diminuta
ATCC 19146* bacteria/cm2filtered 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 Total Challenge Filtrate Rinse Log
Pressure Challenge / sq. ran Count Count Reduction
FF 200 Cartridge
20 sq. cm., 0.2 µm None None
Lot 6323-02-19 #1 30 PSIG 220 mL/57 sec. 2.40E+09 1.2E+08 detected detected > 9.4
FF 200 Cartridge
20 sq. cm., 0.2 µm None None
Lot 6323-02-19 #2 30 PSIG 220 mL/59 sec. 2.40E+09 1.2E+08 detected detected > 9.4
FF 200 Cartridge
20 sq. cm., 0.2 µm None None
Lot 6330-02-07 #1 30 PSIG 220 mL/76 sec. 2.40E+09 1.2E+08 detected detected > 9.4
FF 200 Cartridge
20 sq. cm., 0.2 µm None None
Lot 6330-02-07 #2 30 PSIG 220 mL/75 sec. 2.40E+09 1.2E+08 detected detected > 9.4
FF 200 Cartridge
20 sq. cm., 0.2 µm None None
Lot 6330-02-07 #3 30 PSIG 220 mL/81 sec. 2.40E+09 1.2E+08 detected detected > 9.4
*Brevundimonas diminuta ATCC 19146 is now preferred over Pseudomonas diminuta in the
filtration industry.
Validation Guide:
FiberFlo®HF-200 Cartridge Filters, Page 17
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:
Page 18, FiberFlo®HF-200 Cartridge Filters
Validation Guide:
FiberFlo®HF-200 Cartridge Filters, Page 19
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 Extractables mg/cartridge
FiberFlo 200 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:
Page 20, FiberFlo®HF-200 Cartridge Filters
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
10.6 0.7 0.8
21.1 1.1 1.2
31.6 1.6 1.8
42.2 2.2 2.4
52.8 2.9 3.2
63.4 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:
FiberFlo®HF-200 Cartridge Filters, Page 21
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 D P After A/C, Dry D P After A/C, Wet
21.1 1.1 1.2
31.6 1.5 1.6
42.2 2.3 2.4
52.8 2.9 3.0
63.4 3.4 3.5
Diffusive Flow
(ml/min) Less than 80 Less than 80 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 Pin (mmHg) Pout (mmHg) ∆P (mmHg)
0 minutes 0 minutes
FiberFlo 200 423 417 6
FiberFlo 200 407 404
FiberFlo 200 411 408 3
A complete description of the pressure decay test appears in the
section entitled "Test Methods."
Validation Guide:
Page 22, FiberFlo®HF-200 Cartridge Filters
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:
FiberFlo®HF-200 Cartridge Filters, Page 23
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 DESCRIPTION
300 ml 0.10 Reagent Grade Water
1.25 ml 0.09 diameter polystyrene beads
2Luer stopcocks
1Digidyne®pressure monitor
1500 ml beaker
260 cc luer lock syringe
113 mm stainless filter holder
10.05 Nucleopore polycarbonate filter
1Rubber stopper with hole
1Vacuum Source
115 fiber test mat
2Headers for 250 case
2Header nuts for 250 case
2O-rings for 250 case
1+ inch dead end
a/r + inch blood tubing
a/r + inch vacuum tubing
1Teflon®stir bar
5Cuvettes
1Spectrophotometer (Beckman)
a/r D. I. Water
1Stand
a/r Disposable Pipettes
1Petri dish
110 ml polypropylene cup
1+ 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:
Page 24, FiberFlo®HF-200 Cartridge Filters
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 Digi-
Dyne 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:
FiberFlo®HF-200 Cartridge Filters, Page 25
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 121OC 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.
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
