Integrity Testing LifeASSURE™ PSA020 and PSA010 Series Filter

Integrity Testing LifeASSURE™ PSA020 and PSA010 Series Filter
Integrity Testing LifeASSURE™ PSA020 and PSA010 Series Filter Cartridges
and Capsules
SAFETY INFORMATION
Read, understand, and follow all safety information contained in these instructions and the instructions
provided with the original filtration system, prior to installation and use. Retain for future reference.
INTRODUCTION
The integrity test is the End User’s method to confirm the structural integrity of a
LifeASSURE™ PSA series filter before and after use. It is a non-destructive test that has been
correlated to bacteria retention and validates the performance of the filter cartridge. An “in
specification” result confirms the porosity of the filter membrane and that the cartridge is
structurally integral.
Three integrity test methods can be employed to integrity test hydrophilic (water wettable)
LifeASSURE PSA series filters. These methods are:
1. Forward Flow Integrity Test (FFIT)
2. Bubble Point Test (BPT)
3. Pressure Hold Test (PHT)
All three Integrity tests can be performed manually or with the CUNOCheck™ 2 Automated
Integrity Tester. For more information about using the CUNOCheck 2 tester to perform an
integrity test, refer to the CUNOCheck 2 Operator Manual (LITCCK2OPS).
FORWARD FLOW INTEGRITY TEST
Definition
Figure 1 – Forward Flow Integrity Test (Manual Method)
According to Fick’s Law of
Diffusion, when a differential gas
pressure exists across a wetted
membrane, the gas molecules will
“diffuse” through the water filling
the pores of the membrane. The rate
of passage is proportional to the
solubility of the gas in the wetting
fluid, the surface tension of the
wetting fluid, the differential
pressure, the thickness of the
membrane, the pore size, and the
surface area of the membrane. The
diffusion rate is measured at a
pressure below the membrane
bubble point pressure. If no bulk
flow exists, there are no pores large enough to compromise the filter’s integrity. The Forward
Flow Integrity Test (FFIT) may be employed with a multi-cartridge housing.
Procedure 1. Forward Flow Integrity Test (Manual Method – Figure 1)
` WARNING
To reduce the risk associated with burn or system burst related injuries:
Do not exceed maximum operating pressure or temperature limits.
•
Do not use product for continuous service with compressed gases.
•
Do not use with or expose this product to hot liquids (104 ˚F) or pressurized steam.
•
` CAUTION
To reduce the risk associated with exposure to contaminants:
Always use appropriate personal protective equipment (PPE) when installing, operating or changing the product
•
as per your standard operating procedure.
Ensure that inlet/outlet valves are closed and all system pressure has been relieved prior to opening the system
•
to atmosphere.
A. Configure the system as shown in Figure 1.
B. Install the filter in the housing and wet with clean, ambient temperature, filtered water at
a flow rate of 3 GPM (11 liters/min) per 10" equivalent for ten minutes or more with a
minimum of 5 psid back pressure.
C. Close inlet V1 and outlet valve V6 to isolate the housing. Drain all the water from the
upstream side of the filter by positioning V5 to direct flow to drain. Adjust the pressure
regulator to deliver 3 – 5 psig of air or nitrogen (DO NOT USE CO2). Slowly open V3.
Close V3 when water discharge is no longer evident.
D. Connect one end of a flexible tube to the outlet port V5 and submerse the other end in a
container of water. Position V5 to direct flow to the container of water.
E. Open V3 and slowly adjust the pressure regulator to pressurize the system to the specified
FFIT pressure value and allow the system to equilibrate for a minimum of one minute, or
until steady bubbling is seen from the submersed end of the tube.
F. Place the opening of the tube under an inverted graduated cylinder or burette (calibrated
in milliliters or cubic centimeters) of an appropriate size filled with and submersed under
sterile water.
G. Measure the air flow for 5 minutes. Calculate the diffusion rate in cc/min.
H. When the test is complete, compare the result to the cartridge FFIT specification.
I. After the test is complete, drain the water from the housing and place the cartridge back
in service.
J. If the diffusion rate is higher than the specification, consider following questions and retest if necessary:
Was the filter completely wetted out?
Was the correct pore size filter installed?
Was the temperature of the water and filter ambient?
Was the stabilization time adequate?
Was the test time adequate?
Was the filter seated correctly in the housing; were the o-rings undamaged?
2
LifeASSURE™ PSA
series
Test Pressure
psi (bar)
Maximum Diffusion Flow – cc/min
10” cartridge/capsule
5” mini-cartridge/capsule
2.5” minicartridge/capsule
PSA010
70 (4.83)
<18
<6.3
<3.0
PSA020
35 (2.41)
<13.1
<4.3
<2.1
It is important to make an aseptic connection and to close the outlet port immediately after the system has been
integrity tested to prevent contamination
Procedure 2. Forward Flow Integrity Test (Automated Method - Figure 2)
` WARNING
To reduce the risk associated with burn or system burst related injuries:
Do not exceed maximum operating pressure or temperature limits.
•
Do not use product for continuous service with compressed gases.
•
Do not use with or expose this product to hot liquids (104 ˚F) or pressurized steam.
•
` CAUTION
To reduce the risk associated with exposure to contaminants:
Always use appropriate personal protective equipment (PPE) when installing, operating or changing the product
•
as per your standard operating procedure.
Ensure that inlet/outlet valves are closed and all system pressure has been relieved prior to opening the system
•
to atmosphere.
Figure 2 – Forward Flow Integrity Test (Automated Method)
A. Configure the system as shown
in Figure 2.
B. Install the filter in the housing
and wet with clean, ambient
temperature, filtered water at
ambient temperature at a flow
rate of 3 GPM (11 liters/min)
per 10" equivalent for ten
minutes or more with a
minimum of 5 psid back
pressure.
C. Close inlet V1 and outlet valve
V6 to isolate the housing.
Drain all the water from the upstream side of the filter by positioning V5 to direct flow to
drain. Adjust the pressure regulator to deliver 3 – 5 psig of air or nitrogen (DO NOT
USE CO2). Slowly open V3. Close V3 when water discharge is no longer evident.
D. Close the housing inlet valve V1 and connect the CUNOCheck™ 2 Automated Integrity
Tester at V3 and initiate the automated forward flow integrity test protocol.
E. When the test is complete, compare the measured forward flow integrity value against the
acceptable limit for the filter cartridge under test.
F. After the test is complete, drain the water from the housing and place the cartridge back
in service.
G. Disconnect the CUNOCheck 2 Automated Integrity Tester from the housing.
3
BUBBLE POINT TEST (Refer to Figure 3)
Definition
Figure 3 –Bubble Point Test (Manual Method)
The bubble point is the minimum
gas pressure required to overcome
the surface tension holding water
in a membrane filter’s largest pore.
The bubble point pressure
measurement is only recommended
for single 10-inch cartridge filters
or smaller. When more filter area is
on line, it becomes difficult to
distinguish diffusion flow from the
true bulk flow which occurs at the
bubble point pressure. For setups
with 2 or more 10-inch equivalent
cartridges, Forward Flow or
Pressure Hold measurements are
recommended.
The CUNOCheck™ 2 Automated Integrity Tester can be used to perform a bubble point test.
When using the CUNOCheck 2 tester, follow the installation instructions for connecting the unit
to the upstream valve as shown in Figure 4. Consult 3M Purification Inc. document 70-02018848-1 for the filter cartridge bubble point value for the filter cartridge to be used and program
this value into the CUNOCheck 2 tester when requested during the test set-up.
Procedure 1. Bubble Point Test (Manual Method - Figure 3)
` WARNING
To reduce the risk associated with burn or system burst related injuries:
Do not exceed maximum operating pressure or temperature limits.
•
Do not use product for continuous service with compressed gases.
•
Do not use with or expose this product to hot liquids (104 ˚F) or pressurized steam.
•
` CAUTION
To reduce the risk associated with exposure to contaminants:
Always use appropriate personal protective equipment (PPE) when installing, operating or changing the product
•
as per your standard operating procedure.
Ensure that inlet/outlet valves are closed and all system pressure has been relieved prior to opening the system
•
to atmosphere.
A. Configure the system as shown in Figure 3.
B. Install the filter in the housing and wet with clean, ambient temperature, filtered water at
a flow rate of 3 GPM (11 liters/min) per 10" cartridge for 10 minutes or more with a
minimum of 5 psid back pressure.
C. Close inlet V1 and outlet valve V6 to isolate the housing. Drain all the water from the
upstream side of the filter by positioning V5 to direct flow to drain. Adjust the pressure
regulator to deliver 3 – 5 psig of air or nitrogen (DO NOT USE CO2). Slowly open V3.
Close V3 when water discharge is no longer evident.
4
D. Connect a tube from the outlet port V5 to a container of water. PLEASE NOTE: It is
important to make an aseptic connection and to close the outlet port immediately after the
system has been integrity tested to prevent contamination.
E. Open V3. Using the pressure regulator, slowly pressurize the system with air or nitrogen
(DO NOT USE CO2), raising the pressure 5 psi (0.34 bar) per minute. When within 5 psi
(0.34 bar) of the expected bubble point pressure, make only very gradual 1 psi (0.07 bar)
increases allowing 5 - 10 seconds between pressure increases to observe evidence of
bubbling.
F. Observe any air flow from the tube connected to the downstream port. A modest flow of
small bubbles is diffusion flow only. When a continuous flow of large bubbles appears,
the filter’s bubble point has been reached.
G. When the test is complete, compare the measured bubble point value against the
acceptable limit for the filter cartridge under test.
H. After the test is complete, drain the water from the housing and place the cartridge back
in service.
I. If the bubble point is less than the recommended value, consider the following consider
following questions and re-test if necessary:
Was the filter completely wetted out?
Was the correct pore size filter installed?
Was the temperature of the water and filter ambient?
Was the stabilization time adequate?
Was the filter seated correctly in the housing and were the o-rings
undamaged?
LifeASSURE™ PSA
series
Minimum Bubble Point Pressure – psi (bar))
10” cartridge/capsule
5” mini-cartridge/capsule
2.5” mini-cartridge/capsule
PSA010
74
74*
74*
PSA020
38
38
38
*The bubble point pressure test is not recommended for PSA010 grade filters in the capsule format. Please use either the
Forward Flow Integrity Test or the Pressure Hold Test. It is important to make an aseptic connection and to close the outlet
port immediately after the system has been integrity tested to prevent contamination.
Procedure 2. Bubble Point Test (Automated Method - Figure 4)
` WARNING
To reduce the risk associated with burn or system burst related injuries:
Do not exceed maximum operating pressure or temperature limits.
•
Do not use product for continuous service with compressed gases.
•
Do not use with or expose this product to hot liquids (104 ˚F) or pressurized steam.
•
` CAUTION
To reduce the risk associated with exposure to contaminants:
Always use appropriate personal protective equipment (PPE) when installing, operating or changing the product
•
as per your standard operating procedure.
Ensure that inlet/outlet valves are closed and all system pressure has been relieved prior to opening the system
•
to atmosphere.
5
A. Configure the system as
Figure 4 –Bubble Point Test (Automated Method)
shown in Figure 4.
B. Install the filter in the
housing and wet with
clean, ambient
temperature, filtered
water at a flow rate of 3
GPM (11 liters/min) per
10" cartridge for 10
minutes or more with a
minimum of 5 psid back
pressure.
C. Close inlet V1 and outlet
valve V6 to isolate the
housing. Drain all the
water from the upstream side of the filter by positioning V5 to direct flow to drain.
Adjust the pressure regulator to deliver 3 – 5 psig of air or nitrogen (DO NOT USE CO2).
Slowly open V3. Close V3 when water discharge is no longer evident.
D. Disconnect the water supply line and allow the water to drain from the housing. Leave
V5 or V6 open to atmosphere.
E. Close V1 and connect the CUNOCheck™ 2 Automated Integrity Tester at V3 and initiate
the automated bubble point test protocol.
F. When the test is complete, compare the measured bubble point value against the
acceptable limit for the filter cartridge under test.
G. After the test is complete, drain the water from the housing and place the cartridge back
in service.
H. Disconnect the CUNOCheck 2 Automated Integrity Tester from the housing.
PRESSURE HOLD TEST
Definition
A variation of the FFIT is the Pressure Hold Test (PHT). Instead of measuring the diffusion rate
of gas across the membrane, the PHT uses a sensitive pressure gauge to measure the decay of
pressure in a closed volume on the upstream side of the membrane as the gas diffuses. PHT
values are dependent on the volume of the specific filter housing employed, less the volume of
the installed cartridges. Therefore, they must be determined on a case by case basis. Please
contact 3M Purification Technical Service for assistance, if necessary.
The CUNOCheck™ 2 Automated Integrity Tester can be used to perform a pressure hold test.
When using the CUNOCheck 2 tester, follow the installation instructions for connecting the unit
to the upstream valve as shown in Figure 6. Consult the appropriate 3M Purification literature for
the test pressure and PHT value for the filter cartridge to be used and program these values into
the CUNOCheck 2 tester when requested during the test set-up.
6
The following equation can be used to calculate the PHT value:
D=Manufacturer’s maximum allowable diffusion rate for all the installed filters in cc/min (see DFT specifications)
T=Time (typically 5 minutes)
Pa=Atmospheric pressure
Vhsg=Upstream housing volume (cc) less the volume occupied by the cartridge(s)
ΔP=Allowable pressure loss
Procedure 1. Pressure Hold Test (Manual Method– Figure 5)
` WARNING
To reduce the risk associated with burn or system burst related injuries:
Do not exceed maximum operating pressure or temperature limits.
•
Do not use product for continuous service with compressed gases.
•
Do not use with or expose this product to hot liquids (104 ˚F) or pressurized steam.
•
` CAUTION
To reduce the risk associated with exposure to contaminants:
Always use appropriate personal protective equipment (PPE) when installing, operating or changing the product
•
as per your standard operating procedure.
Ensure that inlet/outlet valves are closed and all system pressure has been relieved prior to opening the system
•
to atmosphere.
Figure 5 –Pressure Hold Test (Manual Method)
A. Configure the system as shown in Figure
5.
B. Install the filter in the housing and wet
with clean, ambient temperature, filtered
water at a flow rate of 3 GPM (11
liters/min) per 10" equivalent for ten
minutes or more with a minimum of 5 psid
back pressure.
C. Close inlet V1 and outlet valve V6 to
isolate the housing. Drain all the water
from the upstream side of the filter by
positioning V5 to direct flow to drain.
Adjust the pressure regulator to deliver 3 –
5 psig of air or nitrogen (DO NOT USE
CO2). Slowly open V3. Close V3 when
water discharge is no longer evident.
D. Disconnect the water supply line and allow the water to drain from the housing. Leave
V5 or V6 open to atmosphere.
E. Open V3 and slowly adjust the pressure regulator to pressurize the system to the specified
PHT pressure value and allow the system to equilibrate for a minimum of two minutes.
F. Using a stopwatch, measure the pressure decay for 10 minutes. Calculate the pressure
decay over the 10 minute period in psi/min.
7
G. When the test is complete, compare the result to the cartridge PHT specification.
H. After the test is complete, drain the water from the housing and place the cartridge back
in service.
I. If the pressure decay is higher than the specification, consider following questions and retest if necessary:
• Was the filter completely wetted out?
• Was the correct pore size filter installed?
• Was the temperature of the water and filter ambient?
• Was the stabilization time adequate?
• Was the filter seated correctly in the housing and were the o-rings
undamaged?
Procedure 2. Pressure Hold Test (Automated Method- Figure 6)
` WARNING
To reduce the risk associated with burn or system burst related injuries:
Do not exceed maximum operating pressure or temperature limits.
•
Do not use product for continuous service with compressed gases.
•
Do not use with or expose this product to hot liquids (104 ˚F) or pressurized steam.
•
` CAUTION
To reduce the risk associated with exposure to contaminants:
Always use appropriate personal protective equipment (PPE) when installing, operating or changing the product
•
as per your standard operating procedure.
Ensure that inlet/outlet valves are closed and all system pressure has been relieved prior to opening the system
•
to atmosphere.
A. Configure the system as
Figure 6 –Pressure Hold Test (Automated Method)
shown in Figure 6.
B. Install the filter in the
housing and wet with clean,
ambient temperature,
filtered water at a flow rate
of 3 GPM (11 liters/min)
per 10" cartridge for 10
minutes or more with a
minimum of 5 psid back
pressure.
C. Close inlet V1 and outlet
valve V6 to isolate the
housing. Drain all the
water from the upstream
side of the filter by positioning V5 to direct flow to drain. Adjust the pressure regulator
to deliver 3 – 5 psig of air or nitrogen (DO NOT USE CO2). Slowly open V3. Close V3
when water discharge is no longer evident.
D. Disconnect the water supply line and allow the water to drain from the housing. Leave
V5 or V6 open to atmosphere.
8
E. Close V1 and connect the CUNOCheck™ 2 Automated Integrity Tester at V3 and initiate
the pressure hold test protocol.
F. When the test is complete, compare the measured pressure hold value against the
acceptable limit for the filter cartridge under test.
G. After the test is complete, drain the water from the housing and place the cartridge back
in service.
H. Disconnect the CUNOCheck 2 Automated Integrity Tester from the housing.
9
Important Notice:
The test results described in this literature are accurate to the best of our knowledge. A variety of factors, however, can
affect the performance of the product(s) in a particular application, some of which are uniquely within your knowledge and
control. INFORMATION IS SUPPLIED UPON THE CONDITION THAT THE PERSONS RECEIVING THE SAME WILL
MAKE THEIR OWN DETERMINATION AS TO ITS SUITABILITY FOR THEIR USE. IN NO EVENT WILL 3M BE
PURIFICATION INC. RESPONSIBLE FOR DAMAGES OF ANY NATURE WHATSOEVER RESULTING FROM THE
USE OF OR RELIANCE UPON INFORMATION.
It is your responsibility to determine if additional testing or information is required and if the 3M Purification Inc. product is
fit for a particular purpose and suitable in your specific application.
3M PURIFICATION INC. MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED
INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR OF ANY OTHER NATURE HEREUNDER WITH RESPECT TO INFORMATION OR THE PRODUCT TO
WHICH INFORMATION REFERS.
Limitation of Liability:
3M Purification Inc. will not be liable for any loss or damage arising from the product(s), whether direct, indirect, special,
incidental, or consequential, regardless of the legal theory asserted, including warranty, contract, negligence or strict
liability. Some states and countries do not allow the exclusion of limitation of incidental or consequential damages, so the
above limitation or exclusion may not apply to you.
3M is a trademark of 3M Company.
CUNOCheck and LifeASSURE are trademarks of 3M Company used under license.
© 2010 3M Company. All rights reserved.
70-0201-8836-6
REV1110
10
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