09.3731 USTR2184b Palltronic AquaWIT Flowstar VG EN

Validation Guide USTR 2184b
Palltronic® Flowstar and

AquaWIT Integrity Test Instruments
Contents
1. Introduction, Design Philosophy and Description of the Tests .......................................5

1.1 Introduction ....................................................................................................................5
1.2 The Design and Development Program..........................................................................5
1.2.1 Standards and Guidelines ....................................................................................5
1.2.2 Change Control ....................................................................................................6
1.3 Design Features of the Palltronic Flowstar and AquaWIT Instruments ............................6
1.3.1 Volume Dosing Measurement Method ..................................................................6
1.3.2 Variation between the Standard and High Flow Models ........................................6
1.3.3 Hydraulic Bridge System ......................................................................................7
2. Description of Critical Test Algorithms .............................................................................8
2.1 Self Test Sequence ........................................................................................................8
2.2 The Forward Flow Test ..................................................................................................8
2.2.1 Pressurization........................................................................................................9
2.2.2 Stabilization ..........................................................................................................9
2.2.3 Measurement Phase ............................................................................................9
2.2.4 Fixed Test Time ....................................................................................................9
2.2.5 Auto Test Time Mode............................................................................................9
2.2.6 Venting................................................................................................................11
2.3 The Water Intrusion Test ..............................................................................................11
2.4 The Fully Automated Water Intrusion Test using the Palltronic AquaWIT System..........11
2.4.1 Check on Water Temperature ............................................................................11
2.4.2 Filling of Filter System ........................................................................................11
2.4.3 Hydrostatic Pressure Measurement ....................................................................11
2.4.4 Pressurization, Stabilization and Measurement Phases ......................................12
2.4.5 Draining and Drying ............................................................................................12
2.5 The Bubble Point Test ..................................................................................................12
2.5.1 Pressurization and Stabilization ..........................................................................12
2.5.2 Measurement Phase ..........................................................................................12
2.6 The Flow Check Test....................................................................................................13
3. Accuracy and Reproducibility of Critical Test Functions...............................................13
3.1 Accuracy and Consistency of Set Pressures by the Palltronic Instrument ....................13
3.1.1 Purpose ..............................................................................................................13
3.1.2 Test Method ........................................................................................................13
3.1.3 Results................................................................................................................14
3.1.4 Summary ............................................................................................................14
3.2 Conversion of Pressure Units ......................................................................................15
3.2.1 Purpose ..............................................................................................................15
3.2.2 Test Method ........................................................................................................16
3.2.3 Test Results ........................................................................................................16
3.2.4 Summary ............................................................................................................16
2
3.3 Accuracy and Reproducibility of Forward Flow Measurements ....................................17
3.3.1 Purpose ..............................................................................................................17
3.3.2 Test Method ........................................................................................................17
3.3.3 Results................................................................................................................18
3.3.4 Summary ............................................................................................................18
3.4 Accuracy of Forward Flow Measurements High Flow Range – Applicable to
High Flow Instruments Only ........................................................................................20
3.4.1 Purpose ..............................................................................................................20
3.4.2 Test Method ........................................................................................................20
3.4.3 Results................................................................................................................20
3.4.4 Summary ............................................................................................................21
3.5 Accuracy of Water Intrusion Measurements by the Palltronic Flowstar Instrument ......21
3.5.1 Purpose ..............................................................................................................21
3.5.2 Test Method ........................................................................................................21
3.5.3 Results................................................................................................................22
3.5.4 Summary ............................................................................................................23
3.6 Comparison of ‘Auto’ and ‘Fixed’ Test Times ..............................................................23
3.6.1 Purpose ..............................................................................................................23
3.6.2 Test Method ........................................................................................................23
3.6.3 Results................................................................................................................24
3.6.4 Summary ............................................................................................................24
3.7 Accuracy and Reproducibility of Bubble Point Measurements......................................25
3.7.1 Purpose ..............................................................................................................25
3.7.2 Methods..............................................................................................................25
3.7.3 Results................................................................................................................26
3.7.4 Summary ............................................................................................................26
4. Qualification of the Palltronic AquaWIT System ............................................................28
4.1.Accuracy of Set Pressures by the Palltronic AquaWIT System ....................................28
4.1.1 Purpose ..............................................................................................................28
4.1.2 Test Method ........................................................................................................28
4.1.3 Results................................................................................................................29
4.1.4 Summary ............................................................................................................29
4.2 Reproducibility of Palltronic AquaWIT Water Intrusion Test Flow Measurements ..........30
4.2.1 Purpose ..............................................................................................................30
4.2.2 Test Method ........................................................................................................30
4.2.3 Results................................................................................................................31
4.2.4 Summary ............................................................................................................32
4.3 Influence of the Distance and Height of the Filter System on Flow Measurement
by the Palltronic AquaWIT System ..............................................................................32
4.3.1 Purpose ..............................................................................................................32
4.3.2 Method ..............................................................................................................32
4.3.3 Results................................................................................................................33
4.3.4 Summary ............................................................................................................34
www.pall.com/biopharm 3
5. Steam Trial Report............................................................................................................35
5.1 Purpose ......................................................................................................................35
5.2 Test Method ................................................................................................................35
5.3 Results ........................................................................................................................35
5.4 Summary ....................................................................................................................35
6. Software Validation ..........................................................................................................37
6.1 Qualification of the Palltronic Flowstar XC Instrument ..................................................38
Section 1 – Software Qualification of the Palltronic Flowstar XC Instrument ................38
Section 2 – Functional Qualification of the Palltronic Flowstar XC Instrument ..............39
6.2 Qualification of the Palltronic AquaWIT XC System ......................................................40
Section 1 – Software Qualification of the Palltronic AquaWIT XC System ....................40
Section 2 – Functional Qualification of the Palltronic AquaWIT XC system ..................41
Appendix A - Definitions ......................................................................................................41
1. Good Automated Manufacturing Practice (GAMP) Guidelines ......................................41
GAMP ..........................................................................................................................41
Appendix B - Qualification of the Calibration Procedure...................................................42
1. Purpose ......................................................................................................................42
2. Test Devices and References ......................................................................................42
2.1 Test Devices used for Qualification ......................................................................42
2.2 References used during Qualification ..................................................................42
3. Test Method ................................................................................................................43
3.1 Forward Flow Test ..............................................................................................43
3.2 Water Intrusion Test ............................................................................................43
4. Test Results..................................................................................................................44
4.1 Forward Flow Test ..............................................................................................44
4.2 Water Intrusion Test ............................................................................................47
7. Summary...........................................................................................................................49
8. Document Revision Index................................................................................................49
4
1. Introduction, Design Philosophy and Description of the Tests
1.1 Introduction
This report contains validation data for the Palltronic Flowstar and Palltronic AquaWIT filter
integrity test systems. The report is designed to assist users of the device in meeting the
validation requirements of the various regulatory authorities within the pharmaceutical industry.
The validation program included tests to qualify the following functions:
• Accuracy and consistency of set pressures
• Accuracy and reproducibility of Forward Flow measurements
• Accuracy of Forward Flow measurements in the high flow range (high flow models)
• Accuracy of water intrusion measurements
• ‘Auto’ and ‘Fixed’ test time options
• Accuracy and reproducibility of bubble point measurements
• Accuracy of set pressures by the Palltronic AquaWIT system
• Reproducibility of Palltronic AquaWIT Water Intrusion Test measurements
• Influence of distance and height of the filter system on flow measurement for the
Palltronic AquaWIT system
• Qualification of the calibration procedure
The basic measurement function of the Palltronic AquaWIT system is the same as for the
Palltronic Flowstar instrument. The hydraulic bridge forms an incompressible link between the
filter and the measurement system.
The primary validation has therefore been performed on the Palltronic Flowstar instrument, as
this contains the main measurement function. Additional testing has been performed on the
Palltronic AquaWIT system to show that the hydraulic bridge has no influence on the water
intrusion measurement accuracy and reproducibility. These tests are described in Part 4.
The validation work in this guide was carried out on instruments with the part numbers FFS02,
FFS02H and AW02. However, because the hardware and software control used is the same for
the FFS02, FFS02H, FFS02AM, FFS02HAM, FFSXC, FFSXCH, FFSXCAM, FFSXCHAM,
FFSXCJ, FFSXCHJ, AW02, AW02XC and AW02XCH instruments this validation work is
applicable to all of them.
In addition to this Validation Guide, ask your Pall representative or distributor for the following
documents and services:
• IQ procedures and on-site services
• OQ procedures and on-site services
• PQ services
• On-site calibration and calibration documentation
• 21 CFR part 11 compliance guidance
• Design and Specification Documentation Package prepared to a GAMP format
• On-site operator training
1.2 The Design and Development Program
1.2.1 Standards and Guidelines
The Palltronic Flowstar and AquaWIT instruments have been developed in
accordance with Good Automated Manufacturing Practice (GAMP) guidelines.
The Palltronic Flowstar and AquaWIT devices are manufactured under quality
management systems certified to ISO9001.
]The Palltronic Flowstar and AquaWIT systems are CE marked to indicate compliance
with relevant European Directives.
1.2.2 Change Control

Documented procedures exist for change control for both software and hardware
components. Each Palltronic Flowstar and AquaWIT system is identified by a unique
serial number allowing full manufacturing traceability. Full records are maintained for
each instrument manufactured.
1.3 Design Features of the Palltronic Flowstar and AquaWIT Instruments
1.3.1 Volume Dosing Measurement Method
The Palltronic Flowstar and AquaWIT integrity instruments measure flow on the
upstream side of the filter test assembly using a patented technique. This is based
on measurement of the amount of gas required to maintain a constant test pressure
on the filter.
The measurement principle is one of ‘volume dosing’. The measurement module
consists of high-precision pressure transducers and internal chambers of precisely
defined volume. The system is controlled by purpose-designed software.
Figure 1
Illustration of the Volume Dosing Measurement System inside the Palltronic Flowstar
and AquaWIT Instruments
Volume 1
P1 P2
Filter
Volume 2
One transducer (P1) measures the pressurization of one of the volume chambers.
The other (P2) measures the filter test pressure.
As gas or liquid passes through the test filter, constant pressure is maintained on the
upstream side by discharging the pressurized gas held in one of the volume
chambers. The volume chamber used depends on the flow rate across the filter
membrane. The precise quantity of gas discharged is known and by counting the
number of discharges over time, the precise flow rate is measured.
Volume dosing has been shown to be a reliable, robust and stable flow measurement
method that has been successfully used in Palltronic instruments for over ten years.
1.3.2 Variation between the Standard and High Flow Models

In order to increase the flow measurement range of the Palltronic Flowstar and
AquaWIT instruments a third volume chamber has been incorporated into the high
6
flow models (Pall part numbers FFS02H, FFS02HAM, FFSXCH, FFSXCHAM,
FFSXCHJ, AW02H and AW02XCH). See Figure 2.
Figure 2
Schematic of the Volume Dosing Measurement System inside the Palltronic High Flow
Flowstar and AquaWIT Instruments
Volume 1
P1 P2
Volume 2
Filter
Volume 3
1.3.3 Hydraulic Bridge System

The Palltronic AquaWIT integrity test system is made up of a Palltronic Flowstar
integrity test instrument and a base unit. The base unit enables the Water Intrusion
Test function of the Palltronic Flowstar instrument to be extended to include
automatic filling of the filter housing before the test and draining after the test.
The gas flow measurement does not extend directly to the filter housing as it typically
would when using the Palltronic Flowstar instrument alone, but to the measurement
chamber inside the Palltronic AquaWIT system (see Figure 3).
Figure 3
Schematic of the Palltronic AquaWIT System Test Set-up for a Fully Automated Water
Intrusion Test
Palltronic
Flowstar
Instrument
Measurement Chamber
Filter System
The hydraulic bridge system eliminates all air from the upstream filter system and
tubing. Flow measurement is then performed in a more controlled location within the
Palltronic AquaWIT system. Stable results can be obtained even when the
environmental temperature is changing.
The hydraulic bridge system and automated operation of three external process
valves by the Palltronic AquaWIT system also mean that testing vent filters in
positions with difficult access is simple and quick.
2. Description of Critical Test Algorithms

2.1 Self Test Sequence
The Palltronic Flowstar self-test sequence is automatically performed each time the unit is
switched on. The purpose of these tests is to provide the user with assurance that the
software, electronic, mechanical and pneumatic components are operating correctly. The test is
performed during the 600 second warm-up period, designed to allow the unit to reach thermal
equilibrium before each use.
The following tests are performed during the self-test:
• Check on last calibration date
• Check on last back-up date
• EPROM checksum test
• Internal communication check
• Inlet pressure check
• Check on pressure transducers
• Valve check
• Pressure regulator check
• Internal leak test
• Compact Flash test
2.2 The Forward Flow Test
The Forward Flow test quantitatively measures the diffusive gas flow (typically air or nitrogen)
through all the wetted pores, and the bulk gas flow through larger non-wetted pores, when a
predetermined gas pressure is applied to a wetted filter. The Palltronic Flowstar test system
measures Forward Flow by measuring the gas flow required to maintain constant pressure on
the upstream side of a filter assembly containing a wetted filter. The upstream flow of gas is
converted to a flow at standard temperature and pressure that equates to a downstream flow
measurement.
If the gas flow though the filter membrane is equal to or less than the pass limit input by the
operator then the filter passes the test. If the gas flow exceeds the pass limit then the filter fails
the test.
The Forward Flow test conducted by the Palltronic Flowstar system is performed in four stages
as shown in Figure 4.
8
Figure 4
The Four Stages of the Automated Forward Flow Test
Pressurization Stabilization Testing Venting
Pressure in
(measurement)
measurement
chamber
Time
2.2.1 Pressurization
A zero check is performed immediately prior to pressurization. This check ensures
that the test pressure is accurately set relative to the actual atmospheric pressure in
the environment in which the test is to be performed. Compressed gas is then
directed through the Palltronic Flowstar instrument and into the filter assembly being
tested. When pressure in the filter assembly reaches the assigned test pressure, the
stabilization phase automatically starts.
2.2.2 Stabilization
During the stabilization phase the Palltronic Flowstar system monitors the upstream
pressure and feeds exactly the same amount of compressed gas into the filter
assembly as that leaving the upstream volume across the wetted membrane. During
this phase of the test a bar chart is displayed which shows the upstream pressure
that is continuously being measured. The instrument automatically switches to the
measurement phase of the test when the upstream pressure can be properly
maintained by the system.
2.2.3 Measurement Phase

During the measurement phase of the test, flow through the filter is continuously
measured and monitored. Flow is determined by measuring the exact volume of gas
required to keep a constant pressure on the upstream side of the filter assembly.
Changes in flow are sensed and evaluated. During the measurement phase the
upstream pressure, flow rate and time elapsed are represented in bar charts on the
display. A real time graph showing time elapsed and flow rate can also be displayed
during the measurement phase of the test.
The duration of the test is determined by the test time mode selected by the
operator. The instrument uses either ‘Fixed’ or ‘Auto’ test mode.
2.2.4 Fixed Test Time

When the ‘Fixed’ test time mode is selected the measurement phase lasts for a pre-
determined time entered by the operator. The result reported is the average flow
value determined over the last 150 seconds of the measurement phase.
Figure 5 shows a typical graph of flow versus time during a Forward Flow or Water
Intrusion Test performed under stable environmental conditions. Higher flow rates are
typically observed at the start of the measurement phase. This higher flow is primarily
due to the small temperature increase that takes place as a result of gas
compression at the start of the test. As the system stabilizes, the flow gradually
decreases to a stable and constant rate.
2.2.5 Auto Test Time Mode

When the ‘Auto’ test time mode is selected the Palltronic Flowstar instrument
automatically ends the test when certain criteria have been met. During the
measurement phase the instrument measures the actual flow rate and the rolling
average value over a 150 second interval.
If, at the start of the measurement phase, the measured flow value is under the pass
limit then a 120 second countdown is performed. If at any time the measured value
goes over the pass limit then the timer is reset. After 120 seconds the test will
automatically end and the average result will be reported providing that the flow is
stable and well below the pass limit, as determined using the following criteria:
1. The average value is under 75% of the pass limit
2. The variation coefficient of continuous measurements is within an acceptable range
If these criteria are not met then the test continues for a further 30 seconds and
criterion (1) is increased to 80% of the pass limit. After this time if the ‘Auto’ criteria
have again not been met the test time is extended for a further 30 seconds. After
each additional 30 second interval, criterion (1) is gradually increased until the
average value is 95% of the pass limit.
The algorithms used during the ‘Auto’ test ensure that test times are minimized when
testing stable filter systems that have flow values well below the pass limit (see
Figure 5). For filter systems where the flow rate fluctuates or where the measured
value is close to the pass limit the test times are automatically extended to ensure a
safe and accurate result as shown in Figures 6 and 7.
Figure 5
Representation of ‘Auto’ and ‘Fixed’ Test Times when Testing a Filter Assembly under
Stable Environmental Conditions
Test end point using Test end point using
Auto test mode Fixed test mode
Flow Pass limit
(mL/min)
Time (seconds)
Figure 6
Representation of ‘Auto’ and ‘Fixed’ Test Times when Testing a Filter Assembly under
Initially Fluctuating Environmental Conditions
Flow Pass limit
(mL/min)
Time (seconds)
10
Figure 7
Representation of ‘Auto’ and ‘Fixed’ Test Times when Testing a Filter Assembly with a
Flow Rate Close to the Pass Limit
Flow Pass limit
(mL/min)
Time (seconds)
2.2.6 Venting
On completion of the test the instrument automatically vents the test system in two
phases. The remote vent valve initially vents the compressed gas in the upstream
side of the filter assembly and then the compressed gas in the manifold of the
Palltronic Flowstar instrument is vented through the vent connection on the side of
the unit.
2.3 The Water Intrusion Test
The Water Intrusion Test quantitatively measures the flow of water through a hydrophobic
membrane when a predetermined gas pressure is applied to a water-filled filter assembly.
The Palltronic Flowstar Flowstar instrument determines water flow by measuring the exact flow
of compressed gas on the upstream side required to maintain constant upstream pressure.
This compressed gas flow equates to the water flow through the filter.
The test protocol used for the Water Intrusion Test is identical to that used for the Forward Flow
test. The results are expressed as actual flow on the upstream side of the filter whereas the
Forward Flow reports results that have been converted to a downstream gas flow under
standard temperature and pressure.
2.4 The Fully Automated Water Intrusion Test using the Palltronic AquaWIT System
The Palltronic AquaWIT system can be used to perform a fully automated Water Intrusion
Test on a filter system. In addition to the test protocol described above the following steps
take place.
2.4.1 Check on Water Temperature

The Water Intrusion flow rate across a filter membrane is dependent on water temperature.
A higher water temperature will give higher flow rates. Standard Pall Water Intrusion Test values
are issued for a water temperature between 18 and 22 °C and water temperatures less than
18 °C may cause a false pass result.
The water temperature in the main water tank is checked before the test and displayed on the
screen. If the water temperature is below 18 °C, the option to abort the test is given.
2.4.2 Filling of Filter System

The filter housing and associated tubing is automatically filled with water on the
upstream side of the filter.
2.4.3 Hydrostatic Pressure Measurement

Where the filter is positioned above the Palltronic AquaWIT system, the hydraulic
bridge transmits the hydrostatic pressure to the measurement chamber. Therefore, to
ensure that the test pressure at the filter is correct, the system automatically
measures the hydrostatic pressure and adjusts the pressure in the measurement
chamber to compensate.
(Note: “Hydraulic bridge” refers to the piping or tubing between the measurement
instrument and the filter under test when it and the filter assembly are completely
filled with water. “Hydrostatic pressure” refers to the pressure exerted by the weight
of water in a vertical pipe.)
2.4.4 Pressurization, Stabilization and Measurement Phases

A standard Water Intrusion Test as described in Section 2.3 is then performed.
Instead of measuring water flow in the upstream side of the filter housing, flow is
measured in the measurement chamber of the Palltronic AquaWIT system.
2.4.5 Draining and Drying

On completion of the Water Intrusion Test the Palltronic AquaWIT system drains the
filter housing and blows air across the filter membrane to minimize excess water in
the assembly.
2.5 The Bubble Point Test
A Bubble Point test is performed by incrementally increasing the pressure on the upstream side
of a filter assembly containing a wetted filter. The Bubble Point value is the upstream pressure
at which liquid is forced from the largest pores of the membrane. During a visual Bubble Point
test a tube is connected to the outlet of the filter assembly and the other end is submerged in a
container filled with liquid. The Bubble Point is identified when vigorous bubbling is observed
issuing from the downstream tube.
The Bubble Point test conducted by the Palltronic AquaWIT system is performed in four stages
Figure 8
Four Automated Stages of the Bubble Point Test
Pressurization Stabilization Testing Venting
Leak Test (measurement)
Upstream
pressure
Time
2.5.1 Pressurization and Stabilization
Compressed gas is directed through the Palltronic AquaWIT system and into the filter
assembly being tested until a pressure of 700 mbar (10.2 psig) is reached. The
instrument stabilizes the pressure for
30 seconds and then monitors the upstream pressure for a period of 60 seconds in
order to determine if there are any large leaks in the system.
2.5.2 Measurement Phase

During the measurement phase of the test the pressure in the upstream volume of
the filter system is increased in increments of reducing size until the upstream
pressure is 500 mbar (7.3 psig) below the Bubble Point pressure entered by the
operator. Between each pressure increment the inlet supply pressure is closed and
pressure decay is measured over a short interval. The upstream pressure is then
increased in 50 mbar (0.73 psi) increments and between each step the pressure
decay is measured over a 5 second interval.
The Bubble Point is identified when two sequential pressure decay values are
obtained that are significantly greater than the preceding values. The Bubble Point
value reported is the pressure at which the first of the significantly higher pressure
decay values was obtained.
12
2.6 The Flow Check Test
The Flow Check test uses the Forward Flow test algorithm to measure the flow of gas through
a calibrated capillary (Palltronic Flow Check instrument). The test result is compared to the
expected flow through the capillary and reported as a percentage. The test has been designed
to check that the Palltronic Flowstar instrument is measuring flow correctly.
3. Accuracy and Reproducibility of Critical Test Functions

3.1 Accuracy and Consistency of Set Pressures by the Palltronic Instrument
3.1.1 Purpose
The Palltronic Flowstar instrument measures Forward Flow and water intrusion by
measuring the flow required to maintain constant pressure in the upstream side of
the test assembly. The aim of this series of tests was to qualify the accuracy and
consistency of upstream pressures set by the Palltronic Flowstar instrument during
Forward Flow and Water Intrusion Tests.
3.1.2 Test Method

A calibrated pressure reference device (Druck Limited, part number DPI 601, serial
number 162967/73-03) was installed between the filter assembly under test and the
Palltronic Flowstar instrument (serial number 11011926), as shown in Figure 9.
The calibrated pressure reference device had previously been calibrated to be within
± 0.025 % of the applied pressure.
Figure 9
Diagram of Test Set-up for Measuring Accuracy and Consistency of Set Pressures
Calibrated pressure reference
Palltronic Flowstar
device upstream of
integrity test instrument
filter assembly
Wetted filter
(in housing)
Regulated
compressed Outlet open to
gas supply atmospheric
Upstream pressure
isolated
Forward Flow and Water Intrusion integrity tests were performed using a number of
different filter assemblies in order to cover a range of pressure settings (Table 1).
The integrity tests were performed using a fixed test time of 600 seconds and during
the test phase the pressure displayed on the upstream indicator was measured every
30 seconds.
Table 1
Filters and Test Parameters used for the Tests
Pall Filter Part
and Serial Numbers Type of Test Wetting Liquid Set Air Test Pressure
KA1V002PV1 Forward Flow Isopropanol in water 830 mbar
IA8757268 (60/40 v/v) (12.0 psi)
KA2NLP1 Forward Flow Water 1720 mbar
IB0995007 (24.9 psi)
KA3PFRP1 Water Intrusion Not applicable 2500 mbar
IA3982116 (36.3 psi)
C3DFLP1 Forward Flow Water 2760 mbar
IB70351019 (40.0 psi)
KA2NDP1 Forward Flow Water 3440 mbar
IA9521005 (49.9 psi)
KA3PFRP1 Water Intrusion Not applicable 3500 mbar
IA3982116 (50.8 psi)
C3DV50P1 Forward Flow Water 5875 mbar
PB515100 (85.2 psi)
3.1.3 Results
During each test the upstream pressure was measured using the reference calibrated
pressure reference device at intervals during the test phase. These measured values
were compared with the previously programmed set test pressures. The set
pressures used during the tests ranged from between 830 mbar to 5875 mbar
(12.0 psi to 85.2 psi). The results are shown in Table 3.
The accuracy of the upstream pressures set by the Palltronic Flowstar instrument
was determined by comparing the maximum difference between the measured
values and the set test pressure for each test. The maximum difference observed
between the programmed and measured pressures was found to range from -
1 mbar to +14 mbar (-0.015 psi to +0.203 psi).
The consistency of the upstream pressure during each test was determined by
calculating the difference between the maximum and minimum measured values
during each test. The upstream pressure was always maintained within a range of
2 mbar (0.029 psi) during the test phase.
3.1.4 Summary
Table 2
Summary of Tests
Pressure Control and Accuracy Test pressures set by the Palltronic Flowstar
instrument for Forward Flow and Water Intrusion
Tests were accurate to within 0.72% of the
programmed set pressure.
Consistency of Upstream Pressure Upstream pressures were found to remain stable
within a range of 2 mbar (0.029 psi) during the test
phase of Forward Flow and Water Intrusion Tests.
14
Table 3
Upstream Test Pressures measured using a Reference Device compared to
Programmed Set Pressures
Time in 830 1720 2500 2760 3440 3500 5875
Seconds mbar mbar mbar mbar mbar mbar mbar
(12.0 psi) (24.9 psi) (36.3 psi) (40.0 psi) (49.9 psi) (50.8 psi) (85.2 psi)
30 836 1724 2499 2765 3446 3500 5888
(12.1) (25.0) (36.2) (40.1) (50.3) (50.8) (85.4)
60 836 1723 2499 2766 3446 3499 5888
(12.1) (25.0) (36.2) (40.1) (50.3) (50.8) (85.4)
90 836 1723 2499 2766 3446 3500 5887
(12.1) (25.0) (36.2) (40.1) (50.3) (50.8) (85.4)
120 836 1723 2499 2766 3446 3500 5888
(12.1) (25.0) (36.2) (40.1) (50.3) (50.8) (85.4)
150 836 1723 2499 2765 3446 3500 5888
(12.1) (25.0) (36.2) (40.1) (50.3) (50.8) (85.4)
180 836 1723 2499 2765 3446 3500 5889
(12.1) (25.0) (36.2) (40.1) (50.3) (50.8) (85.4)
210 836 1723 2499 2765 3446 3500 5888
(12.1) (25.0) (36.2) (40.1) (50.3) (50.8) (85.4)
240 836 1722 2499 2765 3446 3499 5888
(12.1) (25.0) (36.2) (40.1) (50.3) (50.8) (85.4)
270 836 1723 2500 2765 3446 3500 5888
(12.1) (25.0) (36.3) (40.1) (50.3) (50.8) (85.4)
300 836 1723 2500 2765 3445 3500 5886
(12.1) (25.0) (36.3) (40.1) (50.3) (50.8) (85.4)
Accuracy of Pressure Control

Maximum Difference between Measured Values and the Set Test Pressure:
mbar +6 +4 -1 +6 +6 -1 +14
(psi) (+0.087) (+0.058) (-0.015) (+0.087) (+0.087) (-0.015) (+0.203)
Maximum Difference as a percentage of Set Test Pressure:
0.72% 0.23% 0.04% 0.21% 0.17% 0.03% 0.24%
Consistency Of Pressure Control

Difference between Maximum and Minimum Measured Values:
0 mbar 2 mbar 1 mbar 1 mbar 1 mbar 1 mbar 2 mbar
(0 psi) (0.029 psi) (0.015 psi) (0.015 psi) (0.015 psi) (0.015 psi) (0.029 psi)
Note: Measurements were made in mbar, conversions to psi are for information only.
3.2 Conversion of Pressure Units
3.2.1 Purpose
The validation and qualification work on the Palltronic Flowstar instrument was
completed using millibar (mbar) as the unit to measure pressure. The aim of this test
is to demonstrate that the Palltronic Flowstar instrument converts pressure units to
psi, kp/cm2 and kPa with accuracy and precision.
3.2.2 Test Method
Forward Flow integrity tests were performed on a wetted integral filter cartridge with
an accurate calibrated pressure reference device (Mano Cali, Keller
Druckmesstecknik, serial number 6584) installed upstream of the filter assembly as
shown in Figure 10.
Tests were performed with the system programmed to show units of pressure in psi,
kp/cm2 and kPa. The upstream pressure on the filter assembly was compared to the
pressure programmed into the Palltronic Flowstar instrument (serial number
05020326) for the Forward Flow test.
Figure 10
Diagram of Test Set-up for Checking Conversion of Pressure Units
Palltronic Flowstar Calibrated pressure reference
integrity test instrument device upstream of
filter assembly
Wetted filter
(in housing)
Regulated Outlet open to

compressed atmosphere
gas supply
Upstream
isolated
3.2.3 Test Results

During each test the upstream pressure was measured using the reference calibrated
pressure reference device during the test phase. These measured values were
compared with the previously programmed set test pressures.
The pressure readings displayed on the upstream calibrated pressure reference
device, were all within ± 0.2% of the expected pressures.
3.2.4 Summary
Table 4
Summary of Tests
Conversion of Pressure Units Test pressures were converted by the Palltronic
Flowstar instrument to an accuracy of 0.2%.
Table 5
Upstream Test Pressures measured using a Reference Device compared to
Programmed Set Pressures in psi, kp/cm2 and kPa
Pressure
Programmed Expected Value Displayed on Deviation Deviation
Test Pressure (mbar) Reference (mbar) (mbar) (%)
40 psi 2757 2761 4 0.14
3 kp/cm2 2941 2947 6 0.20
276 kPa 2760 2763 3 0.11
16
3.3 Accuracy and Reproducibility of Forward Flow Measurements
3.3.1 Purpose
The aim of these tests was to qualify the accuracy and reproducibility of the flow
measurement system of the Palltronic Flowstar instrument using calibrated capillaries.
This method was chosen because capillaries provide highly reproducible flow rates
when a pre-determined gas pressure is applied.
3.3.2 Test Method

Forward Flow tests were conducted using a Palltronic Flowstar integrity instrument
on three different capillary units. In order to ensure stable flow conditions, each
capillary was connected to a fixed volume empty chamber that was connected
immediately upstream of the capillary. The capillary units had previously been
calibrated so they were known to provide an expected and reproducible flow rate
when a pressure of 2000 mbar (29.0 psi) was applied to them.
In order to perform the tests a capillary unit was connected to the outlet of a
Palltronic Flowstar instrument as shown in Figure 11. The Palltronic Flowstar unit was
programmed to perform Forward Flow tests using an air test pressure of 2000 mbar
(29.0 psi) with a fixed test time of 600 seconds.
Repeat measurements were performed on each capillary unit in order to qualify the
reproducibility of Forward Flow measurements. The influence of upstream volume
was also investigated by performing some tests with additional upstream volume
connected to the capillary unit.
Figure 11
Diagram of Test Set-up for Measuring Accuracy and Reproducibility of
Forward Flow measurements
Palltronic Flowstar
Capillary
Empty
Chamber
Regulated
compressed
gas supply
Capillary Tube
For each series of tests the percentage difference between the average measured
flow values and the expected flow was calculated. The coefficient of variation for
repeat measurements was also calculated. The calculations were performed using
the following formulae:
% Difference = ( Average measured value - Expected value

Expected value ) x 100
=( ) x 100
% Coefficient Standard deviation
of variation Average measured value
3.3.3 Results
The Forward Flow values measured through the capillary units using a Palltronic
Flowstar instrument are shown in Table 7. Forward Flow tests were performed on five
capillary units which provided expected flows of 2.50 mL/min, 7.76 mL/min,
50.4 mL/min, 97.5 mL/min and 184.5 mL/min.
Each capillary unit was tested with different volumes between the instrument and the
capillary. Upstream volumes of 60 mL, 260 mL, 2500 mL and 15,000 mL were
tested.
The Forward Flow results reported by the Palltronic Flowstar instrument are widely
independent of upstream volume. When the flow/upstream ratio was less than 0.7
and above 0.001 the value reported by the Palltronic Flowstar instrument differed
from the expected value by between 0.03% and 2%.
The flow to upstream volume ratio for a standard Pall filter system is typically within
the range 0.006 and 0.3.
Test to test variability as determined by the variation coefficient for these
measurements was found to be less than 1%.
3.3.4 Summary
Table 6
Summary of Tests
Accuracy of Forward Flow Measurements Forward Flow measurements obtained using a
Palltronic Flowstar instrument were found to be
accurate to within 2% of expected flow values.
Reproducibility of Forward Flow Test to test variability as determined by the
Measurements coefficient of variation was less than 1%.
Influence of Upstream Volume Accuracy and reproducibility of Forward Flow
measurements as given above were found for a
wide range of upstream volumes. Only if the ratio
between flow and upstream volume is above 0.7
and below 0.002 are the accuracy and the variation
coefficients significantly affected. These data
demonstrate that the Palltronic Flowstar Forward
Flow test is suitable for testing a wide range of filter
assemblies without the requirement to control or
measure upstream volumes.
18
Table 7
Comparison of Forward Flow Values measured by the Palltronic Flowstar Instrument
with Previously Calibrated Values
Upstream Volume: 60 mL
Expected Flow (mL/min) 2.5 7.76 50.4 97.5 184.5
Expected Flow/ 0.04 0.13 0.84 1.63 3.08
Upstream Volume
Measured Flow (mL/min) 2.48 7.88 48.7 * *
2.47 7.82 48.6 * *
2.47 7.85 48.7 * *
Average Measured Flow 2.47 7.85 48.67 – –
(mL/min)
Difference Measured/ -1.20 1.16 -3.43 – –
Expected Flow (%)
Variation Coefficient (%) 0.19 0.32 0.09 – –
Expected Flow/ 0.01 0.02 0.19 0.38 0.71
Upstream volume
Measured Flow (mL/min) 2.49 7.74 49.9 97.7 184.4
2.56 7.79 49.6 97.7 185.0
2.57 7.78 49.8 96.8 185.6
Average Measured Flow 2.54 7.77 49.77 97.40 185.00
(mL/min)
Difference Measured/ 1.60 0.13 -1.25 -0.10 0.27
Expected Flow (%)
Variation Coefficient (%) 1.42 0.28 0.25 0.44 0.27
Expected Flow/ 0.001 0.003 0.02 0.04 0.07
Upstream Volume
2.59 7.96 51.0 98.6 185.3
2.49 7.91 50.6 98.8 185.9
(mL/min)
Difference Measured/ 4.40 1.98 0.66 1.30 0.60
Expected Flow (%)
Expected Flow/ 0.000 0.001 0.003 0.007 0.012
Upstream Volume
3.46 8.38 50.5 96.8 184.1
2.81 9.19 50.9 96.8 185.0
Table 7 Continued
Comparison of Forward Flow Values measured by the Palltronic Flowstar Instrument
with Previously Calibrated Values
(mL/min)
Difference Measured/ 38.40 13.79 0.20 -0.03 0.05
Expected Flow (%)
* ‘Flow Too High’ error message
3.4 Accuracy of Forward Flow Measurements High Flow Range – Applicable to High Flow
Instruments Only
3.4.1 Purpose
The aim of these tests is to qualify the accuracy and reproducibility of the Palltronic
High Flow Flowstar instrument for the extended flow range (200 – 2,000 mL/min).
3.4.2 Test Method

Forward Flow tests were conducted using a Palltronic High Flow Flowstar integrity
instrument (serial number 3699926) as described in Section 3.3. The capillary units
were replaced by a Molbox™ (part number 400433, serial number 1453)/Molbloc™
(part number FAM006, serial number 131) gas flow calibration system
(DH nstruments, Phoenix, AZ, USA) and the flow was controlled by a needle valve
Figure 12
Diagram of Test Set-up for Measuring Accuracy of Forward Flow Measurements in
the High Flow Range
Palltronic High Flow
Flowstar Instrument
Needle
Valve
Molbloc
Variable Calibration
Pressure supply Volume System
The influence of upstream volume was also investigated by performing some tests
with additional upstream volume between the Palltronic High Flow Flowstar
instrument and the needle valve.
The percentage difference between the expected flow value and the measured flow
value was calculated using the following formula:
% Difference = ( Measured value - Expected value

Expected value ) x 100
3.4.3 Results
The Forward Flow values measured using the Palltronic High Flow Flowstar
instrument are shown in Table 9. Forward Flow measurements were performed on
expected flows between 300 mL/min and 2,000 mL/min.
20
The Forward Flow results reported by the Palltronic High Flow Flowstar instrument in
the high flow range were found to be within 3% of the expected flow rates.
3.4.4 Summary
Table 8
Summary of Tests
Accuracy of Forward Flow Forward Flow measurements obtained using a
Measurements (High Flow Range) Palltronic High Flow Flowstar instrument were
found to be accurate to within 3% of expected flow
values for the high flow range.
Influence of Upstream Volume Accuracy of Forward Flow measurements
(High Flow Range) demonstrate that the Palltronic High Flow Flowstar
Forward Flow test is suitable for testing a wide
range of filter assemblies without the requirement
to control or measure upstream volumes.
Table 9
Comparison of Forward Flow Values measured by the Palltronic High Flow Flowstar
Instrument and a Reference Device
Expected flow (mL/min) 302.9 302.1 1157 1159 2097 2123
Measured flow (mL/min) 309.7 309.7 1132 1131 2039 2061
Difference measured/ 2.2 2.5 -2.2 -2.5 -2.8 -3
expected flow (%)
Measured flow (mL/min) 310.4 310 1238 1231 2038 2025
Difference measured/ 1 0.9 -0.3 -0.6 -2.0 -2.6
expected flow (%)
Upstream Volume 20000 mL
Measured flow (mL/min) 313.5 312.9 1019 1016 2095 2087
Difference measured/ 1.8 1.7 0.9 0.7 0 -0.5
expected flow (%)
3.5 Accuracy of Water Intrusion Measurements by the Palltronic Flowstar Instrument
3.5.1 Purpose
The aim of this series of tests was to qualify the accuracy of water intrusion
measurements using a test system that had been designed to produce small water
flows typical of those measured during Water Intrusion Tests through hydrophobic
filter cartridges.
3.5.2 Test Method

The test system was comprised of a vessel partly filled with water with a needle valve
(Swagelok™ part number SS-4MG) fitted to the downstream outlet. The test
assembly was connected to the outlet of a Palltronic Flowstar instrument (serial
number 02010125) as shown in Figure 13.
Figure 13
Diagram of Test Set-up for Measuring Accuracy of Water Intrusion Measurements
Palltronic Flowstar
Air
Water
Needle Valve
Regulated
compressed
gas supply
Balance
The Palltronic Flowstar instrument was programmed to perform Water Intrusion Tests
using an air test pressure of 2500 mbar (36.3 psi) and a fixed test time of 600
seconds. Prior to the start of each test the needle valve was adjusted to provide a
small and stable flow of water.
During the Water Intrusion Tests performed by the Palltronic Flowstar instrument, the
flow of water was simultaneously measured by collecting the water issuing from the
needle valve in a small container placed on a calibrated electronic balance
(Mettler-ToledoTM PG 203S, serial number 1117281654). The balance was linked
to a PC and the data recorded by the balance was recorded automatically every
5 seconds. The weight of water collected over a three-minute interval during the last
four minutes of the test performed by the Palltronic Flowstar instrument was used as
a reference measurement of water flow.
Two series of tests were performed. In the first series of tests the upstream volume of
air in the system was adjusted to 100 ± 15 mL and in the second series of tests the
upstream volume of air was increased to 300 ± 25 mL.
3.5.3 Results
The results are shown in Table 11. The needle valve in the test system was adjusted
so that the Palltronic Flowstar instrument was tested at a number of different water
flow rates ranging from 0.08 mL/min to 1.45 mL/min.
The accuracy of the results obtained using the Palltronic Flowstar instrument was
determined by comparing the results with those obtained using the reference
measurement of water flow. The maximum deviation between the results obtained
with the Palltronic Flowstar instrument and the reference measurement was less than
or equal to ± 0.009 mL/min.
The influence of upstream volume was determined by performing two series of tests,
one series where the upstream volume was approximately 100 mL and another
series where the upstream volume was approximately 300 mL. The accuracy of the
results obtained was not influenced by the change in upstream volume
demonstrating that Water Intrusion Tests performed by the Palltronic Flowstar
instrument are independent of system volumes.
22
3.5.4 Summary
Table 10
Summary of Tests
Accuracy of Water Intrusion Water intrusion measurements obtained using
Measurements a Palltronic Flowstar instrument were demonstrated
to be accurate to within ± 0.009 mL/min compared
to a reference measurement of flow.
Influence of Upstream Volume Water intrusion measurements determined by the
Palltronic Flowstar intrument were demonstrated
to be independent of system volumes. These data
demonstrate that the Palltronic Flowstar Water
Intrusion Test is suitable for testing a wide range of
filter assemblies without the requirement to control
or measure upstream volumes.
Table 11
Comparison of Water Intrusion Values measured by the Palltronic Flowstar Instrument
with a Reference Water Flow Measurement
Upstream Gas Volume 100 ± 15 mL Upstream Gas Volume 300 ± 25 mL
A-Palltronic A-Palltronic
Flowstar B-Reference Deviation Flowstar B-Reference
Results Measurement (B-A) Results Measurement Deviation
(mL/min) (mL/min) (mL/min) (mL/min) (B-A)
1.45 1.441 -0.009 1.34 1.342 +0.002
0.96 0.964 -0.004 0.95 0.956 +0.006
0.94 0.945 +0.005 0.72 0.729 +0.009
0.56 0.564 +0.004 0.71 0.715 +0.005
0.47 0.466 -0.004 0.59 0.599 +0.009
0.40 0.395 -0.005 0.38 0.378 -0.002
0.26 0.264 +0.004 0.36 0.364 +0.004
0.21 0.211 +0.001 0.29 0.298 +0.008
0.11 0.112 +0.002 0.08 0.078 -0.002
3.6 Comparison of ‘Auto’ and ‘Fixed’ Test Times
3.6.1 Purpose
The Palltronic Flowstar instrument has ‘Auto’ and ‘Fixed’ test time options for
Forward Flow and Water Intrusion Tests. For the ‘Fixed’ test mode, the measurement
phase of the test lasts for the programmed test time input by the operator. In the
‘Auto’ test mode, the measurement phase automatically ends when the measured
flow characteristics satisfy the internal algorithms for determining stable flow.
The purpose of this series of tests was to compare Forward Flow and Water Intrusion
results when ‘Auto’ and ‘Fixed’ test times were used.
3.6.2 Test Method

Appropriate Novasip™ and Kleenpak™ filter assemblies were selected for performing
Forward Flow and Water Intrusion Tests (part number C3DFLP1 and KA3PFRP1
respectively). The Forward Flow and Water Intrusion Tests were performed using a
Palltronic Flowstar instrument (serial number 04012126) according to the normal
recommended procedures. The filter assemblies were protected from temperature
changes in the surrounding environment during the tests in order to ensure stable
flow conditions.
Repeat integrity tests were performed using the ‘Fixed’ and ‘Auto’ test modes.
During the tests performed with the fixed test time, a test time of 600 seconds was
used. Further tests were then performed using the ‘Auto’ test mode where the
entered pass limit for the test was reduced so that it was closer to the measured
flow. In each of the tests performed the stabilization and test times were measured
using an electronic timer. On completion of the tests, the graphical display on the
Palltronic Flowstar unit was observed to check if the flow rate was stable over the
last 90 seconds of the test.
3.6.3 Results
The stabilization, test times and reported flow results are shown in Table 13.
During the tests with the ‘Fixed’ test times the overall test times ranged between
780 to 795 seconds for the Forward Flow tests, and 814 to 886 seconds for the
Water Intrusion Tests. In all of these tests the graphical display of the results on the
Palltronic Flowstar instrument indicated that the flow rate had been stable and
constant over the last 150 seconds of the tests.
Under the same test conditions, when the ‘Auto’ test mode was used, the overall
test times were significantly reduced, down to 369 to 383 seconds for the Forward
Flow tests and 428 to 495 seconds for the Water Intrusion tests. During these tests
the ‘Auto’ test mode allowed almost a 50% reduction in the overall test times.
In all of these tests a ‘pass’ result was obtained because the measured flow rates
were well below the entered pass limit. During the tests performed with the ‘Auto’
test mode the reported flow rates were slightly higher than the results obtained with
the ‘Fixed’ test time because in these tests the flow had not completely stabilized to
a constant value.
In order to determine the safety of the ‘Auto’ test mode when the measured flow was
close to the entered pass limit, tests were performed where the flow pass limit was
lowered so that it was just above the results reported during the earlier tests. During
these tests the overall test times were extended to between 434 to 463 seconds for
the Forward Flow tests and 498 to 522 seconds for the Water Intrusion results.
As the measured flows were closer to the pass limit the tests lasted longer before the
‘Auto’ test time criteria were satisfied. Again all of the results were passes and the
reported flow rates were again slightly higher than the results obtained during the
original ‘Fixed’ test time tests as the flow rates had not completely stabilized to a
constant value.
3.6.4 Summary
Table 12
Summary of Tests
Use of ‘Auto’ Test Time Mode Use of the ‘Auto’ test time mode reduced overall
Forward Flow and Water Intrusion Test times by
almost 50% compared to standard test times using
the ‘Fixed’ test time mode.
Safety of the ‘Auto’ Test Mode During tests performed where the measured flow
value was close to the pass limit, the test times
automatically extended to ensure that safe results
were obtained.
24
Table 13
Comparison of ‘Auto’ and ‘Fixed’ Test Times measured by the Palltronic
Flowstar Instrument
Forward Flow Tests
Part number of filter used: C3DFLP1, air test pressure 2760 mbar (40.0 psi), wetting liquid water
Maximum Test Stabilization Test Total Test
Flow Value Time Time Time Time Result
Entered Mode (Seconds) (Seconds) (Seconds) (mL/min)
3.4 mL/min Fixed 180 600 780 2.04
195 600 795 2.12
181 600 781 2.08
3.4 mL/min Auto 203 179 382 2.30
178 191 369 2.14
184 199 383 2.19
2.4 mL/min Auto 113 350 463 2.12
194 240 434 2.11
130 327 457 2.13
Water Intrusion Tests
Part number of filter used: KA3PFRP1, air test pressure 2500 mbar (36.3 psi)
Maximum Test Stabilization Test Total Test
Flow Value Time Time Time Time Result
Entered Mode (Seconds) (Seconds) (Seconds) (mL/min)
0.1 mL/min Fixed 260 600 860 0.04
214 600 814 0.04
286 600 886 0.05
0.1 mL/min Auto 359 136 495 0.05
341 120 461 0.06
294 134 428 0.05
0.07 mL/min Auto 346 169 515 0.06
339 183 522 0.06
338 160 498 0.06
3.7 Accuracy and Reproducibility of Bubble Point Measurements
3.7.1 Purpose
The aim of this series of tests was to demonstrate that the Bubble Point values
determined by the Palltronic Flowstar instrument are comparable to the Bubble Point
observed visually downstream at the same time as the automatic test is performed.
Repeated measurements were also taken in order to qualify the reproducibility of the
Palltronic Flowstar Bubble Point test.
3.7.2 Methods
Bubble Point measurements were performed using a Palltronic Flowstar instrument
(serial number 04012126) on three filter assemblies, including a 47 mm membrane
disc and a high area pleated filter cartridge (part numbers FTKNFZ, KA2NLP1 and
KA4DFLP1).
A length of clear plastic tubing was connected to the downstream side of the filter
assembly and inserted into a beaker containing water. A calibrated pressure
reference device (Druck Limited, part number DPI601, serial number 162967/73-03)
was also installed on the upstream side of the filter assembly, as shown in Figure 14.
As the automatic test was performed, the pressure at which a steady stream of
bubbles was observed coming out of the tubing was recorded using the external
calibrated pressure reference device. This pressure was compared to the Bubble
Point value reported by the Palltronic Flowstar instrument.
Figure 14
Diagram of Test Set-up for Performing Bubble Point Tests
Palltronic Flowstar Calibrated pressure reference
integrity test instrument device upstream of
filter assembly
Water-filled downstream
beaker for observation
of visual bubble point
Regulated
compressed
gas supply
Upstream
isolated
3.7.3 Results
The results showing a comparison of the results obtained with the Palltronic Flowstar
instrument with the visual observations of the Bubble Point values are shown in
Tables 15 to 17.
The automated and visual Bubble Point determinations were found to be highly
comparable. A total of thirty bubble point tests were performed and the deviations
observed between the automated and visual tests ranged from 0 to 86 mbar
(1.2 psi).
The Bubble Point tests performed by the Palltronic Flowstar instrument were found
to be extremely reproducible. The test to test variability, as determined by the
coefficient of variation, was found to be 0.67, 1.03 and 1.62 in the three series of
tests performed.
3.7.4 Summary
Table 14
Summary of Tests
Comparison of Bubble Point Results with Palltronic Flowstar Bubble Point tests were
Visual Observations of Bubble Point comparable to visual observations of Bubble Point
for three different test filter systems, the maximum
deviation between the two types of measurement
was 86 mbar (1.2 psi).
Bubble Point Reproducibility The Bubble Point results reported by the Palltronic
Flowstar instrument were found to be highly
reproducible, the coefficient of variation was less
than 1.7 in the three series of tests performed.
26
Table 15
Comparison of Bubble Point Values measured by the Palltronic Flowstar Instrument
with a Visual Determination of Bubble Point (Filter Part Number FTKNFZ)
A - Bubble Point Values
reported by Palltronic B - Visual Observation of
Flowstar Instrument Bubble Point Deviation (B-A)
(mbar) (psi) (mbar) (psi) (mbar) (psi)
3450 50.0 3505 50.8 55 0.8
3500 50.8 3530 51.2 30 0.4
3500 50.8 3570 51.8 70 1.0
3500 50.8 3570 51.8 70 1.0
3500 50.8 3580 51.9 80 1.1
3500 50.8 3580 51.9 80 1.1
3500 50.8 3530 51.2 30 0.4
3500 50.8 3580 51.9 80 1.1
3500 50.8 3586 52.0 86 1.2
3550 51.5 3580 51.9 30 0.4
For repeat Palltronic Flowstar instrument Bubble Point values: % Coefficient of variation = 0.67
Table 16
with a Visual Determination of Bubble Point (Filter Part Number KA2NLP1,
Serial Number IB0996007)
2300 33.4 2360 34.2 60 0.8
2300 33.4 2340 34.0 40 0.6
2300 33.4 2358 34.2 58 0.8
2350 34.1 2380 34.5 30 0.4
2350 34.1 2380 34.5 30 0.4
2350 34.1 2390 34.7 40 0.6
2350 34.1 2390 34.7 40 0.6
2350 34.1 2410 34.9 60 0.8
2350 34.1 2400 34.8 50 0.7
2350 34.1 2400 34.8 50 0.7
Table 17
with a Visual Determination of Bubble Point (Filter Part Number KA4DFLP1,
Serial Number IA9106016)
3300 47.9 3350 48.6 50 0.7
3350 48.6 3375 48.9 25 0.3
3350 48.6 3380 49.0 30 0.4
3400 49.3 3450 50.0 50 0.7
3400 49.3 3400 49.3 0 0
3400 49.3 3450 50.0 50 0.7
3400 49.3 3400 49.3 0 0
3400 49.3 3450 50.0 50 0.7
3450 50.0 3480 50.5 30 0.5
3500 50.8 3440 49.9 -60 -0.9
4. Qualification of the Palltronic AquaWIT System

The basic measurement function of the Palltronic AquaWIT system is the same as for the Palltronic
Flowstar instrument. The hydraulic bridge forms an incompressible link between the filter and the
measurement system.
The primary validation has therefore been performed on the Palltronic Flowstar instrument, as this
contains the main measurement function. Additional testing has been performed on the Palltronic
AquaWIT system to show that the hydraulic bridge has no influence on the water intrusion
measurement accuracy and reproducibility. These tests are described in following section.
4.1. Accuracy of Set Pressures by the Palltronic AquaWIT System
4.1.1 Purpose
The Palltronic AquaWIT system fills the filter system with water on the upstream side
of the filter. If the filter system is at a different height to the measurement chamber
there will be a hydrostatic pressure on the measurement chamber. This is measured
by the Palltronic AquaWIT system which automatically adjusts the pressure in the
measurement chamber to ensure that the pressure on the filter is the test pressure.
The aim of this series of tests was to qualify the accuracy and consistency of
upstream pressures set by the Palltronic AquaWIT system at the filter assembly.
4.1.2 Test Method

A calibrated pressure reference device (Mano Cali, Keller Druckmesstechnik, serial
number 6583) was installed at the filter assembly.
Water Intrusion Tests were performed using a Palltronic AquaWIT system (serial
number 01010028 / 08060226) with the filter assembly at 50 cm (1.6 feet), 150 cm
(4.9 feet) and 250 cm (8.2 feet) above the measurement chamber. The integrity tests
were performed using a fixed test time of 600 seconds and repeated 3 times for
each filter height.
28
Figure 15
Diagram of Test Set-up for Measuring Accuracy of Filter Test Pressures Set by the
Palltronic AquaWIT System
Palltronic
Flowstar
Instrument
V13
V1
V2 V3 Reference
Manometer
A
V4
V5 FILTER
C
B
V6
V8
V7
V9
4.1.3 Results
During each test the upstream pressure was measured using the calibrated pressure
reference device. The measured values were compared with the previously
programmed set test pressure of 2500 mbar (36.3 psi). The difference observed
between the programmed and measured pressures was found to range from
23 mbar to -32 mbar (0.33 psi to -0.46 psi).
4.1.4 Summary
Table 18
Summary of Tests
Pressure Control and Accuracy Test pressures set by the Palltronic AquaWIT
system for Water Intrusion Tests were accurate to
within 1.28% of the programmed set pressure for
filter heights between 50 cm (1.6 feet) and 250 cm
(8.2 feet).
Table 19
Influence of Height of the Filter System on the Test Pressure
Height: 50 cm (1.6 feet)
Test Pressure Set Test Pressure Actual Deviation Deviation (%)
2500 mbar (36.3 psi) 2519 mbar (36.5 psi) 19 mbar (0.2 psi) 0.76
Table 19 Continued
Influence of Height of the Filter System on the Test Pressure
Height 150 cm (4.9 feet)
2500 mbar (36.3 psi) 2486 mbar (36.1 psi) -14 mbar (-0.2 psi) -0.56
Height 250 cm (8.2 feet)
It is possible to test filters which are more than 250 cm (8.2 feet) above the test
system. For these installations we recommend an installation specific performance
qualification. Contact your local Pall office or distributor for more information.
4.2 Reproducibility of Palltronic AquaWIT Water Intrusion Test Flow Measurements
4.2.1 Purpose
The aim of this series of tests was to show the reproducibility of the Water Intrusion
Test measurements made using the Palltronic AquaWIT system.
4.2.2 Test Method

Water Intrusion Tests were performed using a Palltronic AquaWIT system (serial
number 01010028/08060226). In order to remove the influence of the filter on the
test result measurement, no filter was connected to the test system. Connections A
and B were directly connected with pneumatic tubing. A calibrated capillary
(Palltronic Flow Check instrument FC01) was connected between the test instrument
and the test system to simulate a flow across a filter. This method was chosen
because capillaries provide highly reproducible flow rates when a pre-determined gas
pressure is applied. The Palltronic Flow Check instrument had previously been
calibrated so it was known to provide an expected and reproducible flow rate when a
pressure of 2000 mbar (29.0 psi) was applied to it.
30
Figure 16
Diagram of Test Set-up for Measuring Reproducibility of Water Intrusion Test
Measurements with the Palltronic AquaWIT System
Palltronic
Flowstar
Instrument
FC01
V13
V1
V2 V3
V4
V5
C
B
V6
V8
V7
V9
The test was set up as shown in Figure 16 and the Water Intrusion Test program was
started from the Palltronic AquaWIT menu of the test instrument.
Six tests were carried out during which the tubing between connections A and B was
filled with water and the measurement automatically carried out. After the
measurement was completed the system was emptied following the Palltronic
AquaWIT Water Intrusion Test protocol.
4.2.3 Results
The Water Intrusion values measured using the Palltronic AquaWIT system are shown
in Table 21.
The maximum deviation of the measurement from the average flow value was
± 0.005 mL/min. The results show high reproducibility of flow measurement.
4.2.4 Summary
Table 20
Summary of Tests
Reproducibility of Water Intrusion The maximum deviation of the measurement
measurements by the Palltronic AquaWIT from the average flow values was system
± 0.005 mL/min. The results show high
reproducibility of flow measurement.
Table 21
Reproducibility of Flow Measurement of the Palltronic AquaWIT System
Test Instrument Flow Measurement (mL/min) Deviation from Average Value (mL/min)
0.84 +0.005
0.84 +0.005
0.83 -0.005
0.83 -0.005
0.83 -0.005
0.84 +0.005
The average value of the measurement was 0.835 mL/min
4.3 Influence of the Distance and Height of the Filter System on Flow Measurement by the
Palltronic AquaWIT System
4.3.1 Purpose
The aim of these tests was to show filter height and distance from the Palltronic
AquaWIT system have no influence on the Water Intrusion Test measurement.
4.3.2 Method
The test set-up is shown inFigure 17.
32
Figure 17
Diagram of Test Set-up to show Height and Distance of Palltronic AquaWIT System
from the Filter have no influence on Flow Measurement
Palltronic
Flowstar
Instrument
V13
V1
V2 V3
A
V4
V5 FILTER
C
B
V6
V8
V7
V9
A Pall Emflon® PFR filter, part number AB1PFR7PVH4, serial number IE4280174,
was connected to the Palltronic AquaWIT system (serial number 01010028/
08060226) as shown in Figure 17. The filter was tested at distances of 2 m (6.6 feet),
5 m (16.4 feet) and 10 m (32.8 feet) from the Palltronic AquaWIT system. A final
measurement with the filter at 2.5 m (8.2 feet) above the test instrument and a
distance of 10 m (32.8 feet) was also made.
The filter was tested 3 times at each distance using the standard automated Water
Intrusion Test function in the Palltronic AquaWIT Main Menu screen.
The reference value for the flow across the filter was defined as the average value
with 2 m (6.6 feet) of tubing.
4.3.3 Results
The reference value for the measurement at 2 m (6.6 feet) distance between the
Palltronic AquaWIT unit and the filter system was found to be 0.163 mL/min as
shown in Table 23.
The results from each test were compared to the reference value. These results are
shown in Tables 24 and 25.
It is possible to test filters which are more than 2.5m (8.2 feet) above the test system
or greater than 10 m (32.8 feet) distance. For these installations we recommend an
installation specific performance qualification. Contact your local Pall office or
distributor for more information.
4.3.4 Summary
Table 22
Summary of Tests
Influence of filter height and distance on Water Intrusion measurements were all within
Water Intrusion measurements by the ±0.013 mL/min of the reference value.
These Palltronic AquaWIT system results show that
heights up to 2.5 m (8.2 feet) and a distance of
10 m (32.8 feet) between the filter system and the
Palltronic AquaWIT unit has no significant effect on
the flow measured by the Palltronic AquaWIT
instrument.
Table 23
Test Results for the Reference Value (2 m [6.6 feet] Distance between Test System
and Filter)
Tubing Length 2 m (6.6 feet)
Test Result (mL/min) Reference (Average) Value (mL/min)
0.16 –
0.17 –
0.16 –
– 0.163
Table 24
Measurement at 5 m (16.4 feet) and 10 m (32.8 feet) distance between Test System
and Filter
Test Result (mL/min) Deviation from Reference (mL/min)
0.17 +0.007
0.16 -0.003
0.15 -0.013

0.17 +0.007
0.17 +0.007
0.16 -0.003
Table 25
Qualification of the Palltronic AquaWIT Test System with a Tubing Length of 10 m
(32.8 feet) and a Height Difference of 2.5 m (8.2 feet)
Tubing Length 10 m (32.8 feet) and 2.5 m (8.2 feet) Height Difference
0.16 -0.003
0.15 -0.013
0.15 -0.013
34
5. Steam Trial Report
5.1 Purpose
The Palltronic AquaWIT system includes the capability to sanitize the water contact parts of the
pipework with steam. During the steam phase the temperature in the main water tank is
elevated to 121 °C for a period of twenty minutes. The purpose of the thermal mapping
was to determine the efficiency of the steam phase by determining the steam distribution
and temperature.
5.2 Test Method
Thermocouples were placed in the Palltronic AquaWIT system (serial number 01010028/
08060226) at points indicated in Figure 18. Once the Palltronic AquaWIT system steam phase
was started, data from the thermocouples was recorded using a Kaye Validator® 2000 system
Serial Number: 0011027. The temperature data was displayed using line Temperature/Time
charts with which the results of steam efficiency and distribution were analyzed. A full length
(20 minute) test was performed to analyze the system’s performance.
The steam supply pressure was set to 1.3 barg (18.9 psi). The Kaye Datalogger took
temperature readings at 30 second intervals.
5.3 Results
During the test (T > 121 °C timer set to 1200 seconds) the steam stability was monitored by
the Palltronic AquaWIT internal temperature sensor. The temperature reading showing the
temperature was maintained between 121 °C and 122 °C.
The warm up period of the steam phase was short, lasting only two to three minutes before the
steam timer commenced its count down. All thermocouple test points heated at a similar rate,
aside from the steam inlet point, which reached temperature before the others. During the
steaming phase, all test points located in the system reached 121 °C. This included the filling
tank B1, the chamber B2, the measurement chamber B3 and all water wetted pipework.
Once at temperature the steam was stable, fluctuating by a maximum of 1 °C . The results of
the steam trials show the unit is suitable for the steaming process.
5.4 Summary
Table 26
Summary of Tests
Palltronic AquaWIT system steam trial The Palltronic AquaWIT system is suitable for steaming.
Figure 18
Diagram of Test Set-up for Performing Steaming Trial
OUT
Palltronic Flowstar IN
Instrument VENT
AIR IN D
FF OUT
Control Box V10
V11
V12
V8
V16
TP1
V13
V1
B3 L1
TP3 0.4 ltr
TP2 P1 TP4 A
V2 V3
V4 V14
V
B2 TP5
0.3 ltr
V5
TP6
C
14 ltr
L2 STEAM
TP8 B
B1
T1 TP7 14.5 ltr 3 ltr V6
L3
TP10 E
V9 TP9 V7
36
Figure 19
Temperature/Time 20 Minute Test
47 47
45 45
43 43
41 41
39 39
37 37
35 35
33 33
31 31
29 29
27 27
Time in Minutes
Time in Minutes
25 25
23 23
21 21
19 19
17 17
15 15
13 13
11 11
9 9
7 7
5 5
3 3
1 1
126 125 124 123 122 121 120 50 40 30

Temperature Deg C Temperature Deg C
TP1 TP4 TP7 TP10

TP2 TP5 TP8
TP3 TP6 TP9
6. Software Validation
In addition to the tests described in this report and which validate the measurement functions of the
Palltronic Flowstar XC and AquaWIT XC systems, the other functions of the Palltronic Flowstar XC and
AquaWIT XC systems were tested to complete the software validation. The tests performed are listed
below. These tests are performed for each software version prior to release.
6.1 Qualification of the Palltronic Flowstar XC Instrument
Section 1 – Software Qualification of the Palltronic Flowstar XC Instrument
1 Data entry, handling and printing
1.1 Manual entry
1.1.1 Check on correspondence between the data entered and the data printed on
the output (FF test option)
the output (WIT option)
the output (BP test option)
the output (FF + BP test option)
the output (FC test option)
the output when reprinting stored test results
1.2 Usage of pre-configured test data (Test Programs)
1.2.1 Check on correspondence between the data entered in the test program
function and the data printed on the output (FF test option)
function and the data printed on the output (WIT option)
function and the data printed on the output (BP test option)
function and the data printed on the output (FF + BP test option)
1.3 Check on password function
1.3.1 Password challenge on System and Test Program functions
1.3.2 Password change
1.4 Check on time and date change
1.4.1 Time and date change
1.5 Check on ‘User Rights’ function
1.5.1 Check on the correct function of the user management
1.5.2 Check on the change of name for User 1
1.5.3 Check on the possibility to create two users with the same user name
1.5.4 Check if the usage of the same PIN for two users is not allowed
1.5.5 Check on the PIN/Password change function
1.5.6 Check on the correct function of the access control
1.5.7 Check if Level 2 access is required to create/edit test Programs
1.5.8 Check on the correct printout using the Electronic signature function
1.5.9 Check if notes entered in the notes field of the signature screen are printed
and stored
38
1.6 Check on Differential of Electronically Signed and Unsigned Records
1.6.1 Check if the device differentiates between signed and unsigned test programs
1.6.2 Check if the device differentiates between signed and unsigned test result
1.6.3 Check if the device stores a test result as unsigned if the signature is not
performed in the correct way
1.7 Check on Password Management features
1.7.1 Check on the password ageing function
1.7.2 Check on the password length feature
1.7.3 Check on user lock out after entering repeatedly wrong passwords
1.7.4 Check on System lock out after entering repeatedly wrong PINs
1.8 Check on Self Test Sequence with ‘User Rights’ on
1.8.1 Check on self test function with ‘User Rights’ on
1.9 Check on Audit Trail Planning
1.9.1 Check on printing the system audit trail
1.9.2 Check on printing the test program audit trail
1.9.3 Check on printing the user audit trail
Section 2 – Functional Qualification of the Palltronic Flowstar XC Instrument

2 Functional Qualification
2.1 General System
2.1.1 Verification of serial number and software version
2.1.2 Check on “line pressure too low” error message
2.1.3 Check on “cancel self test” message
2.1.4 Verification of correct operation of Palltronic Flowstar XC self test
2.2 Test Pressure Setting
2.2.1 Check on set test pressures (FF test option)
2.2.2 Check on set test pressures (WIT option)
2.2.3 Check on set test pressures (FC test option)
2.2.4 Check on correct conversion to other units (psi, kg/cm2, kPa)
2.2.5 Check on correct usage of a test program defined in a different pressure unit
than the system configuration
2.2.6 Power off test
2.3 Forward Flow
2.3.1 Check “within limits” and “outside limits” analysis is accurate
2.3.2 Check on “flow too low” error message
2.3.3 Check on “flow too high” error message
2.3.4 Check on “flow measurement unstable” error message
2.3.5 Check on “manual abort” message
2.3.6 Check on Auto test time function
2.4 Water Intrusion
2.4.1 Check “within limits” and “outside limits” analysis is accurate
2.4.5 Check on “manual abort” message
2.4.6 Check on Auto test time function
2.5 Bubble Point
2.5.1 Check that the “within limits” and “outside limits” analysis of results is accurate
2.5.2 Check on function of the leak test
2.5.3 Check on manual abort function
2.6 Forward Flow and Bubble Point
2.6.1 Check on automatic operation of FF + BP function
2.7 Flow Check
2.7.1 Check on the correct operation of the Flow Check function
6.2 Qualification of the Palltronic AquaWIT XC System
Section 1 – Software Qualification of the Palltronic AquaWIT XC System
1 Data entry, handling and printing
1.1 Manual Entry
the output (WIT option)
the output (Parameter entry
1.2 Use of pre-configured test data (Test Programs)
1.2.1 Check on correspondence between the data entered in the test programme
function and the data printed on output (WIT option)
1.3 Check on correct data transfer using the Transfer Program
1.3.1 Password challenge using the transfer program
1.3.2 Check on the correct transfer of test programs from the Palltronic AquaWIT XC
system to a PC
1.3.3 Check on the correct transfer of test programs from a PC to the Palltronic
AquaWIT XC system
1.4 Check on password function
1.4.1 Password challenge on Parameter Input, Test Program and Service functions
1.5 Check on “User Rights” feature
1.5.1 Check on “User Rights” function
1.5.2 Check on the correct level access of the “User Rights” feature
40
Section 2 – Functional Qualification of the Palltronic AquaWIT XC system
2 Functional Qualification
2.1 General system
2.1.1 Verification of serial number
2.1.2 Verification of correct software version installed
2.2 Test pressure setting
2.2.1 Check on set test pressures including correction for hydrostatic pressure
(WIT option)
2.2.2 Power off test
2.2.3 Check on correct conversion to other units (PSI, kg/cm2, kPa)
2.3 Water Intrusion Test
2.3.1 Check that the “within limits” and “outside limits” analysis is correct
2.3.6 Check on temperature warning
2.3.7 Check on correct function of sensor L1
2.3.8 Check on valve sequence for the external valves (V10, V11, V12)
2.4 Water discard function
2.4.1 Check on water discard function
2.5 Steaming
2.5.1 Check on operation of the steaming function
2.5.2 Check on correct detection of low temperature during steaming
2.5.3 Check on systems reaction to insufficient steam supply
2.6 Cleaning and rinsing
2.6.1 Check on cleaning and rinsing step functions
2.7 Drying of the system
2.7.1 Check on drying function
2.8 Filter cooling
2.8.1 Check on filter cooling function
Installation and Operational qualification protocols are available from Pall.
Appendix A - Definitions
1. Good Automated Manufacturing Practice (GAMP) Guidelines
GAMP
The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated
Systems is the most widely used, internationally accepted guideline for validation of computer
systems. The GAMP guide is produced by International Society for Pharmaceutical Engineering
(ISPE) and the GAMP forum. More information on GAMP and copies of the guide can be found
at www.ISPE.org.
The GAMP guide recommends that comprehensive documentation is produced during
development of a computer system. Various documentation packages are available from Pall
including the following documents:
• Functional Specification
• Hardware Design Specification
• Software Design Specification
• Hardware Acceptance Test Specification
• System Acceptance Test Specification
• Installation and Operational Qualification protocols
Appendix B - Qualification of the Calibration Procedure

1. Purpose
The current calibration method of the Palltronic Flowstar instruments is based on the
technical requirements and, beside the calibration of the pressure transducers, includes the
calibration against flow references in the range of 5 – 10 mL/min and 30 – 60 mL/min.
The calibration points are selected based on the technical requirements of the measuring
principles of the device.
The calibration of test devices is, especially at the low flow end, difficult due to limited sources
for transfer standards for the complete flow range.
The aim of the investigation is to demonstrate that this calibration method of the Palltronic
Flowstar instrument is valid for the complete flow range of the device.
2. Test Devices and References
2.1 Test Devices used for Qualification
Table 27
Devices used for Qualification
Test Device Serial Number Calibration Date
Palltronic Flowstar FFS02 08030526 26th April 2001
Palltronic Flowstar FFS02 20059626 8th June 2001
Palltronic Flowstar FFS02H 05020326 20th September 2001
2.2 References used during Qualification
References for the Gas Flow Measurements (Forward Flow Test)

The gas flow of the capillaries used was estimated with a Molbox/Molbloc
reference system
Table 28
Instruments used for Qualification
Instrument Type Serial Number
Molbox RFM-M 169
Molbloc 1E1-VCR-V-Q 2126
Molbloc 2E2-VCR-V-Q 1817
Reference Instrument for the Water Flow Measurements (WIT)
42
Table 28 Continued
Instruments used for Qualification
Instrument Type Serial Number
Mettler Balance PG 203 S 1117281654
3. Test Method
All tests were performed at room temperature (19 °C – 23 °C)
3.1 Forward Flow Test

The Forward Flow tests were conducted at six capillaries with different flow values
using three Palltronic Flowstar integrity instruments which had been calibrated on the
dates shown.
The flow values of the capillary units at 2000 mbar (29.0 psi) differential pressure
were estimated using a Molbox™ (Type Molbox™ RFM-M, serial number
169)/Molbloc™ (Type 1E1-VCR-V-Q, serial number 2196 and type 2E2-VCR-V-Q,
Serial number 1817) gas flow calibration system (DH Instruments, Phoenix, AZ, USA).
In order to perform the tests a capillary unit was connected to the outlet of a
Palltronic Flowstar instrument as shown in Figure 20. The Palltronic Flowstar
instrument was programmed to perform Forward Flow tests using an air pressure of
2000 mbar (29.0 psi) with a fixed test time of 600 seconds.
Figure 20
Diagram of Test Set-up for the Forward Flow Measurements
Palltronic Flowstar
Capillary
Empty
Chamber
Regulated
compressed
gas supply
Capillary Tube

Water Intrusion tests were conducted at six different expected flow values using three
Palltronic Flowstar integrity instruments which had been calibrated on the dates
shown.
The test system was comprised of a vessel partly filled with water with a needle valve
(Swagelok™ part number SS-4MG) fitted to the downstream outlet. The test
assembly was connected to the outlet of a Palltronic Flowstar instrument as shown in
Figure 21.
Figure 21
Diagram of Test Set-up for the Water Intrusion Measurements
Palltronic Flowstar
Air
Water
Needle Valve
Regulated
compressed
gas supply
Balance
The Palltronic Flowstar instrument was programmed to perform Water Intrusion Tests
using an air test pressure of 2500 mbar (36.3 psi) and a fixed test time of 600
seconds. Prior to the start of each test the needle valve was adjusted to provide a
small and stable flow of water.
During the Water Intrusion tests performed by the Palltronic Flowstar instrument, the
flow of water was simultaneously measured by collecting the water issuing from the
needle valve in a small container placed on a calibrated electronic balance (Mettler™
PG 203S, serial number 1117281654). The balance was linked to a PC and the data
recorded by the balance was recorded automatically every 5 seconds. From these
data the weight increase per minute (= water flow in mL/min) was calculated. The
weight increase over a three-minute interval at the end of the test performed by the
Palltronic Flowstar instrument was used as a reference measurement of water flow.
4. Test Results
4.1 Forward Flow Test
The Forward Flow values measured using three Palltronic Flowstar instruments are
shown in Figures 22 to 24. Forward Flow tests were performed on capillaries
between 1.26 mL/min and 184.5 mL/min at 2000 mbar (29.0 psi). The allowed
deviation was ± 3% as acceptance criteria.
44
Figure 22
Comparison of Forward Flow Values measured by the Palltronic Flowstar Instruments
with Reference Values (Test Device 1)
200
180
160
Measured Flow (mL/min)

140
120
100
80
60
40
20
0
0 50 100 150 200
Expected Flow (mL/min)
Table 29
Test Device 1
Serial Number: 08030526
Calibration Date: 26th April 2001
Test Date: 14th December 2001
Expected Flow Measured Flow
(mL/min) (mL/min) Deviation (mL/min) Deviation (%)
1.26 1.27 0.01 0.8
2.5 2.47 -0.03 -1.2
7.76 7.85 0.09 1.2
50.4 49.8 -0.6 -1.2
97.5 96.7 -0.8 -0.8
184.5 180.6 -3.9 -2.1
Figure 23
200
180
160
140
120
100
80
60
40
20
0
0 50 100 150 200
Table 30
Test Device 2
Calibration Date: 8th June 2001
1.26 1.27 0.01 0.8
2.5 2.46 -0.04 -1.6
7.76 7.80 0.04 0.5
50.4 51.2 0.8 1.6
97.5 99.1 1.6 1.7
184.5 186.7 2.2 1.2
Figure 24
200
180
160
140
120
100
80
60
40
20
0
0 50 100 150 200
Table 31
Test Device 3
Calibration Date: 20th September 2001
1.26 1.24 -0.02 -1.6
2.5 2.47 -0.03 -1.3
7.76 7.81 0.05 0.6
50.4 50.6 0.2 0.4
97.5 98.9 1.4 1.4
184.5 186.6 2.1 1.1
The acceptance criteria were achieved.
46
The Water Intrusion values measured using three Palltronic Flowstar instruments are
shown in Figures 25 to 26. Water Intrusion Tests were performed in the flow range
0.04 mL/min to 1.06 mL/min. the allowed deviation was ±0.02 mL/min as
acceptance criteria.
Figure 25
with Reference Water Flow Measurement (Test Device 1)
1.2
1.0
0.8
0.6
0.4
0.2
0.0
0 0.2 0.4 0.6 0.8 1.0 1.2
Table 32
Test Device 1
Calibration Date: 20th September 2001
Test Date: 7th February 2002
Expected Flow (mL/min) Measured Flow (mL/min) Deviation (mL/min)
0.05 0.06 0.01
0.08 0.08 0
0.13 0.14 0.01
0.33 0.34 0.01
0.53 0.54 0.01
0.72 0.73 0.01
1.01 1.01 0
Figure 26
1.2
1.0

0.8
0.6
0.4
0.2
0.0
0 0.2 0.4 0.6 0.8 1.0 1.2
Table 33
Test Device 2
Calibration Date: 26th April 2001
0.03 0.04 0.01
0.11 0.12 0.01
0.40 0.40 0
0.70 0.72 0.02
1.04 1.06 0.02
Figure 27
1.2
1.0
0.8
0.6
0.4
0.2
0.0
0 0.2 0.4 0.6 0.8 1.0 1.2
48
Table 34
Test Device 3
Calibration Date: 8th June 2001
0.05 0.05 0
0.12 0.12 0
0.41 0.42 0.01
0.67 0.69 0.02
1.00 1.01 0.01
The acceptance criteria were achieved.
7. Summary
Table 35
Summary of Tests
Validity of the calibration method for the flow The standard calibration method is valid for the complete flow range
range of the Palltronic Flowstar instrument and especially for the low flow range (< 1 mL/min) which cannot be
included in standard calibration procedures.
8. Document Revision Index

Issue Date Item Change Page
b 13 August 2009 All Formula typographical error amended – now divided 18/20
by expected flow
The Average Measured Flow value has been rounded 19/20
to two decimal points
Millibar to psi conversion in Table 19 amended – 30
affecting ‘Test pressure actual’ (247 mbar at 8.2 ft)
Visit us on the Web at www.pall.com/biopharm

E-mail us at [email protected]
United States
International Offices
800.717.7255 toll free (USA) Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria,
516.484.5400 phone Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico,
516.801.9548 fax the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major
[email protected] E-mail industrial areas of the world.
Europe The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be
subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.
+41 (0)26 350 53 00 phone
+41 (0)26 350 53 53 fax
© 2010, Pall Corporation. Pall, , Palltronic, Novasip, Emflon and Kleenpak are trademarks of Pall
[email protected] E-mail Corporation. ® indicates a trademark registered in the USA. Filtration. Separation. Solution.SM is a service
u
mark of Pall Corporation. Swagelok is a trademark of Swagelok Company. Mettler-Toledo is a registered
trademark of Mettler-Toledo Ltd. Validator is a registered trademark of Kaye Inc. Molbloc and Molbox are
trademarks of DH Industries Inc. GAMP is a trademark of ISPE.
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Validation Guide USTR 2184b

Palltronic® Flowstar and

1. Introduction, Design Philosophy and Description of the Tests .......................................5

1.2.2 Change Control

1.3.2 Variation between the Standard and High Flow Models

1.3.3 Hydraulic Bridge System

2. Description of Critical Test Algorithms

2.2.3 Measurement Phase

2.2.4 Fixed Test Time

2.2.5 Auto Test Time Mode

2.4.1 Check on Water Temperature

2.4.2 Filling of Filter System

2.4.3 Hydrostatic Pressure Measurement

2.4.4 Pressurization, Stabilization and Measurement Phases

2.4.5 Draining and Drying

2.5.2 Measurement Phase

3. Accuracy and Reproducibility of Critical Test Functions

3.1.2 Test Method

Accuracy of Pressure Control

Consistency Of Pressure Control

Regulated Outlet open to

3.2.3 Test Results

3.3.2 Test Method

% Difference = ( Average measured value - Expected value

3.4.2 Test Method

% Difference = ( Measured value - Expected value

3.5.2 Test Method

3.6.2 Test Method

4. Qualification of the Palltronic AquaWIT System

4.1.2 Test Method

4.2.2 Test Method

Tubing Length 10 m (32.8 feet)

126 125 124 123 122 121 120 50 40 30

TP1 TP4 TP7 TP10

Section 2 – Functional Qualification of the Palltronic Flowstar XC Instrument

Appendix B - Qualification of the Calibration Procedure

2.2 References used during Qualification

References for the Gas Flow Measurements (Forward Flow Test)

Reference Instrument for the Water Flow Measurements (WIT)

3.1 Forward Flow Test

3.2 Water Intrusion Test

Measured Flow (mL/min)

Measured Flow (mL/min)

8. Document Revision Index

Visit us on the Web at www.pall.com/biopharm

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