USD 2145a

Palltronic

AquaWIT XC System
Automated integrity test system for sterile
gas and vent filters
1
2
Introduction ... The Palltronic AquaWIT XC system offers
major benefits for integrity testing of hydrophobic gas filters. All stages
of the Water Intrusion test can now be performed fully automatically
on gas filters - and on line. The operator simply connects the
Palltronic AquaWIT XC unit to the filter
system, inputs test parameters on
the easy to use touchscreen and starts the
test sequence . The fil l ing , testing ,
draining and drying are performed without
further operator involvement and a detailed
test result is saved and printed.
With Pal l

direct fl ow measurement technol ogy

and a hydraul ic bridge l ink to the test fil ter, accurate
and reproducible results are ensured even during changes in
environmental temperature. The new XC version provides enhanced
memory and 21CFR Part 11 features.
It is expected that there be some program for integrity testing this (vent) filter to assure
that it is intact. There are methods for integrity testing of vent filters in-place.
FDA Guidance Document on High Purity Water Systems for Pharmaceutical Use 1996
The integrity of critical gas and air vent filters should be confirmed after use
European GMP
Water Breakthrough
The Water Intrusion Test
3
Pharmaceutical regulatory bodies now require
that cri ti cal gas fi l ters are i ntegri ty tested
regularly, preferably in-situ. The Water Intrusion
test is non-destructive and can be performed
on a dry hydrophobic filter. Unlike the Forward
Flow or "Bubble Point" type tests there is no
need to wet with alcohol. The Water Intrusion test
is suitable for a wide range of Pall filters including
Emflon

PFR and CPFR filters.

To perform the test, the upstream side of the
f i l ter assembl y i s f i l l ed wi th water and a
pre-determined gas pressure is applied. The
resulting water flow through the membrane is
measured directly on the upstream side.
The Palltronic AquaWIT XC device performs
all parts of the Water Intrusion test, including
filling and draining of the filter system, fully
automatically. The mobile system can easily
be moved from site to site, enabling automatic
testing to be performed in-place, conveniently and
cost effectively on many filter installations, both
large and small.
Direct Flow Measurement
The Palltronic AquaWIT XC unit measures water
flow during the Water Intrusion test using the
direct flow method. The benefits of using direct
flow measurement include:
G Very high measurement accuracy
G Upstream volume measurement and flow
calculations are eliminated, reducing
potential measurement errors and
simplifying validation
G Real time measurement and graphical
display
G Test times can be up to 50% shorter than
pressure decay devices
For further information on the basis of the Water Intrusion test see "Studies on
the Theoretical Basis of the Water Intrusion Test (WIT)," R Jaenchen,
J Schubert, S Jafari and A West, European Journal of Parenteral Science 1997,
volume 2, No. 2, pages 39 - 45.
Evaporative Flow
Pressurized Water
Integral Filter
Defective Filter
Pressurized Water
4
Accurate and reliable
In validation studies flow was measured at
different environmental temperatures using a
small filter with a typical water intrusion fiow rate
of 0.04 mL/mi n to represent worst case
conditions. Even under conditions where the
environmental temperature of the filter was 20C
(36F) higher than water temperature, an accurate
test result was obtained.
Validation work has also shown that accurate
measurements can be performed using filter
installations at a distance of at least 10m (33 ft)
and a height of 2.5 m (8.2 ft) or more. Pall can
assist in qualifying the Palltronic AquaWIT XC
device for increased distances.
Hydraulic Bridge
The hydraulic bridge removes all air from the
upstream f i l ter system and tubi ng. Fl ow
measurement is then performed in a more
controlled environment within the Palltronic
AquaWIT XC unit. Stable results can be obtained
even when environmental temperatures are
changing by 10C (18F) or more. Direct flow
and real time measurement further adds to the
accuracy, speed and reliability of the test result.
A Versatile System
The Palltronic AquaWIT XC unit has been
designed to test vent filters in positions with
difficult access where environmental temp-
eratures may be fluctuating. The hydraulic bridge
permi ts the Water I ntrusi on test to be
performed on:
G Filters in elevated positions, for example,
product storage and WFI tanks
G Filters which are inside equipment, for
example lyophilizers or sterilizers which
are difficult to access
G Several different filter installations testing
from a fixed point
Making Water
Intrusion Testing Easier
W
a
t
e
r

i
n
t
r
u
s
i
o
n

f
l
o
w

r
a
t
e

m
L
/
m
i
n
Environmental Temperature C
0.14
0.12
0.1
0.08
0.06
0.04
0.02
0
20C
Water intrusion limit value
30C 40C
Direct Flow Measurement using a Hydraulic Bridge
Sterilizer vent Lyophilizer vent
WFI or product
tank vent
Variable environmental temperature
Palltronic AquaWIT XC System
Palltronic direct flow
measurement system
Measurement
chamber
Air space
Water tank
Air space
replaced
by water
Hydraulic bridge

Water temperature 18
O
C
Filling machine
Water Intrusion Testing from a fixed point
WIT result
5
Purpose designed
for the Production Environment
Overview
The Palltronic AquaWIT XC integrity test device
is based on Pall's experience with integrity test
equipment and automated systems over more
than 20 years. The Palltronic AquaWIT XC
system is contained within a stainless steel cabinet
and includes a detachable Palltronic Flowstar
XC unit. External surfaces are easy to clean and
ideal for clean room application. The unit is robust
and splash-proof to IP54 standard. The system
is CE marked.
Touch Screen for Easy Operation
Modern touch screen technology eliminates the
need for a separate keyboard and means that
commands can be entered simply with the touch
of a finger. The large screen clearly displays test
data and results both graphically and numerically.
Adjustable contrast means that the display can
be optimized to suit process conditions and user
preferences.
Remote Operation
An RS232C interface allows the Palltronic
AquaWIT XC unit to be integrated into a process
control system. See Pall publication USD2133 for
more information.
Integration into Automated Processes
Addi ti onal pneumati c ports are f i tted as
standard and can be used to operate process
valves in the filter installation.
Pall offers a complete service for integration
of the Palltronic AquaWIT XC unit into automated
processes.
6
CIP and SIP functions
The si mpl e to use cl ean-i n-pl ace and steam-
in-place features help to ensure system cleanliness,
control of bi oburden and preventi on of cross-
contamination in the liquid wetted parts of the system.
A steam condensate manifold collects condensate and
minimizes discharge of steam from the instrument.
Used test water can either be returned to the reservoir
or drained to waste.
Detachable Palltronic Flowstar XC Function
The Palltronic Flowstar XC unit can be removed from
the Palltronic AquaWIT XC cabinet and used as a
stand-alone instrument. Standard Forward Flow and
Bubble Point type tests can be performed, making
thePalltronicAquaWITXC instrument extremelyversatile.
Precision control and engineering
In addition to the hydraulic bridge, the following
features ensure that a reliable result is always obtained:
G A temperature sensor in the water tank
measures the water temperature to ensure
testing within a validated range
G An internal pressure sensor automatically
compensates for hydrostatic pressure on
the measurement chamber
G High level sensor in the water tank for
automatic filling
G Low level sensor in the water tank gives a
warning when the tank is empty
G Temperature sensor in the water tank
monitors the temperature during steaming
Fully Mobile
The wheel mounted unit is equipped with a handrail
ensuring maximum mobility.
7
The progress of all test results can be viewed
as bar charts and line graphs. This provides
useful information during validation and routine
production testing.
Up to 10,000 test results can be stored in
the memory of the Palltronic AquaWIT XC
instrument. Test results can also be transferred to
a computer via an Ethernet port for secure archiving
and records retention.
Test results including line graphs are automati-
cally printed on the internal printer which is silent
and fast. In addition, the printer casing has been
designed to protect the printer and make it
suitable for clean room environments. The
112 mm (4.4") width paper provides a clear and
detailed printout that is both permanent
and waterproof.
A new notes field allows operators to input
additional information to all electronic records.
Electronic Records and Signatures
The regulatory requirements for the handling of
electronic records and signatures are well defined
by the FDA in Code of Federal Regulations 21
Part 11. To support users of Palltronic AquaWIT
XC test equipment, the software includes a user
ID and password system whi ch has been
developed around the requirements of 21 CFR
Part 11 and contains the following features:
G System access limited to authorized
individuals
G Three levels of access: System
Administrator, Supervisor and Operator
G Electronic signing of all electronic records
G Date and time stamped audit trail of all
electronic records including: test results,
test programs, user IDs and system
settings
G Electronic records of test results cannot be
altered
G Users are forced to change their password
at a time interval set by the system
administrator
Testing WFI Vent Filters
The Palltronic AquaWIT XC device is part of the
Pall system for WFI tank vent filters. See Pall
publication USD2121 for further information.
Comprehensive Documentation
and 21CFR Part 11 Features
Schematic drawing of the
Palltronic

AquaWIT XC integrity test device

8
Palltronic Flowstar
integrity test device
Filter
element
and housing
V2
V5
V7
V6
L1
C
V
A
D
P
V13
V3
V4
V9
E
F
B
V8
T
V1
V10
V11
V12
AIR IN
VENT
TEST
AIR IN
FF/BP TEST
V10
V11
V12
V80
V16
Palltronic Flowstar XC
Instrument
Control Box
Level sensor
Measurement
Chamber
Drain test water to waste
valve
Water tank fill
Water tank drain
}
Additional pneumatic ports
Vent
Hydraulic bridge link
Hydraulic bridge link
L1
T
P
Temperature sensor
Pressure sensor
L2
L3
Water Tank
9
Calibration
The Palltronic AquaWIT XC test device has
been designed for assurance of instrument
cal i brati on and conti nuous, troubl e
f ree operati on. An i nter nal f i l ter ensures
contaminant-free air. Units can be calibrated on
or off-site by an experienced Pall technician,
and we recommend calibration annually with a
full preventative service every 3 years.
Our i nter nati onal servi ci ng centers are
purpose desi gned and ful l y equi pped for
calibration and repair. All flow and pressure
measurement equi pment i s regul arl y
re-calibrated against international standards. Full
traceabi l i ty and documentati on i s
mai ntai ned, consi stent wi th the hi ghest
standards in the pharmaceutical industry.
Documentation
The Palltronic AquaWIT XC system is supplied
with comprehensive documentation including:
G Calibration certificate
G System drawings
G Full component list
G CE certificates
G Instruction manual
G Factory acceptance test results
G EN10204.3.1b certification for all wetted
stainless steel parts
Calibration
Validation, Documentation
and Training
10
Validation
The Palltronic AquaWIT XC software has been
devel oped i n accordance wi th current
Good Automated Manufacturing Practice (GAMP)
guidelines.
Support documentation available for purchase
include:
G GAMP documentation
G A generic Operational Qualification (OQ1)
and system specific IQ and OQ2
documents
G IQ/OQ documentation can be customized
to your requirements
A detailed validation guide is available and GAMP
documentation can be audited at Pall sites.
Pall Validation Services can provide on-site or
off-site IQ/OQ testing and assist with Performance
Qualification protocols.
Training Services
Full training on all aspects of operation is
avai l abl e f rom our trai ni ng speci al i sts.
Customized programs can be provided, ranging
from semi nars on the basi c pri nci pl es of
the i ntegri ty test to advanced operator
training. Certificates are issued to all attendees
for inclusion into personal training records.
11
Technical Specifications
Product
Part Number AW02XC (Standard)
AW02XCH (High Flow)
Physical Dimensions
Weight empty 100 kg (220 lb)
Height, Width, Depth 1100 mm, 580 mm, 840 mm
(43 in, 22 in, 33 in)
Water tank volume 14 Liters (3.7 US gallons)
Filter Tests
Water Intrusion Test (fully-automatic)
Forward Flow Test (semi-automatic)
Bubble Point Test (semi-automatic)
Combined FF / BP Test (semi-automatic)
Function Tests
Self Test
Flow Check Test
Valve Check
Other Functions
Clean-in-place
Steam-in-place
Level sensors for automatic filling and draining of
filter system
Pressure sensor to measure hydrostatic pressure
Temperature measurement of water or steam in tank
Adjustable filter system filling and draining pressures
Adjustable filter and Palltronic AquaWIT XC system
drying pressures and times
Air Clean
Test result storage - up to 10,000 tests
Test programs - up to 500 test programs
Up to 250 active user IDs
Standard Languages
English
French
German
Italian
Spanish
US English
Japanese
Units
psi
mbar
kPa
kp/cm
2
Communication Ports
COM1 RS232C for external printer or
PC Ethernet Port
Measuring Range
Water Intrusion Test 0.05 - 50 mL/min water
Forward Flow Test
Standard 0.1 - 200 mL/min
High Flow 0.1 - 2,000 mL/min
Bubble Point Test 700 - 6000 mbar (10 - 87 psi)
Water Intrusion Test 0.05 - 50 mL/min
Resolution
Water Intrusion Test 0.01 mL/min
Forward Flow Test
Measured Flow >10 mL/min: 0.1 mL/min
Measured Flow <10 mL/min: 0.01 mL/min
Bubble Point Test 50 mbar (0.72 psi)
Calibration Limits
Flow measurement +/- 3% of measurement
Pressure measurement +/- 0.33% of full scale
Accuracy
Forward Flow test +/- 3% or +/- 0.05 mL/min,
whichever is the greater
Water Intrusion test +/- 3% or +/- 0.02 mL/min,
whichever is the greater
Electrical Data
Mains Voltage 90 - 230 Volts
Mains Frequency 50 - 60 Hz
Power 200 W
Interface 1 x RS232C, serial,
asynchronous, DB9 auxiliary
External Vent Valve 24 V
12
Electrical Safety
CE Marked
Maximum Steam Temperature 125C (257F)
Design Specifications
AD Merkblatter
Pneumatic Specifications
Maximum gas supply pressure 8 bar (116 psi)
Minimum gas supply pressure for automatic WIT test 5600 mbar (82 psi)
Test pressure range 20 - 6000 mbar (0.3 - 87 psi)
Connections
Compressed air inlet
'Stubli' nipple RBE03.6150
Compressed air outlet
Stubli coupling RBE03.2904
Water line to fill filter 1" 'Tri-Clamp'
Water line to fill tank 1" Tri-Clamp
Water drain (bottom level) 1" Tri-Clamp
Environmental Conditions
Splash proof IP54
Operating Temperature +5C to +40C (+41F to +104F)
Storage Temperature -20C to +70C (-4F to +158F)
Humidity 95% rh (no condensation)
Touch Screen Specifications
Size 238 mm (9.4 inch) 640 x 480 pixel
Features black & white, illuminated background,
adjustable contrast
Materials
Stainless Steel - product wet DIN 1.4404*
Stainless Steel - frame DIN 1.4301**
Seals EPDM
*DIN 1.4404 element composition limits are comparable to 316L.
** DIN 1.4301 element composition limits are comparable to 304.
2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.625.3610 fax
pharmafilter@pall.com e-mail
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com e-mail
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hong Kong,
India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands,
New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
Copyright 2003, Pall Europe Ltd. , Pall, Palltronic and Emflon are trade marks of Pall Corporation.
Stubli is a trademark of Stubli International AG. Tri-Clamp is a trademark of Alfa Laval Inc.
Filtration, Separation, Solution is a service mark of Pall Corporation.
indicates a Pall trademark registered in the USA.
PELEH/01-ZP.SH/CS/8.2003
Visit us on the web at www.pall.com/biopharmaceutical