USD 2145a

Palltronic AquaWIT XC SystemAutomated integrity test system for sterile gas and vent filters

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2Introduction ... 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 filling , testing ,

draining and drying are performed without

further operator involvement and a detailed

test result is saved and printed.

With Pall direct flow measurement technology

and a hydraulic bridge link to the test filter, 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 assurethat 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 useEuropean GMP

Water Breakthrough

The Water Intrusion Test

3

Pharmaceutical regulatory bodies now require

that critical gas filters are integrity 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 assembly is f i l led with 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:

Very high measurement accuracy

Upstream volume measurement and flow

calculations are eliminated, reducing

potential measurement errors and

simplifying validation

Real time measurement and graphical

display

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 onthe 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

4Accurate 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/min 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 10 m (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 fi l ter system and tubing. Flow

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

permits the Water Intrusion test to be

performed on:

Filters in elevated positions, for example,

product storage and WFI tanks

Filters which are inside equipment, for

example lyophilizers or sterilizers which

are difficult to access

Several different filter installations testing

from a fixed point

Making Water Intrusion Testing Easier

Wat

er in

trus

ion

flow

rat

e m

L/m

in

Environmental Temperature C

0.14

0.12

0.1

0.08

0.06

0.04

0.02

020C

Water intrusion limit value

30C 40C

Direct Flow Measurement using a Hydraulic Bridge

Sterilizer vent Lyophilizer vent

WFI or producttank 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 18OC

Filling machine

Water Intrusion Testing from a fixed point

WIT result

5Purpose 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

Addit ional pneumatic ports are f itted 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.

6CIP and SIP functions

The simple to use clean-in-place and steam-

in-place features help to ensure system cleanliness,

control of bioburden and prevention 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 instrumentextremelyversatile.

Precision control and engineering

In addition to the hydraulic bridge, the following

features ensure that a reliable result is always obtained:

A temperature sensor in the water tank

measures the water temperature to ensure

testing within a validated range

An internal pressure sensor automatically

compensates for hydrostatic pressure on

the measurement chamber

High level sensor in the water tank for

automatic filling

Low level sensor in the water tank gives a

warning when the tank is empty

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.

7The 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 which has been

developed around the requirements of 21 CFR

Part 11 and contains the following features:

System access limited to authorized

individuals

Three levels of access: System

Administrator, Supervisor and Operator

Electronic signing of all electronic records

Date and time stamped audit trail of all

electronic records including: test results,

test programs, user IDs and system

settings

Electronic records of test results cannot be

altered

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 Documentationand 21CFR Part 11 Features

Schematic drawing of the Palltronic AquaWIT XC integrity test device

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Palltronic Flowstarintegrity test device

Filter element

and housingV2

V5

V7

V6

L1

C

V

A

D

P

V13

V3

V4

V9E

F

B

V8T

V1

V10

V11

V12

AIR INVENT

TEST

AIR INFF/BP TEST

V10V11V12V80V16

Palltronic Flowstar XCInstrument

Control Box

Level sensor

MeasurementChamber

Drain test water to wastevalve

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

9Calibration

The Palltronic AquaWIT XC test device has

been designed for assurance of instrument

cal ibrat ion and continuous, trouble

free operation. An internal 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 international servicing centers are

purpose designed and fully equipped for

calibration and repair. All flow and pressure

measurement equipment is regularly

re-calibrated against international standards. Full

traceabi l i ty and documentation is

maintained, consistent with the highest

standards in the pharmaceutical industry.

Documentation

The Palltronic AquaWIT XC system is supplied

with comprehensive documentation including:

Calibration certificate

System drawings

Full component list

CE certificates

Instruction manual

Factory acceptance test results

EN10204.3.1b certification for all wetted

stainless steel parts

Calibration

Validation, Documentation and Training

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Validation

The Palltronic AquaWIT XC software has been

developed in accordance with current

Good Automated Manufacturing Practice (GAMP)

guidelines.

Support documentation available for purchase

include:

GAMP documentation

A generic Operational Qualification (OQ1)

and system specific IQ and OQ2

documents

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 lable from our training special ists.

Customized programs can be provided, ranging

from seminars on the basic principles of

the integrity test to advanced operator

training. Certificates are issued to all attendees

for inclusion into personal training records.

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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/cm2

Communication Ports

COM1 RS232C for external printer or PC Ethernet Port

Measuring Range

Water Intrusion Test 0.05 - 50 mL/min water

Forward Flow TestStandard 0.1 - 200 mL/minHigh 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 TestMeasured Flow >10 mL/min: 0.1 mL/minMeasured Flow

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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 BoulevardEast 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 StreetPortsmouth 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