Data

Data Sheet
Sheet

Integritest® 4 Series
Automated Filter Integrity Test Instruments and
Central Instrument Management Tool Software
Easy-to-use, portable, networkable*,
and fully-automated integrity
test systems that offer reliable,
repeatable measurements fast
The Integritest 4 instrument is an easy-to-use,
portable, fully-automated integrity test system.
Available in either a standalone or networkable
configuration, the Integritest 4 instrument offers
reliable and repeatable integrity test data. The intuitive
touch screen user interface streamlines the test while
the accelerated testing capability provides users with
more time for processing. On-site calibration support
and diagnostic capability minimizes downtime, saving
time and money. Leveraging a proven test algorithm,
the Integritest 4 instrument performs bubble point,
diffusion, enhanced bubble point, and HydroCorrSM
(Millipore water-based test for hydrophobic filters)
tests on a wide range of filters including disks,
cartridges and TFF filters, virus, and asymmetric
Key Benefits:
membrane filters.
o Portable, easy to use The rugged, ergonomic design of the system
o Reliable, accurate measurements enables users to easily carry the Integritest 4
o Fast testing improves productivity instrument to any site. The standalone configuration
enables users to print the results on the onboard
o Network model is 21 CFR Part 11 printer.
compliance ready The Integritest 4N networkable configuration
o Centralized administration with enables users to print results directly to any
networked printer via Ethernet connection.
IMT software
The Integritest 4N instrument is 21 CFR Part 11
o Available in multiple languages compliance ready for electronic records and electronic
signatures, improving productivity and facilitating
record keeping.
*Integritest 4N only.
Easy to Use
The Integritest 4 instrument features a graphical
user interface with touch-screen menus and intuitive
icons for faster testing, enabling more effective use
of production equipment and resources. Millipore and
customer specific filter testing information can be easily
entered on-site. Test results can be printed using the
built-in printer. Printed test results can be customized
to include operator, batch, or other desired data.
• Intuitive, multilingual graphical user interface
• 10-inch touch-screen color SVGA display
with active matrix
• Pivoting base for easy adjustment of display angle
• Bar code input for easy filter identification
and data entry*
• Utilizes market-leading Windows XP®
embedded operating system
• Customized interface based on operational roles
Sound Algorithm
• Context-based online help
The Integritest 4 instrument uses a software algorithm
to determine the bubble point of a filter. The accuracy
of this algorithm is key to proving that your filter is
Accurate, Reliable Results integral. Our algorithm is based on a mathematically
The instrument has been designed and qualified
proven tangent method. Unlike other solutions on the
to achieve high test accuracy. To ensure correct
market today, it extrapolates the accurate portion of a
performance, the software automatically checks the
flow curve while avoiding dependencies on the volatile
functionality of the computer and pneumatic manifold
portions. This, in combination with an event-based
components prior to each test. User programmable test
capture of the flow curve, gives you the most reliable,
parameters allow for more case specific testing when
sustainable method of bubble point testing.
needed for analysis.
• Supports all traditional tests such as bubble point
and diffusion
Rugged Industrial Design
The exterior surfaces can be easily wiped clean with • Optional accelerated test allows you to quickly obtain
alcohol or bleach. Instrument-grade inlet and outlet accurate, repeatable results
connections on the pneumatic manifold assembly • Accurate, reliable testing for asymmetric
minimize leaks, providing accurate results. bubble point
• Compact industrial design with quick-connect ports • Programmable prepressurization for properly testing
for easy set up multilayer virus removal filters
• External valve array prevents back flow of fluids into • New pressure hold test to test vessels, valves,
the instrument equipment and pipework
• Modular hardware design allows for easy servicing on
location

• Durable, onboard printer produces a printout

that does not fade, even when wet

• Easily field calibrated for routine maintenance and

record keeping
 Central Instrument
Management Tool Software
Centralized instrument management and
automated electronic recordkeeping
The Integritest 4N Central Instrument Management Tool
(Central IMT) software allows centralized management
of all Integritest 4N instruments integrated to a
network domain, improving manufacturing and system
administrator productivity.

The Integritest 4N Central IMT software enables system

administrators to:

• Manage Users
The ability to manage remote instruments via – Assign users to instruments
a networked PC, streamlines operations as well – Define user roles
as optimizing integrity testing consistency and – No need to create user IDs or assign passwords*
reliability throughout manufacturing. – Track password* changes

• Manage Integritest 4N Instruments

Networkable Configuration – Add or change test definitions
Leveraging the built-in networking capability of the – Define report formats
Integritest 4N instrument together with the Windows – Track the addition and deletion of users*
XP tool kit, users can share a networked printer for • Manage Filter Test Reports
central printout of test reports. The software also ena­
– Define data repository location
bles electronic signatures for sign-off of test reports,
which can be transferred to a central data repos­i­tory • Automatically download setups when Integritest 4N
for the backup of all Integritest 4N instrument test instruments are logged onto the network
reports. The Integritest 4N instrument can also support • Organize instrument groups
wireless Ethernet communication eliminating the need to
• Automatically generate remote backups
physically plug the unit into the network.
– Periodically
21 CFR Part 11 Compliance Ready – Information for instrument recovery and event logs
The Integritest 4N software meets the technical
• Security
requirements of FDA regulation 21 CFR Part 11
for electronic records and electronic signatures. – Domain controller assigned user names

Assign Instruments and Users

Increase Process Speed to Logical Groups
When integrated into a network, final filter integrity • Users are selected from the domain of users
test results are uploaded into the main control system provided by the domain controller
enabling an immediate stop/go decision, improving • Tests are assigned to defined instruments in the
the pharmaceutical production process without group
compromising quality control. • An instrument tab lists all the instruments added
to the Central IMT software. All checked
instruments are part of the group.
• Report transfer, remote backup and electronic
signature parameters are assigned to a group of
instruments

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 Consistent, Effective and Comprehensive Services
Reliable Integrity Tester and Support
Instrument Management Access Services is available to conduct installation,
Centralized user and instrument management of calibration and validation on-site. Millipore offers a
all Integritest 4N test systems enhances testing proven validation protocol that tests the range of
consistency and repeatability. Central IMT allows a filters and tests used in a facility. Millipore Service
user in one location to access and configure multiple Representatives offer factory or on-site maintenance
instruments in several locations. A test can be entered and repair services.
on one PC and added to a group of Integritest 4N
instruments without having to access each instrument The Requirement of
individually. A password change on one instrument Integrity Testing
automatically propagates to all instruments on the same Regulatory agencies require integrity testing of
network when a domain controller is used. sterilizing grade filters as well as the integrity of
process critical filters, such as bioburden reduction
Available Expedited Instrument filters, which directly affect product quality. For
Validation Service production operators, supervisors, and validation
The Integritest 4 instrument was developed and managers who need to perform on-site filter integrity
validated according to the GAMP Guide for Validation tests, the Integritest 4 instrument is a solution that
of Automated Systems. Validation reports are available is easy to learn and gives you the confidence and
for review during an on-site audit. The Integritest 4 assurance you need for your test results. Users can
instrument can be validated on-site using a validation conduct bubble point, diffusion, enhanced bubble point,
protocol customized for you and executed by a Millipore HydroCorr and pressure hold tests on disk, cartridge and
Access® Services team. TFF filters, virus, and asymmetric membrane filters.

Hub

Networked Attached
Printer
Storage (NAS) or
PC File Server

Figure 1. The Integritest 4N systems can be connected to a network printer and a central data repository.

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 Domain PC with Central
Controller IMT Software
Corporate Network

Print Server and Central Data

Hub Repository File Server

Printer

Figure 2. The Integritest 4N systems can also be networked to a domain-controlled Local Area Network (LAN).

specifications
Test Accuracy (at standard, stable conditions)
Test Type Range Accuracy

Diffusion (Standard and Accelerated) Flow rates < 20 mL/min ≤ 1mL/min

Flow rates ≥ 20 mL/min (water) ≤ 5%
Flow rates ≥ 20 mL/min (alcohol) ≤ 10%
30 Second Diffusion* Flow rates < 20 mL/min ≤ 2 mL/min
Flow rates ≥ 20 mL/min ≤ 15% /–10%
Bubble Point (BP) Standard 345–6205 mbar (5–90 psig) ≤ 68.9 mbar (1 psig)
Bubble Point Asymmetric 345–6205 mbar (5–90 psig) < 344.7 mbar (5 psig)
Accelerated BP Hydrophilic PVDF 345–6205 mbar (5–90 psig) ≤ 137.9 mbar (2 psig)
Accelerated BP Hydrophobic PTFE 345–6205 mbar (5–90 psig) ≤ 206.8 mbar (3 psig)
HydroCorr Flow rates < 0.4 mL/min ≤ 0.02 mL/min
Flow rates ≥ 0.4 mL/min ≤ 5%
Virus Diffusion Flow rates < 20 mL/min ≤ 2 mL/mi
Flow rates ≥ 20 mL/min ≤ 10%
Pressure Hold Pressure drops < 68.9 mbar (1 psig) ≤ 3.5 mbar (0.05 psi)
Pressure drops ≥ 68.9 mbar (1 psig) ≤ 5%

* Used in accelerated enhanced bubble point and asymmetric enhanced bubble point tests.

Test Reproducibility (at standard, stable conditions)

Coefficient of variation (CV) or standard deviation (sn–1)
Test Type Range Accuracy

Diffusion* Flow rates < 20 mL/min sn–1 ≤ 2 mL/min

Flow rates ≥ 20 mL/min CV ≤ 10%
All Bubble Point Tests 345–6205 mbar (5–90 psig) CV ≤ 10%
HydroCorr Flow rates < 0.4 mL/min sn–1 ≤ 0.04 mL/min
Flow rates ≥ 0.4 mL/min CV ≤ 10%
Virus Diffusion Flow rates < 20 mL/min sn–1 ≤ 2 mL/min
Flow rates ≥ 20 mL/min CV ≤ 10%
Pressure Hold Pressure drops < 68.9 mbar (1 psi) sn–1 ≤ 6.9 mbar
Pressure drops ≥ 68.9 mbar (1 psi) (0.1 psi) CV ≤ 10%

* Diffusion reproducibility is not specified for the 30 second diffusion test.

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 specifications
Test Specifications
Test Type Range Accuracy

Diffusion* 47 mm disks – 12 round x 30 in. systems Diffusion rate: 1 – 750 mL/min

Capsules to TFF systems Test pressure: 345–6550 mbar (5–95 psig)
Bubble Point (All Except 47 mm disks – 3 round x 30 in. systems Test pressure: 345–6205 mbar Accelerated
Accelerated Hydrophobic) Hydrophobic) (5–90 psig)
Accelerated Hydrophobic Bubble Point 47 mm disks – 1 round x 30 in. systems Test pressure: 345–6205 mbar (5–90 psig)
HydroCorr 47 mm disks (Aervent-50) – Test pressure: 345–6205 mbar (5–90 psig)
3 round x 30 in. systems
Flow rate: 0.01 – 10 mL/min
Virus Diffusion 25 mm disks – 3 round x 30 in. systems Diffusion rate: 1 – 600 mL/min
Test pressure: 345–6550 mbar (5–95 psig)
Pressure Hold Up to 12 round x 30 in. systems Test pressure: 345–6550 mbar (5–95 psig)

* Pneumatic flow rate is at least 2500 mL/min at 5516 mbar (80 psi). The operating range claim of 750 mL/min is based upon the qualification
testing of a 12 x 30-inch filter configuration. However, the maximum physical capacity of the pneumatic module is 2500 mL/min, which enables
integrity testing of large TFF systems.

Power Requirements
Voltage 90 –264 volts AC, 50/60 Hz
Current rating 3.5 amps

Compressed Gas
Inlet pressure Clean, dry air or nitrogen source of 2.4 – 8.2 bar (35 –120 psi) at least 1.03 bar (15 psi)
greater than the highest test pressure
Operating pressure range 0.34 – 7.03 bar (5 –102 psig)

Environmental
Storage temperature –20 to 80 °C
Operating temperature 1 to 40 °C
Humidity 5 to 95%, non-condensing

Nominal Dimensions
Height 37.2 cm (14.6 in.)
Width 41.6 cm (16.4 in.)
Depth 25.4 cm (10.0 in.)
Weight < 15 kg (32 lb)

Computer
Software operating system Windows XP embedded
Port 1 5-pin DIN connector for service access
Port 2 PS/2 Bar code reader input
Port 3* RJ45 for Ethernet connection

*Integritest 4N only..

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system attributes

Integritest 4N
Used with PC
Integritest 4* Integritest 4N Central IMT
Instrument Instrument Software

Comprehensive library of integrity testing modes that include

diffusion (standard, accelerated/virus); bubble point (standard/ l l l
asymmetric/accelerated; enhanced BP; HydroCorr test; pressure hold

Intuitive, multilingual, easy to use 10.4 in. SVGA touch user interface l l l

Rugged, portable industrial design l l l

Developed according to GAMP 4 Guidelines l l l

Network Ready l l

Ethernet printer support l l

Remote Integritest 4N database backup with Networked Attached

Storage (NAS) or networked server PC l l
Automatic filter test report transfer and storage on a central
repository with a NAS or networked PC when electronic signature l l
requirements are met

Meets the technical requirements of 21 CFR Part 11 l l

From a networked PC:

Add or change network definitions l

Define users and user permissions l

Track additiom and deletions of users l

Organize instruments into groups l

Track changing of passwords l

*The Integritest 4 can be upgraded to an Integritest 4N instrument. Contact Millipore for details.

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 Ordering Information
Description Catalogue No.

Integritest 4 Standalone Instrument* XIT4 S00 01

Integritest 4N Instrument* XIT4 N00 01
Integritest 4 External Valve Array XIT4S PEVA 01
Integritest 4 Field Calibration Kit XIT4SP FCA 01
Integritest 4 Printer Paper (3 pack) P83071
Integritest 4 Printer Ribbon Cartridge (3 pack) P83075
Integritest 4N Central IMT Software XIT4N CIMT 01
Integritest 4 Inlet Tubing with Dessicant Air Filter P83076
Inlet Air Filter (2 pack) XITXSP111
HydroCorr Sight Glass P91830

* Includes power cord, external valve array and operators manual

TO PLACE AN ORDER OR
RECEIVE TECHNICAL ASSISTANCE
For additional information call your nearest Millipore office.

To find the office nearest you: www.millipore.com/offices

Internet: www.millipore.com
www.millipore.com/offices Technical Service: www.millipore.com/techservice

Millipore, Integritest, and Access are registered trademarks of Millipore Corporation.

The M mark and Advancing Life Science Together are trademarks of Millipore Corporation.
HydroCorr is a service mark of Millipore Corporation.
Windows XP is a registered trademark of Microsoft Corporation.
Lit No. DS1675EN00 – Rev D 03/09 Printed in U.S.A. DP-SBU-09-01612
© 2009 Millipore Corporation, Billerica, MA 01821 U.S.A. All rights reserved.