Data Sheet

Integritest® 5 instrument: Integrity

assurance with ease and confidence
Accurately and reliably verify the integrity Benefits
of your filters and processing equipment
• Robust unit protects against water and dust entry,
with the portable, easy to implement, and automatically checks calibration
and automated Integritest® 5 instrument.
• Improved test algorithm reduces test time and
The Integritest® 5 instrument delivers a simplifies test creation
simple and intuitive user experience, while
• Intuitive software includes help screens available for
providing optional depth of flexibility to fit every step
your process.
• Flexible displays, run information, and test collections
to suit your process
• Standard model offers all networking functions,
including multi-unit management and synchronization

The life science business of Merck

operates as MilliporeSigma in the
U.S. and Canada.
Compliance Reliability
Improved test speed while maintaining Prevent water and dust entry with IP54 rating
high accuracy
Eliminate setup mistakes with errorless
For bubble point tests, the proven tangent method is used to quick connectors
maximize readings from stable portions of the filters' profiles
Protect against liquid back-flow issues with sensor
See more in Feature Details on following pages feedback, float valve and more
Designed to support GMP and See more in Feature Details on following pages
21 CFR p11 compliance
Remove contamination concerns with cleanable,
User access rights can be controlled, data integrity is replaceable Housing Interface Module
ensured, and a full audit trail is available. Single or double,
manual or electronic signatures are all supported Stay informed of calibration issues with automatic
self-check
See more in Feature Details on following pages

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Usability Flexibility
Queue tests and pre-enter run information to save time Organize tests into collections and users into groups
for easy access, management and security
See more in Feature Details in following pages
Reduce risk of human error by assigning tests to specific users
Convenient on-board printer
See more in Feature Details on following pages
Thermal printer paper removes particulate generation
concerns and the need for ink, and stays legible for over 12 Pick the information you want to see with the highly
years or after exposure to water and alcohol configurable display and reports
See more in Feature Details on following pages See more in Feature Details on following pages
Streamlined screens that are easy to learn Choose regional settings such as language or
Designed for an operator to quickly learn to run tests and
date/time format
print reports. Test creation offers step by step guidance

Accessible help for every screen and search function just where
you need it

Various human input

Control with the touch screen, even with plastic gloves
Attach a mouse and/or keyboard if you prefer via
USB or Bluetooth

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Integration
Save time by synchronizing tests, users, and
settings on all instruments
Connect to a router, then enter the instrument cluster name
and a file path. Make edits only once, and everything stays
synchronized

Never lose data and settings by centrally storing

reports, backups, and more
Set folder paths to store your files on a network location

Use your corporate single sign on with Windows®

Active Directory users on the instrument
See more in Feature Details in following pages

Supports Wi-Fi, Bluetooth, USB printers and barcode

scanners for data input
802.11a/b/g/n/ac wireless Ethernet and dual band support,
2.4GHz and 5GHz
Wi-Fi CERTIFIED by the Wi-Fi Alliance
Dual Mode Bluetooth 2.1, 2.1 + EDR, 3.0, 3.0 + HS, 4.0 (BLE)

Supports wired Ethernet up to 1 Gbit/s

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Supported by a Knowledgeable, Responsive, Global Partner

25+ years of developing integrity testers

Integritest® E Integritest® 2 Exacta 3.0 Integritest® 4 Integritest® 5

instrument instrument instrument instrument instrument

1989 1992 1998 2005 2016

History and experience matter. We introduced the first commercial automated integrity tester over 25 years ago. We were the first to automate
sizing, and we developed the first water intrusion test - the HydroCorr™ test. We know filters. We know integrity testing.

Feature detail

Compliance: integrity test instruments, also monitors for pressure drops within the instrument and will react
to imminent fluid blow back by quickly switching to the exhaust
bubble point tangent method, and flow path. As a final line of defense, the Housing Interface Module
improved test speed (HIM) incorporates a float valve that will seal against rising fluid.
Even in emergency cases of power loss or compressed gas loss, the
The Integritest® 5 takes precise pressure measurements and known instrument will protect itself by springing valves shut.
internal volumes to derive flow rates. Upstream volumes are found by If contamination is a concern to you, the HIM's flow path is validated
measuring pressure changes from releasing precise quantities of gas. to be fully cleanable. Simply remove the HIM, attach the cleaning
The instrument then measures the pressure decay, and based on accessory, and use the cleaning instructions found in the user guide.
the upstream volume, calculates the final flowrate for diffusion and
HydroCorr™ water intrusion tests. This flowrate is compared with the If your process conducts pre-use, post-sterilization integrity testing
test specification for the integrity conclusion. and you assess that cross-contamination between products or
processes is a risk, it is even possible to keep specific HIMs to be
Bubble point and pressure hold tests follow a similar method of used separately.
monitoring pressure drops but provide the necessary pressure results
instead. Bubble point tests use the tangent method, and takes
several pressure decay measurements at different applied pressures Compliance: signatures, users,
to map the filter’s integrity profile. Stable diffusive flow is achieved
at lower pressures, and stable convective flow is achieved at higher
and audit trails
pressures. By mapping the profile of the filter through both types The Integritest® 5 supports single and double signatures, in either
of flow, the instrument can accurately calculate the intersection of manual or electronic forms. Appropriate space and fields are
these curves to find the actual bubble point of the filter. This also provided for manual signatures. Electronic signatures follow all
reduces emphasis on measurements in the volatile portion of the curve. regulations to help you stay 21 CFR part 11 compliant. A username
and password are required to sign, and all necessary information
The Integritest® 5 improves on test speed by optimizing the
are automatically provided, such as name, date, time, and even a
algorithm. For example, for diffusion tests, the instrument reads
configurable standard message that the user signs to. Signatures
through fluctuations and ends the test as soon as a stable, accurate
cannot be transferred, removed, or altered.
result is achieved. For bubble point tests, the instrument identifies
optimum points to take measurements based on test parameters Usernames and passwords restrictions, such as length, can be
and ongoing readings, which reduces the number of measurements restricted with the same rules as Windows®. There are five roles that
needed to reliably map the filters’ profile and return an accurate result. are assigned on the instrument with increasing access rights.

The Integritest® 5 application automatically loads up and prevents

Reliability: back-flow ingress prevention any access to the underlying Windows® operating system. This
with cleanable Housing Interface Module ensures a robust platform that prevents accidental or untrained
changes that may hinder operation.
Sometimes even despite the best training, process, and equipment,
The Auditor tool logs all actions, results, and edits, along with the
liquid backflow into the system can occur as a natural result of
timestamp of occurrence. Electronic records and test data are
working with fluids, pressurized equipment, and human error. High
protected from alteration.
precision instruments like filter integrity testers can be affected by
fluid ingress and may require disruptive repair, so the Integritest® 5
has been designed to eliminate this problem. Usability: test queue and preview
As a preventive technique, all exhaust steps are monitored by Tests can be added to a queue list to help you save time when
a pressure sensor to check that the housing or capsule is fully testing multiple filters. When a test is running, you can pick or
exhausted and depressurized before opening valves leading into search for the tests you need next and add them to the queue. Run
the instrument. This prevents the condition of a lower instrument information for tests, such as batch number and filter serial number,
pressure causing air and possible fluids to be pushed into the can also be entered ahead of time when you’re waiting for the
instrument. During other steps of a test run, this pressure sensor previous test to finish.

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Flexibility: highly configurable groupings A network shared folder can increase availability of the Cluster
synchronization data, and can also be used for other exported data
and security such as auto-backups and reports. If you need certain instruments
to have different settings, such as a local printer or a different
Simple usability has been a guiding principle in designing the report repository, you can assign specific settings to a subgroup of
Integritest® 5 instrument. However, there is a depth of configurability instruments within a Cluster. Test Collections can also have instrument
with optional features should you need it. based security to control which instruments can run which tests.
If you have many tests, separate them into Collections to add
structure and find them more easily. For example, you can create Integration: domain and corporate
a Collection with all tests for Durapore® filters, or tests used in a
certain suite, or tests for your newest product. Information Technology compliance
Tests in a Collection can be secured to limit access, and reduce Domain users are supported to simplify user management by using
human error. If only one team is trained to run tests on alcohol-wetted corporate user ID and password. Authentication uses standard
filters, secure those tests in a Collection and only let that group of Windows® functions and registration mechanisms, and roles are then
users see and access those tests. Securing Collections this way also defined in the IT5 application.
prevents operators from running the wrong test, since the tests that
aren’t relevant to them are hidden from view. The Integritest® 5 software can be installed on an office PC to
centrally manage your instrument Cluster from a Windows® 10
To help manage this security, Users can be assigned to Groups. If a computer instead of a Master instrument.
Group of operators was just trained to run a new Collection of tests, just
add the access rights to the Group instead of each individual.
Description Part Number
Integritest® 5 Instrument IT5INS001
Flexibility: highly configurable display (North American power cable included)
Pick the information to see. It may be easier to identify your test by Power Cord Japan P83066
the filter manufacturer instead of by the test type. Or choose to view
and sort test reports by batch number, and the name of the user Power Cord Australia, NZ P83067
who ran the test. Power Cord UK, IE, HK, SG P83068
Many headings are also fully configurable, such as choosing to add a Power Cord Western Europe P83069
Collection description, or specifying the fields to enter as run information. AT, BE, FR, FI, DE, GR, NO, NL, PL, PT, ES, SE
Choose the information to enter, and whether it is required.
Power Cable Argentina PWRCABLEAR
Reports can also be configured to show and print the information you Power Cable Brazil PWRCABLEBR
want to see. This keeps it relevant to your process and more easily
understood, which reduces mistakes. Power Cable Switzerland PWRCABLECH
Power Cable China PWRCABLECN
Integration: powerful cluster Power Cable Denmark PWRCABLEDK
synchronizations and networking Power Cable Italy PWRCABLEIT
Settings, Users, and Tests can be published from one instrument to Power Cable South Korea PWRCABLEKR
keep a Cluster of instruments synchronized. This simplifies and saves
Power Cable Taiwan PWRCABLETW
time on managing tests, users, and configurations across multiple
instruments. The fastest setup only uses a router connection and Power Cable South Africa, India, Pakistan PWRCABLEZA
a shared folder within the instrument. The rest of the instrument
Cluster can then be set to update from that folder. If you then edit
a test or create a new user on the Master IT5, all instruments in the
Cluster will pull this information and update accordingly. Even a USB
memory stick can be used if a router isn’t available.

Services By using our services, you can benefit from

• Unrivaled access to parts and testing equipment
Qualification services help you minimize regulatory risks,
save qualification time, and maximize your process efficiency. • Up-to-date training, service protocols and practices
Preventive maintenance services help you keep your equipment • A better understanding of the equipment due to our global
running, increase production time, and save emergency repair installed base
costs over the long term.
• Service protocols and reports that meet industry and
Our services are provided by trained engineers, application regulatory expectations
scientists and system designers with unique knowledge of the Our on-site calibration and maintenance services offers the least
equipment and years of experience.
disruption to your workflow and process.

To place an order or receive technical assistance

In Europe, please call Customer Service:
France: 0825 045 645 Spain: 901 516 645 Option 1
Germany: 069 86798021 Switzerland: 0848 645 645
Italy: 848 845 645 United Kingdom: 0870 900 4645

For other countries across Europe, please call: +44 (0) 115 943 0840
Or visit: MerckMillipore.com/offices

For Technical Service visit: MerckMillipore.com/techservice

© 2018 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved. Merck, the vibrant M, Integritest, Durapore, and Lit. No. MK_DS1970EN Ver. 2.0
Mobius are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective 2018-10850
owners. Detailed information on trademarks is available via publicly accessible resources. 04/2018