Integritest^® 5

The Integritest^® 5 is an easy-to-use, portable, and fully-automated instrument that verifies the integrity of filters or processing equipment. MilliporeSigma introduced the first commercial automated integrity test instrument more than 25 years ago; our latest model now incorporates an improved algorithm to simplify test creation and accelerate test completion.
The Integritest^® 5 has an updated algorithm that decreases test run times while maintaining accuracy. The unit was designed for portability and cleaning, including water and dust ingress protection, and a removable Housing Interface Module that incorporates the inlet and outlet valves. An accessible onboard printer and powerful network connectivity tools are included with every instrument. The newly designed software has an intuitive user interface, simplified test creation screens, management tools for tests, users, and units, and highly configurable lists and displays. Users can easily access help for every screen, and utilize search functions to quickly find what they need. The Integritest® 5 has multi-language support and is designed to support 21 CFR part 11 compliance. Video tutorials are available on the Integritest^® 5 website.

• Robust unit protects against water and dust entry, and automatically checks calibration
  
• Improved test algorithm reduces test time and simplifies test creation
  
• Intuitive software includes help screens available for every step
  
• Flexible displays, run information, and test collections to suit your process
  
• Standard model offers all networking functions, including multi-unit management and synchronization

Easy to Use

The Integritest^® 5 instrument features a touch screen with a familiar and user-friendly interface. Test results can be printed using the built-in printer or accessed via networked connected computers. Tests can be added to a queue list to help you save time when testing multiple filters; when a test is running, you can save time by adding tests to the queue and entering run information such as batch numbers and filter serial numbers.

• Improved algorithm reduces test time and simplifies test creation
  
• Bar code readers supported for easy data entry (requires external bar code reader)
  
• Context-based help screens
  
• Kickstand for easy adjustment of display angle

Automation – Connectivity to MES/DCS

A driving component of achieving digital maturity is the use of manufacturing network systems, such as a Distributed Control System (DCS) or Manufacturing Execution System (MES) to integrate data from each process step on a single platform. Information can then be collected, stored, and manipulated from a single interface, providing efficiencies to the plant operations. Additionally, automation can be used to provide control of each process step at a higher level and reduce the risk of operator error. To meet these market needs, MilliporeSigma has added automation capabilities to the IT5 integrity tester unit. This allows for real-time communication and control of the instrument through secure OPC UA (Open Platform Communications United Architecture) communication, ensuring reliability and security of filter integrity testing.

Remote Access:
Secure access to your IT5 from anywhere on the network Access from a simple Web browser

Real-Time Data Sharing:
Real-time monitoring from your DCS or MES system Industry standard OPC UA communication to share data in real-time Transfer report and audit trail files via XML Secure data transfers meeting 21 CFR Part 11 and FDA data integrity guidelines

Process Level Control:
Manage recipes from DCS or MES – ability to select, control, and write testsSend test recipes to the equipment skid directly for operator to execute OPC UA communications to higher level systems Secure and specific local access

Compliance and integrity testing

Regulatory agencies require integrity testing of sterilizing grade filters. For production operators, supervisors, and validation managers who need to perform on-site filter integrity tests, the Integritest^® 5 instrument is a solution that is easy to learn and gives you the confidence and assurance you need for your test results. Users can conduct bubble point, diffusion, enhanced bubble point, and HydroCorr™ tests on disk, cartridge, capsule, and virus filters.
The Integritest^® 5 software is designed to support the technical requirements of FDA regulation 21 CFR Part 11 for electronic records and electronic signatures.
The Integritest^® 5 takes precise pressure measurements and known internal volumes to derive flow rates. Upstream volumes are found by measuring pressure changes from releasing precise quantities of gas. The instrument then measures the pressure decay, and can calculate flow rates based on measured upstream volume.

• All traditional tests are supported, including diffusion, bubble point, HydroCorr™, and pressure hold
  
• Bubble point tests use the tangent method, taking pressure decay measurements at different applied pressures to map the filter’s integrity profile
  
• Test result reports can be signed manually or electronically, with single or double signatures
  
• Access rights can be controlled by assigning users to roles
  
• Audit trail available, including filter and search tools
  
• Backups can be done manually or automatically to save your data and configuration

Reliable and rugged industrial design

The exterior surfaces can be easily wiped clean with alcohol or bleach. Instrument-grade inlet and outlet connections minimize leaks, providing accurate results.
High precision instruments like filter integrity testers can be affected by fluid ingress that may require disruptive repair, so the Integritest^® 5 has been designed to eliminate this problem. As a preventive technique, all exhaust steps are monitored by a pressure sensor to check that the housing or capsule is fully exhausted and depressurized before opening valves leading into the instrument. As a final line of defense, the Housing Interface Module incorporates a float valve that will seal against rising fluid, and can even be cleaned to remove contamination concerns.

• Compact industrial design with quick-connect ports for easy set-up
  
• Durable, on-board printer produces printout that does not fade, even when wet
  
• Cleanable, replaceable Housing Interface Module
  
• Convenient field calibration for routine maintenance
  
• Modular hardware design allows for servicing on-site

Flexibility and Security

Simple usability has been a guiding principle in designing the Integritest^® 5. However, there is a depth of configurability with optional features should you need it.

If you have many tests, separate them into Collections to add structure and find them more easily. Tests in a Collection can be secured to limit access, and reduce human error. Securing Collections this way also prevents operators from running the wrong test, since the tests that aren’t relevant to them are hidden from view. To help manage this security, Users can be assigned to Groups. If a 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.

• Organize tests into collections and users into groups for easy access, management, and security
  
• Pick information you want to see with the highly configurable display and reports
  
• Choose regional settings such as language or date/time format

Network Connectivity

Use network shared folders to centrally store files and keep data and reports easily accessible. Domain users are also supported to simplify user management by using corporate user ID and password. Authentication uses standard Windows® functions and registration mechanisms, and roles are then defined in the IT5 application.

Settings, Users, and Tests can be published from one instrument to keep a Cluster of instruments synchronized. This simplifies and saves time on managing tests, users, and configurations across multiple instruments. The fastest setup only uses a router connection and 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.

• Never lose data and settings by centrally storing reports, backups, and more
  
• Use corporate single sign on with Windows Active Directory of users on the instrument
  
• Save time by synchronizing tests, users, and settings on all instruments
  
• Supports Wifi, Bluetooth, USB printers and barcode scanners for data input
  
• Supports wired Ethernet up to 1 Gbit/s

Comprehensive Services and Support

Equipment services are available to conduct installation, calibration and qualification on-site. Proven qualification protocols are offered, and the process qualification service can even help qualify the specific the filters and tests used in a facility. Service engineers can execute maintenance and repair services on-site, or at the factory or local workshop.

• Unrivaled access to parts and testing equipment
  
• Up-to-date training, service protocols and practices
  
• Better equipment understanding due to experience from a global installed base
  
• Service protocols and reports that meet industry and regulatory expectations