Integritest^® 4 Series Automated Filter Integrity Test Instruments

Integritest® 4 Series Automated Filter Integrity Test Instruments

Description
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, repeatable integrity test data. The intuitive touch screen user interface streamlines the test process and 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 HydroCorr_SM (Millipore water-based test for hydrophobic filters) tests on a wide range of filters including disks, cartridges and TFF filters, virus, and asymmetric membrane filters.

The rugged, ergonomic design of the system enables users to easily carry the Integritest 4 instrument to any site. The standalone configuration enables users to print the results on the onboard printer.

The Integritest 4N networkable configuration enables users to print results directly to any networked printer via Ethernet connection. The Integritest 4N instrument is 21 CFR Part 11 compliance ready for electronic records and electronic signatures, improving productivity and facilitating record keeping.


- Portable, easy to use
- Reliable, accurate measurements
- Fast testing improves productivity
- Network model is 21 CFR Part 11 compliance ready
- Available in multiple languages


Easy to Use
The Integritest 4 instrument features a graphical user interface with touch-screen menus and toolbars. 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 (requires external bar code reader)
- Utilizes market-leading Windows XP^® embedded operating system
- Customized interface based on operational roles
- Context-based online help

Accurate, Reliable Results
The instrument has been designed and qualified to achieve high test accuracy. To ensure correct performance, the software automatically checks the functionality of the computer and pneumatic manifold components prior to each test. User programmable test parameters allow for more case specific testing when needed for analysis.

Rugged Industrial Design
The exterior surfaces can be easily wiped clean with alcohol or bleach. Instrument-grade inlet and outlet connections on the pneumatic manifold assembly minimize leaks, providing accurate results.
- Compact industrial design with quick-connect ports for easy set-up
- External valve array prevents back flow into the instrument
- Modular hardware design allows for easy servicing on location
- Durable, on-board printer produces printout that does not fade, even when wet
- Easily field calibrated for routine maintenance and record keeping

Networkable Configuration
Leveraging the built-in networking capability of the Integritest 4N instrument together with the Windows XP^® tool kit, users can share a networked printer for central printout of test reports. The software also enables electronic signatures for sign-off of test reports, which can be transferred to a central data repository for the backup of all Integritest 4N instrument test reports. The Integritest 4N instrument can also support wireless Ethernet communication eliminating the need to physically plug the unit into the network.


Sound Algorithm
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 integral. Our algorithm is based on a mathematically proven tangent method. Unlike other solutions on the market today, it extrapolates the accurate portion of a flow curve while avoiding dependencies on the volatile portions. This, in combination with an event-based capture of the flow curve, gives you the most reliable, sustainable method of bubble point testing.
- Supports all traditional tests such as bubble point and diffusion
- Optional accelerated test allows you to improve efficiency yet maintain reliability of your results
- Accurate, reliable testing for asymmetric bubble point
- Programmable prepressurization for properly testing multilayer virus removal filters
- New pressure hold test to test vessels, valves, equipment and pipework


21 CFR Part 11 Compliance Ready
The Integritest 4N software meets the technical requirements of FDA regulation 21 CFR Part 11 for electronic records and electronic signatures.


Available Expedited Instrument Validation
The Integritest 4 instrument was developed and validated according to the GAMP Guide for Validation of Automated Systems. Validation reports are available for review during an on-site audit. The Integrites t4 instrument can be validated on-site using a validation protocol customized for you and executed by a Millipore Access^® Services team.


Comprehensive Services and Support
Access Services is available to conduct installation, calibration and validation on-site. Millipore offers a proven validation protocol that tests the range of filters and tests used in a facility. Millipore Service Representatives offer factory or on-site maintenance and repair services.


The Requirement of 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 4 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 and TFF filters, virus, and asymmetric membrane filters.


Specifications    (return to top)

Power Requirements Voltage 90–264 V/50–60 Hz Current rating 3.5 A Compressed Gas Inlet pressure Clean, dry air or nitrogen source of 2.4 – 8.2 bar (35 – 120 psi) at least 1 bar (15 psi) greater than the highest test pressure Operating pressure range, bar (psig) 0.34 – 7.03 (5 – 102) Environmental Storage temperature, °C -20–80 Operating temperature, °C 1–40 Humidity 5 to 95%, non-condensing Nominal Dimensions Height, cm (in.) 37.2 (14.6) Width, cm (in.) 41.6 (16.4) Depth, cm (in.) 25.4 (10.0) Weight, kg (lb) <15 (32) Computer Software operating system Windows XP embedded Port 1 5-pin DIN connector for service access Port 2 PS/2 Barcode Reader Input Port 3* RJ45 for Ethernet connection *Integritest 4N only

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/min Flow rates ≥20 mL/min ≤10% Pressure Hold Pressure drops <69 mbar (1 psig) ≤3.5 mbar (0.05 psi) Pressure drops ≥69 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 Reproducibility 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 <69 mbar (1 psi) sn–1 ≤6.9 mbar (0.1 psi) Pressure drops ≥69 mbar (1 psi) CV ≤10% *Diffusion reproducibility and confidence are not specified for the 30 second diffusion test.

Test Specifications Test Type Configuration Range Operating Range Diffusion* 47 mm disks – 12 round x 30 in. systems Capsules to TFF systems Diffusion rate: 1 – 600 mL/min Test pressure: 345–6550 mbar (5 – 95 psig) Bubble Point (All Except Accelerated Hydrophobic) 47 mm disks – 3 round x 30 in. systems Test pressure: 345–6205 mbar (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) – 3 round x 30 in. systems Test pressure: 345–6205 mbar (5 – 90 psig) 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).