Integritest® 4 Series Automated Filter Integrity Test Instruments
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Documentation
Referências
| Visão geral das referências |
|---|
| In acht Minuten (In eight minutes) Claude Arth, WW Automatic Integrity Testing Service Manager, located in Molsheim, France Pharma + Food (German), issue March 2006, page 72 2006 |
FAQ
| Pergunta | Resposta |
|---|---|
| Why does the information read from the bar code reader not appear on the screen properly when using a bar code reader with the Integritest 4 (IT4) Automatic Integrity Tester? | In order for the bar code reader to work properly, the bar code reader must be configured to input information to the instrument in the same language that the instrument is set to. Please refer to the operating manual that was provided with the bar coder reader. Also, be aware that bar code readers may be available in more local languages than the instrument has been programmed with. The barcode reader will not work in languages that the IT4 is not programmed for. |
Produtos e aplicações relacionadas
Famílias de produtos
Integrity Testing MethodsIntegrity testing sterilizing filters is a fundamental requirement of critical process filtration applications in the pharmaceutical industry.Saiba mais >> |
Automatic Integrity Test Instrument QualificationMillipore validation engineers, familiar with the operation, can provide on-site assistance with performing Installation Qualification (IQ) and Operational Qualification (OQ).Saiba mais >> |
Produtos relacionados por: Application Facete
| Disinfection control |
| Process Water Analysis |
| Dialysis and Filtration |
Produtos relacionados por: Brand Facete
| Integritest® |
Categorias
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Integrity Testing |
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 HydroCorrSM (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)
- 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.
| 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 | -20 to 80 °C | |
| Operating temperature, °C | 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 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). | ||