Integritest Exacta Automatic Filter Integrity Test Instrument

Integritest Exacta Automatic Filter Integrity Test Instrument

Description
The Integritest Exacta is an easy to use, easy to validate, highly accurate, automatic integrity tester for the regulated biopharmaceutical industry.

For production operators, supervisors, and validation managers who need to perform on-site filter integrity tests, Millipore's Integritest Exacta Integrity Tester is a premium instrument providing the highest level of confidence in the regulated biopharmaceutical industry.

Users can conduct bubble point, diffusion and HydroCorr (water-based test for hydrophobic filters) tests on disk, cartridge and TFF filters.


Complete Validation
- Final System Qualification (FSQ) included testing on a wide range of actual disk, cartridge, and TFF filters.
- Software meets or exceeds industry software standards and Millipore's software quality assurance plan.
- The ITX instrument can be validated on-site to conform to cGMP standards for software and computer validation.
- Millipore's ACCESS services can provide validation and production managers with customized protocols and assistance in completing IQ/OQ/PQ validation efforts.
- To ensure security, the system is password protected. Up to five levels of password access may be assigned, each with its unique set of allowable functions.

Accurate
- Test processes and algorithms have been designed and qualified to achieve test accuracy greater than 95%.
- Software for diagnosing and electronically calibrating the transducers and checking the functionality of the computer and pneumatic manifold components is included.

Easy to Use
- The ITX features a graphical user interface with "point & click" menus and toolbars, based on the Microsoft Windows operating system.
- Millipore filter specifications for diffusion, bubble point, and HydroCorr tests are pre-loaded. Other filter testing information can be added on site.
- The ITX can be operated remotely by networking to other ITX units or to a central computer via the Ethernet port.
- Test results can be printed on standard-size plain paper via the parallel port to an external printer.
- Context-sensitive help screens provide instruction on demand.
- Test results are saved to a local database and can be searched by the test or batch number or date.
- Test editor screen fields can be customized to include operator, batch, or other desired data.


Industrial Design
- Rugged case
- Water and splash resistant
- Clean room compatible - built-in high efficiency filter prevents generation of dust by the instrument



Pneumatics
Pressure regulators
Electronic inlet pressure regulator self- regulates inlet gas pressure up to 6.5 bar (100 psi). Simply hook up to facilities air (or regulated nitrogen/air tank) and the Integritest Exacta will regulate the pressure at the required value for each test.

Valves
A solenoid feed valve, solenoid tank select valve, external pneumatic exhaust pilot valve and pneumatic exhaust valve all control pressurization of the filter housing. This provides automatic control of pressurized air to instrument and to housing.

Direct attachment to the manifold minimizes the risk of leaks which improves accuracy due to less "noise" in the pressure decay value.

Internal tank
The internal reference tank has a tightly controlled gas volume. This ensures accuracy in the final flow rate calculation.

Pressure Transducers
Highly accurate pressure transducers enable the pressure decay values to be accurately determined, translating into accurate flowrates for diffusion, bubble point, and HydroCorr tests.



Computer
- Pentium processor
- Easy-to-clean membrane keyboard with touchpad mouse and numeric keypad. Full-size keys with tactile response makes entering information easy.
- 10 in. active color matrix LCD 640x480 screen with VGA output.
- Universal input switching power supply accepts voltages of 110–240 VAC at frequencies of 50–60 Hz.
- 3.5 in. (1.4 MB) floppy disc drive allows saving to diskette for backup or data transfer.
- Built-in hard disk drive permits test software, filter specifications, and filter test results to be stored easily.
- Instrument-grade inlet and outlet connections on the pneumatic manifold assembly minimize leaks, providing more accurate results.
- Ethernet communication port allows instrument-to-instrument and instrument-to-PC networking.
- The inkjet printer prints results on 3 in. plain-paper strip at 120 cps, 40 characters/line.
- Parallel port, DB–25 pin, permits connection to an external printer.

Operating System
The Integritest Exacta Integrity Tester uses Microsoft Windows NT as the operating system and is available in either Pan-European or Japanese versions.

Integrity Test Software
The Integritest Exacta test software has the capability to run diffusion, bubble-point, enhanced bubble-point and HydroCorr tests and can test hydrophilic and hydrophobic filters.
This software features a graphical user interface to program and run integrity tests. Test information can be saved after programming the specifications.


Specifications    (return to top)
Languages
All menus, data and help screens and reports can be displayed in one of several languages. Test software is available in a Pan-European version, supporting English, French, Spanish, German and Italian, or in a Japanese version.

Filter Specifications
The Integritest Exacta Integrity Tester has pre-loaded specifications for Millipore filters, which are automatically imported with a selected filter when programming diffusion, bubble-point, enhanced bubble-point and HydroCorr tests.

System Sizing Accuracy
5% of volume

Utility Requirements
Electrical:
100–240 VAC, 50–60 Hz
Compressed Gas:
Clean, dry air or nitrogen source of 2.4–8.6 bar (35–125 psi), but at least 1.0 bar (15 psi) greater than the highest test pressure.
System Operating Pressure:
0–7 bar (0–100 psig).

Environmental Requirements
Storage Temperature:
-20 °C to +40 °C, dry
Operating Temperature:
4 °C to +40 °C
Humidity Range:
20% to 80%, non-condensing



Accessories
Integritest Exacta systems are shipped with the following:
- Operating Manual
- Certificate of Quality
- Inlet tubing assembly with air filter
- Outlet tubing assembly with 2-way instrument valve and water trap
- Tubing Loop-Back assembly
- 5 Rolls of printer paper
- Paper roll rod
- Power cords, 110V and European
- 3 Inkjet cartridges
- Millipore software license agreements
- Registration return envelope

Dimensions Length Height Depth Weight 48 cm (19.0 in.) 20 cm (8 in.) 53 cm (21 in.) 18 kg (39 lbs)

Test Accuracy Test Type Range Accuracy (error) Reproducibility Diffusion Flow rates <20 mL/min Flow rates ≥20 mL/min +1 mL/min at 23 °C <5% for water <10% for IPA mixtures SD<2 mL/min CV<10% Bubble Point 345–6200 mbar (5–90 psi) + 70 mbar (1 psi) CV<10% HydroCorr Flow rates <0.4 mL/min Flow rates ≥0.4 mL/min + 0.02 mL/min <5% SD<0.04 mL/min CV<10%

Test Configurations Test Type Configuration Range Considerations Diffusion 47 mm disks 12 round x 30 in. systems Maximum diffusion rate: 2500 mL/min at 2760 mbar (40 psi)   Capsules to TFF systems Test pressure: 345–6200 mbar (5–90 psi) Minimum diffusion rate: 1 mL/min Bubble Point 47 mm disks 3 round x 30 in. systems Test pressure: 345–6200 mbar (5–90 psi) Granularity: bubble point intervals<30 mbar (0.5 psi) HydroCorr 47 mm disks (Aervent 50) 3 round x 30 in. systems Test pressure: 345–6200 mbar (5–90 psi) Flow Rate: 0.01–100 mL/min