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Integritest® 4 Series Automated Filter Integrity Test Instruments

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产品名称: Integritest® 4 Series Automated Filter Integrity Test Instruments
产品型号: XIT4S0001
产品展商: MILLIPORE
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简单介绍

Integritest® 4 Series Automated Filter Integrity Test Instruments


Integritest® 4 Series Automated Filter Integrity Test Instruments  的详细介绍

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 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
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).

 
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