Integritest? 4 Series Automated Filter Integrity Test Instruments

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產品名稱: Integritest? 4 Series Automated Filter Integrity Test Instruments

產品型號: XIT4S0001

產品展商: MILLIPORE

會員價格: 0.00 元

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Integritest? 4 Series Automated Filter Integrity Test Instruments

Integritest? 4 Series Automated Filter Integrity Test Instruments 的詳細介紹

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

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
30 Second Diffusion*	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
HydroCorr	Flow rates ≥0.4 mL/min	≤5%
Virus Diffusion	Flow rates <20 mL/min	≤2 mL/min
Virus Diffusion	Flow rates ≥20 mL/min	≤10%
Pressure Hold	Pressure drops <69 mbar (1 psig)	≤3.5 mbar (0.05 psi)
Pressure Hold	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
Diffusion*	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
HydroCorr	Flow rates ≥0.4 mL/min	CV ≤10%
Virus Diffusion	Flow rates <20 mL/min	sn–1 ≤2 mL/min
Virus Diffusion	Flow rates ≥20 mL/min	CV ≤10%
Pressure Hold	Pressure drops <69 mbar (1 psi)	sn–1 ≤6.9 mbar (0.1 psi)
Pressure Hold	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).