Vacuum decay leak tester C690H

differential pressure decayhigh-pressurepressure rise

C690H Nondestructive Package Leak Detector is based on the testing principle of the vacuum decay method, designed and manufactured according to ASTM F2338 and other standards. It is professionally suitable for batch sealing leak detection of vials, and trace leakage detection of ampoule, cartridge bottles, infusion bottles, prefilled syringes and other pharmaceutical packaging.


Featuresnote1Batch Testing

• Equipped with fully-automatic gravity fed sample feeder, which is Labthink’s latest scientific and technological achievement that can facilitate continuous testing of 20 to 120 samples.
• A & B dual-channel design can test samples of two different specifications simultaneously.
• The target vacuum degree can be set by the operator to meet testing requirements of different samples.
• Dual methods of vacuum decay and pressure decay provide the flexibility to accommodate various types of package samples.

Precise Data

• Advanced pressure detection technology, using world renowned components for data stability which is not affected by ambient environment.
• Advanced microflow automatic flow control technology that can accurately simulate different sizes of leakage holes without manual adjustment.
• Both the differential pressure transducer and flow meter are traceable to NIST.
• The system can achieve a higher test repeatability of ±1um.

Intelligent Control

• 15.6 embedded touch tablet computer with Windows OS.
• New longitudinal interface layout, and easy to use graphic user interface.
• Automatic alarm, automatic capture, automatic collection of unqualified samples.
• The pressure curve is displayed in real time, and the test results are counted automatically.
• Leakage rates are calculated automatically.
• The system is equipped with various sensors as intelligent reminders for safer operation and control.
• Universal printer can be connected for test results output.
• The system features embedded with USB and network ports to facilitate the external access and data transmission of the system, which can be upgraded remotely

Security Compliance

• Verified by compensation and calibration methods.
• The leak tester meets GMP requirements for data traceability and meets the needs of the pharmaceutical industry.
• User operation permission is managed at multiple levels, and the permission content can be configured on demand.
• Electronic signature is designed according to the standard requirements of 21 CFR Part11.

Test PrincipleThe sample is placed in the sample feeder and automatically delivered into the test cell. The leak rate and other results can be calculated and obtained by analyzing pressure changes measured by the sensor.


Reference Standards
ASTM F2338, YY-T 0681.18, and USP<1207>


Applications
Basic Applications
Vials
Various vial leak test.
Extended Applications
Ampoule
Various ampoule bottle leak tests.
Cartridge Bottles
Various cartridge bottle leak tests.
Injection bottles
Various injection bottles leak test.
Flexible Packaging Bags
Various IV bags and flexible packaging bags.


Technical Parameters
Table 1: Test Parameters Note2
Parameter\ModelC690H
Testing Range: um(Reference aperture size USP1207): 2-8-great leakage
Detection Lower Limit: um≤2
Resolution: um0.1
Repeatability: um±1
Pressure Range: kPa-100-0-100
Extended Functions
21 CFR Part11: Optional
GMP computer system requirements: Optional
Table 2: Technical Specifications
Testing Cell1 set for A group and 1 set for B group
Sample Feeder1 set for A group and 1 set for B group
Sample Size≤Φ45 mm×80mmNote3
Sample Quantity20~120 pieces
Gas SpecificationsCompressed Air (Gas source is provided by the user)
Gas Source Pressure0.5 mPa ~ 0.7 mPa (72.5 PSI ~ 101.5 PSI)
Port SizeΦ6 mm Polyurethane tube
Dimensions33.4” H x 19.6” W x 28.7” D (85cm× 50cm× 73cm)
Power120VAC±10% 60Hz / 220VAC±10% 50Hzselect one from the two
Net weight209Lbs (95kg)


Product Configuration
Standard Configuration
Mainframe, embedded tablet computer, software, flow meter, European vacuum pump, Φ6 mm polyurethane tube
Customization
Test cell and sample feeder of group A, test cell and sample feeder of group B, negative standard reference sample and positive standard reference sample designed according to sample specifications
Optional Parts
GMP computer system requirements, 21 CFR Part11, air compressor, IQ/OQ/PQ documents
Note 1: The described product characteristics are subject to the specific annotation of the Technical Parameters table.
Note 2: The parameters in the table are measured in the Labthink laboratory by professional operators according to the requirements and conditions of the relevant laboratory environmental standards.
Note 3: Group C test cell can be customized for samples beyond the Sample Size, but the lower detection limit and test range will change according to the sample size, and the actual delivery shall prevail.
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We can help you select or customize the proper unit for your test requirements.