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Labthink Instruments Co., Ltd.
non destructive leak test apparatus

non destructive leak test apparatus

Product catalog summary

Overview: The C690H Non-destructive Package Leak Detector is designed for vacuum method testing, adhering to ASTM F2338 and other standards. It is suitable for detecting leaks in pharmaceutical packaging such as vials, ampoules, cartridge bottles, infusion bottles, and prefilled syringes.

Features:

Batch Testing: Equipped with an automatic sample feeder for continuous testing of 20 to 120 samples. Dual-channel design allows simultaneous testing of different specifications. Adjustable vacuum degree and dual methods of vacuum and positive pressure address hole plugging issues.
Precise Data: Utilizes advanced pressure detection and microflow control technologies for stable and accurate data. Pressure and flow data are traceable to NIST, with a test repetition accuracy of ±1um.
Intelligent Control: Features a 15.6" touch tablet with Windows OS, real-time pressure curve display, automatic alarms, and data collection. Supports USB and network connectivity for data transmission and remote upgrades.
Security Compliance: Meets GMP requirements for data traceability and 21 CFR Part11 for electronic signatures. User permissions are configurable.

Test Principle: Samples are placed in a feeder and delivered to a test cell where vacuum is applied. Pressure changes are analyzed to calculate leak rate and reference aperture.

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

Applications:

Basic Applications: Vial sealing tests.
Extended Applications: Ampoule, cartridge bottle, and injection bottle sealing tests.

Technical Parameters:

Testing Range: 3 to 8 um (reference aperture size USP1207).
Detection Lower Limit: ≤3 um.
Resolution: 0.1 um.
Repetitiveness: ±1 um.
Pressure Range: -100 to +100 kPa.

Technical Specifications:

Testing Cell: 1 set each for A and B groups.
Sample Feeder: 1 set each for A and B groups.
Sample Size: ≤Φ45 mm×80mm.
Sample Quantity: 20 to 120 pieces.
Gas Specifications: Compressed air with a pressure of ≥ 40.6 PSI / 500 kPa.
Dimensions: 33.4” H x 19.6” W x 28.7” D.
Power: 120VAC±10% 60Hz / 220VAC±10% 50Hz.
Net Weight: 209 lbs (95 kg).

Product Configuration:

Standard Configuration: Includes mainframe, embedded tablet computer, software, flow meter, European vacuum pump, and Φ6 mm polyurethane tube.
Customization: Test cells and feeders can be customized according to sample specifications.
Optional Parts: GMP computer system requirements, 21 CFR Part11, air compressor.

Catalog excerpts

C690H Non-Destructive Package Leak Detector C690H Non-destructive Package Leak Detector is based on the testing principle of vacuum method, designed and manufactured according to ASTM F2338 and other standards. It is professionally suitable for batch sealing detection of vials, and trace leakage detection of ampoule, cartridge bottles, infusion bottles, prefilled syringes and other pharmaceutical packaging. Features Note 1 Batch Testing  Equipped with fully-automatic falling sample feeder, which is Labthink latest scientific and technological achievement that can realize continuous test 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 freely to meet testing requirements of different samples. Dual methods of vacuum and positive pressure, effectively solve the problem of hole plugging. International advanced pressure detection technology for data stability which is not affected by ambient environment. International advanced microflow automatic control technology that can accurately simulate different sizes of leakage holes without manual adjustment. Both the pressure and flow data are traceable to NIST. The system can achieve a higher test repetition of ±1um. 15.6" embedded touch tablet computer with Windows OS. New longitudinal interface layout, and professional visual design. Automatic alarm, automatic capture, automatic collection of

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The pressure curve is displayed in real time, and the test results are counted automatically. Leakage and reference aperture are calculated automatically. The system is equipped with various sensors as intelligent reminder for safer operation and control. Universal printer can be connected for test results output. The system has been embedded with USB and network port to facilitate the external access and data transmission of the system, and can be upgraded remotely. Verified by professional packaging sealing method. The detector meets the GMP requirements for data traceability and meets the...

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Table 1: Test Parameters Note 2 Parameter \ Model Testing Range um(Reference aperture size USP1207) Detection Lower Limit Pressure Range Extended Functions GMP computer system requirements Table 2: Technical Specifications Testing Cell Sample Feeder Sample Size Sample Quantity Compressed Air (Gas source is provided by the user) Port Size Table 3: Product Configuration Standard Configuration Mainframe, embedded tablet computer, software, flow meter, European vacuum pump, Φ6 mm polyurethane tube Test cell and sample feeder of group A, test cell and sample feeder of group B, negative standard reference...

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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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