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Labthink Instruments Co., Ltd.
Vacuum Decay Container Closure Integrity Inspection System

Vacuum Decay Container Closure Integrity Inspection System

Product catalog summary

Overview: The C690M Non-destructive Package Leakage Detector is designed for detecting trace leakage in pharmaceutical packaging using vacuum and pressure methods. It adheres to ASTM F2338 and other standards, making it suitable for various drug packaging types such as vials, ampoules, and prefilled needles.

Features:

Multi-stage Vacuum: Utilizes both vacuum and positive pressure to address hole plugging issues. Features automatic clamping and fast switching technology for flexibility and reliability. The vacuum degree is adjustable, and the test cell is transparent for easy observation. An optional oil-free vacuum pump is available.
Precise Data: Employs advanced pressure detection and micro flow control technologies for stable and accurate data. Pressure and flow data are traceable to NIST, with a test repetition accuracy of ±1um.
Intelligent Control: Includes a 12.1" touch tablet with Windows OS, real-time pressure curve display, automatic result calculation, and connectivity options 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: The sample is sealed in a test cell and vacuumized. Pressure changes are analyzed to calculate the leakage rate.

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

Applications:

Basic Applications: Vial sealing tests.
Extended Applications: Sealing tests for ampoules, cartridge bottles, and injection bottles.

Technical Parameters:

Test Range: 2 to 8 um (reference aperture size USP1207)
Detection Lower Limit: ≤2 um
Resolution: 0.1 um
Repetitiveness: ±1 um
Pressure Range: -100 to +100 kPa
Extended Functions: Optional 21 CFR Part11 and GMP computer system requirements

Technical Specifications:

Test Cell: 1 set
Sample Size: ≤Φ45 mm×80mm
Sample Quantity: 1 piece
Gas Specification: Compressed air, user-provided
Gas Source Pressure: ≥ 40.6 PSI / 500 kPa
Port Size: Φ6 mm Polyurethane tube
Dimensions: 12” H x 22” W x 15” D
Power: 120VAC±10% 60Hz / 220VAC±10% 50Hz
Net Weight: 58Lbs (26kg)

Product Configuration:

Standard Configuration: Mainframe, embedded tablet computer, software, flow meter, vacuum pump, Φ6 mm polyurethane tube
Customization: Test cell and reference samples designed according to specifications
Optional Parts: GMP computer system, 21 CFR Part11, air compressor, built-in European vacuum pump

Catalog excerpts

Vacuum Decay Container Closure Integrity Inspection System-1

C690M Non-destructive Package Leakage Detector C690M Non-destructive Package Leakage Detector is based on the testing principles of vacuum method and pressure method, and is designed and manufactured according to ASTM F2338 and other standards. It is professionally suitable for the trace leakage detection of various drug packaging such as vials, ampoule bottles, cartridge bottles, infusion bottle, and prefilled needle and so on. Features Note 1 Multi-stage Vacuum  Dual methods of vacuum and positive pressure effectively solve the problem of hole plugging. Test cell adopts swing arm automatic clamping and fast switching technology, which is flexible and reliable. The target vacuum degree is set freely to meet detection requirements of different samples. Transparent test cell for easy observation of the sample state. Built-in European oil-free vacuum pump, which is maintenance-free and pollution-free (optional). International advanced pressure detection technology with stable data. International advanced micro flow 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. 12.1" embedded touch tablet computer with Windows OS. The pressure curve is displayed in real time, and the test results are counted automatically. The leakage amount is calculated automatically. Universal printer can be connected for test results output. The system is embedded with USB and network port to facilitate th

Open the catalog to page 1

Vacuum Decay Container Closure Integrity Inspection System-2

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 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 Principle The sample is sealed in the test cell, and the sealed test cell is vacuumized. By analyzing the pressure change measured by the sensor, the leakage rate of the...

Open the catalog to page 2

Vacuum Decay Container Closure Integrity Inspection System-3

Pressure Range GMP computer system requirements Extended Functions Table 2: Technical Specifications Test Cell Sample Size Sample Quantity Compressed air (Air source is provided by the user) Port Size Table 3: Product Configuration Standard Configuration Mainframe, embedded tablet computer, software, flow meter, vacuum pump, Φ6 mm polyurethane tube Test cell, negative standard reference sample and positive standard reference sample are designed according to the sample specifications Optional Parts GMP computer system requirements, 21 CFR Part11, air compressor, built-in European vacuum pump Note...

Open the catalog to page 3

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