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Labthink C690M CCIT Nondestructive Package Leak Tester - Vacuum Decay / Pressure Decay for Pharmaceutical Packaging

Labthink C690M CCIT Nondestructive Package Leak Tester - Vacuum Decay / Pressure Decay for Pharmaceutical Packaging

Labthink C690M CCIT Nondestructive Package Leak Tester - Vacuum Decay / Pressure Decay for Pharmaceutical Packaging

Product catalog summary
Overview
The C690M Nondestructive Package Leakage Detector utilizes vacuum and pressure decay methods for detecting trace leakage in pharmaceutical packaging, such as vials, ampoules, and prefilled syringes. It adheres to ASTM F2338 and other standards.

Features
  • Multi-stage Vacuum: Offers dual methods for flexibility, automatic clamping, customizable vacuum settings, and a transparent test chamber. An optional oil-free vacuum pump is available.
  • Precise Data: Utilizes advanced pressure detection and microflow control technology for stable and accurate data. Components are traceable to NIST, ensuring high repeatability.
  • Intelligent Control: Features a 12.1" touch tablet with Windows OS, real-time pressure curve display, automatic result calculation, and connectivity options for data transmission.
  • Security Compliance: Meets GMP requirements, supports multi-level user permissions, and includes electronic signature capabilities per 21 CFR Part 11.

Test Principle
The sample is sealed and vacuumized in a test cell. 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, injection bottles, and flexible packaging bags.

Technical Parameters
  • Test Range: 2 to 8 um, with a detection lower limit of ≤2 um and resolution of 0.1 um.
  • Pressure Range: -100 to +100 kPa.
  • Sample Size: ≤Φ45 mm×80mm, customizable for larger samples.
  • Gas Specification: Requires user-provided compressed air at 0.5 MPa~0.7 MPa.
  • Dimensions and Power: 12” H x 22” W x 15” D, 120VAC or 220VAC options.

Product Configuration
  • Standard Configuration: Includes mainframe, tablet computer, software, flow meter, and vacuum pump.
  • Customization: Test cells and reference samples can be customized.
  • Optional Parts: GMP system requirements, 21 CFR Part 11 compliance, air compressor, and additional documentation.
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Catalog excerpts

Labthink C690M CCIT Nondestructive Package Leak Tester - Vacuum Decay / Pressure Decay for Pharmaceutical Packaging-1

C690M Nondestructive Package Leakage Detector is based on the vacuum decay method and pressure decay 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 syringes and so on. • Dual methods of vacuum decay and pressure decay provide the flexibility to accommodate various types of package samples. The system features automatic clamping method to fasten test chamber reliably. The target vacuum degree can be set by the operator to meet detection requirements of different samples. A custom made transparent test chamber facilitates easy observation of the sample state. Built-in European oil-free vacuum pump, which is maintenance-free and pollution-free (optional). 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. 12.1" embedded touch tablet computer with Windows OS. The pressure curve is displayed in real time, and the test results are counted automatically. Labthink Instruments Co., Ltd. 144 Wuyingshan Road, Jinan, P.R.China (250031) Phone: +86-531-85068566 FAX: +86-531-85062108 Labthink International, Inc. 200 River's Edge Drive, Medford, MA, 02155, U.S.A. Phone:+1-617-830-2190 FAX: +1-781-219-3638

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Labthink C690M CCIT Nondestructive Package Leak Tester - Vacuum Decay / Pressure Decay for Pharmaceutical Packaging-2

• Leakage rates are calculated automatically. • 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 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...

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Labthink C690M CCIT Nondestructive Package Leak Tester - Vacuum Decay / Pressure Decay for Pharmaceutical Packaging-3

Technical ParametersTable 1: Test Parameters Note 2 Test Range Parameter \ Model um (Reference aperture size USP1207) Detection Lower LimitResolution um GMP computer system requirements Table 2: Technical Specifications Test Cell Sample Size Sample Quantity Port Size Dimensions Power Compressed air (Air source is provided by the user) Table 3: Product Configuration Standard Optional Parts Mainframe, embedded tablet computer, software, flow meter, vacuum pump, $6 mm polyurethane tube Test cell, negative standard reference sample and positive standard reference sample designed according to the...

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Labthink C690M CCIT Nondestructive Package Leak Tester - Vacuum Decay / Pressure Decay for Pharmaceutical Packaging-4

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: Samples beyond the "Sample Size" can be customized, but the lower detection limit and test range will change according to the sample size, the actual delivery shall prevail. Labthink Instruments Co., Ltd. 144 Wuyingshan Road, Jinan, P.R.China (250031) Phone: +86-531-85068566...

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