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Labthink Instruments Co., Ltd.
Leak testing machine for ampoules and vials | Micro Leak Testing

Leak testing machine for ampoules and vials | Micro Leak Testing

Product catalog summary

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

Features:

Multi-stage Vacuum: Offers dual methods for flexibility, automatic clamping, customizable vacuum settings, and a transparent test chamber. Includes an optional oil-free vacuum pump.
Precise Data: Utilizes advanced pressure detection and microflow control technologies 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 electronic signatures per 21 CFR Part11, and offers configurable user permissions.

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, and injection bottles.

Technical Parameters:

Test Range: 2 to 8 um, with a detection lower limit of ≤2 um and a resolution of 0.1 um.
Pressure Range: -100 to +100 kPa.
Sample Size: ≤Φ45 mm×80mm, with customization options available.
Power: 120VAC±10% 60Hz or 220VAC±10% 50Hz.

Product Configuration:

Standard Configuration: Includes mainframe, tablet computer, software, flow meter, vacuum pump, and polyurethane tube.
Customization: Test cells and reference samples can be customized.
Optional Parts: GMP system requirements, 21 CFR Part11 compliance, air compressor, and European vacuum pump.

Catalog excerpts

Leak testing machine for ampoules and vials | Micro Leak Testing-1

C690M Nondestructive Package Leakage Detector 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. Multi-stage Vacuum • 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). 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 • 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

Open the catalog to page 1

Leak testing machine for ampoules and vials | Micro Leak Testing-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...

Open the catalog to page 2

Leak testing machine for ampoules and vials | Micro Leak Testing-3

Test Range um (Reference aperture size USP1207) labthink* 2~8~great leakage Detection Lower LimitResolution um 0.1 Pressure Range ExtendedFunctions kPa21 CFR Part11 GMP computer system requirements Table 2: Technical Specifications Test Cell Sample Size Sample Quantity Port Size Dimensions Power Net Weight 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, 06 mm polyurethane tube Test cell, negative standard reference sample and positive standard reference sample designed...

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Leak testing machine for ampoules and vials | Micro Leak Testing-4

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 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

Open the catalog to page 4

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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