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Saicheng Non-destructive Leak Tester MK-2000H

Saicheng Non-destructive Leak Tester MK-2000H

Saicheng Non-destructive Leak Tester MK-2000H

Product catalog summary
Overview
The MK-2000H Non-destructive Leak Tester, also known as the Vacuum/Pressure Decay Leak Tester, is designed for testing micro leakage and package seal integrity of various pharmaceutical packaging such as ampoules, vials, and pre-filled packages. It employs non-destructive testing methods, ensuring no damage to samples and reducing testing costs.

Product Features
  • Non-destructive testing methods for micro-leakage without affecting sample usability.
  • Stainless steel 316 test chamber.
  • Environmental temperature and humidity monitoring with compensation functions.
  • Capable of detecting both small and large leakage holes, automatically determining pass/fail status.
  • Integration of vacuum and pressure decay methods for broad applicability.
  • High accuracy up to 0.03ccm (approx. 2 µm).
  • Customizable test chambers for different sample types.
  • Safe pneumatic protection doors and automatic test result printing.
  • 10-inch industrial control interface for user-friendly operation.
  • Automatic statistical analysis of test results, including yield and distribution plots.
  • Equipped with micro-printer, USB interface, and PC software support.
  • History of test records can be saved and exported in various formats.
  • User authority settings to comply with GMP requirements.

Standards
The instrument complies with standards such as YY/T 0681.18-2020, ASTM F2338-13, ASTM F2095, and USP1207.

Applications
Primarily used for microleakage detection in ampoules, vials, injection vials, lyophilized powder vials, and pre-filled packaging samples.

Technical Specifications
  • Screen Size: 10-inch industrial control all-in-one machine.
  • Test Methods: Vacuum and pressure attenuation.
  • Vacuum: Excellent down to 10 Pa.
  • Accuracy: 0.25 FS.
  • Detection Aperture Accuracy: 1 ~ 2 μm (Optional 5 μm).
  • Detection Sensitivity: Minimum 0.01sccm (Equivalent pore size approx. 1μm).
  • Test System: Dual System Triple Sensor Technology.
  • Instrument Dimension: 650 mm(L) × 360 mm(B) × 590 mm(H).
  • Power Supply: AC 220 V 50 Hz.
  • Net Weight: 40 kg.

Configurations
Standard configuration includes the main unit, micro-printer, and a customizable test chamber. Optional configurations include micro flow meters and various test chambers.

Note
Saicheng Instrument is committed to continuous innovation and improvement, and technical specifications may change without notice. Visit their website for the latest updates.
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Catalog excerpts

Saicheng Non-destructive Leak Tester MK-2000H-1

MK-2000H Non-destructive Leak Tester, also known as Vacuum/Pressure Decay Leak Tester, adopts non-destructive test method, using vacuum decay method or pressure decay method, which is professionally suitable fortesting micro leakage and package seal integrity of ampoules, cilindrical vials, injectable vials, lyophilized powdered vials, and pre-filled package samples. Product Features • Adopting non-destructive testing methods for micro-leakage testing of finished packaging, no damage to the sample after testing does not affect the normal use, effectively reducing the cost of testing • Test chamber made of stainless steel 316 • The host comes with environmental temperature and humidity monitoring device, with temperature and humidity fluctuations in the compensation and calculation function • Used to detect small leakage holes, can also identify large leakage hole samples, the system according to the leakage situation automatically determine qualified and unqualified • Integration of vacuum attenuation method and pressure attenuation method for wider application areas and better applicability • Vacuum/pressure decay method accuracy up to 0.03ccm (approx. 2 ^m) • Wide range of applications, for different samples can be equipped with corresponding test chamber, the user can easily replace the sample • Safe pneumatic protection doors for operating stations, pneumatic clamping of test chambers • Automatic printing of test results at the end of the test, without manual participation, to ensure the accuracy and objectivity of the data • 10-inch embedded industrial control all-in-one machine, humanized operation is more convenient • After the test is completed, the test results are automatically analyzed statistically, including yield statistics, sample normal distribution plot statistics. • Equipped with micro-printer, USB data interface, support PC software measurement and control operation • Automatically save the history of the test records, local query, and can be exported to EXCEL, PDF format for storage • User hierarchical authority settings to meet GMP requirements, test records audit trail function Add:Building BIO, LukunTianhong Chuanggu, Licheng District, Jinan, Shandong Province,China E-mail: [email protected]

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Saicheng Non-destructive Leak Tester MK-2000H-2

This test instrument conforms to many national and international standards: YY/T 0681.18-2020:, ASTM F2338-13 , ASTM F2095, USP1207 Applications Basic For microleakage detection of ampoules, vials, injection vials, lyophilized powder Applications vials and pre-filled packaging samples. Technical Specifications Items Screen Size Test Methods Vacuum Accuracy Detection Aperture Accuracy Test Chamber 10-inch industrial control all-in-one machine Vacuum attenuation and pressure attenuation Excellent vacuum down to 10 Pa Size and type are customized according to the specimen Detection Sensitivity Minimum...

 Open the catalog to page 2

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