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Saicheng Non-destructive Leak Tester MK-500

Saicheng Non-destructive Leak Tester MK-500

Saicheng Non-destructive Leak Tester MK-500

Product catalog summary
Overview
The MK-500 Non-Destructive Leak Tester is designed for micro-leakage and package seal integrity testing of various pharmaceutical packaging such as ampoules, vials, and pre-filled packaging samples. It employs a vacuum decay method for non-destructive testing, ensuring the integrity of the sample post-test.

Product Features
  • Interchangeable test chambers for different sample types, enhancing adaptability and cost-efficiency.
  • Capable of detecting both small and large leakage holes, providing clear pass/fail results.
  • Non-destructive testing ensures samples remain usable post-test, with low testing costs.
  • Automated testing process completed in approximately 30 seconds, ensuring accuracy and objectivity without manual intervention.
  • Utilizes deterministic and quantitative detection methods with imported vacuum components for stability and durability.
  • Features password protection with four levels of authority management for secure operation.
  • Complies with GMP requirements for data storage, processing, and export in immutable formats.
  • Includes a micro-printer for comprehensive test information output and data backup in a non-editable database format.
  • Equipped with RS232 serial port for LAN data transmission and ISP online upgrades.
  • Optional specialized computer software available.

Principle
The tester operates on the vacuum attenuation method, compliant with ASTM F2338-09 and USP 40-1207 standards. It uses dual sensor technology to detect pressure changes and determine leakage by comparing with standard values.

Standards
Conforms to ASTM F2338, USP1207, and YY/T 0681.18-2020 standards.

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

Technical Specifications
  • Vacuum: 0 ~ -100 kPa
  • Detection Sensitivity: 1 ~ 3 μm
  • Testing Time: Around 30 seconds
  • Test System: Dual Sensor Technology
  • Vacuum Source: External vacuum pump
  • Test Chamber: Customized according to samples
  • Applicable Products: Vials, ampoules, pre-filled seals
  • Detection Principle: Vacuum attenuation method/non-destructive testing
  • Instrument Dimension: 520 mm(L) × 320 mm(B) × 350 mm(H)
  • Weight: 20 kg
  • Environmental Temperature: 15℃ ~ 30℃
  • Relative Humidity: <80%RH, condensationless
  • Power Supply: 220 V

Configurations
  • Standard: Main unit, vacuum pump, micro printer, touch LCD, test chamber
  • Optional: Computer software, communication cables

Note: Saicheng Instrument is committed to continuous innovation and improvement, and technical specifications may change without notice. Visit global.saicheng.cn for updates. Saicheng Instrument reserves the rights of final interpretation and revision.
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Catalog excerpts

Saicheng Non-destructive Leak Tester MK-500-1

MK-500 Non-Destructive Leak Tester MK-500 Non-Destructive Leak Tester, Adopting a non-destructive test method and using the vacuum decay method test principle, it is specialized in micro-leakage and package seal integrity testing of ampoules, vials, injection vials, lyophilized powder injection vials and pre-filled packaging samples. • For different test samples can be equipped with corresponding test chamber, the user can easily replace, in order to meet more kinds of samples, minimize the cost of the user, so that the instrument has a better detection of adaptability. • Suitable for detecting small leakage holes, but also can identify large leakage hole samples, and give qualified and unqualified judgment • Adopt non-destructive testing method to detect the leakage of the package containing the drug, no damage to the sample after the test does not affect the normal use of the test, low test cost. • Non-subjective judgment of the test results, each sample testing process is completed in about 30s, without manual participation, to ensure the accuracy and objectivity of the data • The instrument utilizes both deterministic and quantitative detection methods • Imported brand vacuum components, stable performance and durability • With adequate password protection, divided into four levels of authority management, each operator has a unique combination of login name and password to enter the instrument operation • Meet the GMP requirements of data local storage, automatic processing, statistical test data functions, and export in a format that can not be modified and deleted, to ensure that the test results of the permanent storage • The instrument comes with a micro-printer, which can print the serial number of the equipment, sample lot number, laboratory personnel, test results, test time and other complete test information. • The original data is backed up on the computer in the form of a database that cannot be changed and can be exported in PDF format. • The instrument is equipped with RS232 serial port to support data transmission over LAN and ISP online upgrade function to meet customers' individual requirements. • Optional: specialized computer software Fully compliant with ASTM F2338-09 standard and USP 40-1207 regulatory requirements, based on the principle of vacuum attenuation method with dual sensor technology and dual circulation system. 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-500-2

The main unit of the Micro Leakage Tester is connected to a test chamber specially designed to hold the package to be tested. The instrument evacuates the test chamber, forming a pressure difference between the inside and outside of the package. Underpressure, the gas inside the package diffuses through the leakage holes into the test chamber, and the dual-sensor technology detects the relationship between time and pressure changes, compares them with the standard values, and determines whether the sample is leaking or not. This test instrument conforms to many national and international standards:...

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Saicheng Non-destructive Leak Tester MK-500-3

Packaging Material Testing Instrument Manufacturer Standard: Main unit, vacuum pump, micro printer, touch LCD, test chamber Optional: Computer software, communication cables Please Note: Saicheng Instrument is always dedicated to the innovation and improvement of product performance and functionality. Therefore, technical specifications are subject to change without further notice. Please visit our website at global.saicheng.cn for the latest updates. Saicheng Instrument reserves the rights of final interpretation and revision. Add:Building BIO, LukunTianhong Chuanggu, Licheng District, Jinan,...

 Open the catalog to page 3

All Jinan Saicheng Electronic Technology Co.,LTD catalogs and technical brochures

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