MK-500H Non-Destructive Leak Tester MK-500H Non-Destructive Leak Tester , Adopting a nondestructive 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 • Branded vacuum components for stable performance and durability • Instrument can perform qualitative and quantitative testing • With adequate password protection, divided into three 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. • 10-inch embedded industrial control all-in-one machine, humanized operation is more convenient • The instrument is equipped with RS232 serial port to support data transmission over LAN and ISP online upgrade function to meet customers' individual requirements. • User hierarchical authority settings to meet GMP requirements, test records audit trail function 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. 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 Add:Building BIO, LukunTianhong Chuanggu, Licheng District, Jinan, Shandong Province,China E-mail: [email protected]

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: ASTM F2338 , USP1207 , YY/T 0681.18-2020 Basic For microleakage detection of ampoules, vials, injection vials, lyophilized powder Applications vials and pre-filled packaging samples. Technical Specifications detection sensitivity Testing time Equipment test system Vacuum Source test chamber Applicable products Detection Principle Instrument Dimension weights relative humidity Power...

Standard: Main unit, vacuum pump, micro printer, embedded computer, test chamber Optional: Micro flow meters, positive specimens, test chambers of different sizes 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, Shandong...