Product Introduction:

Specifically designed for the integrity testing of package seals, this instrument utilizes the vacuum decay + pressure decay method. It is a completely non-destructive testing technology suitable for non-destructive micro-leakage testing of various empty/pre-filled syringes, ampoules and powder vials (glass/plastic), filled capped bottles, other rigid packaging containers, and electrical components.

Technical Features：    

? Industrial-grade touch screen computer with Windows operating system for real-time viewing of test data and curves;

? Uses the principle of dual sensors for vacuum and micro-pressure difference for non-destructive testing of package seals;

? Precise pressure testing system improves testing accuracy significantly;

? Uses world-renowned pneumatic components,micro-pressure difference and pressure sensors for stable and reliable performance;

? Multiple levels of vacuum can be preset for analyzing the leakage pressure of samples;

? The test chamber uses a pneumatic clamping method, which facilitates the replacement of the test chamber while ensuring the sealing of the entire testing system;

? One-click operation with an intuitive interface that can be remotely upgraded and maintained;

? Adjustable vacuum, testing, and infiltration times are stored in a database to ensure consistency of testing conditions;

? Real-time display of test curves with intelligent data statistics for easy and quick viewing of test results;

? Complies with China GMP requirements for data traceability, meeting the needs of the pharmaceutical industry with multi-level permission management settings;

? Automatic data storage and automatic memory in case of power loss;

? Historical data can be quickly reviewed, and it is equipped with a mini printer and standard data interface for convenient data printing and transmission.

Testing Principle:

The main unit is connected to the test chamber, and the sample is placed inside to draw a vacuum. There is a pressure difference between the inside and outside of the sample, and the gas enters the vacuum decay chamber and the main unit through the leak hole. The main unit uses a pressure sensor and a differential pressure sensor to monitor the change in vacuum inside the test chamber, and judges whether the sample is qualified based on the change in vacuum.

Reference Standards:

《Guidelines for the Sealing of Sterile Pharmaceutical Packaging Systems》

《ASTM F2338-13 Standard Test Method for Sealed Packaging - Vacuum Decay Method》

《USP1207 United States Pharmacopeia Standard》

《GMP Guide for Pharmaceuticals-Sterile Pharmaceuticals》 11.1 Seal Integrity Testing

《Chinese Pharmacopoeia》 2020 edition, Part Four Microbiological Examination Method

《Technical Guidelines for the Study of Seal Integrity of Packaging Systems for Chemical Pharmaceutical Injections (Trial)》

Technical Specifications：

Product Configuration:

Standard Configuration： Main unit, keyboard, mouse, mini printer, vacuum pump, test chamber customized according to sample size

Optional Accessories: Mini flowmeter, air compressor, non-standard test chamber, negative control bottles, positive control bottles;

Note: Jinan Zhongke Electronic Technology Co., Ltd. is always committed to the innovation and improvement of product performance and functions. For this reason, product technical specifications and appearance may also change accordingly, and we will not notify separately in the above situations. The company reserves the right to modify and the final interpretation.