>>   Vacuum Decay method detectors(Offline)

Instrument is composed of main machine and the test chamber. Put the packaging container which need to test in the test chamber and make it vacuum, Press difference makes the gas inside the container through leak into the test chamber, the pressure sensor inside the instrument wll detect the changes , to compare the pressure value and the reference pressure value to determine whether the packaging container leak or not. The relationship between pressure and leaky hole can be established through the miniature flowmeter, so that the leaky hole size of the packaging container can be obtained.

>>    Vacuum Decay method detectors(Online)

Compliance of Vacuum Decay method

Conforming to USP 1207

ASTM F2338-09 (2020)

Meet the technical requirements of F injection

Comply with the technical guidelines for injection F

Compliance with 21CFR part 11

>>  Leak detection device （Online)

Compliance with the standards and regulations

USP 1207 Low voltage charged method is subordinate to the HVLD method, and HVLD is cited and recommended by USP.  

EU GMP annex 1 2022 Can meet the regulatory requirements of BFS 100% full inspection.

>>   Argo -Offline desktop detector

Based on the law of charge conservation and the principle of electromagnetic field, the detected body is charged. When the inspected body has leakage, it will produce discharge. According to the voltage generated by the discharge and the non-leakage package, it can be judged whether the package is leakage. During detection, a low voltage within 20kV (the voltage relative to the conventional HVLD) is usually applied to the inspected body to energize the inspected body. Traditional HVLD devices are based on the electrification principle of Ohm's law.

Vacuum Decay Method

HVLD(Low voltage) Method

>>   Applicability of vacuum decay method

Can measure gas leakage, also can measure liquid leakage

Can measure negative pressure vessel, also can measure atmospheric pressure vessel

Both flexible and hard packing are available

Conductive or non-conductive liquid inside the package can be detected

Small and large headspace can be tested

Freeze-dried needle products are available

>>   Applicable packaging type: infusion bag, plastic bottle, BFS, blood bag and other pharmaceutical packaging