Solution Details

2020year5moon14On [date], the Drug Evaluation Center of the National Medical Products Administration issued a notice on the technical requirements for the consistency evaluation of quality and efficacy of generic drugs for chemical drug injections（2020Year's Day2The physical integrity testing method (such as pressure) can be used for the sealing of the packaging system in the article/Detect vacuum attenuation, etc.

2020year10moon21Recently, the Drug Evaluation Center of the National Medical Products Administration released the "Technical Guidelines for Sealing Research of Chemical Drug Injection Packaging Systems"(trial implementation)》The article clearly proposes that the sealing inspection method can be tested using deterministic methods such as "pressure attenuation method" and "vacuum attenuation method".

For the understanding of the document, we recommend using differential pressure measurement method:

l advantage

u Low testing cost

u Leakage can be quantified and digitally managed for more efficient quality control

l principle

Place the workpiece and reference piece into two sealed chambers, and then apply pressure to the chambers. If the workpiece leaks, the pressure inside the cavity will decrease, thus detecting the leak. However, if there is a large leakage in the workpiece, pressure will fill the interior of the workpiece while applying pressure,Unable to measure correctly.

In packaging system leak testing, measuring large leaks is a key point. Need to be able to measure both large and small leaks. Small leakage refers to sealing the workpiece in a closed chamber and measuring the small pressure drop caused by the pressure leakage from the sealed chamber into the workpiece. Large leakage measurement is the process of dividing the air inside a sealed chamber into an expanded volume tank and measuring the resulting differential pressure

Place the test workpiece into a sealed chamber and apply pressure

Test I: Conduct a small leak test: If a non-conforming product (small leak) is detected during the test, the equipment will be shut down and an alarm will be triggered

Test II conducts a large leakage test: After passing Test I, open the expansion tank and test the differential pressure after partial pressure