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The first thing in the packaging test is its tightness, which refers to the reliability of the bag seal, through which the integrity of the packaging seal can be ensured, and the leakage, contamination, deterioration and other problems caused by the poor sealing performance of the product can be prevented.
Packaging system tightness refers to the packaging system of the sample to prevent microbial invasion and maintain the quality indicators of the sample to continue to meet the safety and quality requirements. The study of packaging system tightness begins in the product development stage and continues throughout the product life cycle, which is a key point of production quality research and evaluation, and will refer to the United States Pharmacopeia 1207 series of guidelines for aseptic packaging from the perspective of review.
The LEAK-02 testing instrument is suitable for the tightness test of microbial invasion method, and is widely used in the tightness testing of various materials such as vials, ampoules, infusion bags, pre-filled needles, eye drops, etc., and is suitable for pharmaceutical factories, medical device enterprises, drug inspection, quality inspection departments, etc., also known as vial sealing tester, ampoule sealing tester, infusion bag sealing tester, pre-filled needle sealing instrument and eye drop bottle sealing tester, etc.
Test Principle:The microbial challenge method, also known as the microbial intrusion test, is one of the more common seal integrity testing methods, often performed at the same time as simulated filling. By simulating the filling of the medium according to the simulated filling verification scheme, and then after the tampon and capping, the visual inspection is qualified, and after the sterilization of the verified sterilization cabinet, the sealing surface of the container is immersed in a high concentration of bacterial solution, so that the medium in the sample container fully touches the inner surface of the seal, and the neck of the sample and the outer surface of the seal should be completely soaked in the bacterial suspension, and taken out after soaking for a certain time, and checked for microbial invasion after regular incubation to determine the integrity of the container sealing system. At the same time, a positive control test is required to confirm the growth promotion capacity of the medium.
Reference standard:Refer to the Technical Guidelines for the Study of the Tightness of Chemical Injectable Packaging Systems (Trial), USP<1207> and PDA Technical Report No. 27.