How to test sealing of pharma bottles in USP

The sealing of pharma bottles is a topic which is concerned by pharmaceutical workers, the traditional test methods have some cons, like material wastage much,unidentified the leak level and so on. So many countries are being developed new test methods. The USP 1207 of USA  put forward multiple test measures, such as pressure/vacuum decay, tracer gas detection,electrion process and laser method.

pharma bottles

The following is three main methods.

First is vacuum decay, the theory of vacuum decay is that put packaging container in the special test chamber, vacuumize the chamber, the air of the packaging container will enter into the test chamber on account of inner and outer pressure difference,the pressure sensor will detect the pressure change, then compare the pressure changing value with reference value,then you can judge the packaging container whether qualified. The vacuum decay method is a nondestructive and quantitative assay (USP <1207.2>). It detects leaks in nonporous, rigid or flexible packages. Packages with a porous component can be tested by masking the porous package component (USP <1207.2>). The test sample is placed in a closely fitting evacuation test chamber, which is equipped with an external vacuum source (USP <1207.2>). The test chamber plus test system dead space are evacuated for a predetermined period of time (USP <1207.2>). The targeted vacuum level chosen for the test is predetermined on the basis of the test sample type under evaluation (USP <1207.2>). The rise in dead space pressure (i.e., vacuum decay) is monitored for a predetermined length of time using absolute and/or differential pressure transducers (USP <1207.2>). A pressure increase that exceeds a predetermined pass/fail limit established using negative controls indicates container leakage (USP <1207.2>).

packaging for effervescent tablets

Second is Electrical Conductivity and Capacitance Test, which is also known as High Voltage Leak Detection (HVLD). This assay looks for leaks in walls of nonporous, rigid or flexible packaging containing liquid or semi-liquid product (e.g. ampoules) (USP <1207.2> ). During the assay, a high voltage and high frequency charge is applied across the containerclosure system (White, 2012). A detected leak will cause an increase in current across the high voltage electrodes, triggering the reject mechanism for the leak detector (White, 2012). Key factors for the assay include the voltage level, probe positioning, the container-closure system geometry, the wall thickness, and the product formulation.

eye dropper bottle

Third is Laser-based Gas Headspace Analysis.According to detect the change of the pressure,water vapour and oxygen gas of gas headspace of packaging container,to judge the completeness of plastic bottles.The theory is that when the laser penetrate the gas headspace of packaging container,the water vapour and oxygen gas will absorb some laser,the laser absorptive amount is proportional to corresponding matter content.