Automated test apparatus for testing risk and integrity of pharmaceutical filtration membranes and method thereof
An automated test apparatus for risk and integrity testing for pharmaceutical filtration membranes, including at least the following components: a liquid injection inlet, a pump, a fluid pressure gauge, a gas pressure gauge, a plurality of solenoid valves, a plurality of membranes, a gas pressure regulator valve, a pharmaceutical product bottle, and a bubble generation bottle. The automated test apparatus of the present invention is controlled by computer software in connection with an automatic pharmaceutical synthesis apparatus for automated testing. In use of the automated test apparatus of the present invention, it needs only to start the operating system of the automated test apparatus for membrane risk and integrity test after the completion of the automatic pharmaceutical synthesis. The membrane risk and integrity test can be accomplished in a short time by measuring pressures of gas and liquid with pressure gauges deposed online concurrently.
1. An automated test method for risk and integrity of a pharmaceutical filtration membrane comprising:
(1) risk testing by gas, comprising the following steps:
Step S 11 : passing nitrogen or an inert gas of 5 psi gauge pressure through the pharmaceutical filtration membrane disposed in a dried state;
Step S 12 : conveying nitrogen or inert gas into bubble bottles through a solenoid valve to observe conditions of bubble generation;
(2) risk testing by liquid, comprising at least the following steps:
Step S 21 : passing a pharmaceutical product through the pharmaceutical filtration membrane for filtration with nitrogen or an inert gas in a range of 20-25 psi gauge pressure;
Step S 22 : collecting the pharmaceutical product in a pharmaceutical vial after the filtration;
Step S 23 : passing nitrogen or an inert gas through the membrane in a moist state and checking the gauge pressure and, if it has remained the same as in step S 21 , it is determined that no hole exists, and if it is now in a range of 5-12 psi, it is determined that a hole exists in the pharmaceutical filtration membrane;
(3) integrity test by gas, comprising at least the following steps:
Step S 31 : passing nitrogen or an inert gas of 20-25 psi gauge pressure through the pharmaceutical filtration membrane;
Step S 32 : checking the gauge pressure to determine if it has remained the same as in step S 31 or it is now in a range of 5-12 psi to determine the integrity of the pharmaceutical filtration membrane after production.
2. The automated test method for risk and integrity of the pharmaceutical filtration membrane of claim 1 , wherein the pharmaceutical filtration membrane in step S 11 is dry and subject to a gauge pressure of 5 psi.
3. The automated test method for risk and integrity of the pharmaceutical filtration membrane of claim 2 , wherein the gas is nitrogen or an inert gas.