Test of no load leakage rate of lyophilization.
1. What is the leakage rate of lyophilization.
The leakage rate refers to the pressure rise of the freeze-dried case in unit time t (the pressure difference between the initial pressure P1 and the end pressure P2). Leakage rate = (p2-p1) * V / T
2. The specific operation process is as follows (take rtfd-gzl-2 as an example).
1) Wipe the water inside the drying bin and cold trap to make sure there is no liquid;
2) Wipe the sealing strip to make sure there are no foreign matters. If the sealing strip is aged, please replace the same type of sealing strip;
3) Close the box door and valve, connect the vacuum gauge and the vacuum pump (there must be a stop valve between the vacuum pump and the box);
4) Start vacuum pump. When the vacuum value is close to the limit vacuum of the equipment (such as 5pa (0.05mba)), close the stop valve and the vacuum pump. The time T1 and vacuum P1 were recorded;
5) Keep the pressure for a certain time (more than 30min), and record a value every 5 minutes;
6) Time T2 and vacuum value P2 were recorded at the end;
7) Calculate the volume of the current box V (m 3);
8) Calculate the leakage rate: (p2-p1) * V / (t2-t1);
P1 and P2 are in PA or MBA
T1 and T2 are in S
V in M 3
9) The final test leakage rate ≤ 0.025 PA * m 3 / s or 0.00025mba * m 3 / S is qualified.
The above content is the detection of leakage rate under no-load condition. The purpose of no-load leakage rate detection is to check whether the freeze-dried chassis, cold trap, plate layer and other parts are qualified;
The detection of full load leakage rate of lyophilizer is an important basis for testing the performance of equipment and judging the end point of lyophilizer.
