Problems of dry heat sterilization and moist heat sterilization
Problems of dry heat sterilization
I. Open the door to the hundred grade purification hot air circulation air box:
1、Usually use 250℃, time not less than 45 minutes;
2, at 250 degrees, 1min, FH = 30.3;
3, then 45 minutes, the FH value is 30.3 * 45 = 1363.5;
4, then is not greater than the basic requirements FH equal to 1000?
5, the 2000 version of the pharmacopoeia is not less than 30 minutes (FH = 30.3 * 30 = 909.1), then why will be in the 2005 version to do so modified?
6, because the 250 degrees here is the temperature of the cavity, not the internal or surface temperature of the item, and not ** low point temperature, so the time will be increased by 15 minutes! As the saying goes: the temperature is not enough time to make up for the time
Second, the tunnel oven.
1, usually using 320 degrees, time not less than 4 minutes;
2, its in 300 degrees (recognized temperature, lower than usual, really!) 1 minute, FH = 255.5,
3, then 4 minutes, FH value is 255.5 * 4 = 1022;
4, then why is usually used 320 degrees? The reason is the same as above, the bottom of the bottle temperature at 320 degrees, the bottle temperature will reach 300 degrees." To increase the output, you have to increase the temperature, the temperature is not uniform more to increase the temperature, the complement is the temperature, a complement time, a complement temperature.
Dry heat sterilization FH value calculation
SDA for some reason, FH is greater than 1400.
Dry heat standard temperature is 170C,Z is 54.
F(T)=10^((T-170)/Z)
F(320)=10^((320-170)/54)=600, that is: 320C 1 minute is equivalent to the standard temperature (170C) 600 minutes
320C,10MIN,F(H)=6000(5995).
Tunnel oven set 320 degrees, but can not reach the whole 320C, our company is 5 minutes.
I have done experience. F(H) is between 2000 and 3000. Why? The normal calculation is to start with a long temperature rise of 100 degrees and end with a temperature drop of **100 degrees, should be included in the calculation of the FH value, so the calculation of the FH value is an inverted ship-shaped collection, even if it is lower than the normal standards of the pharmacopoeia, but still achieve FH values greater than 1000, but this calculation is a bit of trouble.
From the information reported, G outside the production can meet the requirements of sterilization to pyrogen, its FH ≥ 1000. according to the requirements of the G2000 version of the pharmacopoeia and the formula calculation, that empty bottles FH ≥ 1400 is appropriate. Therefore, the sterilization procedure for the continuous tunnel sterilization oven is: at 300℃, it is more than 4min to meet the process requirements.
