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1, usually using 250 ° C, the time is not less than 45 minutes;
2, at 250 degrees, 1min, FH = 30.3;
3, then 45 minutes, its FH value is 30.3 * 45 = 1363.5;
4, then is it greater than the basic requirement FH is equal to 1000?
5. The 2000 edition of the Pharmacopoeia is no less than 30 minutes (FH = 30.3 * 30 = 909.1), so why did the revision in 2005?
6, because the 250 degrees here is the temperature inside the chamber, not the internal or surface temperature of the item, nor the temperature of the low point of zui, so increase the time by 15 minutes! The so-called: the temperature is not enough time to make up, the time is added.
Second, the tunnel oven:
1, usually adopt 320 degrees, the time is not less than 4 minutes;
2, it is at 300 degrees (accepted temperature, lower than usual, really!), 1 minute, FH = 255.5,
3, then 4 minutes, the FH value is 255.5*4=1022;
4, then why is it usually used 320 degrees? The reason is the same as above, when the temperature of the bottom of the bottle is 320 degrees, the temperature inside the bottle will reach 300 degrees. "To increase the output, you have to increase the temperature, the temperature is not uniform, you have to increase the temperature, make up It is temperature, one time, one temperature.
Dry heat sterilization FH value calculation SDA I do not know why? FH is greater than 1400. Accurately it is 1364.
The dry heat standard temperature is 170C and the Z is 54.
F(T)=10^((T-170)/Z)
F(320)=10^((320-170)/54)=600, that is: 320C1 minutes is equivalent to standard temperature (170C) 600 minutes 320C, 10MIN, F(H)=6000(5995).
The tunnel oven is set at 320 degrees, but it can't reach 320C in the whole process. Our company is 5 minutes.
In the experience I have done, F(H) is between 2000 and 3000. Why? The normal calculation is to start with a temperature rise of 100 degrees and a temperature of 100 degrees, and the calculation should be included in the FH value. The calculation of the FH value is a set of inverted buckles. Even if it is lower than the normal standard of the pharmacopoeia, the FH value can reach more than 1000, but this is a bit cumbersome to calculate.
From the data report, foreign production can meet the requirements of sterilization and pyrogen removal, and its FH≥1000. According to the requirements and formulas of the Chinese version of the Pharmacopoeia, it is considered that the empty bottle FH ≥ 1400 is appropriate. By calculation: When FH ≥ 1400, the exposure (sterilization) time of the ampoule at 300 ° C must be greater than 3.45 min. Therefore, the sterilization procedure for the continuous tunnel sterilization oven is: 300 ° C, more than 4 min can meet the process requirements.
Comparison of the advantages and disadvantages of dry heat and damp heat
Dry heat sterilization problem 1. Open the door for 100-level purification hot air circulation bellows: