For the door of 100 level purifying hot air circulation bellows:
1, usually adopt 250 ℃, time of no less than 45 minutes;
2. At 250 degrees, 1min, FH = 30.3;
3. So 45 minutes, its FH value is 30.3 * 45 = 1363.5;
Is it not greater than the basic requirement FH is equal to 1000?
5. The 2000 edition of the pharmacopoeia is not less than 30 minutes (FH = 30.3 * 30 = 909.1), so why did it do so in 2005?
6. Because the 250 degrees here is the temperature in the cavity, not the interior or surface temperature of the object, nor the lowest temperature, so increase the time by 15 minutes! "The temperature is not enough time to fix, it is time"
1. Usually adopted 320 degrees, not less than 4 minutes;
2. It is at 300 degrees (the accepted temperature is lower than normal, really!). , 1 minute, FH = 255.5,
3. So 4 minutes, the FH value is 255.5 * 4 = 1022;
4. So why is it commonly used 320 degrees? For the same reason, the temperature in the bottle will reach 300 degrees when the bottom temperature is 320 degrees. "to increase the output, raise the temperature, increase the temperature, and increase the temperature, and the temperature will be added."
A patch of time, a patch of temperature, the Chinese is really a big complement ah! The reason is not to say, to fill a gas, anyway the equipment cannot speak, and we have some not efficiency, but time.
Calculation of FH value of dry heat sterilization
What does SDA do not know? FH is greater than 1400. Exactly 1364.
The dry heat standard temperature is 170C, and Z is 54.
F (T) = 10 ^ ((T - 170)/Z)
F (320) = 10 ^ ((320-170) / 54) = 600, that is: 320 c for 1 minute is equal to the standard temperature (170 c) for 170 minutes
320 c, 10 min, F (H) = 6000 (5995).
The tunnel oven set 320 degrees, but not all the way to 320C. Our company has five minutes.
In my experience, F (H) is between 2000 and 3000. Why? Normal calculation is to get the long boom end with cooled to 100 degrees 100 degrees, shall be included in the calculation of the FH value, so the FH value computing is a collection of overturned boat form, even if under standard of pharmacopoeia of normal, still can achieve FH values greater than 1000, but a little bit of a problem to the calculation.
From the data report, foreign production can meet the requirement of sterilization to heat the original, its FH is greater than 1000. According to the requirements and formula of China's 2000 edition of the pharmacopoeia, it is advisable to have an empty bottle of FH greater than 1400. By calculating: when the FH 1400 or higher, ampoule at 300 ℃ (sterilization) exposure time must be greater than 3.45 min. Therefore, the continuous tunnel oven sterilization procedures for: 300 ℃, greater than 4 min can satisfy the technological requirements.
Temperature equipment verification standard
From GMP validation guide 2003
Dry heat sterilization
Evaluation of dry heat sterilization process F0 value is compared with sterilization ability will convert the change of time and temperature conditions of 170 ℃ when the quite time, at the same time set the Z value of 20 ℃ FH value namely. BP1993 edition rules only to sterilization for the final purpose of dry heat sterilization system, must ensure that its smallest FH value is greater than 170 ℃ 60 min. General dry except the pyrogen in the continuous process (such as tunnel sterilization in addition to heat the original system) using the temperature is higher than or equal to 300 ℃, often in the intermittent method (such as dry sterilization cabinet) use often higher than or equal to the temperature of 220 ℃, but must ensure that its exposure to the actual temperature is 250 ℃ and the time for more than 30 min. (GMP validation guide 2003 P248)
In general, the temperature value of each point in the chamber should not be lower than the temperature value of the control system. , notes the United States pharmacopoeia USPXXIII operating temperature higher than 250 ℃ dry sterilization, in addition to the original system in terms of its sterilization chamber indoor light hot distribution of the acceptable range of plus or minus 15 ℃. (GMP validation guide 2003 P253)
Sterilization procedures given FH 30 or more are sterilized product standard dry time, sterilization temperature coefficient value Z value in dry heat sterilization sterilization is 20 ℃, and in removing pyrogen, Z values for 54 ℃ values (2003 P319 GMP guidelines)
To the validation plan, due to the requirement of each company is different, so there are quite different in package, there are only in order to have a look at the temperature of the sterilization cabinet general situation, accomplish know fairly well, to international standard, according to the national GMP or the FDA standard strict authentication, some foreign companies do light heat distribution light more than 20 cycle, because different may have different colors of probe cold spots, more complex and full load experiment, the influence of different loading capacity for cold spots is very big. The verification scheme shall include the manufacturer, equipment number and model of the verification equipment. Verify the name, model, certificate (of NIST precision traceable), calibration equipment, etc., check the drawing, verify the summary, operation supervisor and other relevant personnel.
Wet and heat sterilization
Sterile booster injection of damp heat sterilization system validation: asepsis packing with rubber plug, equipment, spare parts, tools, containers, and smock after autoclave sterilization is generally used to aseptic production area.
Standard: in the condition of maximum load, heat penetration test results to the cold sterilization items exposure time at 121 ℃ for 15 min or more, namely F0 15 or more. (P255-266)
Recommended sterilization procedure:
Sterile overalls 121 ℃ 35 min
T, aluminum cover stopper is 121 ℃ for 40 min
Can unpick and wash with large volume injection and small needle can such as 121 ℃ for 40 min
The filter 121 ℃ for 40 min
Thermal distribution test application at least 10 or more than 10 after correction of standard thermocouple under no-load condition for continuous 3 times or more than 3 times test, to prove that light sterilizer cavity interior various points (including the cold spots) temperature difference in the process of sterilization program runs every time the + / - 1 ℃ or less. (P256)
Began when the product reaches the sterilization temperature until the cooling process, the temperature change should remain within + / - 0.5 ℃.
Analyzing the experimental data for statistics, the most cold spots and chamber average temperature difference between should not more than plus or minus 2.5 ℃, if more than the poor equipment performance or there is a fault. There is a good thermal distribution state, the difference between the F0 value of the cold point and the F0 value of the product is not more than 2.5 (P352-354).
Temperature heating temperature, respectively, set to dry hole: sterilization temperature - 10 ℃, sterilization temperature and sterilization temperature + 10 ℃, the time interval measurement record for 10 s.
Thermal distribution uniformity, sterilization process regulation stage time is inside the bottle of medicine for heating, heat preservation, cooling the entire sterilization process, any temperature inside the cabinet should meet requirements in the process of temperature. Especially constant temperature stage, the temperature difference should be 0.5 ℃ or less. (drug GMP authentication tutorial P273)
FH value means to the thermal sterilization intensity in dry heat sterilization (points), is a reference T0 = 170 ℃ temperature standard dry sterilization time.
The calculation formula of FH is as follows:
FH = when calculating the sterilization, Z take 20 ℃; In addition to the heat source, Z taking 54 ℃.