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Under normal circumstances, the temperature value at each point in the chamber should not be lower than the temperature value of the device's own control system. The United States Pharmacopoeia USPXXIII states that for dry heat sterilization and depyrogenation systems operating at temperatures above 250 °C, the acceptable acceptable range for no-load heat distribution within the sterilization chamber is ±15 °C. (GMP Validation Guide 2003P253)
The sterilization procedure gives the standard dry heat time of the sterilized product FH ≥ 30, the sterilization temperature coefficient Z value is 20 ° C when dry heat sterilization, and the Z value is 54 ° C when the pyrogen is removed ( GMP Validation Guide 2003P319)
For the verification scheme, because the requirements of each company are different, the schemes are also very different. Some are just to look at the general temperature of the sterilizer, so that you can do it with your heart, and some have to be in line with the international. National GMP or US FDA standards are strictly verified. Some foreign-funded enterprises do more than 20 cycles of light-to-air heat distribution, because different probes may have different cold spots, and full-load experiments are more complicated. The impact of the cold spot is great. The verification plan shall include the manufacturer of the equipment to be verified, the equipment number and model number; the name, model, certificate (NIST accuracy traceability), calibration equipment, etc. of the verification equipment, probe layout diagram, verification summary, operation supervisor and other relevant personnel.
The FH value refers to the sterilizing heat intensity (minutes) in dry heat sterilization, and is a standard dry heat sterilization time with reference to the reference temperature T0 = 170 °C.
The formula for calculating FH is as follows:
FH=When calculating sterilization, Z should be 20 °C; except for heat source, Z should be 54 °C.
Calculation and interpretation of FH value * According to the People's Republic of China pharmaceutical machinery industry standard JB/T20093-2007 "Antibiotic bottle table cold tunnel sterilization dryer": dry sterilization sterilization heat intensity FH (min), It is obtained with reference to the standard dry sterilization time at the reference temperature T0 = 170 °C. The eligibility criteria are FH ≥ 1365. Calculated as follows:
FH=∑△t10(T1-T0)/z
Where: T1 - measured temperature;
T0 - guaranteed temperature for sterilization at 170 ° C
Z - the sterilization rate of the temperature change is increased, the depyrogen is 54 and the sterilization is 20
△ t - sterilization time, such as taking one data every half minute, and calculating FH value of 10 data in 5 minutes, then Δt is 0.5.
Adding the FH value is the FH value of the channel for 5 minutes (such as taking one data every half minute, adding 5 data to 5 minFH)
The second part of the old-fashioned dry heat sterilizer is designed according to the actual sterilization temperature of 260 degrees. Therefore, after 30 minutes of sterilization, the FH value is calculated as ∑10 (260-170)/54=1392, and the result is greater than 1365.
The new dry heat sterilizer is designed according to the actual sterilization temperature of 320 degrees, so after 5 minutes of sterilization, the FH value is calculated as ∑10 (320-170) / 54 = 2997.
At present, in the software of ValteSoft version 4.3 provided by Yan Fu Technology, the T0 taken by dry heat sterilization (except pyrogen) is 170°C or 250°C, and the Z value can be 20, 46.4, 54 and so on. Can be adjusted for different needs of enterprises. Therefore, in actual use, please adjust the temperature value and Z value of T0.
Dry heat sterilization monitoring method 1) Indicative strain: Bacillus subtilis var. niger spore (ATCC9372), and the bacterial microbial amount is 5.0×10 5 cfu/piece to 5.0×10 6 cfu/tablet. The resistance should meet the following conditions: at a temperature of 160 ° C ± 2 ° C, the D value is 1.3 min ~ 1.9 min, the survival time is ≥ 3.9 min, and the death time is ≤ 19 min.
2) Detection method: The Bacillus subtilis spores were separately placed in a sterile test tube (1 piece/tube). Within the diagonal of the sterilizer and each door handle, two test tubes containing the bacteria are placed at the outer corners, the test tube cap is placed next to the test tube, and the door is closed. After a sterilization cycle, the temperature is lowered to 80 ° C. Remove the test tube cap and remove the test tube. Under sterile conditions, ordinary nutrient broth medium (5 ml/tube) was added and cultured at 36 ° C ± 1 ° C for 48 h. The preliminary results were observed, and the sterile growth tube was further cultured until the seventh day.
3) Judgment of results: If the broth tube inoculated for each indicator tablet is clarified, it is judged to be sterilized. If the broth tube inoculated by one of the indicated tablets is turbid, it is judged to be unqualified, and it is difficult to determine the broth tube. 0.1 ml was inoculated on a nutrient agar plate, spread with a sterile L rod, and cultured at 36 ° C ± 1 ° C for 48 h, observe the colony morphology, and do smear staining microscopic examination to determine whether there is indicator bacteria growth, if there is indicator bacteria Growth, was judged to be unqualified by sterilization; if there is no indicator growth, it is judged to be sterilized.
Verification of damp heat sterilization sterile powder needle moist heat sterilization system: rubber plugs, equipment parts, tools, containers, and sterile clothes for aseptic dispensing are generally sterilized by autoclave and transferred to no Used in the bacterial production area.
Standard: In the large load state of zui, the result of the heat penetration test reaches the exposure time of the Zui cold-point sterilized article is 121 ° C ≥ 15 min, that is, F0 ≥ 15. (P255-266)
Recommended sterilization procedure:
Sterile overalls 121 ° C 35min
T-shaped rubber plug, aluminum cover 121 ° C40min
Removable and washable large-volume injection and small needle preparation tank, etc. 121°C40min
Filter 121 ° C 40 min
(P354)
The heat distribution test uses at least 10 or more calibrated standard thermocouples to perform three or more consecutive tests under no-load conditions to demonstrate the various points in the empty sterilizer chamber (including the zui cold spot). The difference in temperature during each sterilization procedure is ≤±1°C. (P256)
When the product reaches the sterilization temperature until the start of cooling, the temperature change should be kept within ±0.5 °C.
For statistical analysis of the experimental data, the difference between the zui cold spot and the average temperature of the chamber should not exceed ±2.5 ° C. If it exceeds the description, the equipment performance is too poor or there is some kind of failure. There is a good heat distribution state, the difference between the F0 value of the cold spot and the average value of the product F0 does not exceed 2.5 (P352-354)
The heating temperature of the temperature dry well was set to: sterilization temperature -10 ° C, sterilization temperature, sterilization temperature + 10 ° C, and the measurement recording time interval was 10 S.
The uniformity of heat distribution, the stage time specified by the sterilization process is the whole sterilization process for heating, heat preservation and cooling of the pharmaceutical industry in the bottle. The temperature at any point inside the sterilization cabinet should reach the temperature specified by the process. Especially in the constant temperature stage, the temperature difference should be ≤0.5 °C. (Pharmaceutical GMP Verification Tutorial P273)
Dry heat sterilization The F0 value of the relative sterilization ability of the dry heat sterilization process is equivalent to the time when the change of time and temperature conditions is converted to 170 ° C, and the Z value is set to 20 ° C or FH value. The BP 1993 edition stipulates that the dry heat sterilization system with only the sterilization goal is to ensure that the small FH value of the zui is greater than 170 ° C for 60 min. Dry heat depyrogenation is generally used in continuous processes (such as tunnel sterilization and pyrogen removal systems). The temperature used is often higher than or equal to 300 ° C. In batch processes (such as dry heat sterilization cabinets), the temperature used is often higher than or It is equal to 220 ° C, but it must be guaranteed that the actual temperature and time of exposure is equivalent to 250 ° C for more than 30 min. (GMP Validation Guide 2003P248)