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Comparison Of Verification Of Hot And Humid Sterilization Cabinet And Verification Of Dry Sterilizer

(1)Hot and humid sterilization verification: mainly on the product, sterilization equipment and loading method validation. Verification activities include: sterilization parameters designed against sterilization equipment to check the performance of sterilization cabinets, the establishment of a product sterilization procedures and loading methods of the effectiveness and reproducibility, estimated sterilization process of product changes may occur. (Hot and humidified (118-134 ° C) – steam, superheated water)
(2)Dry sterilizer cabinet verification: mainly used for packaging glass containers or metal products for sterilization and heat source, the use of sterilization procedures should be verified by the test. (Dry heat sterilization (160-320 ° C) – hot air)
2.Verify the purpose:
(1)Damp heat: Provide sufficient data and documentation based on a series of validation tests to find the most effective and most reasonable sterilization parameters and apply the approved steam sterilization equipment and sterilization process parameters to the product Sterilization process to demonstrate that the process and sterilization effect of each saturated steam sterilization process used in the pharmaceutical production process is reliable and reproducible. Mainly applicable to withstand high temperature, high pressure saturated steam products.
(2)Dry heat: intermittent or tunnel hot air sterilization commonly used to deal with can withstand higher temperatures and not suitable for hot and humid sterilization methods such as glass bottles, powder, oil, glassware, stainless steel equipment…
3.Sterilization principle:
(1)Hot and humid sterilization – leading to critical proteins and enzymes within the cell thermal denaturation or solidification, humidity on the destructive process of promoting the role.
(2)Dry sterilizer- microbial oxidation rather than protein denaturation.
4.Sterilization process:
(1)Damp heat: Saturated steam sterilization process with additional exhaust system, saturated steam sterilization process with additional vacuum system, saturated steam sterilization process with additional air pressurization system.
(2)Dry heat:
1)Residual probability method: the law for the purpose of sterilization. It is usually suitable for thermally unstable substances. The sterilization procedure shall ensure that the microbial residual probability of the article after sterilization is 10 -6, that is, the number of stained cells in a million sterilized units shall not exceed one.
2)Excessive killing method: the law is also for the purpose of sterilization. It is usually suitable for materials with good heat resistance. The sterilization procedure shall ensure that the residual probability of the microorganisms in the sterilized product is less than 10 -6, and the dry heat sterilization value FH obtained by the “overgrowth” sterilization procedure allows the total amount of dry heat sterilized biological indicator Down 12 log units.
3)Sterile pyrogen-free method: The purpose of this method is to achieve aseptic and pyrogen-free. In view of the need to achieve the purpose of pyrogen, usually using a higher temperature and longer sterilization time, so the completion of the sterilization process, the probability of microbial residues will be far less than 10 -6. The pyro in descending 3 log units.
5.Commonly used sterilization equipment:
(1)Hot and humid: steam sterilizer, fast-type sterilizer, pulsating vacuum sterilizer, water shower sterilizer.
(2)Dry heat: convection intermittent, that is, dry heat sterilization oven, convection continuous, that is, tunnel dry heat sterilizer.
6.Performance verification:
Installation confirmation and operation confirmation is usually done by the equipment supplier and the use of the unit together, the supplier through the operation to confirm, the sterilization equipment transferred to the appropriate working condition, while training business personnel. The performance of the damp heat and dry heat sterilization equipment is confirmed by the use unit. The validation test should confirm the reliability of the sterilization operation and the reproducibility of the sterilization procedure, depending on the sterilization procedure set.
(1)Hot and humid: the thermal distribution of sterilization test, a variety of sterilizers to be sterilized in the full load method of hot penetration test to confirm the effect of steam sterilization test.
U Thermal distribution test:
Thermocouple Correction: Correct the results of the thermal distribution test
No-load thermal distribution test: at least 10 standard thermocouple to do the temperature probe, the temperature difference should be ≦ ± 1 ℃
Load the thermal distribution test: the temperature difference should be ≦ ± 1.5 ℃
(No load sterilization product is not placed in the sterilization cabinet.) The purpose of the no-load thermal distribution test is to check and confirm that the temperature uniformity of the sterilizer in the sterilization cabinet is in accordance with the product under the intended sterilization conditions The process requires that the sterilization control sensor be located at the cold spot in the sterilization cabinet.)
U Thermal penetration test:
The purpose is to determine the coldest point in the sterilization cabinet loading and to confirm that the point is given sufficient sterile assurance in the intended sterilization conditions.
(2)Dry heat: no-load thermal distribution test, loading thermal distribution test, thermal penetration test and sterilization, to heat source verification. (The verification method of dry heat sterilization oven is similar to that of hot and humid sterilization cabinet. The temperature difference of each point in the chamber should not exceed ± 15 ℃ when the operation is carried out at no less than 250 ℃.
Thermal distribution test: temperature difference should be <± 1 ℃
Load thermal distribution test: the determination of air heat distribution and “cold”, “hot” position
Thermal penetration test
Sterilization, to heat source verification
7.To confirm the sterilization effect of the test: the general use of biological indicators (also known as microbial challenge test) to confirm.
(1)The microorganisms used
Hot and humid: Bacillus stearothermophilus, Clostridium perfringens, Bacillus coagulans or Bacillus subtilis
Dry heat: Bacillus subtilis black variant spores and E. coli endotoxin
(2)Common physical quantities to verify the sterilization effect
Hot and humid: Validated with F0 value (F0 = △ t * Σ10 (T-121) / 10)
Dry heat: the value of FH to verify (FH = △ t * Σ10 (T-T0) / Z, dry heat sterilization, Z value of 20; to heat, Z value of 54), sterilization effect must be guaranteed FH value greater than 60min, to the heat source effect must ensure that FH value greater than 120min.
8.Damp heat and dry sterilizer test results analysis:
Hot and dry heat and have their own characteristics, but in general, hot and humid sterilization effect is more dry and hot, so the use of universal. Damp heat more heat and heat sterilization effect of good reasons are: ① protein in the water for a long time volatile, water content, the more solidification. ② hot and heat penetration, fast conduction. ③ steam with latent heat, when the steam and sterilized items in contact, can be condensed into water and release latent heat, so that the rapid increase in humidity, strengthen the sterilization effect. At the same time, due to dry and hot air on the effect of microbial kill much lower than the hot and humid steam. Therefore, dry heat sterilization requires a higher temperature or longer time.
9.Hot and dry heat sterilization test sterilization conditions difference:
Humidity: 121 ℃, 15min or 115 ℃, 35min.
Dry heat: 160 ~ 170 ℃, 2h or more; 170 ~ 180 ℃, 1h above; 250 ℃, 45min or more.
10.Aseptic guarantee value
The sterilization effect validation should demonstrate that the sterility guaranteed value due to 10-6, the heat source effect validation should be able to demonstrate the sterility guarantee value due to 10-12.

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