1. Concepts Between Steam Sterilizer and Dry Sterilizer:
(1) Moisture heat sterilization verification: the verification is mainly for the product, sterilization equipment and loading method. Verification activities include: Check the performance of sterilization cabinets by designed sterilization parameters, establish product sterilization procedures and loading methods of the effectiveness and reproducibility, estimate the changes that may occur during the sterilization process. (moisture heating sterilization (118-134 ° C) – steam, superheated water).
(2) Sterilization cabinet verification: mainly used for packaging glass containers or metal products for sterilization and remove the heat source, the sterilization procedures should be verified by the test. (Dry heat sterilization (160-320 ° C) – hot air) dry heat.
2. Verification Purposes Between Steam Sterilizer and Dry Sterilizer:
(1) Moisture heat: Seek adequate data and documentation based on a series of validation tests to find the most effective and reasonable sterilization parameters and apply the steam sterilization equipment and sterilization process parameters to the sterilization process. To demonstrate the reliable and reproducible of the process and sterilization effect of each of the saturated steam sterilization processes. Mainly applicable to the products that could withstand high temperature, high pressure saturated steam.
(2) Dry heat: intermittent or tunnel hot air sterilization is often used to deal with items that can withstand higher temperatures and are not suitable for use with hot and humid sterilization methods such as glass bottles, powders, oils, glassware, stainless steel equipment and so on.
3. Sterilization Principle Between Steam Sterilizer and Dry Sterilizer:
(1) Moisture heat sterilization – leading to critical proteins and enzymes in the cells that undergo thermal denaturation or coagulation, and the humidity contributes to the destructive process.
(2) Dry heat sterilization – microbial oxidation rather than protein denaturation.
4. sterilization Crafts Between Steam Sterilizer and Dry Sterilizer:
(1) Moisture heat: It adopts saturated steam as sterilization medium.
(2) Dry heat:
(2.1) Residual probability method: the method is 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.
(2.2) Excessive killing: the method 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 remaining after sterilization is less than 10 -6, and the dry heat sterilization value F H obtained by the “sterilization” sterilization procedure allows the total amount of dry heat sterilized biological indicator The amount dropped by 12 log units.
(2.3) 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:
a. Moisture heating type: steam sterilizer, fast-type sterilizer, pulsating vacuum sterilizer, water bath sterilizer.
b. Dry heat type: convection intermittent, that is, dry heat sterilization oven, convection continuous, that is, tunnel dry heat sterilizer.
6. Performance Verification Between Steam Sterilizer and Dry Sterilizer:
Installation confirmation and operation confirmation is usually done by the equipment supplier and the user of the unit together, the supplier confirms through the operation, and adjust the sterilization equipment to the appropriate working condition while training business personnel. The performance of the moisture heat and dry heat sterilization equipment is confirmed by the user of the autoclave. The validation test should confirm the reliability of the sterilization operation and the reproducibility of the sterilization procedure, depending on the set sterilization procedure.
(1) Moisture heat: Conduct thermal distribution test of sterilization cabinet, heat sterilization penetration test and sterilization effect confirmation after various sterilized products are fully loaded.
Heat distribution test: thermal distribution test of sterilization cabinet, heat penetration test of various sterilized products in full load mode, confirmation of effect test of steam sterilization.
Thermocouple Correction: Correct the results of the thermal distribution test.
No-load thermal distribution test: at least 10 standard thermocouples as the temperature probe, the temperature difference should be ≦ ± 1 ℃.
Load the thermal distribution test: the temperature difference should be ≦ ± 1.5 ℃.
(No load sterilization means products will not be 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 set sterilization conditions. The process requires that the sterilization control sensor is located at the cold spot in the sterilization cabinet.)
u heat 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 set sterilization conditions.
(2) Dry heat type: no-load heat distribution test, full load heat distribution test, heat penetration test and sterilization, heat source remove 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 ℃.
Heat distribution test: temperature difference should be <± 1 ℃.
Full load heat penetration test: test air heat penetration status and “ cold point”,”heat point” position.
Heat penetration test.
Sterilization, heat source remove the verification.