Various Sterilization Introduction

Sterilization by means of a suitable physical or chemical means to kill microorganisms living in the article or method to remove. This law applies to sterile preparation, raw materials, accessories and medical equipment and other items. Sterile refers to goods does not contain any living micro-organisms. However, for any number of steam bottle sterilizer products, both can not guarantee absolute sterility test can not be used to confirm. Physical or chemical means sterilization tests showed: kill microorganisms on the number of rules to follow, therefore, sterile sterilized items after items sterilization standards generally microbial survival probability – sterility assurance level SAL (Sterility Assurance Level) said. Probability of surviving microorganisms terminally sterilized product shall not exceed 10-6. Sterilized products meet the sterility assurance level can be determined by verification. Sterilization and sterility assurance products can not rely on sterility testing of the final product, but on the process used in the production of qualified sterilization process, strict management and good GMP comprehensive quality assurance system. Sterilization process should be determined by considering the nature of the items to be sterilized, effective and economic method of sterilization, the sterilization integrity and stability of the article and other factors.
Validate the sterilization process is a necessary condition of sterility assurance. Sterilization process validated only after the delivery of official use. Verify that include:
⑴ written verification program and the development of assessment criteria.
⑵ confirm sterilization equipment technical information is complete, correct installation , and can be in normal operation ( Installation Qualification ).
⑶ confirm critical control equipment and instrumentation to the normal operation ( OQ ) within the parameters specified.
⑷ using sterilized items or items repeated simulation tests to confirm compliance with the sterilizing effect ( Performance Qualification ) .
⑸ Summary and improve a variety of documents and records, written verification reports. Daily production in response to the operation of sterilization procedures to monitor, identify key parameters ( such as temperature, pressure, time, humidity, gas concentration and irradiation sterilization absorbed dose absorption, etc. ) are within the range defined in the verification.

Sterilization procedures should be periodically re-verified. When changes (including sterilization load and number of items changes ) occur when sterilization procedures, should be re- verified. Characteristics of the product prior to sterilization and sterility assurance products is the extent of contamination and pollution associated bacteria. Therefore, strict monitoring of microbial contamination levels before sterilization and sterilization product contamination tolerance of bacteria, and to take all measures in all aspects of production to reduce pollution and ensure control of microbial contamination within the specified limits. After sterilization, the sterilized items should prevent recontamination . Under no circumstances, should be required to ensure that the product container and sealing system in the period in line with sterile requirements.
Sterilization methods have used methods of sterilization heat sterilization, dry heat sterilization, gas sterilization, radiation sterilization and sterile filtration method. The method may be employed in combination with one or more items to be sterilized in the sterilization according to the characteristics. As long as the product allows, should be chosen as the final sterilization method ( ie, product packaging to packaging containers after sterilization ) sterilization. If the product is not suitable for terminal sterilization method, the choice of filter sterilization method or sterile production process sterility assurance requirements, whenever possible, to deal with non- terminally sterilized products as complementary sterilization ( such as circulating steam sterilization ).

First, heat sterilization
Items will be placed in this Act shall mean the use of high-pressure saturated steam sterilization cabinet, hot water spray and other means to make the microbial cell protein, nucleic acid denaturation and kill microorganisms. The Act sterilization capability for heat sterilization is the most effective and most widely used method of sterilization. Medicines, container, medium, sterile clothing, and other items stopper when the temperature and humidity do not change or damage are available sterilization law . Live steam can not completely kill bacterial spores, and can be used as an auxiliary heat-sterilized instruments sterile products.
Moist heat sterilization conditions usually 121 ℃ × 20min or 116 ℃ × 40min procedure can also be used with other temperature and time parameters. In short, we must ensure that SAL items after sterilization ≤ 10-6. The thermal stability of the article, can be over- kill method, the SAL should be ≤ 10-12. Standard sterilizing tattoo equipment of heat-sensitive products F0 time may be less than 8min, but it should be in the whole production process, the product of strict monitoring of microbial contamination, and to take all measures to prevent pollution and reduce microbial resistant bacteria pollution levels, ensure that sterilized product sterility assurance requirements.
When using moist heat sterilization, should be sterilized items are packed and loaded the appropriate way to ensure the effectiveness and uniformity of sterilization.
When moist heat sterilization process validation, testing should be conducted heat distribution, heat penetration testing and validation testing of biological indicators. To determine the distribution of heat sterilizer load and load when the different chambers and the possible existence of cold spots; under no-load conditions, the temperature difference is recognized when the chamber 121 ℃ points should be ≤ ± 1 ℃; Use temperature probe inserted into the actual items or items within the simulation confirmed sterilizer at different loading, the coldest point of the article standard sterilization time (F0) to reach the set standards; further confirmed when the cold spots at different loading biological indicator sterilized items at a sterility assurance level. Law is commonly used biological indicators Bacillus stearothermophilus spores (Spores of Bacillus stearothermophilus).

Second, the dry heat sterilization
Law refers to items in the dry heat sterilizer, sterilization tunnel and other equipment, the use of dry and hot air to kill the microbes or eliminate pyrogen approach. But not suitable for high-temperature sterilization with moist heat sterilization sterilization items, such as glassware, metal containers, fiber products , solid reagents, liquid paraffin etc Act can be sterilized.
Dry heat sterilization conditions is generally 160 ~ 170 ℃ × 120min above , 170 ~ 180 ℃ × 60min or more, or 250 ℃ × 45min or more , may also have other temperature and time parameters. In short, should ensure that their products after sterilization SAL ≤ 10-6. After the dry heat over the killing of products SAL should ≤ 10-12, this time items generally determined prior to sterilization without microbial contamination. 250 ℃ 45min dry heat sterilization can also be removed by aseptic packaging containers and related equipment in the production of filling pyrogenic substances.
When using dry heat sterilization, should be sterilized items are packed and loaded the appropriate way to ensure the effectiveness and uniformity of sterilization.
Dry heat sterilization and moist heat sterilization validation same test should be carried out heat distribution, heat penetration test, validate biological indicator inactivation of bacterial endotoxin test or validation tests. To confirm the sterilizer temperature distribution in compliance with the standards set, to determine the coldest point, confirm the coldest point standard sterilization time (FH) can reach the set standards and achieve SAL requirements. Commonly used as a biological indicator Bacillus subtilis spores (Spores of Bacillus subtilis). Inactivation of bacterial endotoxin test in addition to verification test is to prove the effectiveness of pyrogenic process. Will generally not be less than 1,000 units of the bacterial toxin to be added to the items of pyrogen, the pyrogen- proof inner process can go down at least three pairs of endotoxin unit. Bacterial endotoxin test to verify inactivation of bacterial endotoxin used generally within Escherichia coli endotoxin (Escherichia coli endoxin). When validated, the general maximum loading mode.

Third, the radiation sterilization
Law refers to the electron beam sterilization product in the γ-ray radiation sources suitable or desirable for the occurrence of electron accelerators ionizing radiation to kill the microorganisms. Law is the most commonly used 60Co-γ ray radiation sterilization. Medical equipment, containers, production aids, from radiation damage of pharmaceutical raw materials and finished products etc. Sterilization Act is available.
Radiation sterilization sterilization method using sterile product which SAL should ≤ 10-6. γ -ray radiation sterilization is mainly controlled by the parameters of the radiation dose ( absorbed dose refers sterilized items ). The dose should be considered sterile goods develop adaptability and the maximum number of possible microbial contamination and the strongest anti- radiation, the dose should be used in advance to verify its effectiveness and safety. The absorbed dose of radiation sterilization used as 25kGy. The final product, bulk drugs, certain medical equipment sterilization should be used whenever possible low radiation dose. Before sterilization, items to be sterilized response quantity of microbial contamination and radiation intensity was measured to evaluate the sterilization process of the sterilized items given sterility assurance level.
When sterilization should be appropriate chemical or physical methods for sterilizing articles absorbed radiation dose monitor the extent to fully confirm the sterilization dose is absorbed in the article required. Such as the use of radiation and sterilization items are together radioactive dosimeters, dosimeter to put the provisions of the site. Dosimeter in the early installation using standard calibration source and regularly re- calibration.
When 60Co-γ ray radiation sterilization validation, verification testing in addition to biological indicator, it should also confirm that the radiation dose distribution of load and loading chamber sterilization, sterilization items absorbed dose and the maximum and minimum absorption dose distribution uniformity, loading patterns sterilization chamber and other items sterilized items. Commonly used as a biological indicator Bacillus pumilus spores (Spores of Bacillus pumilus).

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