Sterilization equipment is the key to ensure the sterility of the goods, and is an important guarantee for the production of excellent, efficient and stable medicines. The pulsation vacuum sterilizer is one of the advanced and advanced advanced sterilization equipments in the domestic market in recent years. Our company has purchased more than 10 sets since 2005. Now we share the problems and solutions we encountered in the use and maintenance, and make a sterilization effect and verification procedure and method for the sterilizer. Brief description.
1 pulsating vacuum sterilizer working principle and characteristics 1.1 pulsating vacuum sterilizer working principle pulsating vacuum sterilization system between gravity conversion sterilizer and high vacuum sterilizer. After using the steam pulse method, high vacuum is not required. The working principle of the pulsating vacuum sterilizer is shown in Figure 1.
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Typical steam pulse program: under continuous steaming conditions, evacuate to an absolute pressure of 10.7 to 13.3 kPa (80 to 100 mmHg), repeat 2 to 3 times; or evacuate to an absolute value of 10.7 to 13.3 kPa (80 to 100 mmHg). After the pressure, steam (a steam pulse) is repeated for 2 to 3 times, so that the pyrogen-free steam is repeatedly introduced into the cavity to achieve effective replacement of the cold air in the cavity and the sterilized article, so that there is no cold spot in the cavity. When the pressure in the chamber is stable, the sterilization steam is evenly distributed in the effective part of the sterilization article in the cavity for thorough sterilization, thereby ensuring the sterilization effect. Continuous steaming is beneficial to prevent and reduce the amount of air remaining in the article. The temperature-pressure curve in the pulsating vacuum sterilizer chamber is shown in Figure 2. Of course, if it is necessary to have a special nature of the sterilized article, more than three steam pulses and a vacuuming step may be employed. The sterilizers commonly used in pharmaceutical companies are generally pulsating sterilizers. After the sterilization process is completed, leak detection is required, so the corresponding function settings are required.
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1.2 pulsation vacuum sterilizer features main advantages: (1) short sterilization cycle; (2) no need for high vacuum; (3) small air retention problem; (4) good sterilization under small load conditions effect.
Main disadvantages: (1) When the sterilized product is over-tight, the sterilization effect is poor; (2) In the vacuum range, the steam pulse requires more complicated auxiliary facilities (such as vacuum pump, condenser, jet pump, etc.). This adds to the difficulty of repair and maintenance.
2 Common problems and solutions in the use of equipment 2.1 PLC fault and black and white screen phenomenon of touch screen At present, PLC fault and black and white of touch screen are easy to occur in equipment with ≥3.5m3 among pulse-type vacuum sterilizers equipped with touch screen. Screen phenomenon.
The reason for this phenomenon: (1) PLC, the reason of the touch screen itself, such as component aging, DC24V power failure, etc.; (2) When the door is opened after sterilization is completed, the steam in the sterilizer is instantaneously shredded, and the air in the room The contact forms water vapor, which has a great influence on the circuit part of the sterilizer, especially the touch screen and PLC, and is prone to moisture and short circuit.
Solution: If the components are themselves, replace the components, or increase the power of the exhaust motor above the door of the sterilizer, and control the remote control.
2.2 Vacuum pump continuous operation Negative pressure does not fall Causes of this phenomenon: (1) The vacuum pump itself causes the vacuum pump kinetic energy to drop, the vacuum pump reverses; (2) the total water pressure is too low (<0.1MPa/cm2); (3) water The flow rate is too small or the pipe diameter of the tap water pipe is too thin.
Solution: (1) For the objective reasons, give replacement parts, such as vacuum pump, water pressure gauge, water pipe; (2) sterilizer water pipe zui a separate pipe, and install a water flow meter next to the water pressure gauge, at any time Observe the water pressure and water flow rate to avoid the water flow is too small and the negative pressure does not drop, so that the vacuum pump produces dry pumping and causes component damage.
2.3 sterilizer seal door can not open the reason for this phenomenon: (1) the inner chamber has positive or negative pressure; (2) the door seal strip is not pumped back; (3) the program is running; (4) the door motor The starting capacitor is damaged; (5) the drive system inside the door is damaged.
Solution: (1) After the indoor pressure returns to 0, open the door again; (2) Check whether the vacuum pump is evacuated, whether the door sealing pipeline is blocked, whether the pump is reversed, whether there is water; (3) Exit the sterilization procedure; (4) Replace the door motor starting capacitor and check the door motor; (5) Check the door drive system.
3 Factors affecting the sterilization effect 3.1 Physical/chemical conditions A variety of environmental factors in the process of bacterial spore formation affect the heat resistance of the spores. For example, when the temperature is high and divalent cations (such as Ca2+, Fe2+, Mg2+, Mn2+) are present, the heat resistance of the spores is enhanced. In contrast, when the pH exceeds the range of 6.0 to 8.0, or when spores are formed in a high concentration of saline or phosphate, the heat resistance is lowered.
The heat resistance of spores in nature is related to environmental conditions, such as solution concentration, moisture, pH, physical factors that damage spores, and chemicals that inhibit spores, all of which affect the heat resistance of spores.
The spores contained in crystals or organic matter are usually significantly more heat-resistant than the generally non-encapsulated spores. Therefore, under a certain temperature condition, when the soil-containing spores and the spores separated and cultivated from the soil are simultaneously sterilized, in order to obtain the same sterilization effect, the sterilization time required by the former at the same sterilization temperature is obtained. More than 10 times higher than the latter. It is difficult to completely kill spores because the sterilized product is contaminated by spores in the soil, such as by unfiltered airborne particles during transportation, or when it is contaminated by contact with people or other objects. Because of this, GMP requires all necessary measures to prevent pollution.
3.2 Relative Humidity In heat sterilization, water plays an important role in killing bacterial spores. There are only two types of water-related sterilization methods: hot and dry. The sterilization method when the humidity reaches saturation [relative humidity (RH) is 100% (or aw=1.0)] is called moist heat sterilization; the sterilization method under the condition of relative humidity lower than 100% is collectively referred to as dry heat sterilization. The experimental data show that when the temperature is between 90 and 125 ° C and the relative humidity is between 20% and 50%, bacterial spores are more difficult to kill; when the relative humidity is higher than 50% or lower than 20%, it is easier to kill. This is instructive for the selection of sterilization conditions.
3.3 Exposure time During the sterilization process, the death of the prokaryotic cells (killed) follows the rules of the first order reaction. The relationship between temperature and the logarithm of spore survival at a time is linear in many cases. That is to say, at a particular sterilization temperature, spore death at any one time is only related to the concentration of spores at this time, and the time required to reduce the number of spores by one log unit is not affected by the original concentration of spores.
4 Verification of the pulse pulverizer The verification of the pulsation vacuum sterilizer mainly includes installation confirmation, operation confirmation and performance confirmation.
4.1 Installation Confirmation (1) Manufacturer name of the inspection and registration equipment, equipment name, model number, manufacturer's serial number and production date, company internal equipment registration number; (2) Whether the installation location and installation status meet the requirements of the relevant national pressure vessel; 3) Whether the equipment specification meets the design requirements; (4) the accuracy and accuracy of the metering and instrumentation; (5) the corresponding public works and building facilities, such as power supply, vacuum system, compressed air system, cooling water, etc. Whether the connection meets the requirements put forward by the supplier; (6) whether the specifications and models of various accessories and spare parts (such as pressure gauges, safety valves, solenoid valves, etc.) are checked and registered; (7) the cleaning procedures and recording formats are formulated; 8) Develop a draft SOP draft and record form for calibration, maintenance and operation.
4.2 Operation confirmation (1) The steam pressure and temperature are within the set range; (2) The interlocking system of the sterilizer door is safe and reliable; (3) Whether the various operating procedures required for the normal operation of the sterilizer are established; 4) The selection and verification of the temperature monitoring equipment meets the requirements of the sterilization procedure.
Eligibility Criteria: The procedures of each step of the sterilizer are normal, consistent with the operating instructions, and there is no obvious deviation; no abnormal noise occurs during the whole operation.
4.3 Performance Confirmation 4.3.1 Heat Distribution Test The heat distribution test is an important test to verify the temperature uniformity at different positions of the sterilizer to find out the temperature difference at different positions in the chamber during the sterilization process. Provide the basis for the test. It includes a no-load heat distribution test and a full load (80% loading) heat distribution test.
4.3.1.1 Heat distribution test procedure (1) Select 10 to 20 thermocouples or thermal resistors as temperature probes, number them, fix them in different positions in the sterilizer chamber and seal them with Teflon sealing tape and silicone. The installation position of the temperature probe inside the device should include possible high temperature points (such as the steam inlet) and low temperature points (such as the condensate drain). Another probe is placed at the sterilizer temperature control probe, and one probe is placed. The temperature of the sterilizer is recorded near the control probe, and the rest is evenly distributed in the sterilizer chamber to make the temperature monitoring representative. In the full load heat distribution test, the load should be as much as possible to use the product to be sterilized or the like and be careful not to connect the temperature probe to the container to be sterilized, but should be around it; (2) sterilize according to the preliminary setting Procedures, sterilization parameters and loading methods are sterilized; (3) At least 3 repetitive tests should be carried out for each loading method, and the data obtained by the test should be collated and analyzed, and the cold spot position of the loading should be determined on this basis; 4) Before and after the test, the temperature probe should be placed in the freezing point tank and the oil bath to be calibrated; (5) After a few no-load tests to determine the location of the cold spot, a small load test of zui big and zui is performed; (6) The test data is used for statistical analysis. The difference between the zui cold spot and the average temperature of the chamber shall not exceed ±2.5 °C. Otherwise, the equipment performance is poor or there is some kind of failure. The reason for this bad condition is design, installation, loading method or control means. There are defects and should be improved.
4.3.1.2 Acceptable standards for heat distribution test (1) Temperature uniformity of empty heat distribution sterilization chamber ≤±1°C; (2) Temperature uniformity of sterilization chamber with full load heat distribution ≤±1.5°C; (3) The range of temperature control is customized according to the accuracy of the equipment.
4.3.2 Thermal penetration test The thermal penetration test is a test to verify the suitability of the sterilizer and sterilization procedure for the product. The purpose is to determine the "zui cold spot" in the sterilization chamber loading and confirm that the point is scheduled. Obtain sufficient sterility assurance values ​​in the sterilization procedure.
4.3.2.1 Thermal penetration test steps and requirements The heat penetration test steps and requirements are generally the same as the full load heat distribution test. The main difference is the temperature probe placement method. The heat penetration test requires the temperature probe to be inserted into the product to be sterilized. The product with the temperature probe shall be placed in the following positions: (1) the location of the zui cold spot determined by the heat distribution test; (2) the location of other high temperature points determined by the steam inlet or the heat distribution test; (3) the temperature of the sterilizer (4) Temperature recording probe (if the temperature of the sterilizer is automatically controlled and the temperature recording is not the shared temperature probe); (5) A probe that records the temperature of the chamber is required, and the probe is not inserted into the product. The position is near the temperature control probe.
The heat penetration test must be repeated at least 3 times. The temperature probe should be placed in the freezing point tank and oil bath before and after the test. 4.3.2.2 Acceptance criteria for thermal penetration test (1) For sterilization procedures, the small F0 value obtained at each point in the loading shall be greater than 8 min; (2) the difference between the small F0 value of Zui and the average F0 value shall not be More than 2.5%.
4.3.3 Biological indicator verification test Statistical analysis of the results of the thermal penetration test can be used to determine the operating parameters of the sterilization procedure, and to determine the sterilization procedure of the sterilizer used for an item. A bio-indicator verification test is then performed, in which a certain amount of heat-resistant spores of known D values ​​are introduced into the sterilized article and sterilized under predetermined sterilization conditions to verify whether the set sterilization process is truly The standard sterilization time F0 value that can be given to an item.
4.3.3.1 Heat resistance of biological indicator The steam pressure sterilization procedure verifies that the commonly used biological indicator is Bacillus stearothermophilus Bacillusstereathernophilus, and its conventional microbial heat resistance parameter D121 °C is 1.5-3.0 min. Since the heat resistance of the same biological indicator is different on different media or carriers, the heat resistance of the biological indicator in the article to be sterilized is determined before the test, and the spore to be inoculated at the time of verification is determined according to the heat resistance. Quantity, or whether a standard solution is required to replace an item as a medium for biological indicators.
4.3.3.2 Loading of biological indicator In order to accurately reflect the sterilization effect of the sterilization procedure on the item, the biological indicator is usually inoculated into the packaging container of the verified item, such as the biological indicator is incompatible with the verified item, the available pH For media with similar values ​​and viscosity, the bio-indicator verification can be performed simultaneously with the thermal penetration test. The container containing the biological indicator should be placed next to the container with the temperature probe, and must be placed at the cold spot of the sterilization device. Biological indicator, the cold spot is usually located near the steam or condensate inlet and outlet. In order to facilitate the accurate analysis and verification test results, all biological indicators and temperature probes should be placed with corresponding numbers.
4.3.3.3 Bio-indicator verification eligibility criteria After verification by biological indicators, it can be demonstrated that the sterility assurance level of the item is below 10-6 under the set sterilization procedure or F0 condition.
5 Conclusions Above is some of the knowledge about pulsating vacuum sterilizers that I have learned in equipment management work, and I hope to help you in your future work.
1 pulsating vacuum sterilizer working principle and characteristics 1.1 pulsating vacuum sterilizer working principle pulsating vacuum sterilization system between gravity conversion sterilizer and high vacuum sterilizer. After using the steam pulse method, high vacuum is not required. The working principle of the pulsating vacuum sterilizer is shown in Figure 1.
Typical steam pulse program: under continuous steaming conditions, evacuate to an absolute pressure of 10.7 to 13.3 kPa (80 to 100 mmHg), repeat 2 to 3 times; or evacuate to an absolute value of 10.7 to 13.3 kPa (80 to 100 mmHg). After the pressure, steam (a steam pulse) is repeated for 2 to 3 times, so that the pyrogen-free steam is repeatedly introduced into the cavity to achieve effective replacement of the cold air in the cavity and the sterilized article, so that there is no cold spot in the cavity. When the pressure in the chamber is stable, the sterilization steam is evenly distributed in the effective part of the sterilization article in the cavity for thorough sterilization, thereby ensuring the sterilization effect. Continuous steaming is beneficial to prevent and reduce the amount of air remaining in the article. The temperature-pressure curve in the pulsating vacuum sterilizer chamber is shown in Figure 2. Of course, if it is necessary to have a special nature of the sterilized article, more than three steam pulses and a vacuuming step may be employed. The sterilizers commonly used in pharmaceutical companies are generally pulsating sterilizers. After the sterilization process is completed, leak detection is required, so the corresponding function settings are required.
1.2 pulsation vacuum sterilizer features main advantages: (1) short sterilization cycle; (2) no need for high vacuum; (3) small air retention problem; (4) good sterilization under small load conditions effect.
Main disadvantages: (1) When the sterilized product is over-tight, the sterilization effect is poor; (2) In the vacuum range, the steam pulse requires more complicated auxiliary facilities (such as vacuum pump, condenser, jet pump, etc.). This adds to the difficulty of repair and maintenance.
2 Common problems and solutions in the use of equipment 2.1 PLC fault and black and white screen phenomenon of touch screen At present, PLC fault and black and white of touch screen are easy to occur in equipment with ≥3.5m3 among pulse-type vacuum sterilizers equipped with touch screen. Screen phenomenon.
The reason for this phenomenon: (1) PLC, the reason of the touch screen itself, such as component aging, DC24V power failure, etc.; (2) When the door is opened after sterilization is completed, the steam in the sterilizer is instantaneously shredded, and the air in the room The contact forms water vapor, which has a great influence on the circuit part of the sterilizer, especially the touch screen and PLC, and is prone to moisture and short circuit.
Solution: If the components are themselves, replace the components, or increase the power of the exhaust motor above the door of the sterilizer, and control the remote control.
2.2 Vacuum pump continuous operation Negative pressure does not fall Causes of this phenomenon: (1) The vacuum pump itself causes the vacuum pump kinetic energy to drop, the vacuum pump reverses; (2) the total water pressure is too low (<0.1MPa/cm2); (3) water The flow rate is too small or the pipe diameter of the tap water pipe is too thin.
Solution: (1) For the objective reasons, give replacement parts, such as vacuum pump, water pressure gauge, water pipe; (2) sterilizer water pipe zui a separate pipe, and install a water flow meter next to the water pressure gauge, at any time Observe the water pressure and water flow rate to avoid the water flow is too small and the negative pressure does not drop, so that the vacuum pump produces dry pumping and causes component damage.
2.3 sterilizer seal door can not open the reason for this phenomenon: (1) the inner chamber has positive or negative pressure; (2) the door seal strip is not pumped back; (3) the program is running; (4) the door motor The starting capacitor is damaged; (5) the drive system inside the door is damaged.
Solution: (1) After the indoor pressure returns to 0, open the door again; (2) Check whether the vacuum pump is evacuated, whether the door sealing pipeline is blocked, whether the pump is reversed, whether there is water; (3) Exit the sterilization procedure; (4) Replace the door motor starting capacitor and check the door motor; (5) Check the door drive system.
3 Factors affecting the sterilization effect 3.1 Physical/chemical conditions A variety of environmental factors in the process of bacterial spore formation affect the heat resistance of the spores. For example, when the temperature is high and divalent cations (such as Ca2+, Fe2+, Mg2+, Mn2+) are present, the heat resistance of the spores is enhanced. In contrast, when the pH exceeds the range of 6.0 to 8.0, or when spores are formed in a high concentration of saline or phosphate, the heat resistance is lowered.
The heat resistance of spores in nature is related to environmental conditions, such as solution concentration, moisture, pH, physical factors that damage spores, and chemicals that inhibit spores, all of which affect the heat resistance of spores.
The spores contained in crystals or organic matter are usually significantly more heat-resistant than the generally non-encapsulated spores. Therefore, under a certain temperature condition, when the soil-containing spores and the spores separated and cultivated from the soil are simultaneously sterilized, in order to obtain the same sterilization effect, the sterilization time required by the former at the same sterilization temperature is obtained. More than 10 times higher than the latter. It is difficult to completely kill spores because the sterilized product is contaminated by spores in the soil, such as by unfiltered airborne particles during transportation, or when it is contaminated by contact with people or other objects. Because of this, GMP requires all necessary measures to prevent pollution.
3.2 Relative Humidity In heat sterilization, water plays an important role in killing bacterial spores. There are only two types of water-related sterilization methods: hot and dry. The sterilization method when the humidity reaches saturation [relative humidity (RH) is 100% (or aw=1.0)] is called moist heat sterilization; the sterilization method under the condition of relative humidity lower than 100% is collectively referred to as dry heat sterilization. The experimental data show that when the temperature is between 90 and 125 ° C and the relative humidity is between 20% and 50%, bacterial spores are more difficult to kill; when the relative humidity is higher than 50% or lower than 20%, it is easier to kill. This is instructive for the selection of sterilization conditions.
3.3 Exposure time During the sterilization process, the death of the prokaryotic cells (killed) follows the rules of the first order reaction. The relationship between temperature and the logarithm of spore survival at a time is linear in many cases. That is to say, at a particular sterilization temperature, spore death at any one time is only related to the concentration of spores at this time, and the time required to reduce the number of spores by one log unit is not affected by the original concentration of spores.
4 Verification of the pulse pulverizer The verification of the pulsation vacuum sterilizer mainly includes installation confirmation, operation confirmation and performance confirmation.
4.1 Installation Confirmation (1) Manufacturer name of the inspection and registration equipment, equipment name, model number, manufacturer's serial number and production date, company internal equipment registration number; (2) Whether the installation location and installation status meet the requirements of the relevant national pressure vessel; 3) Whether the equipment specification meets the design requirements; (4) the accuracy and accuracy of the metering and instrumentation; (5) the corresponding public works and building facilities, such as power supply, vacuum system, compressed air system, cooling water, etc. Whether the connection meets the requirements put forward by the supplier; (6) whether the specifications and models of various accessories and spare parts (such as pressure gauges, safety valves, solenoid valves, etc.) are checked and registered; (7) the cleaning procedures and recording formats are formulated; 8) Develop a draft SOP draft and record form for calibration, maintenance and operation.
4.2 Operation confirmation (1) The steam pressure and temperature are within the set range; (2) The interlocking system of the sterilizer door is safe and reliable; (3) Whether the various operating procedures required for the normal operation of the sterilizer are established; 4) The selection and verification of the temperature monitoring equipment meets the requirements of the sterilization procedure.
Eligibility Criteria: The procedures of each step of the sterilizer are normal, consistent with the operating instructions, and there is no obvious deviation; no abnormal noise occurs during the whole operation.
4.3 Performance Confirmation 4.3.1 Heat Distribution Test The heat distribution test is an important test to verify the temperature uniformity at different positions of the sterilizer to find out the temperature difference at different positions in the chamber during the sterilization process. Provide the basis for the test. It includes a no-load heat distribution test and a full load (80% loading) heat distribution test.
4.3.1.1 Heat distribution test procedure (1) Select 10 to 20 thermocouples or thermal resistors as temperature probes, number them, fix them in different positions in the sterilizer chamber and seal them with Teflon sealing tape and silicone. The installation position of the temperature probe inside the device should include possible high temperature points (such as the steam inlet) and low temperature points (such as the condensate drain). Another probe is placed at the sterilizer temperature control probe, and one probe is placed. The temperature of the sterilizer is recorded near the control probe, and the rest is evenly distributed in the sterilizer chamber to make the temperature monitoring representative. In the full load heat distribution test, the load should be as much as possible to use the product to be sterilized or the like and be careful not to connect the temperature probe to the container to be sterilized, but should be around it; (2) sterilize according to the preliminary setting Procedures, sterilization parameters and loading methods are sterilized; (3) At least 3 repetitive tests should be carried out for each loading method, and the data obtained by the test should be collated and analyzed, and the cold spot position of the loading should be determined on this basis; 4) Before and after the test, the temperature probe should be placed in the freezing point tank and the oil bath to be calibrated; (5) After a few no-load tests to determine the location of the cold spot, a small load test of zui big and zui is performed; (6) The test data is used for statistical analysis. The difference between the zui cold spot and the average temperature of the chamber shall not exceed ±2.5 °C. Otherwise, the equipment performance is poor or there is some kind of failure. The reason for this bad condition is design, installation, loading method or control means. There are defects and should be improved.
4.3.1.2 Acceptable standards for heat distribution test (1) Temperature uniformity of empty heat distribution sterilization chamber ≤±1°C; (2) Temperature uniformity of sterilization chamber with full load heat distribution ≤±1.5°C; (3) The range of temperature control is customized according to the accuracy of the equipment.
4.3.2 Thermal penetration test The thermal penetration test is a test to verify the suitability of the sterilizer and sterilization procedure for the product. The purpose is to determine the "zui cold spot" in the sterilization chamber loading and confirm that the point is scheduled. Obtain sufficient sterility assurance values ​​in the sterilization procedure.
4.3.2.1 Thermal penetration test steps and requirements The heat penetration test steps and requirements are generally the same as the full load heat distribution test. The main difference is the temperature probe placement method. The heat penetration test requires the temperature probe to be inserted into the product to be sterilized. The product with the temperature probe shall be placed in the following positions: (1) the location of the zui cold spot determined by the heat distribution test; (2) the location of other high temperature points determined by the steam inlet or the heat distribution test; (3) the temperature of the sterilizer (4) Temperature recording probe (if the temperature of the sterilizer is automatically controlled and the temperature recording is not the shared temperature probe); (5) A probe that records the temperature of the chamber is required, and the probe is not inserted into the product. The position is near the temperature control probe.
The heat penetration test must be repeated at least 3 times. The temperature probe should be placed in the freezing point tank and oil bath before and after the test. 4.3.2.2 Acceptance criteria for thermal penetration test (1) For sterilization procedures, the small F0 value obtained at each point in the loading shall be greater than 8 min; (2) the difference between the small F0 value of Zui and the average F0 value shall not be More than 2.5%.
4.3.3 Biological indicator verification test Statistical analysis of the results of the thermal penetration test can be used to determine the operating parameters of the sterilization procedure, and to determine the sterilization procedure of the sterilizer used for an item. A bio-indicator verification test is then performed, in which a certain amount of heat-resistant spores of known D values ​​are introduced into the sterilized article and sterilized under predetermined sterilization conditions to verify whether the set sterilization process is truly The standard sterilization time F0 value that can be given to an item.
4.3.3.1 Heat resistance of biological indicator The steam pressure sterilization procedure verifies that the commonly used biological indicator is Bacillus stearothermophilus Bacillusstereathernophilus, and its conventional microbial heat resistance parameter D121 °C is 1.5-3.0 min. Since the heat resistance of the same biological indicator is different on different media or carriers, the heat resistance of the biological indicator in the article to be sterilized is determined before the test, and the spore to be inoculated at the time of verification is determined according to the heat resistance. Quantity, or whether a standard solution is required to replace an item as a medium for biological indicators.
4.3.3.2 Loading of biological indicator In order to accurately reflect the sterilization effect of the sterilization procedure on the item, the biological indicator is usually inoculated into the packaging container of the verified item, such as the biological indicator is incompatible with the verified item, the available pH For media with similar values ​​and viscosity, the bio-indicator verification can be performed simultaneously with the thermal penetration test. The container containing the biological indicator should be placed next to the container with the temperature probe, and must be placed at the cold spot of the sterilization device. Biological indicator, the cold spot is usually located near the steam or condensate inlet and outlet. In order to facilitate the accurate analysis and verification test results, all biological indicators and temperature probes should be placed with corresponding numbers.
4.3.3.3 Bio-indicator verification eligibility criteria After verification by biological indicators, it can be demonstrated that the sterility assurance level of the item is below 10-6 under the set sterilization procedure or F0 condition.
5 Conclusions Above is some of the knowledge about pulsating vacuum sterilizers that I have learned in equipment management work, and I hope to help you in your future work.
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