Pasteurisation (French: Pasteurisation) refers to a method of disinfecting microorganisms using damp heat below 100 °C. This disinfection method has long arisen from the problem that Pasteur solves the problem of beer becoming sour. The commonly used pasteurization method is: 60-62 ° C for 30 min; 70-72 ° C for 20 min; 80-82 ° C for 10 min. After these methods are disinfected, the non-spore bacteria can be killed. This method is mainly used for the disinfection of liquid foods, cotton fabrics and cleaning tools that are not resistant to high temperatures; pasteurization in the biomedical field can be used for serum disinfection and vaccine preparation.
Characteristics of high-purity water equipment High-purity water is a colorless, odorless liquid in which the electrolyte has been removed to a very low level, in which insoluble colloidal substances and microbial particles, dissolved gases, organic matter, etc. are almost completely removed. The high-purity water described in this paper uses high-purity water by two-stage reverse osmosis + EDI electric desalination.
The principle of a reverse osmosis (RO) system: the natural flow of water through a semipermeable membrane into a solution or from a low concentration solution to a high concentration solution is called infiltration. A membrane that is selective for water or a solution is called a semipermeable membrane. If an appropriate pressure is applied to the concentrated solution, the permeation can be stopped, and the pressure when the penetration of the dilute solution into the concentrated solution is stopped is called the osmotic pressure of the solution. Reverse osmosis is to add a higher pressure than the natural osmotic pressure on the side of the concentrated solution, to reverse the direction of natural penetration, and to press the water in the solution to the other side of the semipermeable membrane, which is contrary to the normal infiltration process in nature. For reverse osmosis, this reverse osmosis device is called a reverse osmosis device.
EDI works: the feed water enters the EDI system, the main part flows into the resin/film inside, and the other part flows along the outside of the membrane to wash away the ions outside the membrane. The resin traps the dissolved ions in the water, and the trapped ions are at the electrode. Under the action, the anion moves toward the positive electrode, the cation moves toward the negative electrode, the cation passes through the cation membrane, and the cation is discharged outside the resin/membrane. The anion passes through the anion membrane and is discharged outside the resin/membrane. The concentrated ions are discharged from the wastewater flow path. Discharge, no ionized water flows out of the resin/film.
Process flow of high purity water system:
Inlet water pneumatic valve - → original water tank - → original water pump (backwash pump) - → quartz sand filter - → activated carbon filter - → precision filter - → first stage high pressure pump - → first stage reverse osmosis system (RO system) -→ fresh water tank 1 - fresh water pump - → secondary high pressure pump - → secondary reverse osmosis system (RO system) - → fresh water tank 2 - → EDI water pump - → EDI module - → high purity water tank.
The use of each component of high-purity water equipment: 1, quartz sand filter: reduce turbidity and improve clarity. 2. Activated carbon: adsorbing residual chlorine, removing organic matter, oil, colloid and suspended matter, so that the influent reaches the index, and the residual chlorine content is ≤0.1mg/L. 3, precision filter: further remove suspended particles, bacteria and other impurities in the water. 4, RO membrane: remove inorganic salts and bacteria in the water. 5. EDI: Further remove inorganic salts and bacteria from the water.
It can be seen from the above that in the process of preparing high-purity water from high-purity water equipment, the operation of various functional facilities has a blocking effect on bacteria, and the long-term operation of the equipment is bound to increase the accumulation of bacteria. Purified water is used as water for production in the biopharmaceutical field, and excessive accumulation of bacteria in water-making equipment is disadvantageous in any respect.
Article 99 of the new edition of the “Good Manufacturing Practices for Pharmaceutical Production†in China mentioned in 2010; “Preparation, storage and distribution of purified water and water for injection should prevent the growth of microorganisms. The purified water can be recycled, and water for injection can be used. Insulation cycle above 70 °C". * One hundred and one article mentioned; "The purified water and water for injection pipeline should be cleaned and disinfected according to the operating procedures, and relevant records are found. It is found that the microbial contamination of pharmaceutical water should be treated according to the operating procedures when it reaches the warning limit and the correction limit." Therefore, pharmaceutical companies in the preparation of purified water, from the source of water-based equipment should strengthen the prevention of bacterial growth, to eliminate any potential danger from the source.
Application of pasteurization in water-making equipment This paper describes the specific application of pasteurization in high-purification water equipment. The disinfection and sterilization process of such equipment is divided into three functional sections. The disinfection and sterilization operation procedures are as follows: 1. Pretreatment to the primary RO system; 2. Secondary RO system; 3. EDI system. However, pasteurization of high-purity water equipment must start from the third part (EDI system), because the flowmeter in the EDI system is a glass rotor flowmeter. After high-temperature sterilization, it is not possible to pass cold water immediately or the flowmeter will be damaged. Therefore, the EDI system should be sterilized first, the secondary RO system should be sterilized, and the post-sterilization pretreatment should be performed to the first-stage RO system, so that there is a certain time left for the flowmeter cooling time in the EDI system. Because the plate heat exchanger in the equipment system is used to control the water temperature during water production, the plate heat exchanger contains a large amount of pretreatment water. From the viewpoint of water saving, the sterilization and sterilization in the sterilization process should be discharged once. Water can be.
High purity water equipment (secondary reverse osmosis + EDI) pasteurization operation procedure:
1. EDI functional segment sterilization procedure: The valve in front of the EDI system does not need to be adjusted, just like in the working state. Open the valve of 3.8.33.34.36.47.38.49, close the valve of 42.39.37, the water of the 2# fresh water tank is automatically discharged from the 36 valve through the plate heat exchanger. After 2-3 minutes, close the 36 valve and start the EDI water pump. - Close the 47.48 two valves for 3 minutes to allow them to automatically cycle. Set the automatic temperature control temperature between ≥80 °C, open the 5.6.7 valve and steam valve: the water supply heating process for 10 minutes to close the 7 valve. When the water temperature is controlled above ≥80°C, sterilize the EDI system for 30 minutes. After 30 minutes (close the steam valve), stop the EDI pump and let the system automatically cool to normal temperature before entering the cold water and adjust the valve to the running state. Close the 3.8.33.34.36.47.38.48 valve to open the 42.39.37 valve.
2. Two-stage RO functional section sterilization procedure: open 2.9.26.27.28.18.17.45.19.16.20.25.41.46 valve and 2# metering pump are in the stop state, start the fresh water pump and the secondary high pressure pump to let it automatically cycle and open the steam The valve starts to record when the water temperature is heated to ≥80 °C. After sterilizing the secondary RO system for 30 minutes, first close the valve, then stop the secondary high pressure pump and then stop the fresh water pump, and open the 16.19.20.25.45.41 valve and 2# metering. The pump is in an automatic state and the valve of 2.9.26.27.28 is closed.
3, pre-treatment and first-level RO functional segment sterilization procedure: open the total inlet valve on the operation screen of the mechanical filter, the positive wash valve and the outlet valve on the operating screen of the positive wash valve and activated carbon filter and 1.10.18.19. 28.25 valve, slightly open 14 valves, close all pre-treatment and all valves on the RO main engine, start the original water pump and the first-stage high-pressure pump, start the timing and sterilize the pre-treatment and the first-level RO system when the water temperature is heated to ≥80 °C. 30 minutes, close the steam valve after sterilization is complete; adjust all valves to normal operation.
Characteristics of high-purity water equipment High-purity water is a colorless, odorless liquid in which the electrolyte has been removed to a very low level, in which insoluble colloidal substances and microbial particles, dissolved gases, organic matter, etc. are almost completely removed. The high-purity water described in this paper uses high-purity water by two-stage reverse osmosis + EDI electric desalination.
The principle of a reverse osmosis (RO) system: the natural flow of water through a semipermeable membrane into a solution or from a low concentration solution to a high concentration solution is called infiltration. A membrane that is selective for water or a solution is called a semipermeable membrane. If an appropriate pressure is applied to the concentrated solution, the permeation can be stopped, and the pressure when the penetration of the dilute solution into the concentrated solution is stopped is called the osmotic pressure of the solution. Reverse osmosis is to add a higher pressure than the natural osmotic pressure on the side of the concentrated solution, to reverse the direction of natural penetration, and to press the water in the solution to the other side of the semipermeable membrane, which is contrary to the normal infiltration process in nature. For reverse osmosis, this reverse osmosis device is called a reverse osmosis device.
EDI works: the feed water enters the EDI system, the main part flows into the resin/film inside, and the other part flows along the outside of the membrane to wash away the ions outside the membrane. The resin traps the dissolved ions in the water, and the trapped ions are at the electrode. Under the action, the anion moves toward the positive electrode, the cation moves toward the negative electrode, the cation passes through the cation membrane, and the cation is discharged outside the resin/membrane. The anion passes through the anion membrane and is discharged outside the resin/membrane. The concentrated ions are discharged from the wastewater flow path. Discharge, no ionized water flows out of the resin/film.
Process flow of high purity water system:
Inlet water pneumatic valve - → original water tank - → original water pump (backwash pump) - → quartz sand filter - → activated carbon filter - → precision filter - → first stage high pressure pump - → first stage reverse osmosis system (RO system) -→ fresh water tank 1 - fresh water pump - → secondary high pressure pump - → secondary reverse osmosis system (RO system) - → fresh water tank 2 - → EDI water pump - → EDI module - → high purity water tank.
The use of each component of high-purity water equipment: 1, quartz sand filter: reduce turbidity and improve clarity. 2. Activated carbon: adsorbing residual chlorine, removing organic matter, oil, colloid and suspended matter, so that the influent reaches the index, and the residual chlorine content is ≤0.1mg/L. 3, precision filter: further remove suspended particles, bacteria and other impurities in the water. 4, RO membrane: remove inorganic salts and bacteria in the water. 5. EDI: Further remove inorganic salts and bacteria from the water.
It can be seen from the above that in the process of preparing high-purity water from high-purity water equipment, the operation of various functional facilities has a blocking effect on bacteria, and the long-term operation of the equipment is bound to increase the accumulation of bacteria. Purified water is used as water for production in the biopharmaceutical field, and excessive accumulation of bacteria in water-making equipment is disadvantageous in any respect.
Article 99 of the new edition of the “Good Manufacturing Practices for Pharmaceutical Production†in China mentioned in 2010; “Preparation, storage and distribution of purified water and water for injection should prevent the growth of microorganisms. The purified water can be recycled, and water for injection can be used. Insulation cycle above 70 °C". * One hundred and one article mentioned; "The purified water and water for injection pipeline should be cleaned and disinfected according to the operating procedures, and relevant records are found. It is found that the microbial contamination of pharmaceutical water should be treated according to the operating procedures when it reaches the warning limit and the correction limit." Therefore, pharmaceutical companies in the preparation of purified water, from the source of water-based equipment should strengthen the prevention of bacterial growth, to eliminate any potential danger from the source.
Application of pasteurization in water-making equipment This paper describes the specific application of pasteurization in high-purification water equipment. The disinfection and sterilization process of such equipment is divided into three functional sections. The disinfection and sterilization operation procedures are as follows: 1. Pretreatment to the primary RO system; 2. Secondary RO system; 3. EDI system. However, pasteurization of high-purity water equipment must start from the third part (EDI system), because the flowmeter in the EDI system is a glass rotor flowmeter. After high-temperature sterilization, it is not possible to pass cold water immediately or the flowmeter will be damaged. Therefore, the EDI system should be sterilized first, the secondary RO system should be sterilized, and the post-sterilization pretreatment should be performed to the first-stage RO system, so that there is a certain time left for the flowmeter cooling time in the EDI system. Because the plate heat exchanger in the equipment system is used to control the water temperature during water production, the plate heat exchanger contains a large amount of pretreatment water. From the viewpoint of water saving, the sterilization and sterilization in the sterilization process should be discharged once. Water can be.
High purity water equipment (secondary reverse osmosis + EDI) pasteurization operation procedure:
1. EDI functional segment sterilization procedure: The valve in front of the EDI system does not need to be adjusted, just like in the working state. Open the valve of 3.8.33.34.36.47.38.49, close the valve of 42.39.37, the water of the 2# fresh water tank is automatically discharged from the 36 valve through the plate heat exchanger. After 2-3 minutes, close the 36 valve and start the EDI water pump. - Close the 47.48 two valves for 3 minutes to allow them to automatically cycle. Set the automatic temperature control temperature between ≥80 °C, open the 5.6.7 valve and steam valve: the water supply heating process for 10 minutes to close the 7 valve. When the water temperature is controlled above ≥80°C, sterilize the EDI system for 30 minutes. After 30 minutes (close the steam valve), stop the EDI pump and let the system automatically cool to normal temperature before entering the cold water and adjust the valve to the running state. Close the 3.8.33.34.36.47.38.48 valve to open the 42.39.37 valve.
2. Two-stage RO functional section sterilization procedure: open 2.9.26.27.28.18.17.45.19.16.20.25.41.46 valve and 2# metering pump are in the stop state, start the fresh water pump and the secondary high pressure pump to let it automatically cycle and open the steam The valve starts to record when the water temperature is heated to ≥80 °C. After sterilizing the secondary RO system for 30 minutes, first close the valve, then stop the secondary high pressure pump and then stop the fresh water pump, and open the 16.19.20.25.45.41 valve and 2# metering. The pump is in an automatic state and the valve of 2.9.26.27.28 is closed.
3, pre-treatment and first-level RO functional segment sterilization procedure: open the total inlet valve on the operation screen of the mechanical filter, the positive wash valve and the outlet valve on the operating screen of the positive wash valve and activated carbon filter and 1.10.18.19. 28.25 valve, slightly open 14 valves, close all pre-treatment and all valves on the RO main engine, start the original water pump and the first-stage high-pressure pump, start the timing and sterilize the pre-treatment and the first-level RO system when the water temperature is heated to ≥80 °C. 30 minutes, close the steam valve after sterilization is complete; adjust all valves to normal operation.
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