According to the requirements of China's "Standards for Quality Management of Pharmaceutical Production," key equipment used in pharmaceutical production must be verified. In the production of solid oral preparations such as granules and capsules, commonly used hot air drying equipment such as spray dryers, boiling dryers, one-step granulators, and fluidized drying beds directly affect the appearance, particle size, moisture, and microorganisms of the product. Limits and other quality indicators. Therefore, these devices are key devices that must be verified. However, in the verification process of hot air drying equipment, most companies often only verify the installation, inlet/outlet air temperature, wind speed, and moisture content of materials, and they neglect two critical verification items, namely, hot air quality. (or hot air cleanliness) and dust capture effect.
Hot air drying equipment is a kind of drying equipment that allows hot air flow to pass through the gap between the particles of the material to be dried, and directly contacts the material to heat and take away the water evaporated from the material. Because the hot air directly contacts the material, when the hot air fails to meet the quality requirements, external foreign materials may be introduced into the material, causing the product's microbial limit to fail. Therefore, when verifying hot air drying equipment, the quality of the hot air directly passing through the material must be verified. Hot air drying equipments are equipped with dust removal devices. After the hot air passes through the materials, it will take away water and some dust. According to environmental protection requirements, dust must be collected before reaching the atmosphere. Therefore, the dust removal effect of hot air drying equipment is also one of the key items that must be verified.
Verify hot air quality
The sequence, material, and prescriptiveness of the installation of the hot air system components are prerequisites for ensuring that hot air that is in direct contact with the material is clean and acceptable.
The components of the hot air system include air intakes, air ducts, steam heat exchangers or electric heating tubes, rough and efficient three-stage air filters, dust collection and stop air return devices, and induced draft fans. The order of installation and connection according to the direction of hot air flow is: coarse air filter, air inlet, steam heat exchanger, medium efficiency air filter, high efficiency air filter, hot air drying equipment drying chamber, dust collector, stop air return Device, induced draft fan. If the heating device is an electric heating pipe, it can be installed between the medium and high efficiency air filters to reduce the loss of heat. The steam heat exchanger is installed at the front end of the intermediate efficiency air filter to avoid the Leakage of the heater directly affects the safe use of the high-efficiency air filter. It is worth noting that high efficiency air filters must be installed at the end of the air supply system to ensure the quality of hot air. The air intake is generally installed on the roof or the outer wall. If it is installed indoors, it will cause a large air supply load to the air conditioning system due to the balance of the air volume. The installation direction of the air intake should be determined according to the local climate conditions throughout the year, and it is advisable to take the opening of the air outlet toward the downwind side. The rough air filter is installed on the air intake with a pull-out plane structure, which is easy to disassemble and clean. The specification material is 100~150 mesh metal or nylon mesh, so as to block debris, small animals and large particles. The dust particles enter the air supply system to reduce the burden on the air filter. The side of the steam heat exchanger or electric heating tube that is in contact with the hot air must be made of stainless steel to prevent high-temperature oxidation and rust from falling off and affect the service life of the air filter at the lower end. Medium-efficiency air filters use non-woven fabrics or glass fiber materials that are neither exfoliated nor resistant to high temperatures. In order to increase the filter area, a multi-row bag-type medium-efficiency air filter is generally used. The medium efficiency air filter should be installed in an openable box for easy removal and cleaning.
High-efficiency air filters are the last barrier in the air supply system. The installation requirements are extremely stringent. Ultra-fine glass fiber paper that withstands high-temperature dry air of 250°C is used as the filter material. Aluminum foil is used as the material for the filter material. The body is made of stainless steel or aluminum alloy material with high strength and firmness and not easily deformed. The gap between the filter material and the outer frame box should be sealed with a silicone paste resistant to high temperature of 250°C. The connection between the high efficiency air filter and the air inlet and the air duct should be Sealed with a high temperature silicone rubber sheet. The use of high-efficiency air filter heat-resistant materials is a key measure to prevent general materials from being susceptible to ageing and falling off resulting in poorly sealed and contaminated drugs. After passing through the dried material, the exhaust air outlet of the moist air is generally installed on the roof to facilitate the stable installation of the induced draft fan at the exhaust duct end. The exhaust duct must be equipped with a device for dust removal and air return prevention so as to prevent the induced draft fan from being stopped The backflow of unclean air outdoors affects the cleanliness of the drying chamber. The air duct is generally made of galvanized steel sheet. Because the system is under negative pressure, the thickness of the galvanized steel sheet is not suitable for the suction duct deformation. Finally, the sealability of the entire hot air system must also be verified. The method is also verified with the airtightness of the air purification system.
The verification of the operation of the hot air system of the hot air drying equipment is to confirm that the hot air supplied to the drying chamber of the system does not cause contamination of the dried material. For material drying of solid oral formulations such as granules, capsules, etc., this contamination can only be confirmed by comparing the number of microorganisms before and after the material is dried. When verifying the operation, we must first confirm that the hot air entering the drying chamber must meet certain cleanliness requirements. This is an important step to confirm that the dried material is not contaminated, based on the microbial limit of the finished solid oral preparation and the time for drying the material ( That is, the contact time of the material with the hot air. The cleanliness level of the hot air is determined by referring to the cleanliness level of the production purification zone so as to achieve the pollution control of the dried material. As there are no national or industry standards, the current standard of solid oral preparations and the actual production conditions of enterprises, the cleanliness of hot air is determined to be 10,000. It is of course also necessary to compare the amount of microorganisms before and after the drying of the material. . The method of measuring the cleanliness of the hot air is basically the same as the air conditioning purification system, except that the dust particle measurement and the microbiological measurement area are performed in the drying chamber of the hot air drying equipment.
Verify the effect of exhausting dust
In addition to the spray dryer, there are two sets of exhaust dust catchers for hot air drying equipment. One is to prevent the loss of materials. It is installed inside the drying chamber of the equipment to trap the material. Electrostatic non-woven production, equipment suppliers in the provision of equipment according to equipment parts delivery. However, due to cost reasons, some equipment suppliers have provided capture bags with poor collection efficiency and the material loss rate reaches 10% to 15%. This not only results in higher material losses, but also creates great difficulties for the next hot air dust removal. Therefore, when the company purchases equipment, it is necessary to clearly state to the supplier that the collection rate of the trapping bag should be between 96% and 98%. If the supplier cannot provide it, the company should purchase the appropriate materials for processing. However, too high trap rates can cause poor ventilation and affect the rate and effectiveness of drying. Another set of dust-catching device is installed at the end of the exhaust system. It is generally provided by manufacturers specializing in the production of dust catchers. It is a multi-row filter or folded structure filter to increase the filter area of ​​exhaust air and reduce exhaust air. resistance.
When verifying the dust collection effect, first check and confirm the installation sealability of the two dust capture devices. After confirming that the tightness between the material capture bag and the dust filter and the box meets the requirements, load the load to confirm the catch bag. The capture rate and dust emission indicators meet the requirements of the process and national standards. According to the requirements of the “Integrated Emission Standard for Air Pollutants†issued by the State Environmental Protection Administration, the maximum allowable emission concentration of exhaust particulates is 120 mg/m3.
The two-stage high-efficiency cyclone separator is used in the spray dryer's exhaust dust catcher. The end exhaust is discharged to the atmosphere after being adsorbed by water. The spray-dried material is collected after two stages of efficient cyclone separators. The technical specifications of the high-efficiency cyclone separator should be based on the consideration of the speed of the powder gas flow, the particle size and the specific gravity of the powder, and the yield of the material should be about 96% to reduce the material loss and facilitate the treatment of the downstream dust. The hot air of the two-stage high-efficiency cyclone separator still contains a certain amount of dust, which is discharged after the multi-branch exhaust pipe is underwaterly adsorbed. The multi-branch exhaust pipe can increase the contact area between the air flow containing dust and water and improve the effect of adsorption and dust removal.
The verification of the dust-catching effect of the spray dryer is the same as other hot-air drying equipment. After confirming the tightness of the installation of the dust-catching device, the loading operation is added to confirm that the material yield of the high-efficiency cyclone separator is consistent with the dust emission index after water adsorption. Process and national standards requirements.
Hot air drying equipment is a kind of drying equipment that allows hot air flow to pass through the gap between the particles of the material to be dried, and directly contacts the material to heat and take away the water evaporated from the material. Because the hot air directly contacts the material, when the hot air fails to meet the quality requirements, external foreign materials may be introduced into the material, causing the product's microbial limit to fail. Therefore, when verifying hot air drying equipment, the quality of the hot air directly passing through the material must be verified. Hot air drying equipments are equipped with dust removal devices. After the hot air passes through the materials, it will take away water and some dust. According to environmental protection requirements, dust must be collected before reaching the atmosphere. Therefore, the dust removal effect of hot air drying equipment is also one of the key items that must be verified.
Verify hot air quality
The sequence, material, and prescriptiveness of the installation of the hot air system components are prerequisites for ensuring that hot air that is in direct contact with the material is clean and acceptable.
The components of the hot air system include air intakes, air ducts, steam heat exchangers or electric heating tubes, rough and efficient three-stage air filters, dust collection and stop air return devices, and induced draft fans. The order of installation and connection according to the direction of hot air flow is: coarse air filter, air inlet, steam heat exchanger, medium efficiency air filter, high efficiency air filter, hot air drying equipment drying chamber, dust collector, stop air return Device, induced draft fan. If the heating device is an electric heating pipe, it can be installed between the medium and high efficiency air filters to reduce the loss of heat. The steam heat exchanger is installed at the front end of the intermediate efficiency air filter to avoid the Leakage of the heater directly affects the safe use of the high-efficiency air filter. It is worth noting that high efficiency air filters must be installed at the end of the air supply system to ensure the quality of hot air. The air intake is generally installed on the roof or the outer wall. If it is installed indoors, it will cause a large air supply load to the air conditioning system due to the balance of the air volume. The installation direction of the air intake should be determined according to the local climate conditions throughout the year, and it is advisable to take the opening of the air outlet toward the downwind side. The rough air filter is installed on the air intake with a pull-out plane structure, which is easy to disassemble and clean. The specification material is 100~150 mesh metal or nylon mesh, so as to block debris, small animals and large particles. The dust particles enter the air supply system to reduce the burden on the air filter. The side of the steam heat exchanger or electric heating tube that is in contact with the hot air must be made of stainless steel to prevent high-temperature oxidation and rust from falling off and affect the service life of the air filter at the lower end. Medium-efficiency air filters use non-woven fabrics or glass fiber materials that are neither exfoliated nor resistant to high temperatures. In order to increase the filter area, a multi-row bag-type medium-efficiency air filter is generally used. The medium efficiency air filter should be installed in an openable box for easy removal and cleaning.
High-efficiency air filters are the last barrier in the air supply system. The installation requirements are extremely stringent. Ultra-fine glass fiber paper that withstands high-temperature dry air of 250°C is used as the filter material. Aluminum foil is used as the material for the filter material. The body is made of stainless steel or aluminum alloy material with high strength and firmness and not easily deformed. The gap between the filter material and the outer frame box should be sealed with a silicone paste resistant to high temperature of 250°C. The connection between the high efficiency air filter and the air inlet and the air duct should be Sealed with a high temperature silicone rubber sheet. The use of high-efficiency air filter heat-resistant materials is a key measure to prevent general materials from being susceptible to ageing and falling off resulting in poorly sealed and contaminated drugs. After passing through the dried material, the exhaust air outlet of the moist air is generally installed on the roof to facilitate the stable installation of the induced draft fan at the exhaust duct end. The exhaust duct must be equipped with a device for dust removal and air return prevention so as to prevent the induced draft fan from being stopped The backflow of unclean air outdoors affects the cleanliness of the drying chamber. The air duct is generally made of galvanized steel sheet. Because the system is under negative pressure, the thickness of the galvanized steel sheet is not suitable for the suction duct deformation. Finally, the sealability of the entire hot air system must also be verified. The method is also verified with the airtightness of the air purification system.
The verification of the operation of the hot air system of the hot air drying equipment is to confirm that the hot air supplied to the drying chamber of the system does not cause contamination of the dried material. For material drying of solid oral formulations such as granules, capsules, etc., this contamination can only be confirmed by comparing the number of microorganisms before and after the material is dried. When verifying the operation, we must first confirm that the hot air entering the drying chamber must meet certain cleanliness requirements. This is an important step to confirm that the dried material is not contaminated, based on the microbial limit of the finished solid oral preparation and the time for drying the material ( That is, the contact time of the material with the hot air. The cleanliness level of the hot air is determined by referring to the cleanliness level of the production purification zone so as to achieve the pollution control of the dried material. As there are no national or industry standards, the current standard of solid oral preparations and the actual production conditions of enterprises, the cleanliness of hot air is determined to be 10,000. It is of course also necessary to compare the amount of microorganisms before and after the drying of the material. . The method of measuring the cleanliness of the hot air is basically the same as the air conditioning purification system, except that the dust particle measurement and the microbiological measurement area are performed in the drying chamber of the hot air drying equipment.
Verify the effect of exhausting dust
In addition to the spray dryer, there are two sets of exhaust dust catchers for hot air drying equipment. One is to prevent the loss of materials. It is installed inside the drying chamber of the equipment to trap the material. Electrostatic non-woven production, equipment suppliers in the provision of equipment according to equipment parts delivery. However, due to cost reasons, some equipment suppliers have provided capture bags with poor collection efficiency and the material loss rate reaches 10% to 15%. This not only results in higher material losses, but also creates great difficulties for the next hot air dust removal. Therefore, when the company purchases equipment, it is necessary to clearly state to the supplier that the collection rate of the trapping bag should be between 96% and 98%. If the supplier cannot provide it, the company should purchase the appropriate materials for processing. However, too high trap rates can cause poor ventilation and affect the rate and effectiveness of drying. Another set of dust-catching device is installed at the end of the exhaust system. It is generally provided by manufacturers specializing in the production of dust catchers. It is a multi-row filter or folded structure filter to increase the filter area of ​​exhaust air and reduce exhaust air. resistance.
When verifying the dust collection effect, first check and confirm the installation sealability of the two dust capture devices. After confirming that the tightness between the material capture bag and the dust filter and the box meets the requirements, load the load to confirm the catch bag. The capture rate and dust emission indicators meet the requirements of the process and national standards. According to the requirements of the “Integrated Emission Standard for Air Pollutants†issued by the State Environmental Protection Administration, the maximum allowable emission concentration of exhaust particulates is 120 mg/m3.
The two-stage high-efficiency cyclone separator is used in the spray dryer's exhaust dust catcher. The end exhaust is discharged to the atmosphere after being adsorbed by water. The spray-dried material is collected after two stages of efficient cyclone separators. The technical specifications of the high-efficiency cyclone separator should be based on the consideration of the speed of the powder gas flow, the particle size and the specific gravity of the powder, and the yield of the material should be about 96% to reduce the material loss and facilitate the treatment of the downstream dust. The hot air of the two-stage high-efficiency cyclone separator still contains a certain amount of dust, which is discharged after the multi-branch exhaust pipe is underwaterly adsorbed. The multi-branch exhaust pipe can increase the contact area between the air flow containing dust and water and improve the effect of adsorption and dust removal.
The verification of the dust-catching effect of the spray dryer is the same as other hot-air drying equipment. After confirming the tightness of the installation of the dust-catching device, the loading operation is added to confirm that the material yield of the high-efficiency cyclone separator is consistent with the dust emission index after water adsorption. Process and national standards requirements.
Plastic Injection Mold is an assembly of parts containing within it an impression into which plastic material is injected and cooled. It's the impression which gives the moulding its form. The impression may, therefore, be defined as that part of the mould which imparts shape to the moulding.
The impression is formed by two mould members:
- The cavity, which is the female portion of the mould, gives the moulding its external form.
- The core, which is the male portion of the mould, forms the internal shape of the moulding.
Cavity and core plates: This is illustrated for a simple container, the basic mould, in this case, consists of two plates. Into one plate is sunk the cavity which shapes the outside form of the moulding and is therefore known as the cavity plate.
Similarly, the core which projects from the core plate forms the inside shape of the moulding. When the mould is closed, the two plates come together forming a space between the cavity and core which is the impression.
Plastic Injection Mould,Printed Plastic Injection Mould,Plastic Injection Moulding Machine,Plastic Equipment Injection Moulding
Zhejiang Ceeto Molding Technology Co.,Ltd. , https://www.ceetomold.com