1 maintenance 1.1 minor repair, overhaul 1.1.1 minor repair (interval 1500~2000h)
(1) Check the lubrication of each rotating part and tighten the bolts of each part.
(2) Check the sealing device at each opening and joint of the box.
(3) Check the flatness of the two connecting pieces of the mesh belt and the mesh belt surface.
(4) Check the tension of the mesh belt and the positioning groove of the mesh belt to adjust the corresponding position.
(5) Check the running condition of the laminar flow fan and the lubrication of the fan bearing.
(6) Clean and inspect the quartz electric heating tube, fasten the electric heater terminal block, and the electric wire contact screw.
(7) Check the chain of the reducer and motor drive system, and the coupling.
(8) Check the position and sliding condition of the front and rear dampers.
(9) Check and clean the high-efficiency filter and exchange it when it is found to be incomplete.
(10) Check the program setting and control display in the PLC control system. If there is any fault, please consult the professional unit.
(11) Exclude the occurrence of the fault.
1.1.2 Overhaul (interval 6000~7000h)
(1) Includes minor repairs.
(2) Disassembly and repair of the box.
(3) Repair the mesh with two connecting pieces, the flatness of the mesh belt and other damage, and replace if necessary.
(4) Repair the mesh belt to tighten the roller and the mesh belt positioning groove, and replace if necessary (5) to repair the main belt, the passive roller and the transmission mechanism.
(6) Check the body deformation and eliminate it, check each weld and repair it.
(7) Check and replace each part of the bearing.
(8) Check and replace the damaged quartz electric heating tube.
(9) Check and replace the high-efficiency filter and seal the laminar flow box.
(10) Check the operation of the fan and replace the fan bearing.
(11) Cleaning, overhauling the reducer and overhauling the motor.
(12) Overhaul all control systems.
(13) Assembly, commissioning and commissioning.
1.2 Preparation before maintenance 1.2.1 Preparation of materials (1) Replacement of spare parts and maintenance materials.
(2) Disassembly and repair tools, instruments and measuring tools.
1.2.2 Technical preparation (1) Product specifications, drawings, technical standards and other information.
(2) Understand the technical status of the fault occurrence location, the number of times and the running accuracy of the tunnel laminar flow sterilization dryer.
(3) The main technical parameters and performance of the tunnel laminar sterilizing dryer are measured and recorded.
(4) Develop a maintenance plan.
1.2.3 Safety Technology Preparation (1) Replacement parts, inspection tools, instruments and other items and materials should be disinfected and then brought into the site where the equipment is located.
(2) Remove broken glass bottles and other foreign objects from the equipment.
(3) Turn off the power and hang the "Do Not Open" warning sign.
(4) The maintenance personnel must wear sterile overalls when entering the production site and meet the sterility requirements.
(5) Safety measures such as man, machine and fire prevention shall be formulated.
1.3 Maintenance method 1.3.1 Disassembly 1.3.1.1 Motor and transmission system:
(1) Remove the motor drive chain.
(2) Disassemble the steel coupling.
(3) Disassemble the two connecting pieces of a mesh belt to disconnect the mesh belt.
(4) Loosen the bearing caps of the main and driven rollers and lift the main and driven rollers.
1.3.1.2 cabinet:
(1) Inspection of deformation (unevenness) of each section of the box may be checked with a steel ruler not less than 1 m long.
(2) Forming or deforming the deformation.
(3) The surface crack or open welding of the box body is repaired by argon arc welding after repairing, and then repaired by angle grinder grinding. The repair welding at the same place can only be done once.
1.3.1.3 mesh belt conveyor system:
(1) After the conveyor belt is removed, the difference between the two sides should be measured after the flatness is removed. When the dimensional difference exceeds the specified value, the intermediate connection long pin shaft is exchanged.
(2) When adjusting the mesh belt tensioning device, both sides must be synchronized.
(3) Remove the mesh belt positioning long slot.
1.3.1.4 Heating elements:
(1) If there are many cracks and pitting on the surface of the heater quartz tube, it should be replaced.
(2) For the heater whose quartz tube shell is intact and the resistance wire is blown, the resistance wire should be replaced according to the specified capacity.
(3) Check the wiring of the fastening heater and remove it if necessary.
1.3.1.5 Remove the geared motor inside the box.
1.3.1.6 Disassemble the high efficiency filter laminar flow box.
1.3.1.7 Disassemble the laminar flow fan.
1.3.2 Bearings: When the rolling bearings are installed, the matching of the holes and the shaft is a transitional fit to ensure that the shaft does not bend and deform after assembly.
1.3.3 Conveyor belt: After the belt is cleaned and assembled, the plane is not flat and is inspected with a steel ruler;
1.3.4 mesh belt drive system: After cleaning and assembling the main and driven rollers (including the two tension rollers), the parallelism and straightness of the two axes are verified.
1.3.5 Purification system: After the high-efficiency filter is assembled, the integrity test is required; after the high-efficiency laminar flow box is assembled, the sealing test is required.
1.3.6 Instrumentation: After assembly of instruments such as temperature controller and temperature display, standard calibration is required.
1.3.7 Assembly: Assembly is carried out in the reverse procedure of disassembly.
1.4 Maintenance quality standard 1.4.1 After the rolling bearings are installed, the radial backlash of each shaft should be guaranteed to be no more than 0.03mm.
1.4.2 conveyor belt:
(1) The two connecting pieces of the mesh belt are firmly connected and movable. The difference between the two sides of the mesh belt is ±3mm;
(2) The unevenness of the plane of the mesh belt is convex or concave of the full width is not more than 5 mm;
(3) The mesh belt runs smoothly and evenly, and the end of the mesh belt can be flexibly operated in the long slot of the two mesh belts without jamming.
(4) The surface of the mesh belt should be free from rust and bottle debris.
1.4.3 mesh belt drive system:
(1) The parallelism of the two axes of the main and driven rollers is 11-level accuracy, and the total length is not more than 2.5 mm; the straightness is 8-level accuracy.
(2) The main and driven shafts are matched with the bearing as H7/k6, and the bearing housing and the bearing housing are matched as J7/h6.
(3) The parallelism of the two tensioning rollers is 11-level accuracy, the total length is not more than 2.5 mm; the straightness is 8 precision.
1.4.4 Air Purification System:
(1) The high-efficiency filter must have a test certificate, or the aerosol penetration rate ≤0.01%;
(2) After the high-efficiency filter is installed, the peripheral seal must not leak.
(3) The air supply duct should be cleaned and cleaned, and it should be wiped with a non-brick white cloth without any dust or stain.
(4) The laminar flow fan operates without abnormal noise, and the wind speed is uniform.
(5) The adjustment of air volume and wind speed should ensure that the air pressure in the preheating section is greater than the indoor air pressure by 5~10Pa; the air pressure in the cooling section is greater than the indoor air pressure by 15~20Pa; and the laminar flow velocity in the bottle mouth is ensured to be ≥0.3m/sec;
1.4.5 Instrumentation: In the equipment automatic control system, the temperature difference between the collector and the temperature display or temperature recorder is ≤±5°C.
1.5 Commissioning and acceptance 1.5.1 Preparation before commissioning (1) Remove obstacles around the body.
(2) Check that the bolts of each part are not loose and the protective cover is reliable.
(3) Check that the transmission parts should be flexible and the lubrication points should be filled with lubricant.
(4) Jog check that the motor rotates in the correct direction.
1.5.2 Test run 1.5.2.1 Normal temperature no-load test (1) The no-load test runs from low speed to high speed, and the continuous time at rated speed should be no less than 2h.
(2) The reducer unit works normally.
(3) Operation should be free of rubbing, noise and abnormal vibration.
(4) The insulation and pressure resistance of electrical equipment are in accordance with GB5226.
1.5.2.2 Heating no-load test (1) Under normal conditions of normal temperature and no-load test, the electric heating automatic control instrument and the fan switch are turned on in turn, so that the temperature rises to 100 °C, and the main motor transmission mesh belt is started.
(2) The temperature rise time of the tunnel laminar sterilizing and drying cabinet, from the time of power transmission to the specified temperature of each section, shall not exceed 40 minutes.
(4) The temperature rise of each rotating part is normal.
1.5.2.3 Load test (1) Load test should be no less than 1 hour at rated speed after no-load test.
(2) The production capacity of the equipment meets the design requirements, that is, the speed of the mesh belt meets the production requirements.
(3) The operation is stable, no abnormal vibration, and the noise is not more than 70dB (A).
(4) The temperature of the sterilization heating section is not lower than 350 ° C, and the residence time of the medicine bottle in the high temperature zone is not less than 5 min.
(5) The temperature of the vial sterilizing dryer of the vial exiting the tunnel is not higher than room temperature + 15 °C.
(6) After the bottle is sterilized and dried, the quality meets the requirements, and it should be sterile and pyrogen free.
(7) Monitoring of dust particles in the box, in line with the 100-level cleanliness standard.
(8) Differential pressure test, the relative pressure difference of each section is >0Pa;
(9) The pressure difference between the two ends of the general high-efficiency filter laminar flow tank is ≤250Pa (or refer to the relevant regulations for high-efficiency filters).
(10) No-load heat distribution test, the temperature of each point is at a set value ≤ ± 15 °C.
(11) Load heat distribution and heat penetration test, the test points are higher than 350 ° C in the time after 5 minutes of sterilization.
(12) Each control device and instrument is reliable.
(13) The axial flow fan operates without abnormal noise, and the temperature rise at the bearing is less than 60 °C.
(14) The breaking rate of the baking bottle is ≤1‰;
(15) At the end of the test run, first cut off the heating power supply, and wait until the temperature inside the box drops to 100 °C to stop the belt running.
1.5.3 Acceptance and maintenance meet the quality standards, the test run meets the requirements of this regulation and the manual, and the inspection and test record are complete and accurate, and the acceptance procedure can be completed.
2Maintenance and common fault handling 2.1 Maintenance (1) Check the equipment on a daily basis and make a record of the operation.
(2) Lubricating oil (fat) is applied to each lubrication point before starting and during operation.
(3) Always check for noise and abnormal vibration.
(4) Check and adjust the oven feet to make the whole unity and check whether the box fixing bolts are loose.
(5) Always check the running status of the mesh belt and check whether the adjustment of the mesh belt, tensioning and other devices work normally.
(6) After each fan stop, comprehensive cleaning should be carried out before restarting.
(7) During the operation, it is necessary to ensure that the pressure everywhere is within the requirements of the process.
(8) Check the pressure difference between the two ends of the high efficiency filter laminar flow box.
(9) Adjust the height of the damper at any time according to the condition of the bottle.
(10) When leaving work every day, the glass swarf in the box should be cleaned.
(11) Electrical components should always be kept clean and dry. At the same time, regularly check and replace the quartz electric heating tube.
(12) If abnormal conditions are found when operating the equipment, stop immediately and check the cause.
(13) During the start and stop of the equipment, the operator must be carefully monitored and not allowed to leave the operation site.
(14) Deactivated equipment should check if the power is off.
(1) Check the lubrication of each rotating part and tighten the bolts of each part.
(2) Check the sealing device at each opening and joint of the box.
(3) Check the flatness of the two connecting pieces of the mesh belt and the mesh belt surface.
(4) Check the tension of the mesh belt and the positioning groove of the mesh belt to adjust the corresponding position.
(5) Check the running condition of the laminar flow fan and the lubrication of the fan bearing.
(6) Clean and inspect the quartz electric heating tube, fasten the electric heater terminal block, and the electric wire contact screw.
(7) Check the chain of the reducer and motor drive system, and the coupling.
(8) Check the position and sliding condition of the front and rear dampers.
(9) Check and clean the high-efficiency filter and exchange it when it is found to be incomplete.
(10) Check the program setting and control display in the PLC control system. If there is any fault, please consult the professional unit.
(11) Exclude the occurrence of the fault.
1.1.2 Overhaul (interval 6000~7000h)
(1) Includes minor repairs.
(2) Disassembly and repair of the box.
(3) Repair the mesh with two connecting pieces, the flatness of the mesh belt and other damage, and replace if necessary.
(4) Repair the mesh belt to tighten the roller and the mesh belt positioning groove, and replace if necessary (5) to repair the main belt, the passive roller and the transmission mechanism.
(6) Check the body deformation and eliminate it, check each weld and repair it.
(7) Check and replace each part of the bearing.
(8) Check and replace the damaged quartz electric heating tube.
(9) Check and replace the high-efficiency filter and seal the laminar flow box.
(10) Check the operation of the fan and replace the fan bearing.
(11) Cleaning, overhauling the reducer and overhauling the motor.
(12) Overhaul all control systems.
(13) Assembly, commissioning and commissioning.
1.2 Preparation before maintenance 1.2.1 Preparation of materials (1) Replacement of spare parts and maintenance materials.
(2) Disassembly and repair tools, instruments and measuring tools.
1.2.2 Technical preparation (1) Product specifications, drawings, technical standards and other information.
(2) Understand the technical status of the fault occurrence location, the number of times and the running accuracy of the tunnel laminar flow sterilization dryer.
(3) The main technical parameters and performance of the tunnel laminar sterilizing dryer are measured and recorded.
(4) Develop a maintenance plan.
1.2.3 Safety Technology Preparation (1) Replacement parts, inspection tools, instruments and other items and materials should be disinfected and then brought into the site where the equipment is located.
(2) Remove broken glass bottles and other foreign objects from the equipment.
(3) Turn off the power and hang the "Do Not Open" warning sign.
(4) The maintenance personnel must wear sterile overalls when entering the production site and meet the sterility requirements.
(5) Safety measures such as man, machine and fire prevention shall be formulated.
1.3 Maintenance method 1.3.1 Disassembly 1.3.1.1 Motor and transmission system:
(1) Remove the motor drive chain.
(2) Disassemble the steel coupling.
(3) Disassemble the two connecting pieces of a mesh belt to disconnect the mesh belt.
(4) Loosen the bearing caps of the main and driven rollers and lift the main and driven rollers.
1.3.1.2 cabinet:
(1) Inspection of deformation (unevenness) of each section of the box may be checked with a steel ruler not less than 1 m long.
(2) Forming or deforming the deformation.
(3) The surface crack or open welding of the box body is repaired by argon arc welding after repairing, and then repaired by angle grinder grinding. The repair welding at the same place can only be done once.
1.3.1.3 mesh belt conveyor system:
(1) After the conveyor belt is removed, the difference between the two sides should be measured after the flatness is removed. When the dimensional difference exceeds the specified value, the intermediate connection long pin shaft is exchanged.
(2) When adjusting the mesh belt tensioning device, both sides must be synchronized.
(3) Remove the mesh belt positioning long slot.
1.3.1.4 Heating elements:
(1) If there are many cracks and pitting on the surface of the heater quartz tube, it should be replaced.
(2) For the heater whose quartz tube shell is intact and the resistance wire is blown, the resistance wire should be replaced according to the specified capacity.
(3) Check the wiring of the fastening heater and remove it if necessary.
1.3.1.5 Remove the geared motor inside the box.
1.3.1.6 Disassemble the high efficiency filter laminar flow box.
1.3.1.7 Disassemble the laminar flow fan.
1.3.2 Bearings: When the rolling bearings are installed, the matching of the holes and the shaft is a transitional fit to ensure that the shaft does not bend and deform after assembly.
1.3.3 Conveyor belt: After the belt is cleaned and assembled, the plane is not flat and is inspected with a steel ruler;
1.3.4 mesh belt drive system: After cleaning and assembling the main and driven rollers (including the two tension rollers), the parallelism and straightness of the two axes are verified.
1.3.5 Purification system: After the high-efficiency filter is assembled, the integrity test is required; after the high-efficiency laminar flow box is assembled, the sealing test is required.
1.3.6 Instrumentation: After assembly of instruments such as temperature controller and temperature display, standard calibration is required.
1.3.7 Assembly: Assembly is carried out in the reverse procedure of disassembly.
1.4 Maintenance quality standard 1.4.1 After the rolling bearings are installed, the radial backlash of each shaft should be guaranteed to be no more than 0.03mm.
1.4.2 conveyor belt:
(1) The two connecting pieces of the mesh belt are firmly connected and movable. The difference between the two sides of the mesh belt is ±3mm;
(2) The unevenness of the plane of the mesh belt is convex or concave of the full width is not more than 5 mm;
(3) The mesh belt runs smoothly and evenly, and the end of the mesh belt can be flexibly operated in the long slot of the two mesh belts without jamming.
(4) The surface of the mesh belt should be free from rust and bottle debris.
1.4.3 mesh belt drive system:
(1) The parallelism of the two axes of the main and driven rollers is 11-level accuracy, and the total length is not more than 2.5 mm; the straightness is 8-level accuracy.
(2) The main and driven shafts are matched with the bearing as H7/k6, and the bearing housing and the bearing housing are matched as J7/h6.
(3) The parallelism of the two tensioning rollers is 11-level accuracy, the total length is not more than 2.5 mm; the straightness is 8 precision.
1.4.4 Air Purification System:
(1) The high-efficiency filter must have a test certificate, or the aerosol penetration rate ≤0.01%;
(2) After the high-efficiency filter is installed, the peripheral seal must not leak.
(3) The air supply duct should be cleaned and cleaned, and it should be wiped with a non-brick white cloth without any dust or stain.
(4) The laminar flow fan operates without abnormal noise, and the wind speed is uniform.
(5) The adjustment of air volume and wind speed should ensure that the air pressure in the preheating section is greater than the indoor air pressure by 5~10Pa; the air pressure in the cooling section is greater than the indoor air pressure by 15~20Pa; and the laminar flow velocity in the bottle mouth is ensured to be ≥0.3m/sec;
1.4.5 Instrumentation: In the equipment automatic control system, the temperature difference between the collector and the temperature display or temperature recorder is ≤±5°C.
1.5 Commissioning and acceptance 1.5.1 Preparation before commissioning (1) Remove obstacles around the body.
(2) Check that the bolts of each part are not loose and the protective cover is reliable.
(3) Check that the transmission parts should be flexible and the lubrication points should be filled with lubricant.
(4) Jog check that the motor rotates in the correct direction.
1.5.2 Test run 1.5.2.1 Normal temperature no-load test (1) The no-load test runs from low speed to high speed, and the continuous time at rated speed should be no less than 2h.
(2) The reducer unit works normally.
(3) Operation should be free of rubbing, noise and abnormal vibration.
(4) The insulation and pressure resistance of electrical equipment are in accordance with GB5226.
1.5.2.2 Heating no-load test (1) Under normal conditions of normal temperature and no-load test, the electric heating automatic control instrument and the fan switch are turned on in turn, so that the temperature rises to 100 °C, and the main motor transmission mesh belt is started.
(2) The temperature rise time of the tunnel laminar sterilizing and drying cabinet, from the time of power transmission to the specified temperature of each section, shall not exceed 40 minutes.
(4) The temperature rise of each rotating part is normal.
1.5.2.3 Load test (1) Load test should be no less than 1 hour at rated speed after no-load test.
(2) The production capacity of the equipment meets the design requirements, that is, the speed of the mesh belt meets the production requirements.
(3) The operation is stable, no abnormal vibration, and the noise is not more than 70dB (A).
(4) The temperature of the sterilization heating section is not lower than 350 ° C, and the residence time of the medicine bottle in the high temperature zone is not less than 5 min.
(5) The temperature of the vial sterilizing dryer of the vial exiting the tunnel is not higher than room temperature + 15 °C.
(6) After the bottle is sterilized and dried, the quality meets the requirements, and it should be sterile and pyrogen free.
(7) Monitoring of dust particles in the box, in line with the 100-level cleanliness standard.
(8) Differential pressure test, the relative pressure difference of each section is >0Pa;
(9) The pressure difference between the two ends of the general high-efficiency filter laminar flow tank is ≤250Pa (or refer to the relevant regulations for high-efficiency filters).
(10) No-load heat distribution test, the temperature of each point is at a set value ≤ ± 15 °C.
(11) Load heat distribution and heat penetration test, the test points are higher than 350 ° C in the time after 5 minutes of sterilization.
(12) Each control device and instrument is reliable.
(13) The axial flow fan operates without abnormal noise, and the temperature rise at the bearing is less than 60 °C.
(14) The breaking rate of the baking bottle is ≤1‰;
(15) At the end of the test run, first cut off the heating power supply, and wait until the temperature inside the box drops to 100 °C to stop the belt running.
1.5.3 Acceptance and maintenance meet the quality standards, the test run meets the requirements of this regulation and the manual, and the inspection and test record are complete and accurate, and the acceptance procedure can be completed.
2Maintenance and common fault handling 2.1 Maintenance (1) Check the equipment on a daily basis and make a record of the operation.
(2) Lubricating oil (fat) is applied to each lubrication point before starting and during operation.
(3) Always check for noise and abnormal vibration.
(4) Check and adjust the oven feet to make the whole unity and check whether the box fixing bolts are loose.
(5) Always check the running status of the mesh belt and check whether the adjustment of the mesh belt, tensioning and other devices work normally.
(6) After each fan stop, comprehensive cleaning should be carried out before restarting.
(7) During the operation, it is necessary to ensure that the pressure everywhere is within the requirements of the process.
(8) Check the pressure difference between the two ends of the high efficiency filter laminar flow box.
(9) Adjust the height of the damper at any time according to the condition of the bottle.
(10) When leaving work every day, the glass swarf in the box should be cleaned.
(11) Electrical components should always be kept clean and dry. At the same time, regularly check and replace the quartz electric heating tube.
(12) If abnormal conditions are found when operating the equipment, stop immediately and check the cause.
(13) During the start and stop of the equipment, the operator must be carefully monitored and not allowed to leave the operation site.
(14) Deactivated equipment should check if the power is off.
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