GMP workshop tablet coating

GMP workshop for tablet coating

The GMP workshop enters the production site to check whether there is a 'clearance certificate' for the last production, and whether there is a signature of a quality inspector or inspector; according to the relevant cleaning standard management regulations, check the post environment, on-site sanitation and cleanliness, check dry Humidity thermometer, differential pressure gauge, confirm temperature, humidity and pressure...

Text label: GMP pharmaceutical cleanroom installation, GMP workshop design, GMP tablet pharmaceutical cleanroom

GMP workshop for tablet coating

The GMP workshop enters the production site to check whether there is a 'clearance certificate' for the last production, and whether there is a signature of a quality inspector or inspector; according to the relevant cleaning standard management regulations, check the post environment, on-site sanitation and cleanliness, check dry Humidity thermometer, differential pressure gauge, confirm that the temperature, humidity and differential pressure meet the process requirements, the temperature is 18-26 °C, the relative humidity is 45%-65%, the differential pressure and the inner corridor should be relatively negative pressure, the standard is greater than 5Pa; The temperature is 24-32°C, and the relative humidity is 45%-65%. If it does not match, please contact the air-conditioning post for adjustment. Check whether the balance is clean and sensitive, whether it is within the inspection period, and if any problems are found during use, contact for maintenance in time, and the use time cannot exceed the period of the certificate.

Check the mesh number and wear of the screen according to the process prescription, and replace it in time if it is broken; loosen the fastening screws of the oscillating screen and open the upper cover of the machine to check whether there is any debris in the machine and whether it is clean. The screen is installed flat, close the top cover and tighten the fastening screws, and finally check whether the outer wall of the fuselage meets the requirements; turn on the power and start the button, check whether the machine is running normally, whether there is noise, and whether there is leakage, and confirm that it is correct , turn off the start button; check whether there are obstacles around the machine, and other items are not allowed on the machine; check and adjust the safety guards, and check the workers and appliances required for production; check whether the quartz heater and hot air system are well insulated and grounded The zero connection is good, and the electric heating tube must not touch the pot body. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and dust-free workshops.

Set the program, preheat the plain sheet first, set the time to 10min, set the inlet air temperature to 50-75℃, set it to positive ventilation; adjust the flow rate of the peristaltic pump, set it to 0.2mm, and turn on the steam Valve and compressed air switch, steam pressure and compressed air pressure are both greater than 0.4MPa; press manual build, enter the manual operation program, start the homogenization, enter the preheating stage, the pot speed in the preheating stage is maintained at 4r/min, if the tablet bed The temperature of the machine has reached 40 ℃, first click on the compressed air and then click on the spraying to enter the spraying stage; after the spraying program is carried out for 20min, adjust the speed to 5-6r/min, after the program is carried out for 30min, then adjust the speed to 6- 8r/min, and adjust the scale of the peristaltic pump to 0.3mm. After the program runs for 60min, adjust the speed to 8-10r/min, and adjust the atomization pressure to 0.3MPa. During the coating process, keep the outlet air temperature at 45- 55°C, adjust the inlet air temperature at any time according to the height; after spraying the coat, turn off the hot air blower and steam valve, and continue to run for 10 minutes for rolling and cooling. After the film feels dry and the surface appears bright, stop the exhaust fan and stop the package Take out the slurry suction filter of the peristaltic pump from the pot, close the compressed air and the ball valve of the peristaltic pump, and hang the tablet output bucket; after the coated tablets are out of the pan, put them into a stainless steel bucket with a clean cloth bag, and put them in the middle of the bucket. Station staff face to face handover.

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