This article mainly explains how to use the coating machine to wrap the film coating of tablets. After the intermediate product is tested and qualified, film coating is carried out, with one pot for every 500,000 blank vegetarian tablets. Each pot needs 0.7kg of hydroxypropyl methylcellulose, 0.7kg of talc, 0.7kg of titanium dioxide, 13kg of 95% ethanol and 8kg of purified water to prepare the coating solution, with the incoming air temperature ≤ 70℃ and the exhaust air temperature ≤ 50℃.
Operation flow
Production preparation
(1) Check whether the equipment has cleaning signs, check whether the pot body reaches the cleaning standard, otherwise inform the equipment manager, after everything is normal, replace the “operation” signboard and fill in the user and date.
(2) Open the manual valve of compressed air. Open the electronic control cabinet, turn on the main power supply, and then click on the “system monitoring”, and “manual” to enter the operation control interface, open the air nozzle manual valve, and open the heating stir manual valve.
(3) install the nozzle, select the appropriate nozzle and install it, pay attention to the direction, and location.
(4) adjust the position of the nozzle in the drum, so that it is installed in the middle of the drum, to maintain symmetry, adjust the height from the surface of the drug, the general requirements of its height of 250-300mm, the angle of 80 ° or so.
(5) Pay attention to the nozzle can not be blocked, if there is a blockage phenomenon, must be cleaned with solvent (ethanol or cleaning agent), while the nozzle can be rotated 180 °, with high-pressure air blowing clean, and then turn back to 180 °, the blockage is ruled out.
(6) Put the suction slurry filter into the solution barrel, and use the solution to test spray outside the machine, and after working smoothly, move the rotating arm and install the spray pipe with the gun inside the machine.
Production operation
(1) Set the rotating speed and click “homogenize” on the control panel to open the coating drum.
(2) Click the button of “Exhaust”, then click “Temperature control”, set “Inlet temperature”, and make “Temperature on”. status is green, click “back”, and click the “hot air” button.
(3) Wait for the air temperature to rise to 50℃-60℃.
(4) Insert the slurry suction port into the slurry storage barrel with prepared slurry, turn on the “slurry spray”, immediately click the spray pressure control button, make it to the “on” position, adjust the flow manual control knob until the generated mist reaches the standard.
(5) Adjust the inlet and outlet fans to maintain the negative pressure inside the drum to prevent the fine powder from being sprayed out.
End of production
(1) Click the “spray slurry” button, close the nozzle flow rate manual adjustment knob, and stop providing nozzle atomization pressure when no liquid is sprayed.
(2) After the tablet surface is completely dry, click “hot air” to stop heating.
(3) When the temperature of the tablet bed is lowered (both outgoing air temperature and incoming air temperature are lowered) to 40℃, you can stop the exhaust air and close the homogenizer.
(4) Install the device inside and outside the tablet outlet, make sure it is locked, and then click the “screed” button to complete the coated tablets discharge smoothly.
(5) Clean the nozzle. Insert the slurry suction port into the prepared distilled water, reset the nozzle, click “spray slurry”, pass compressed air, adjust the manual knob of flow control, and stop cleaning when the spray mist and the liquid spray pipe are not colored.
(6) Clean the pot body. Clean the inner wall of the pot with a clean towel dipped in distilled water or cleaning agent, and wipe dry with a dry towel after cleaning.
Caution
(1) During gun disassembly and cleaning, ensure that the installation sequence is correct, and pay attention to protecting the gun needle and each seal during disassembly to prevent bumping and scratching.
(2) The fasteners should be checked regularly to prevent loosening. The dust removal cartridge should not be cleaned with water, and the dust on its surface can be cleaned with a vacuum cleaner.
(3) The equipment should be in a neat, clean, and intact condition after maintenance and repair.
(4) After each production, the compressed air inlet valve must be closed to prevent damage to the equipment caused by rapid pressure rise.
Job duties
(1) Dress according to the regulations before and after entering the post, do a good job of plant and equipment cleaning and sanitation and do all the preparatory work before operation.
(2) Receive materials according to production instructions and in accordance with the prescribed procedures.
(3) Prepare coating solution strictly according to the prescription of the film coating preparation process and its SOP.
(4) Coat according to the prescription process requirements and efficient coating SOPs.
(5) Strictly check the appearance, color, and tablet weight gain of the coated tablets during the coating process to ensure that the coated tablets meet the quality requirements.
(6) After the coating is completed, carry out the drying process according to the regulations.
(7) Fill in all kinds of original operation records carefully.
(8) During the work period, it is strictly forbidden to leave the post, crosstalk, and not to do things that are not related to the work of the post.
(9) At the end of work or when replacing varieties, clear the field strictly according to the SOP of this post, and hang the identification plate after passing the inspection by QA.
(10) Check the operation of equipment frequently, pay attention to the maintenance of equipment, and report any malfunction found during the operation.
