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Procedure for Operation and Cleaning of Rapid Mix Granulator (RMG)


Learn how to operate and clean the Rapid Mix Granulator (RMG).

PRE-STARTUP:

1.  Check the cleanliness of the room.
2.  Check the material lying in the room is of the same batch to proceed.
3.  Remove the clean status label of the equipment and tear off them after confirming the details.
4.  Put the equipment label on the machine.

AT THE TIME OF BATCH CHANGEOVER OF THE SAME PRODUCT:

1.  Check and ensure the cleanliness of the equipment / area.
2.  Remove the clean equipment status label.
3.  Put the equipment label on the machine.

AT THE TIME OF PRODUCT CHANGEOVER:

1.  Check the cleanliness of the room / equipment and ensure that the area / equipment is free from remnants of the previous product.
2.  Check and ensure the availability of the rinse water analysis report and attach that in BMR.
3.  Remove the clean equipment status label.
4.  Check the room temperature and relative humidity and record it in BMR, equipment log card, if it is not within limit, inform the maintenance and do not proceed till it get rectified.

START UP:

OPERATION:

1.  Use latex gloves during loading and unloading of material.
2.  Open the top lid of bowl, load the materials from the container into the bowl as per the sequence specified in BMR.
3.  Close the lid and lock the two locking clamps.
4.  Start the dry mixing. Fix the speed as desired in BMR.
5.  Add the binder paste solution by solution inlet.
6.  Start the wet mixing and set the speed of the impeller as specified in BMR.
7.  Start the granulation and judge the end point by regular checking.
8.  Discharge the wet mass into the cleaned FBD bowl kept under the discharge port by opening the discharge gate.
9.  Stop the impeller and open the top lid. Remove the remaining mass by scraping with scrapy.
10.  Ensure that all material has been removed.

SHUTDOWN:

1.  Switch OFF the main power supply.

CLEANING: (Day's end cleaning)

1.  Remove loosely stucked powder from the machine by using vacuum cleaner, duster and lint free cloth.
2.  Dismantle the machine in the following sequence and keep them on pallet-
A.  Agitator dome
B.  Chopper blade
C.  Stainless steel bolt
3.  Clean the dismantled parts by using vacuum cleaner, duster and lint free cloth.
4.  Clean the machine and dismantle parts with a dry lint free cloth.
5.  Clean the room as per SOP.
6.  Assemble the cleaned dismantled parts.
7.  After cleaning affix the cleaned status label on the equipment.
8.  Record the cleaning details in the equipment log card.

CLEANING AT THE TIME OF BATCH CHANGEOVER / SAME PRODUCT OF ASCENDING POTENCY:

1.  Remove loosely stucked powder from the machine by using vacuum cleaner, duster and lint free cloth.
2.  Dismantle the machine in the following sequence and keep them on pallet-
A.  Agitator dome
B.  Chopper blade
C.  Stainless steel bolt
3.  Clean the dismantled parts by using vacuum cleaner, duster and lint free cloth.
4.  Clean the machine and dismantle parts with a dry lint free cloth.
5.  Clean the room as per SOP.
6.  Assemble the cleaned dismantled parts.
7.  After cleaning affix the cleaned status label on the equipment.
8.  Record the cleaning details in the equipment log card.

Related: SOP for Product Changeover in Manufacturing

CLEANING AT THE TIME OF PRODUCT CHANGEOVER / SAME PRODUCT OF DESCENDING POTENCY / PREVENTIVE MAINTENANCE OF THE CONTACT PARTS:

1.  Clean the body of the mixer, assembly surface with a moist duster and then dry with a clean duster.
2.  Fill the bowl to 1/3rd of its capacity with water. Close the lid of the mixer and run the mixer and chopper for five minutes.
3.  Attach stainless steel drum under the discharge port to collect the washing.
4.  Open the top lid of the mixer and remove the dome and agitator blades by loosening the locking nuts.
5.  Dismantle the chopper blades the loosening the bolt and then remove the blades and washer.
6.  Take the blades and chopper assembly to the washing area and clean them with jet of water along with scrubbing with nylon brush.
7.  Wash the bowl with water properly. Scrub it with nylon brush to remove the powder sticking to the sides.
8.  Scrub the discharge port with the scrubber to remove the powder sticking to it then wash it with a jet of water.
9.  Check the bottom of blades, crevices of the chopper, dome, locking nuts, and discharge port for the absence of previous material.
10.  Rinse the machine and the dismantled parts with purified water. And send the sample to Q.A. department to confirm the absence of previous product.
11.  Fix the cleaned status label on the machine.
12.  Record the cleaning details in equipment log card.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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