1. Ensure that no remains of previous product / batch is present.
2. Visually check the equipment and area for its cleanliness.
3. Affix “CLEANED” label on the equipment.
4. Ensure specified temperature and relative humidity of the area.
5. Ensure that the equipment is getting three phase alternating current supply.
6. Ensure that the de-dusting machine is in working condition.
7. Ensure that the operator is wearing proper gown, gloves and nose mask.
8. Check the equipment usage log and ensure that equipment cleaning operation has been recorded.
9. Take line clearance from QA and fill usage log.
1. Replace “CLEANED” label with “UNDER PROCESS” label.
2. Align tablet feeding mouth of de-dusting machine with tablet outlet chute of compression machine.
3. Switch “ON” the equipment along with the compression machine.
4. Collect de-dusted tablets in a double poly bag lined containers.
5. Collect fine powder from powder collection box & treat it as recoverable.
6. On completion of operation, switch “OFF” the equipment.
7. Remove the dust collecting cup from the sifter chamber.
8. Collect & weigh the dust.
9. Record the weight in the relevant document.
10. Replace “UNDER PROCESS” label with “TO BE CLEANED” label.
1. Replace “UNDER PROCESS” label with “TO BE CLEANED” label.
2. Remove loosely stuck powder from the machine by using vacuum cleaner duster and lint free cloth.
3. Dismantle the machine in following sequence and keep the parts on pallet.
a. Feed hopper
b. Food grade gasket
c. Perforated plate
d. Dust collecting plate.
4. Clean the dismantled sifting parts with the help of a nylon brush to remove any residual powder.
5. Wash the equipment with raw water followed by 0.1% Teepol solution.
6. Again wash with raw water to remove Teepol solution.
7. Finally wash with purified water.
8. Dry the parts using lint free cloth and inform the Q.A. department for collecting the rinse water sample.
9. Clean the vibratory base mounting with a lint free wet cloth.
10. Record the cleaning details in equipment log and sign it.
(i) Do not give sample from wet surface.
(ii) Allow the water to run for five minutes before its use.
(iii) Do not allow stagnant water at any place in equipment / container.
(iv) Do not clean only the equipment desired for change over, all equipments in the same room will undergo cleaning in case of product change over.
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.
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