1.0 OBJECTIVE
1.1 To maintain the equipment tidy & clean.
2.0 SCOPE
2.1 To prevent cross contamination between products manufacturing.
2.2 To ensure error free operation of cleaning of Polishing machine.
2.3 This procedure is applicable for dismantling, cleaning of Polishing Machine in production.
3.0 RESPONSIBILITY:
3.1 Execution: Operator
3.2 Production officer
4.0 ACCOUNTABILITY:
4.1 Production Head
5.0 PROCEDURE :
5.1 Procedure for Cleaning :
5.1.1 Remove “TO BE CLEANED” tag from equipment.
5.1.2 Turn “OFF” the electric supply & remove the plug.
5.1.3 Dismantle all parts and take it to the washing area.
5.1.4 Wash the above parts using tape water (Use nylon brushes if requires to clean and to remove adhered sticky mass.
5.1.5 Finally Rinse with D.M. Water, allow to dry it and arranging on polishing machine in reverse order of dismantling.
5.1.6 Clean `Material receiving and delivering assembly’ in the same sequences as above.
5.1.7 Remove the dust from polishing machine belt and clean the belt with lint free cloth dipped in DM water.
5.1.8 Clean surrounding area of the machine as per respective SOP(cleaning of Polishing machine)
5.1.9 Record the details in equipment cleaning record.
5.1.10 Affix a “CLEANED” label on the machine in production area.
5.1.11 SAFETY : Protect Motor from contact of water.
FREQUENCY :
5.2.12 Product to product changes over in production.(cleaning of Polishing machine)
5.2.13 Procedure is given below for batch to batch cleaning.
5.2 Procedure for Operation :
5.2.1 Ensure that the Machine is cleaned as per respective SOP use in production area.
5.2.2 Check the electric supply to the machine.
5.2.3 Check the tube light on inspection hood of the machine for its functioning.
5.2.4 Bring the unpolished capsules packed in drums & check the Product Name & Batch No. on the label.
5.2.5 Affix status label on the machine with :
PRODUCT NAME :
BATCH NO : BATCH SIZE :
MFG. DATE :
EXP. DATE :
CHECKED BY : DATE :
5.2.6 Start the dehumidifier unit and note the room temperature and room humidity respectively.
5.2.7 Switch “ON” the main electric supply.
5.2.8 Switch “ON” the electric switch of machine.
5.2.9 Switch “ON” the Nylon brush rotator.
5.2.10 Load the unpolished capsules in hopper.
5.2.11 Collect the polished capsules from other sides.
5.2.12 Collect polished capsules in plastic drum with polythene bag. Label the container as :
PRODUCT NAME :
BATCH NO. :
POLISHED CAPSULES FOR PACKING :
GROSS WEIGHT :
TARE WEIGHT :
NET WEIGHT :
CHECKED BY : DATE :
5.2.13 After completing the Batch weigh the polished capsules and inform the production pharmacist.
5.2.14 TO STOP
5.2.14.1 After completing the day work machine is stopped as per given schedule :
5.2.14.2 Switch “OFF” the nylon brush rotor.
5.2.14.3 Switch “OFF” the switch of electric supply of machine.
5.2.14.4 Switch “OFF” the main electric supply to machine.
5.2.14.5 Switch “OFF” the room dehumidifier.
5.2.14.6 Clean the machine with clean dry duster.
5.2.15 Note : During the entire operation the person involved should wear hand gloves & mask.(cleaning of Polishing machine)