1.0 PURPOSE:
2.0 SCOPE:
This procedure is applicable for operation and cleaning of slurry preparation vessel at (Company name).
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 Production operator is responsible to follow the SOP.
4.2 Production officer / executive is responsible for execution of the procedure.
4.3 QA officer / executive is responsible for ensuring line clearance.
4.4 Head-Production is responsible to ensure compliance of the procedure.
5.0 PROCEDURE:
5.1 Pre-Operation Check:
5.1.1 Ensure that ’CLEANED’ label is affixed on machine before operation.
5.1.2 Ensure that the compressed air is connected to the of slurry preparation vessel.
5.1.3 Affix appropriate status label on equipment and ensure that the line clearance is completed.
5.2 Operation of slurry preparation vessel:
5.2.1 Take the slurry preparation vessel into the isolator of API dispensing room or into the roll compactor isolator whenever required.
5.2.2 Take the dispensed material inside the isolator.
5.2.3 Open the lid of the vessel, Affix the mechanical stirrer inside the pressure vessel.
5.2.4 Add the required quantity of solvent/ purified water into the pressure vessel as mentioned in the BMR.
5.2.5 Add the dispensed API inside the of slurry preparation vessel and prepare the slurry as per BMR inside the isolator.
5.2.6 Once the slurry is prepared, close the lid of the of slurry preparation vessel.
5.2.7 Wipe the of slurry preparation vessel with deactivation agent.
5.2.8 Put the of slurry preparation vessel in a virgin polybag.
5.2.9 Remove the of slurry preparation vessel from the isolator and take it near to the HSMG or FBP as required.
5.2.10 Fix one end of the silicon tube to the of slurry preparation vessel and another end to the peristaltic pump or paste transfer pump. Operate the peristaltic pump as per the respective SOP.
5.2.11 Enter the operation details in equipment/ instrument log.
5.3 Cleaning of slurry preparation vessel:
5.3.1 Take the of slurry preparation vessel to the wash area.
5.3.2 Connect the potable water line to the inlet of the of slurry preparation vessel.
5.3.3 Put the silicon tube connected to the outlet of the of slurry preparation vessel to the drain point.
5.3.4 Open the potable water line pendent and let the water go to the drain point from the of slurry preparation vessel.
5.3.5 Follow the steps no. 5.3.2 to 5.3.4.
5.3.6 Then remove the lid of the of slurry preparation vessel.
5.3.7 Scrub the inner surface of the of slurry preparation vessel till all the adherent material is removed.
5.3.8 Finally rinse it with potable water followed by purified water.
5.3.9 Dry it with 0.2µ filtered compressed air until all the water droplets are removed.
5.3.10 Wipe it with dry lint free cloth.
5.3.11 Remove the silicon tube connected to the outlet of the of slurry preparation vessel.
5.3.12 Destroy the inlet and outlet silicon tube by cutting it into pieces.
5.3.13 Put the silicon tube into a polybag.
5.3.14 Add sufficient amount of deactivation solution into it so as to neutralize the silicon tube.
5.3.15 Put sufficient quantity of deactivation solution into the drain point.
5.3.16 Enter the cleaning details in equipment/instrument log.
5.3.17 Attach “CLEANED” label to of slurry preparation vessel.
6.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
BMR : Batch manufacturing record.
HSMG : High Shear Mixer Granulator
FBP : Fluid bed equipment
7.0 REFERENCES:
8.0 LIST OF ANNEXURES:
Also read: SOP for inspection of uncoated tablets.
Also read: Procedure For Usage And Control Of Machine Lubricants
Also read: SOP for Polishing of Punches and Dies