Pre-Mixing Vessel, Purpose :
Pre-Mixing Vessel, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Pre-mixing Vessel in order to comply with cGMP standard.
Pre-Mixing Vessel, Scope :
The scope of the procedure is applicable to the Vessels at the Production area of Kidney Dialysis Fluid (KDF) of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]CIP : Clean In Place
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Operation and cleaning of the Pre-mixing Vessel.
[][]Maintaining Equipment Log Book.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Head of Quality Assurance
[][]To approve the SOP.
Procedure
Precautions :
[][]Chamber cover is properly locked.
[][]The wash-down valves are in closed position.
[][]Check for any leakage from discharge valve.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
Machine Assembling
[][]Clean the machine well.
[][]Assemble the machine change parts and all the connections that are necessary for certain types of operation.
[][]Attach the vacuum material transfer unit to the lid cover to transfer Liquid material automatically.
[][]Attach the solution transfer unit to the lid cover to transfer solution automatically by pressure.
[][]Attach the vision unit with clamp to the cover of chamber.
Machine Operation:
[][]Lock the chamber cover with chamber cover locking. Check for proper locking.
[][]Turn the machine ON/OFF key to ON. the machine is ON.
[][]Set the impeller Rotation Per Minute (RPM) and process time to desired value at the regulator at SETUP button (user can change the Impeller speed)
[][]Look the actual speed of the impeller.
[][]To off the impeller off button.
[][]To add solution or water open the chamber covers and then transfers the solution or water pneumatically.
[][]To stop the machine immediately, push the EMERGENCY button backward, machine will be stopped immediately.
[][]To check the solution during process OFF the impeller. Lift the lid cover manually and check.
[][]To Transfer or sample the solutions open the discharge valve manually.
[][]Transfer the solution through the Filter Housing control button (manual option is available).
[][]When discharge is complete push the CLOSED button to close the discharge valve.
[][]Transfer the Solution in product to Mixing Vessel (2000L).
[][]Push the OFF button to stop the Machine.
Machine Dismantling
[][]Turn the machine ON/ OFF key to off the machine.
[][]Remove the solution transfer unit.
[][]Remove the Lid Cover and Vision unit.
[][]Remove the Sample Collection unit.
[][]Remove the Filter housing from the Vessel.
Machine Cleaning
Cleaning of Vessel
[][]Fill the Vessel with Potable Water, the inner surface of the vessel well enough to washout the processing materials .Clean the outer surface of the vessel with rubbing & plenty of potable and purified water.
[][]Stir for 5-10 min after sufficient amount of potable water 500L being aggregated at the bottom.
[][]Rub with brush on the top and side walls of the vessel.
[][]Transfer the total wash water to the Manufacturing Vessel 2000L.
[][]Clean the wall and top with the hot potable water.
[][]Rub with brush on the top and side walls of the vessel again.
[][]Fill the Vessel with Purified Water and stir 15 min and then transfer to mixing vessel.
[][]Transfer the total wash water from 500L to the Vessel 2000L, 2000L drainage via filling machine.
[][]Rinse the wall and top of the vessel with hot potable water again.
[][]Clean the top and wall of the vessel with dry lint free cloth.
[][]Rinse the outer and inner wall of the vessel with IPA.
[][]Remove all water from the vessel and pipe line with Compressed air flow.
[][]After final cleaning affix the ‘CLEANED’ label.
Annexure:
N/A