1.0 PURPOSE:This document deals with the procedure for cleaning of Three Piece Filling machine parts and silicon tubing.
2.0 SCOPE:Applicable to Three Piece vial Filling Machine.
3.0 RESPONSIBILITY:Production Staff
4.0 ACCOUNTABILITY:Head of Department
5.0 PROCEDURE:5.1 Switch off the mains of filling and sealing machine.
5.2 Remove the syringe and silicon tubing from machine in the SS tray.
5.3 Dismantle the nozzle, valve, piston and silicon tubing of syringe.
5.4 Flush fill nozzle, valves, piston and silicon tubing each with 5 L of hot DW.
5.5 Repeat step 5.4 with another 5 L of DW.
5.6 Repeat step 5.4 with another 1 L of DW.
5.7 Repeat step 5.3 to 1.6 for other 3 sets of fill nozzle and syringe.
5.8 Assemble syringe and put in filling machine parts tray.
5.9 Autoclave the machine parts at 121°C for 30 mins. as per SOP.
6.0 ABBREVIATIONS:DW : Distilled Water
L : Litre
Mins : Minutes
°C : Degree Centigrade
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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