1.0 Objective: To lay down the procedure for efficient Cleaning & Operation of Sterilized Powder filling machine in the injection section of the production department
2.0 Scope: This SOP for Cleaning & Operation of Sterilized Powder filling machine is applicable to the Injection section of the production department.
Officer – Production
Head – Production
Master Copy: Quality Assurance Department
Control Copy: Production Department
Display Copy: Production Department
5.0 Procedure for Sterilized Powder Filling Machine:
5.1 The machine should be cleaned after every batch/product processing and at the changeover and end of the shift.
5.2 Remove powder from the hopper and collect powder in a sterile container/ under L.A.F. (Laminar airflow) workstation.
5.3 Switch the mains and dismantle all removable parts from the machine.
5.4 Wash all the removed parts like a hopper, O. Rings, and Pistons wheel with teepol 0.2% v/v, or any other suitable detergent solution.
5.5 Rinse machine parts with sufficient D.M. Water to make the machine parts free from detergency.
5.6 Finally, rinse machine parts with freshly prepared distilled water.
5.7 Request the IPQA person to collect the wash water and send the wash water to Q.C. for further analysis.
5.8 After getting a satisfactory report from Q.C., wrap all machine parts in aluminum foil paper.
5.9 Sterile the wrapped machine parts as per SOP “Filling machine accessories sterilization” and process for further sterilization process.
5.10 Clean the machine’s main body with a dry duster followed by a wet duster dipped in 0.2% v/v (disinfectant solution).
5.11 Finally, prepare the 70% IPA solution and wipe the machine body parts.
5.12 Affix the “cleaned” label on the machine as per status labeling procedure.
6.0 Operation Sterilized Powder Filling Machine :
6.1 Remove all the sterile machine parts in the buffer zone after autoclaving.
6.2 Dry machine parts in D.H.S. (Dry heat sterilization) for 1 hour at 70 °C to 80 °C.
6.3 Remove all the dried sterile machine parts from D.H.S. into the buffer zone after getting a tolerating temperature.
6.4 Transfer it to the filling area and Assemble all the machine parts at their respective positions.
6.5 Check and monitor Temperature and R.H. in the filling area.
6.6 Fill the hopper with sterile powder and put a lid on the hopper.
6.7 Adjust the fill weight as per the respective B.M.R. by losing and tightening of piston knob.
6.8 Load sterile vials onto the feed turntable from cassettes and allow them to pass through the conveyor belt.
6.9 Start the filling operations.
6.10 Load the sterile rubber plug into the hopper of the rubber stopper machine and start the machine.
6.11 Seal the stoppered vials with an appropriate aluminum seal on the vial sealing machine.
6.12 Collect all the sealed vials in the baskets suitably designed for this purpose.
6.13 Transfer all these sealed vials into the visual inspection area through the pass box.
6.14 Record filling and sealing observations in the Equipment log sheet as per SOP “Making entry in Logbooks“.
7.0 Acceptance Criteria
7.1 Compliance with the above guidelines
S.O.P.: Standard Operating Procedure
D.H.S.: Dry Heat Sterilization
QA: Quality Assurance