1.0 Objective:
- To lay down a procedure for Operation and Cleaning of Ultrasonic tool wash system Machine (Parle Elizabeth Tools).
- This SOP shall be applicable for Operation and Cleaning of Ultrasonic tool wash system Machine in Manufacturing Area at Boostyourpharmagyan Pharmaceutical Limited.
3.0 Responsibility:
- Operator Production :
To perform Operation and Cleaning of Ultrasonic tool wash system Machine as per this SOP.
- Officer/Executive Production
To check that operator is following the procedure of Operation and Cleaning of Ultrasonic tool wash system as per this SOP.
- Officer /Above IPQA
To verify that procedure is followed of Operation and Cleaning of Ultrasonic tool wash system as per this SOP.
4.0 Accountability:
- Head Production and Head QA shall be accountable for compliance of this SOP.
5.0 Procedure:
5.1 Precaution:
- Wear PPEs (Heat resistant gloves) during operation and cleaning of Ultrasonic tool wash system Machine.
- Ensure that the Sonicator should not start without filling water.
- Ensure that after completion of total time cycle i.e 99 min. one should always give rest to Sonicator to avoid the heating of tank which may result in the failure of transducer.
- Ensure that the Electrical supply is disconnected before Cleaning activity or any repair work being carried out.
- The Cleaning tank should always be kept clean to avoid any deposition or solvent or soil as this may affect the Ultrasonic energy radiation.
- Always avoid trickling of water or solvent in Ultrasonic generator.
Remove the Power plug from the socket before Cleaning. - Ensure that the Mains should be disconnected before filling or draining liquid.
- Ensure proper Earthing of the equipment.
- Ensure that the temperature of the liquid should not exceed 65°C.
- Don’t dip your hands or fingers in the cleaning liquid while cleaner are on.
- Ensure that the Compressed air supply should be more then 0.5 kg /cm2 .
- In case of emergency, press Emergency Stop button.
5.2 Tools
- Vaccum cleaner
- Lint free cloth
- Scrubber
5.3 Operation
- Pre Start up
Remove the "CLEANED" lable and affix the "STATUS" label.
- Setup
Pre Cleaning:-
- Switch ON the Main Power supply.
- Add Purified water to Pre Cleaning tank.
- Switch ON the Heater from Heater button. A yellow light will appear on heater indicator.
- From the above screen, User can view the Set / Actual temperature and time by pressing DISPLAY button.
- Fill the purified water in the tank up to the level of float switch and set temperature, time by pressing the MODE button. User can check the Set / Actual Temperature and time from the display button.
- User will set the temperature (70°C) by pressing arrow keys (˄, ˅) Place Die / Punches (50 number in each) in perforated basket.
- When temperature reached to 70°C, open the lid and transfer loaded perforated basket in Pre Cleaning tank for cleaning and close the lid.
- User will set the Time (10 minutes) by pressing MODE button and start the cycle by pressing the TIMER button.
- After the completion of cycle, buzzer ON and cycle completed.
- After cleaning, User will drain the potable water (as required) from Water Drain ON/OFF button from the display.
Ultrasonic (1st Stage):-
- Switch ON the Main Power supply.
- Fill the purified water to Ultrasonic chamber (1st stage).
- Switch ON the Heater from Heater button.
- Switch ON the Ultrasonic button. An orange light will appear on display indicator.
- From the above screen, User can view the Set / Actual temperature and time by pressing DISPLAY button.
- User will set the temperature (70°C) and by pressing arrow keys (˄, ˅) When temperature reached to 70°C, open the lid and transfer loaded perforated basket or punch tray from Pre Chamber to Ultrasonic chamber and close the lid.
- Switch ON the Degass by pressing the Degases button for 5 minutes and the equipment will run in ON/OFF condition for maximum degassing of dissolved gases in the solvent. A green light will appear and cleaner ON automatically.
- After Degassing, User will set the Time for 15 minutes by pressing MODE button.
- Now Switch ON the PSP (Pulse Sweep Power) button by pressing the PSP button. A yellow light appear on indicator.
- Switch ON the cleaner button by pressing it. A green light will appear on indicator.
- After completion of Cycle, Ultrasonic Cleaner stop automatically.
- Switch off the heater.
- After cleaning ,User will drain the used water (as required) from Water Drain ON/OFF button from the display User can reset the CLEANER button by pressing the RESET button.
- After completion of process open the lid and sift the punch tray to rinsing chamber for next stage.
Rinsing (2nd Stage):-
- Switch ON the Main Power supply.
- Switch ON the Heater from Heater button. A Yellow light will appear on heater indicator.
- From the above screen, User can view the Set /Actual temperature and time by pressing DISPLAY button.
- Fill the purified water in tank up to the lavel and set the temperature (70°C) and compressed air pressure such that water should not came out from chamber.
- Set the rinsing time (15 minutes) by pressing arrow keys (˄,˅) When temperature reached to 70°C, open the lid and transfer loaded perforated basket from Ultrasonic tank to Rinsing tank and close the lid.
- User will start the cycle by pressing the TIMER button. After the completion of cycle, buzzer ON and cycle will stop.
- After cleaning, User will drain the used water from Water Drain ON/OFF button from the display.
- If water drain button or heater button shall either damage or stop working then SPARE button shall be used as spare .
Drying (3rd Stage):-
- Switch ON the Main Power supply.
- Switch ON the Inlet Air by pressing Inlet Air Button then Switch ON the Heater by pressing the Heater button. A yellow light will appear on heater indicator.
- From the above screen, User can view the Set / Actual temperature and time by pressing DISPLAY button.
- From MODE button, User will set the temperature (80°C) by pressing the arrow keys (˄, ˅) When temperature reached to 80°C, open the lid and transfer loaded perforated basket or tray from Rinsing tank to Dryer tank and close the lid.
- After loading switch on the dryer button and set drying time 5 minutes.
- Now start the cycle by pressing the TIMER button. After the completion of cycle, buzzer ON and cycle will stop.
- After drying completion remove upper punch tray become cool at room temperature.
RPO (Rust Preventive Oil):-
- Switch ON the Main Power supply.
- Switch ON the Heater from Heater button. A Yellow light will appear on heater indicator.
- From the above screen, User can view the Set / Actual temperature and time by pressing DISPLAY button.
- From MODE button, User will set the temperature (70°C) by pressing the arrow keys (˄, ˅) Transfer Food Grade Oil to RPO tank and set the temperature at 70°C.
- When temperature reached to 70°C, open the lid and transfer loaded perforated basket from Dryer tank to RPO tank and close the lid.
- Now start the cycle for 15 minutes by pressing the TIMER button. After the completion of cycle, buzzer ON and cycle will stop.
Note:- Same cleaning process for upper punches lower punches and dies also.
5.4 Cleaning of Ultrasonic tool wash system:-
- Remove "TO BE CLEANED" status label from the equipment.
- Wash the tanks , perforated baskets with potable water or hot water if required.
- After washing with potable water or hot water finally rinse with purified water.
- Clean the Ultrasonic tool wash system Machine using 70% IPA and dry lint free cloth.
- Clean the electric cable with dry lint free cloth.
- Check for visual cleanliness of the cleaned parts, if any traces of previous batch material observed then repeat the above steps.
- Record cleaning details in equipment logbook.
- Affix the "CLEANED"lable on equipment.
5.5 Ultrasonic tool wash system Challenge Test:-
- Fill purified water in cleaning chamber.
- Start ultrasonic cleaning and dip the aluminium foil having size 4"×4" in ultrasonic clening chamber for 30 second.
- Remove the foil from cleaning chamber and perforation shall be achieve in aluminium foil.
- If perforation not achieve, PNC shall initiated and investigated and send work order to engenirning department for rectification.
- Frequency:- Monthly ± 1 days.
6.0 List of Annexure:
Not Applicable.
7.0 Reference:
- SOP for recording of equipment log book.
- SOP for Handling of Breakdown of Equipment.
- SOP for Preventive Maintenance of Compression machine.
8.0 Reason of Revision:
Not Applicable (New SOP).
9.0 Abbreviations:
- SOP - Standard Operating Procedure.
- IPQA - In-process Quality Assurance.
- QA - Quality Assurance
- PPEs - Personnel Protective Equipment.
- % - Percentage
- v/v - Volume by Volume.
- IPA - Isopropyl Alcohol
- i.e - That is
- kg /cm2 - Kilogram per centimeter square
- PSP - Pulse Sweep Power
End Of the SOP....