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Objective: To provide written instruction for operating Autoclave Machine from the computerized control panel using PACS-2000 system.
Scope: This SOP shall be applicable for Autoclave Area.
Associated Documents: Form No. PS001-01, Batch Manufacturing Record
Responsibility:
1. Engineering Officer/Assistant Engineering Officer shall be responsible for the operation of the Autoclave Machine.
2. Sr. Asst. Manager, Engineering or his/her Designee shall be accountable for the training and implementation of the procedure.
Abbreviations: Not applicable.
Precautions: Not applicable.
Procedure:
1. Switch ‘ON’ the main power supply and shift the key position from 2 to 1, beside both the loading and unloading side doors. Check for availability of compressed air, steam and purified water. Pressures of compressed air for main operation 6.8 -7.0 bar and for panel board 5.0 – 5.5 bar and pressure of steam 1.8 -2.4 bar as desired respectively.
2. Select “Online Mode” in the controller and press ENTER. Select “System Program” and press ENTER. Then serially select “Test Function” and “Test Digital Output” by pressing ENTER and select Open Door 1 and change it ‘Auto’ to ‘Manual’ mode by pressing Space Bar and open door 1 by pressing F8. Again change ‘manual’ to Auto’ and press F8 after full opening of the door. Turn the foot rail in reverse direction and load the autoclave with trolleys having bottles. Five trolleys make one full load. Put one stopper at the 5th no. of trolley and other at the end of 1st Trolley. Close front door (Door 1) by selecting the “Test Digital Output Mode”. Ensure closing door by “Test Digital Input Mode” status.
3. Then select “Start Program” and press ENTER. Type operator’s password and press ENTER. Now set parameters for different sizes of bottle.
4. After setting parameters, press F10 button in the keyboard to skip to the next screen. At this stage type batch documentation. Press F10 again.
5. Now the Autoclave is ready for operation. Check the drain valve and close if open. Keep the condensate return line open.
6. Press F8 to start the sterilization cycle. The phases – water chamber, heating, sterilization and cooling and pressure equalization are carried out sequentially. Autoclave ceases operation after pressure equalization. Keep the records of operation in Form No. PS001 – 01.
7. During the cycles, monitor the program. In case of longer time taken in the heating phase, step the programs manually.
8. Now open the unloading side door (door 2) in the same way as mentioned above. Unload all the trolleys and close the door.
9. Tear off the time-temperature-pressure graph from the panel board and enclose it with Form No. PS001-01.
