1.0 OBJECTIVETo ensure that the autoclave functions satisfactorily and completes the sterilization cycle effectively.
2.0 SCOPEThis SOP is applicable for the horizontal autoclave in the Quality Control Department.
3.0 RESPONSIBILITYMicrobiologist - Quality Control
4.0 ACCOUNTABILITYManager - Quality Control
5.0 PROCEDURE5.1 Procedure for General Cleaning
5.1.1 Ensure that power supply to the autoclave is switched ‘OFF’ before cleaning. Remove the plug from the socket.
5.1.2 Clean the outer surfaces of the autoclave with a clean cloth every day.
5.1.3 To clean the chamber, remove all the remaining materials from the autoclave.
5.1.4 After the chamber is emptied, pour additional water in the chamber (all around) so that the residual matters / particles are flushed out, taking care that the particles are not big enough to block the valve.
5.2 Procedure for Operation
5.2.1 Switch ON the MCB
5.2.2 Open the supply of water and compressed air.
5.2.3 Switch on the Main switch and control switch of autoclave.
5.2.4 Open the door of the sterilizer.
5.2.5 Load the Autoclave.
5.2.6 Close the door of sterilizer by pressing NST DOOR CLOSE push button.
5.2.7 DOOR PRECONDITION indicating light will flash ON.
5.2.8 Switch ON the heater.
5.2.9 Switch ON the auto printer
5.2.10 Switch ON the temperature and pressure scanner.
5.2.11 Press F4 button on control panel
5.2.12 Press F1 to check or set the parameter of desired process OR press F4 to go to main menu.
5.2.13 Press F2 will show the START SCREEN
5.2.14 Select the desired process by pressing F3 soft key.
5.2.15 Press F2 for the parameter of desired cycle to print
5.2.16 Select Auto mode by pointing AUTO/MANUAL knob towards AUTO
5.2.17 Press F1 to start desired process. Operation cycle will start.
5.2.18 After completion of cycle switch off the heater.
5.2.19 Let the pressure of chamber to become Zero.
5.2.20 Again select MANUAL by pointing AUTO/MANUAL knob towards Manual.
5.2.21 Push NST DOOR OPEN Push button to open the door.
5.2.22 Unload the autoclave.
5.2.23 Switch off all the switch and MCB.
5.2.24 Maintain the usage record.
5.3.1 Use thermal gloves to open the autoclave.
5.3.2 Do not touch the autoclave when it is hot.
Related: Autoclave Validation in Pharmaceuticals
6.0 ABBREVIATIONS6.1 SOP - Standard Operating Procedure
6.2 SCDM - Soybean Casein Digest Medium
6.3 LAF - Laminar Air Flow
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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