Standard Operating Procedure For Autoclave Operation And Cleaning

by Pharmadocx Consultants

PURPOSE:  To lay down the procedure for autoclave operation and cleaning.

SCOPEThis procedure applies for the cleaning of autoclave.


            1.Production Manager.


Open the steam inlet valve i.e. MBV1 of jacket. The steam will enter inside the jacket.

Observe the desired pressure reading on the gauge provided (PG-1) for the jacket (pressure @1.2 kg/Cm2.)  

Load the Sterilizer Chamber with the product to be sterilized and close the door. Shift the quick through handle and tighten the door locking arms by rotating handle wheel. Lever of the operating valve is in OFF/ SLOW EXHAUST position. Move the lever of the operating valve to STER position. The steam from the jacket will pass into the chamber and the pressure will start developing inside the chamber. (The required pressure in the chamber will be 1.26 or 2.2 kg /cm2.) After reaching this pressure sterilization hold period will start. Manually count the time (whichever hold time decided) according to the watch.

After the sterilization hold time is over there are two position provided on the operating valve for the exhausts i.e. FAST EXHAUST OR SLOW EXHAUST. Depending on the load select the exhausts.

Once the steam gets exhausted, the chamber pressure becomes ‘0’.

Now turn the operating valve knob to VAC DRY Position.

The air will enter from the preheated pipe (Provided between jacket and Chamber where due to the jacket heat the air entering the chamber becomes hot and this hot air will be used to Dry the load inside the chamber) through Vacuum Dryer. Hold the same for couple of minutes and then bring the operating valve to OFF position.

Take out the load from the sterile side.


Open the Chamber Exhaust valve and remove the pressure if any.

Observe the pressure in the compound gauge ‘0’.

Change the operating valve position to OFF / SLOW EXHAUST.

Close all the valves.

Unload the sterilized goods.


ParticularsCheck PointsRemedy
Pressure rises in the chamber but Dial Thermometer doesn’t show the temperature.   Vacuum is not creating   Safety Valves not working at set pressures  Condensate is not properly draining     Pipe Line Leakage   Check the Springs.  Open the trap and clean it.     Tightened the pipe connection   Remove Springs, Clean & Fir


Monthly :-

  1. Steam valves to be cleaned
  2. All joints, if leakage noticed to e tightened.
  3. Locking arms to be checked and tightened when found necessary.
  4. Resistance grease to be applied on the main screw of the door.
  5. Keep electrical contacts clean.
  6. Clean the strainer in the condensate line.
  7. Blow off the safety valve by increasing pressure and check the performance.


Quarterly :-

            All working terminal to be tightened

  1. Check the door lock mechanism and if required, make necessary adjustments.
  2. Greasing on hinge bearing assembly.
  3. Overhauling of pressure Reducing Valve.


  1. Door Gasket
  2. Washer Set for piping
  3. Washer set for Operating Valve
  4. Safety Valve
  5. Pressure Gauge
  6. Compound Gauge
  7. Manual Ball Valve
  8. Dial Thermometer

The above spares are needs to be kept in stock to avoid the breakdown production losses.

Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

10 June 2023

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