1.     Purpose:-                         

                        To describe the procedure for the safe operation of Autoclave in Microbiology
Lab to achieve effective sterilization.

2.     Scope:-

         This SOP is applicable to Shinva Autoclave installed in Microbiological Lab.
3.     HSE Statement:-

                                         Asbestos gloves should be used.
4.     Responsibilities:-

                               i)      Manager Quality Control is responsible to ensure that procedure & formats are followed entirely as approved.
                             ii)       Microbiologist is responsible to operate the instrument.
5.     Materials:-
      6. Definitions:-

An autoclave is a device used to sterilize equipment and supplies by subjecting them to high pressure saturated steam at 121 °C for around 20 minutes depending on the size of the load and the contents

7.Flow Chart:-

8. Description:-
8.1. Procedure:-
8.1.1 Before Start Up:- Clean the equipment around and surrounding and make a good environment. Turn on the valve of water supply to the vacuum pump the pressure
(Should be between 0.15 -0.30 MPa). Turn on the Compressed Air Supply having a pressure of 0.50 – 0.70 MPa. Discharge the condensate water in the pipeline and then turn on the steam supply
           (Pressure should be between 0.30 – 0.50 MPa.)
8.1.2    Automatic Operation:-  Turn on the main power supply & set the operating power switch to “---”Position. The following picture will be available.  Touch the “front door operation” Button in the main menu. Following menu will be available.  Open the front door by pressing the OPEN button. Clean the equipment thoroughly & Load the Sterilizer as per validated load. Then close the door by pressing the CLOSE Button.  When the back door is to be opened / closed press open / closed button relatively from the backside. Now press the BACK button, the menu will return back as shown in Step # 4.2.1.  Now press the PARAMETER SETTING Button in the main menu (Step # 4.2.1) following menu will be available for setting of basic parameter.  Touch any of three relative key except HELP or BACK & Program setting, following menu will be available having key board.  From the Key Board set the parameter values & recognize it by touching                  the key.  The basic standard values are as follows:

                                          Basic Parameters Set Values

Sr. No.
Basic Parameter
Value Range
Ave Set Value
Pulse Upper
65 – 90 KPa
80 KPa

Pulse Lower
- 65 – 90 KPa
- 80 KPa

Platoon Zero
3 – 20 KPa
10 KPa

Back Zero
- 3 – 40 KPa
- 10 KPa

Chamber Pressure Limit
195 – 230 KPa
210 KPa
For Non Liquid
100 – 120 KPa
110 KPa
For Liquid 
After setting the Basic Parameter values as Average set values return to the parameter setting on the keyboard.    Now touch the relative information, a keyboard will be open like in Clause 4.2.5.    Feed the relative values as per requirement. Then press the BACK Button; menu will return to the S # 7 figure then again press BACK Button
in S # 7 menu of S # 5 will be displayed. The standard values of Fabric parameter are as follows:

Sr. No.
      Range Value
Av. Set Value
Sterilization Temperature
Up till 132 o C
121 o C
Sterilization Temperature
0 – 9999 Sec
3600 Sec
Dry Times
0 – 9999 Sec
2700 Sec
Pulse Times
0 – 99 Times
03 Times Press “Program Running” in the main menu in step # 5. Following menu will be available. Feed the operator number and open the printer mode by touching the relative key. Before starting
the program ensure that both the doors are closed (which can be checked through door indicator). Now press the “Program” Button. The program will start the following figure will be on screen.
8.1.3            Manual operation:-  Touch the Manual Operation button in the main menu. Following picture will be available.  Now touch the manual / auto button to change the present condition to the manual condition then touch the valve F1 - F7 & pump B Button for the performance of relative function.  At the end of manual operation close all the valves & turn the manual position to auto.  Manual operation should be performed only under the supervision of Microbiologist, QC Manager or Plant Engineer.  The correspondence relation between operation and valves / button is as follows:

Sr. No.
Valve / Button
Steam Entry Valve of Interlayer (Jacket)
Water Pump Valve
Vacuuming Valve
Vacuum Pump
Steam Entry Valve of Chamber
Condensed Water Valve
Slow Steam Exhausting Valve
Air valve

8.1.4          End of Program:-  At the end of program Alarm will buzzer now press the “Exit” button on the screen the program will turn end.  At the completion of program switch off power supply, steam supply, compressed air supply & water supply to the vacuum pump.
8.2            Precautions:-
8.2.1        Do not put hand & other things on the sealing door.
8.2.2        Open the door only when the pressure in the chamber is zero & temperature is below 90oC.
8.2.3        Do not open the door when the other door is not closed.

Do not touch the screen again & again.
8.2.5        Set / check the Parameter carefully and as per requirement.
8.2.6        Check that printer mode is open before start of operation.
8.2.7        Operate the manual program only under the supervision of Microbiologist, Manager QC and / or Plant Engineer.
8.2.8        Turn off the manual operation to the automatic position at the completion of manual operation.
           In case of any emergency switch off power supply & contact to the In charge pharmacist / Plant
8.3 Calibration Frequency:
Annually from external source
9. Records:-
                   Log of sterilization cycle   (Autoclave)
                  Autoclave Monitoring by Using Ampoule Bioindicator.
10. References:-

                         Manufacturer instructions Manual
11. Distribution:-

This SOP has to be distributed in below mentioned Departments:-

Sr. NO
Distributed to
Quality Control Department

Quality Management Department

14 Revision History:-