SOP for Operation and Cleaning of Steam Sterilizer : Pharmaceutical Guidelines

SOP for Operation and Cleaning of Steam Sterilizer

Standard operating procedure to operate and clean the double door steam sterilizer.


       To lay down the procedure for Operation and Cleaning of Steam Sterilizer (Autoclave).

2.0  SCOPE

       This is applicable to double door Steam Sterilizer present in Microbiology.


       Trained Quality Control Microbiologist or Trained Operator is responsible for operation and cleaning of Steam Sterilizer as per procedure.


       Head of Department


5.1  Checks before starting of equipment

5.1.1  Check the validation status before using the equipment.
5.1.2  Check all utilities such as compressed air, water are connected as per the requirements.
5.1.3  Check the cleaning status of the equipment.
5.1.4  Check the water level in the boiler of the Autoclave. It should be according to mark.
5.1.5  Put the autoclave tape on each item.
5.1.6  Mention the run number and sterilization date on tape.

5.2  Operating Procedure

5.2.1  Put ‘ON’ the electric mains.
5.2.2  Keep main supply switch in ‘ON’ position.
5.2.3  Put control switch in ‘ON’ position.
5.2.4  Keep emergency stop button in ‘Released’ position.
5.2.5  Put Auto-Off-Manual switch in ‘Manual mode’.
5.2.6  Operate ‘Lamp Check Test’ to check functioning status of indicators “ All indicators shall glow”.
5.2.7  Open the door from non-aseptic side by pressing door open button.
5.2.8  Prepare the required materials and pack the materials in sterilization reels for laboratory glassware and accessories, in Dacron bags for garments and with cotton plugs or caps as appropriate for media containers.
5.2.9  Label each pack of laboratory glassware, accessories and garments with a strip of chemical indicator tape and write the date of sterilization and use before date. For media containers label as per SOP for media preparation.
5.2.10  Put the required material on the shelves of the chamber as per validated load patterns and quantity loaded should conform between minimum and maximum validated load patterns. When the load is in between the minimum and maximum load patterns, load as per maximum load pattern.  Enter the load details in appropriate annexures.
5.2.11  Place chemical indicator on at least one of the article to be sterilized / or in sterilization pouch, for every cycle other than Bowie-dick and Vacuum leak test.
5.2.12  Close the door by pressing close button.
5.2.13  Put Auto-Off-Manual key switch in Auto mode.
5.2.14  Switch on the dot-matrix printer and strip chart recorder and ensure the papers are properly loaded.
5.2.15  Enter the cycle details, run number; load details and sterilization hold times in the Autoclave Log Sheet and appropriate Autoclave Load Details format.  Run number shall be allotted to each cycle starting from 01 every day.
5.2.16  Select the desired set parameters that are fed in Programmable Logical Control (PLC) as per validation summary report and run the cycle.
5.2.17  After completion of cycle, unlock the key. Open the door from aseptic side by pressing “Door Open’ button.
5.2.18  Remove the load from the shelves.
5.2.19  Close the door by pressing “Door Close’ button and lock the key.
5.2.20  Post sterilization, write the run number on chemical indicator, sign and attach to Autoclave Load Details reporting format.

5.3  Operation of Programmable Logical Control (PLC).

5.3.1  Press F4 Key in the PLC keypad, “Menu 1’ will appear, with following options:
•  F1 – Set/View Parameter: For Setting and Viewing Cycle Parameters.
•  F2 – Login Password: To Login to PLC.
•  F3 – Menu 2: For Going to Next Menu.
•  F4 – Menu 1: To Return To Previous Menu.
5.3.2  Press F3 Key in PLC Keypad, “Menu 2” will appear with following options:
•  F2 – Process Data: Shows real time readings of all sensors.
•  F2 – Start Process: To select, print and start the required cycle.
•  F3 – Batch Data: To enter batch details
•  F4 – Main menu: To return previous menu
5.3.3  In ‘Menu 2’ press F3 to go to ‘Batch Data’ and enter the Sterilizer No, Load No and Operator Code and return to previous menu.
5.3.4  In ‘Menu 2’ press F2 to Key to go to ‘Start Process’ Menu with options:
•  F1 – Start: to start the process.
•  F2 – Off Print: To print the cycle parameters
•  F3 – To Select the required Cycle
•  F4 –To return to previous menu.
5.3.5  From ‘Menu 2”, select the required cycle, print the cycle parameters and start process by pressing appropriate keys in ‘Start Process’ Menu and its sub menus.

5.4  Vacuum Leak Test (VLT)

5.5.1  Perform the Vacuum Leak Test as the first cycle of the day before any other cycle in the autoclave in cold conditions.
5.5.2  Operate the cycle as per 5.2 by selecting process “Vacuum Leak Test (VLT)”.
5.5.3  At the end of the cycle verify the cycle printouts for vacuum leak and it should be not more than 0.013 bar.

5.5  Bowie - Dick Test (B&D)

5.5.1  Bowie-Dick Test should be performed once every week after completion of Vacuum Leak Test.
5.5.2  Place the Bowie-Dick Test pack in the autoclave and operate the cycle as per 5.2 by selecting process “Bowie – Dick Test (B & D)”.
5.5.3  At the end of the cycle remove the test pack from the autoclave and observe for colour change. The Bowie-Dick pack indicator should turn from blue to black.

5.6  High Pressure High Vacuum (HPHV) Process

5.6.1  HPHV cycle should be operated after completion of Vacuum Leak Test and Bowie – Dick Test (Whenever Applicable) and this cycle is used for sterilization of porus materials.
5.6.2  Place the load as per load configuration and operate the cycle as per 5.2 by selecting appropriate process based on type of load to be sterilized as per following table:

Filtration Accessories
Disinfectant and Sampling Accessories
Glassware and Air Sampling Accessories

5.6.3  At the end of the cycle unload the material from sterile side.

5.7  Standard (STD) Process

5.7.1  Standard cycle should be operated after completion of Vacuum Leak Test and Bowie – Dick Test (Whenever Applicable) and this cycle is used for sterilization of culture media and diluents.
5.7.2  Place the load as per load configuration and operate the cycle as per 5.2 by selecting ‘Standard Process’.

5.8  Sterilization and Replacement of Air In-Line Filter

5.8.1  Air In-Line Filter should be with a sterilized once in every two weeks.
5.8.2  Sterilization: Pack the filter in sterilization reels and place in autoclave and sterilize using HPHV1 Process.
5.8.3  Replacement: Open the stainless steel filter housing and remove the filter and replace with a previously sterilized filter.
5.8.4  Integrity Test: Perform Integrity test/bubble point test of filters before replacement and after removal from the housing. It should conform the specifications as per manufacturer’s instructions.
5.8.5  Sterilization of filters should not exceed the number of cycles mentioned in the filter manufacturer’s CoA.

5.9  Alarms acknowledgement procedure

5.9.1  When an alarm occurs, press F4 key for main menu, then press F3 key for Menu 2.
5.9.2  Press F1 key for process data, press the down arrow ▼ key to scroll the screen.
5.9.3  F1 (Alarm screen) and F4 (Main screen) will appear on the screen.
5.9.4  Press F1 (Alarm screen) then press the down arrow ▼ key to scroll the screen.
5.9.5  F1 (Acknowledge) and F4 (Process data) will appear on the screen.
5.9.6  Press the F1 key to acknowledge the alarm.

5.10  Strip Chart Recording and Reading

5.10.1  When printing the cycle parameters through PLC, simultaneously start the strip chart by pressing ‘Function” button once and ‘Enter’ Button twice. This will print the current values of all sensors.
5.10.2  To start recording of cycle on strip chart, press ‘Red’ Button when the autoclave cycle starts and after completion of cycle again ‘Red’ Button to stop recording.
5.10.3  The Strip Chart should be read horizontally for time and vertically for values. Settings of the Strip Chart as follows:
•   Chart Speed – 60 mm/hour.
•  Horizontally 1 mm equals to 1 min.
•  Vertically 1 mm equals to 2°C
5.10.4  Pictorial depiction of Strip Chart:
5.10.5  Sensors and their details are as follows:

Probe No
Right Hand Sterile Side
Right Hand Front Side
Left Hand Front Side
Left Hand Sterile Side

5.11  Cleaning Procedure

5.11.1  Clean the steam sterilizer external stainless steel surface with a cleaning agent with a clean cloth.
5.11.2  Clean the chamber drain.
5.11.3  Clean the chamber with 2% v/v soap solution and there after with purified water
5.11.4  Frequency: Cleaning once a week or when there is spillage.

5.12  Shut - down procedure

5.12.1  Clean the autoclave before shutdown if there is any spillage.
5.12.2  After completion of the work:
•  Keep ‘control ON’ switch in OFF position.
•  Keep ‘heater ON’ switch in OFF position
•  Keep AUTO-OFF-MANUAL switch in OFF position.
•  Keep the main switch in OFF position

5.13  Autoclave load pattern

5.13.1  For autoclave load pattern details, refer the validation document.


SOP - Standard Operating Procedure
SLV - Solenoid valve
STD - Standard
PLC - Programmable logical control
HPHV - High pressure high vaccum
VLT - Vacuum leak test
B&D - Bowie Dick test

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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