Operating of Horizontal Double door Autoclave

1.0 OBJECTIVE

The objective of this Standard Operating Procedure (SOP) is to provide detailed, step-by-step instructions for the proper operation of a double-door autoclave used for sterilization purposes.

2.0 SCOPE

This procedure applies to the operation of any double-door autoclave within the facility. It covers the steps required for setup, loading, operating, unloading, and shutdown.

3.0 RESPONSIBILITIES

3.1 Operator: Lab Assistant, Technical Assistant, or Executive responsible for performing the procedure as described.

3.2 Reviewer: Technical Assistant, Executive, or Manager responsible for reviewing documented activities against the SOP to ensure compliance.

3.3 Approver: Head of Department or designated authority responsible for approving the SOP and any future revisions.

4.0 PREREQUISITES

4.1 Operator training on autoclave operation, safety precautions, and emergency procedures.

4.2 Preventive maintenance, calibration, and qualification of the autoclave per established schedules.

4.3 Availability of all required materials, accessories, and documentation logs.

5.0 PROCEDURE

Follow the steps below for proper operation of the double-door autoclave:

5.1 Startup

5.1.1 Ensure the autoclave is clean and free of any residual materials from previous runs.

5.1.2 Switch ON the water pump to fill the boiler with purified water to the marked level.

5.1.3 Switch ON the vacuum pump.

5.1.4 Switch the main power to the control panel. Confirm the illumination of the yellow, blue, and red lamps.

5.1.5 If the emergency switch is pressed, release it.

5.2 Automatic Mode Setup

5.2.1 Press the “Control Start” button on the control panel.

5.2.2 Ensure the “Auto/Manual” switch is in the “Auto” mode position.

5.2.3 On the display, note the current date, time, and any other initial information.

5.2.4 Press the down arrow key to access the main menu options.

5.2.5 Press “F4” to access the “Start/Batch Data” menu.

5.2.6 Press “F7” to select the desired sterilization cycle from the list provided.

5.2.7 Press “Enter” to confirm the selected cycle.

5.2.8 Press “F9” to enable a printout of cycle parameters at defined intervals (e.g., every minute).

5.3 Load Autoclaving Materials (Non-Sterile Side)

5.3.1 Set the “Auto/Manual” switch to “Manual” mode.

5.3.2 Switch ON the vacuum switch and Door I vacuum switch.

5.3.3 When the Door I pressure gauge reads 0 to -1, switch ON the Door I open switch to unlock the non-sterile side door.

5.3.4 Carefully load the autoclave with required materials, accessories, or media according to the specified cycle.

5.3.5 Switch OFF the vacuum pump switch, Door I vacuum switch, and Door I open switch.

5.3.6 Press the Door I close switch to seal the non-sterile side door.

5.3.7 Press the Door I and Door II pressure switches to confirm both doors are properly sealed.

5.4 Initiate Sterilization Cycle

5.4.1 Set the “Auto/Manual” switch back to “Auto” mode.

5.4.2 Press “F8” to start the sterilization process once the boiler tank pressure reaches 2 kg.

5.5 Monitor and Adjust Cycle Parameters (Optional)

5.5.1 To change any cycle parameters, press “F1” during operation.

5.5.2 Enter the password when it prompted.

5.5.3 Use the function keys (F1, F2, F3, etc.) to navigate and select the desired cycle.

5.5.4 Press the down arrow key to access parameters like preheat temperature, sterilization temperature, hold time, etc.

5.5.5 Use the numeric keypad to adjust parameter values as needed.

5.5.6 Press “Enter” to confirm any changes.

5.6 Cycle Completion and Unloading (Sterile Side)

5.6.1 Upon cycle completion, an audible alarm will sound.

5.6.2 Immediately press the down arrow key to view cycle phase data like elapsed time, pulse counts, leak test results, etc.

5.6.3 Press “F6” to acknowledge and silence the alarm.

5.6.4 Press “F10” and then “F5” to return to the main menu.

5.6.5 Allow the Door II (sterile side) pressure to drop to 0 to -1 before opening.

5.6.6 Switch ON the Door II open switch to unlock the sterile side door.

5.6.7 Carefully unload the autoclaved materials from the sterile side of the autoclave.

5.6.8 Switch ON the vacuum pump and Door II vacuum switches.

5.6.9 Switch OFF the Door II open switch.

5.6.10 Press the Door II close switch to seal the sterile side door.

5.7 Shutdown

5.7.1 Ensure the “Auto/Manual” switch is in the correct position for shutdown (typically “Manual” mode).

5.7.2 Switch OFF the boiler, vacuum pump, Door I vacuum, and Door II vacuum switches.

5.7.3 Close the emergency switch, if applicable.

5.7.4 Lock the control panel to prevent unauthorized access.

5.7.5 Switch OFF the main power supply to the autoclave.

5.8 Manual Mode Operation (Alternative Method)

5.8.1 Set the “Auto/Manual” switch to “Manual” mode.

5.8.2 Switch ON the boiler, vacuum pump, Door I vacuum, and Door I open switches.

5.8.3 When the Door I pressure gauge reads 0 to -1, load materials through the non-sterile side door.

5.8.4 Switch OFF the Door I open switch and switch ON the Door I close switch.

5.8.5 Switch OFF the Door I vacuum switch and switch ON the vacuum, Door I pressure, and Door II pressure switches.

5.8.6 When the boiler tank pressure reaches 2.0 kg, switch ON the jacket steam and chamber steam switches.

5.8.7 Note the time when the temperature reaches 121°C, and maintain for the required sterilization hold time.

5.8.8 Upon completion, switch OFF the chamber steam and chamber exhaust switches.

5.8.9 When the pressure drops below 0 and temperature below 100°C, switch OFF the jacket steam, chamber exhaust, Door I pressure, and Door II pressure switches.

5.8.10 To unload, switch ON the Door II pressure and Door II open switches.

5.8.11 After unloading, switch ON the Door II close switch.

5.8.12 Switch OFF the main power supply to complete shutdown.

6.0 CYCLE DOCUMENTATION

6.1 Record all cycle data, including cycle name, material details, load contents, time, temperature, pressure, and any other relevant parameters in the designated log or batch record.

6.2 Document any deviations, unexpected events, or corrective actions taken during the cycle.

6.3 Ensure cycle records are reviewed, approved, and maintained as per documentation retention policies.

7.0 SAFETY PRECAUTIONS

7.1 Wear appropriate personal protective equipment, including heat-resistant gloves, lab coat, and safety goggles, when operating the autoclave.

7.2 Exercise caution when loading and unloading hot materials from the autoclave.

7.3 Do not attempt to open the autoclave doors when the chamber is pressurized or at high temperatures.

7.4 Ensure proper ventilation and exhaust systems are in place to handle steam discharge.

7.5 Follow all safety guidelines and emergency procedures in case of any equipment malfunction or incident.

8.0 ABBREVIATIONS

°C: Degree Celsius

kg: Kilogram

 

Author:  Bhavana Tatineni

Qualification: MSc Microbiology