SOP for Operation, Calibration, Cleaning and Maintenance of Vertical Autoclave

OBJECTIVE

To lay down a procedure for the operation, calibration, cleaning, and maintenance of the vertical autoclave.

SCOPE

This procedure is applicable to Vertical Autoclave located in the microbiology laboratory at PharmaInfo Limited.

RESPONSIBILITY

Microbiologist: Responsible for the operation of the instrument.

Section In-charge: Responsible for reviewing the procedure.

QC Head: Responsible for implementing the Procedure.

QA Head: Overall compliance.

PROCEDURE

Operating Procedure

• Ensure that the equipment is clean.
• Open the lid of the autoclave by rotating the knobs in an anti-clockwise direction.
• Pour sufficient water (process water) into the autoclave (up to the stand).

• Transfer material for destruction (used culture slants, agar media Petri plates, media conical flasks, and test tubes, etc.) into a stainless steel container and place it in the autoclave along with a sterilization indicator and close the lid by rotating the knobs in a clockwise direction.

ALSO READ: SOP for Preparation and Sterilization of Microbial Media

• Keep a sterilization indicator in each and every destruction cycle to ensure the destruction cycle is effective and the contents have been sterilized properly.
• Each destruction load is assigned a specific load number as given below

AUB-V/YYZZZ,

Where, 

AUT-V: for Autoclave Vertical,

YY: for the last two digits of the year,

ZZZ: for serial number starts from 001.

• Load details shall be entered in Annexure –I.
• Switch on the mains.
• After switching on the mains the microprocessor controller (MPC) display will show “Print?” press the “PRN/ACK” key to print the cycle data, and then the display will show the present temperature of four temperature sensors.
• Set the required temperature by pressing the “PROG” key then the display shows “STER TEMP (°C) 120”.
• Press the UP or DOWN (▲ or ▼ ) keys to increase or decrease the set temperature and press the “ENTER” key to save the new set point (121°C).
• Now the display shows “STER TIME (mins) 020”.
• Press the UP or DOWN (▲ or ▼ ) keys to increase or decrease the set time and press the “ENTER” key to save the new set point (30 minutes).
• Always run the destruction autoclave cycle with standard parameters like 121°C temperature, and 15 psi pressure for 30 minutes.
• To start the cycling press the “START/STOP” key.
• The air purging relay is ON and it is indicated on the LED till the temperature reaches approximately 100°C in order to purge the air enclosed in the autoclave after which it will automatically close and the air exhaust relay is put OFF.

• After this, the temperature and pressure will gradually increase which will be indicated by MPC and pressure gauge.
• Just before the set temperature the heater will be cut off and then gradually attain the set temperature.
• After attaining the set temperature the display will show “Sterilizing On” and the timer will start its countdown.
• During the count, the temperature and pressure will be maintained by the MPC by switching the ON/OFF heater.
• During this count, the safety valve may leak slightly which is normal.
• After elapse of the set time the audio alarm (buzzer) will sound, the display will show “EXHAUST”, the heater will cut OFF and the solenoid valve will open to exhaust the pressure.
• For faster evacuation of the pressure manual steam release valve (Exhaust valve) may be opened.
• After the complete exhaust of pressure, the display will show “END OF CYCLE” and “Print?” simultaneously, then press the “PRN/ACK” key to take the print of the cycle.
• Take and preserve the printout for each autoclave cycle.
• Open the lid by rotating the knobs in an anticlockwise direction only after the pressure gauge shows “0” (zero).
• Check the sterilization indicator for color change and it shall be signed by the operator along with the date and load number.
• Remove the destructed material from the autoclave and allow it to cool up to approximately 40°C to 50ºC and follow as per current version SOP QC/MB/ (Disposal of used media and cultures).

ALSO READ: Bowie Dick Test for Validation Autoclave

• Preserve the sterilization indicator and record the details in the autoclave usage log book (Annexure-I).
• Mark the autoclave start time, sterilization start time, and sterilization end time in the printout and enter the same details in the autoclave usage log (Annexure – I).
• Preserve the autoclave sterilization temperature printouts for each cycle with the operator's signature and date.

Calibration

• An external agency shall perform calibration of the Vertical Autoclave (Temperature mapping).
• Frequency: Once in a year ± 30 days or after any breakdown activity.

Cleaning Procedure

• Before starting the cleaning procedure, disconnect the power supply to the Autoclave.
• Every day after the completion of the destruction cycle the autoclave shall be cleaned with any disinfectant solutions (5% Dettol, 5% Savlon, 1% Bacillocid special, or 1% Hospital -OT solution).
• Finally, rinse with purified water and allow to dry.
•  Entry shall be made in the autoclave cleaning log sheet (Annexure–II).

Maintenance

• Check the outer body of the autoclave for corrosion and cracks.
• The rubber gasket is checked for cracks and damaged gaskets are replaced promptly.
• Ensure the autoclave is free from leakages before operation.

ABBREVIATIONS

QC: Quality Control

QA: Quality Assurance

ºC: Centigrade

IPA: Isopropyl alcohol

MPC: Micro Processor Controller

%: Percentage

SOP: Standard Operating Procedure

ANNEXURE

Annexure–I: Autoclave usage log book

Annexure–II: Autoclave cleaning log sheet.

REVISION HISTORY

Nil

ALSO READ: Performance Qualification Protocol and Report for Autoclave