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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 microbiology laboratory at PharmaSky Limited.

RESPONSIBILITY
Microbiologist: Responsible for the operation of the instrument.
Section In-charge: Responsible for review 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 clockwise direction.


  • 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 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 micro-processor controller (MPC) display will show “Print?” press the “PRN/ACK” key to print the cycle data, then the display will show present temperature of four temperature sensors.
  • Set the required temperature by pressing “PROG” key then the display show “STER TEMP (° C) 120”.
  • Press UP or DOWN (▲ or ▼ ) keys to increase or decrease the set temperature and press “ENTER” key to save the new set point (121°C).
  • Now the display shows “STER TIME (mins) 020”.


  • Press UP or DOWN (▲ or ▼ ) keys to increase or decrease the set time and press “ENTER” key to save the new set point (30 minutes).
  • Always run the destruction autoclave cycle with standard parameters like 121°C temperature, 15 psi pressure for 30 minutes.
  • To start the cycle press “START/STOP” key.
  • 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 shows “Sterilizing On” and the timer will starts its count down.
  • During the count down the temperature and pressure will be maintained by the MPC by switching ON/OFF the heater.
  • During this count down the safety valve may leak slightly which is normal.
  • After elapse of the set time the audio alarm (buzzer) will sound, the display will shows “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 complete exhaust of pressure the display will shows “END OF CYCLE” and “Print?” simultaneously, then press “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 anticlockwise direction only after the pressure gauge shows “0” (zero).
  • Check the sterilization indicator for colour change and it shall be signed by the operator along with date and load number.
  • Remove the destructed material from the autoclave and allow to cool up to approximately 40°C to 50ºC and follow as per current version SOP QC/MB/ (Disposal of used media and cultures).
  • Preserve the sterilization indicator and record the details in autoclave usage log book (Annexure-I).
  • Mark the autoclave start time, sterilization start time, sterilization end time in printout and enter the same details in autoclave usage log (Annexure – I).
  • Preserve the autoclave sterilization temperature printouts for each cycle with operator sign and date.


Calibration:
  • Calibration of the Vertical Autoclave (Temperature mapping) shall be performed by external agency.
  • 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 one of the disinfectant solutions (5% Dettol, 5% Savlon, 1% Bacillocid special or 1% Hospal -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

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