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SOP for Verticle Autoclave

Standard operating procedure of vertical Autoclave used in laboratory for sterilization of articles u analysis.


       To describe a procedure for Cleaning and Operation of Vertical Autoclave.

2.0  SCOPE

       This SOP is applicable for Cleaning and Operation of Vertical Autoclave.


       Microbiologist - Quality Control


       Manager - Quality Control


5.1  Procedure for general cleaning 
5.1.1  Ensure that power supply to the autoclave is switched ‘OFF’ before cleaning. Remove the plug from the socket. 
5.1.2  Clean the outer surfaces of the autoclave with a clean cloth every day. 
5.1.3  To clean the chamber, a drain valve is provided at the bottom. Place a vessel of adequate size below it and drain the water after every discarded load. 
5.1.4  After the chamber is emptied, pour additional water in the chamber (all around) so that the residual matters / particles are flushed out, taking care that the particles are not big enough to block the valve. 
5.1.5  Close Drain Valve and pour DM water for next cycle. 
5.2  Procedure for operation 
5.2.1  Open the Autoclave by unscrewing the Wing Nuts. 
5.2.2  Remove the Baskets but leave the Heater Cover X stand inside. 
5.2.3  Ensure that the drain Valve at the bottom of the Autoclave is closed. 
5.2.4  Pour DM water direct into the Autoclave; up to the Heater Cover X stand. 
5.2.5  Load the Autoclave, close the lid, clamp the fly-nuts and tighten opposite fly-nuts simultaneously with equal pressure. 
5.2.6 Switch ON the MCB. 
5.2.7  The set temperature & time will be displayed on the Micro Processor Controller (MPC) in brackets (121°C 30 minutes.). Press START. 
5.2.8  The Solenoid Valve will remain open up till the temperature reaches approximately 100°C in order to purge the air enclosed in the Autoclave, after which it will automatically close. 
5.2.9  After this, the temperature and pressure will gradually rise, which will be indicated by MPC and pressure gauge. 
5.2.10  Just before the set temperature the Heater will be cut OFF and then gradually attain the set temperature. The TIMER will start its countdown after the set temperature is attained. During the countdown the temperature and hence the pressure will be maintained by the MPC by switching ON / OFF the heater. 
5.2.11  During this period of countdown, the Safety Valve may leak slightly, which is normal. 
5.2.12  After the elapse of the set time, a Buzzer will sound for about 20 seconds, the Heaters will be cut OFF and the Solenoid Valve open -to exhaust the pressure. 
5.2.13  For faster evacuation of the pressure, the manual steam release valve (Exhaust Valve) may be opened. 
5.2.14  Unscrew the Fly-nuts ONLY AFTER THE PRESSURE GAUGE SHOWS '0'. Do not attempt to open the fly-nuts at even 1 or 2 psi. Always wait up till the Gauge reads zero before opening the lid. 
5.2.15  To avoid recontamination of material, please remove the sterilized material at the earliest after total exhaust of pressure. The Purge Valve cum Vacuum Breaker will allow air to enter inside the chamber to prevent a vacuum within. 
5.2.16  To restart the cycles press the START. Be sure to top up the water level with purified water before starting a new cycle. 
5.2.17  For in load monitoring of temperature, the Pt l00 sensor is fitted with a flexible wire of approximately 40 cm length. 
5.2.18  Push the pt 100 sensor out of its holder and place it anywhere within the load. 
5.2.19  After the cycle is over, be sure to remove the sensor before pulling out the basket 
5.2.20  Attach the printer for print out of the cycle 
5.2.21  Enter the cycle period in daily usage log book as per annexure I.
5.2.22  In case if PLC does not work properly run the cycle in manual mode. 
5.3  Procedure for time & date settings 
5.3.1  To set the Date and Time in scanner press Down arrow key and SET key simultaneously for few seconds bottom display will show Year -change the value if required otherwise press SET for Next. Like this you can set YEAR, MONTH, DAY, HOURS, MINUTES, SECONDS, NON, keep other parameter as it is then press set twice and switch of the mains and restart the Autoclave. 
5.4  Operation of microprocessor based (lip) controller 
5.4.1  Temperature & time are user settable. 
5.4.2  Original factory setting is 121.0°C & 20 minutes. 
5.4.3  When power is switched ON the display will show status OK/EQUITRON for 3 seconds and then the main screen will appear wherein the top line will display the process temperature, bottom line set temperature (in brackets) and bottom line right will display time 000. 
5.4.4  To alter temperature press ÍР. 
5.4.5  Select the parameter which you wish to change by pressing arrow key. 
5.4.6  Change the value by pressing up and down arrow key. Press enter key to register. 
5.4.7  Press ÍРkey to return to main display. 
5.5  Precautions 
5.5.1  Use thermal gloves to open the autoclave. 
5.5.2  Do not touch the autoclave when it is hot.

Related: Autoclave Validation in Pharmaceuticals


6.1  SOP - Standard Operating Procedure 
6.2  SCDM - Soybean Casein Digest Medium 
6.3  MCB - Micro Control Board

Load description
Lot No.
Autoclave Run Time

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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question

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