1.0 OBJECTIVE:To lay down the procedure for cleaning and operation of Autoclave.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
4.0 ACCOUNTABILITY:Head Quality Control Department
5.1 General Cleaning :5.1.1 Clean the Autoclave from inside and out side with a cloth moistened in disinfectant solution.
5.1.2 Clean the Autoclave daily after completion of daily work.
5.1.3 Record the cleaning in “Equipment Cleaning Register”.
5.2 Precautions:5.2.1 Check the calibration status of the pressure gauge, temperature indicator cum controller.
5.2.2 Do not open the lid of autoclave, when cycle is running.
5.2.3 Take care during handling of the articles as they will be hot, after sterilization.
5.2.4 After completion of cycle, open the lid of autoclave, when the pressure gauge shows “0” reading and temperature gauge shows below 90°C.
5.2.5 Heating coils should be completely submerged in water.
5.3 Operation :5.3.1 Open the lid of the autoclave by pressing the steel base at the bottom.
5.3.2 Remove both the perforated steel baskets from the autoclave.
5.3.3 Pour enough purified water into the autoclave such that the heating coils are completely submerged in water.
5.3.4 Replace the stainless steel baskets back into the autoclave.
5.3.5 Load the material to be sterilized into the basket.
5.3.6 Close the lid and clamp the screws in place.
5.3.7 Connect the main cord to the supply socket and switch it on.
5.3.8 Digital display shows “Fully Automated Autoclave” and shows the soak temperature and time and solenoid valve will be on.
5.3.9 Press the PROGRAM key, display shows soak temperature and increase or decrease the pressure by using the up and down keys.
5.3.10 Press the ENTER key and display shows Soak time
5.3.11 Increase or decrease the soak time using the up and down keys and press the ENTER key.
5.3.12 Now press the START key to start the process.
5.3.13 Heater will be on and the temperature starts increase.
5.3.14 Solenoid valve will be off when the temperature reach 100°C and pressure gauge shows the pressure.
5.3.15 When the pressure gauge shows a reading of 15 lbs and the temperature display shows 121° C.
5.3.16 Timer will be on and time starts to decrease in minutes. Heater will be cut on and cut off to maintain the pressure at 15 lbs and the temperature at 121°C.
5.3.17 At the end of 15 minutes, Display shows “Autoclave cycle completed”.
5.3.18 Heater will be off and the solenoid valve will be on to release the steam pressure. Pressure starts falling.
5.3.19 When the temperature reaches below 100°C, Solenoid valve will be off and allow the autoclave to cool for 15 minutes.
5.3.20 Unclamp the screws and unload the sterilized material.
5.4 TST Sterilization Indicator Strips :5.4.1 One strip of the ‘TST Sterilization Indicator’ is placed every time with the materials to be autoclaved.
5.4.2 If sterilization is effective, the yellow mark on the strip turns blue match with the preprinted blue standard reference.
5.4.3 If sterilization is ineffective, the strip shows a pale yellow color whereas a purple color indicates over sterilization.
5.4.4 Sterilization Indicator Strips are used in order to ensure that the sterilization cycle is effective and the contents have been sterilized properly.
5.4.5 Every time a strip of the sterilization indicator is used, it shall be signed by the person handling the Autoclave and the date of sterilization shall be mentioned on it.
5.4.6 Maintain records for the duration for which the autoclave was used, along with the sterilized indicator strip.
5.4.7 The pressure gauge and the temperature gauge of the autoclave shall be calibrated once in a year.
5.5 Traceability of Sterilization Load Numbers:5.5.1 Each sterilization load is assigned a specific lot number as 7 characters as given below.
XX indicates Serial no. of sterilization load
YY indicates Month
ZZ indicates Year
6.0 ABBREVIATIONS:6.1 QC : Quality Control
6.2 Dept. : Department
6.3 SOP : Standard Operating Procedure
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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