To lay down a standard procedure for operation & cleaning of vertical autoclave for destruction.
This Standard Operating Procedure is applicable for vertical autoclave for destruction which is installed in Microbiology laboratory of Quality Control Department.
Microbiologist shall be responsible to follow the procedure mention in this SOP.
Department Head & QA Head shall be accountable for compliance of this SOP.
Format for the Autoclave usage record for destruction. – Attachment-I
6.1.1 Autoclave should be placed on a leveled surface.
6.1.2 Open the autoclave by unscrewing the wing nuts and then pressing paddle-lifting device with the foot.
6.1.3 Remove the perforated baskets from autoclave.
6.1.4 Ensure that the drain valve at the bottom of the autoclave is closed.
6.1.5 Pour distilled water into the autoclave chamber at least 2 inch above heater level. Ensure that the perforated basket shall not dip in the water.
6.1.6 Load the autoclave with desired materials like media, accessories (membrane filter cups and forceps), glass wares and garments. Close the lid, clamp the knobs and tighten opposite knobs simultaneously.
6.1.7 Make sure that the lid and steam releasing valve is tightly close to avoid leakage.
6.1.8 Switch “ON” the main switch.
6.1.9 The set temperature & time will be displayed on micro processor controller.
6.1.10 The solenoid valve will remain open till the temperature reaches approximately 100°C in order to purge the stale air enclosed in the Autoclave, indicated by green light after which it will automatically close.
6.1.11 After this, the temperature and pressure will gradually rise, which will be indicated by the Microprocessor controller and Pressure Gauge.
6.1.12 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 & pressure is attained.
6.1.13 Run the cycle at 121°C temperature and at 15 psi pressure for 30 minutes or validated time period.
6.1.14 During this period of countdown, the safety valve and the extra safety valve may leak slightly,
which is normal.
6.1.15 After the set time period, a Buzzer will sound and the heater will be cut OFF, which indicates that the cycle is completed.
6.1.16 Now switch OFF the main switch and release the steam completely by opening the steam releasing valve.
6.1.17 Unscrew the knobs and open the lid only after the pressure gauge comes back to ‘0’. Do not attempt
to open the knobs at even 1 or 2 psi. Always wait up till the gauge reads zero before opening the lid.
6.1.18 Remove the sterilized material at the earliest after total exhaust of pressure.
6.1.19 Maintain the record of autoclave usage after every cycle in format no. SOP/ML/006/F01-02.
6.2 Procedure for general Cleaning
6.2.1 Ensure that power supply to the autoclave is switched ‘OFF’ before cleaning. Remove the plug from the socket.
6.2.2 To clean the chamber, a drain valve is provided at the bottom. Place a vessel of adequate size below it and open the drain valve.
6.2.3 After the chamber is emptied clean the autoclave with nylon brush, apply mild soap solution. 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.
6.2.4 After chamber is empty, clean the chamber with disinfectant or 70% IPA.
6.2.5 Close drain valve and pour distilled water for next cycle.
6.2.6 Clean the outer surface of the autoclave with 70% IPA using a clean cloth every day.
SOP: Standard operating procedure
°C : Degree Celsius
Psi : Pound per square inch
IPA : Isopropyl alcohol
CC No.: Change Control number
QA : Quality Assurance
QC: Quality Control
9.0 DISTRIBUTION LIST
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION
|Version Number||Effective Date||Reason for Revision|
|Title||:||Vertical Autoclave usage record for destruction|
|Version No.||:||00||Page No.||:||Page 1 of 1
|Effective Date||:||Review Date||:|
|Sterilization cycle: Autoclave to be done at 121 & 15 Psi Pressure for 30 minutes/validated cycle|
|S.no||Date||Load description||Autoclave load No. /cycle No.
|Autoclave Run time||Temp
|Pressure||Sterilization Time||Indicator response
|operator sign & date||Checked by & remarks