PROCEDURE FOR CALIBRATION &CLEANING OF AUTOCLAVE -SOP1.0. PURPOSE:This SOP provides an authorized procedure to carry outcalibration of Autoclave.2.0. SCOPE:This SOP provides the relevant methodology for the calibrationof Autoclave.3.0. RESPONSIBILITY :Q.C. Microbiologist.4.0. ACCOUNTABILITY:Manager-Quality Control5.0. FREQUENCY:5.1 Chemical Indicator - Every load.5.2 Biological Indicator - Every Month.
6.0 Procedure :6.1 Calibration:6.1.1 Calibrate the temperature indicator,pressure gauge and probe once in a year byexternal agency or whenever any replacementor maintenance done on the apparatus.6.1.2 Place the Benzoic acid AR grade as achemical indicator for temperature calibrationin regular sterilization cycle . It melts at 121°C.6.1.3 Maintain the records, and abort theparticular load used for calibration.
CALIBRATION OF INSTRUMENTSINSTALLED ON AUTOCLAVEA. PRESSURE / VACUUM GAUGE-CALIBRATIONB. THERMOCOUPLE OF AUTOCLAVE & DHS-CALIBRATIONC.CALIBRATION OF THERMOCOUPLE OFTEMPERATURE MEASURING DEVICES FORAUTOCLAVE
CALIBRATION OF INSTRUMENTS INSTALLED ONAUTOCLAVEA. PRESSURE / VACUUM GAUGE-CALIBRATION• To the port in the autoclave, attach astandardized pressure/vacuum gauge to thechamber.• Operate the unit &compare readings of thefixed gauge to the standardized gauge.• If a port is not available, remove the gaugefrom the unit & attach it with the standardizedgauge to a suitable vessel or pipe ‘T’.• Apply the pressure & vacuum and comparethe readings of both gauges.• In either case, the gauge should agree within5%. If not so replace it.
B. THERMOCOUPLE OF AUTOCLAVE &DHS-CALIBRATIONThese temperature indicatinginstruments should be calibrated atquarterly interval using silicon oil bathand standard thermometer. Thedeviation from standard temperatureshould not exceed ± 1°C.TimersThermograph timers should becalibrated quarterly against accuratetimepiece . The deviation should be not
Master List1. Autoclave pressure gauge2. Membrane integrity pressure gauge3. Ampoules leak test apparatus vacuum gauge4. Temperature measuring device of autoclave &dry heat sterilizer5. Time measuring device of autoclave & dry heatsterilizer6. Standard thermometerFrequency• Pressure Gauges- Quarterly• Temperature Recorders- Quarterly• Time Measuring Devices- Quarterly• Standard Gauge- Quarterly• Standard Thermometer- Quarterly
C.CALIBRATION OF THERMOCOUPLE OFTEMPERATURE MEASURING DEVICES FORAUTOCLAVEProcedure for thermocouple Calibration ofThermograph & Digital Temperature Indicator• Remove the thermocouples from the autoclave.• Use calibrated ‘zeal’ thermometer as standardthermometer.• Affix a new thermograph on panel.• Check the thermocouple temperature reading ondigital temperature indicator & the thermograph.• Remove from the autoclave & place boththermocouples & standard thermometer in sintexsilicon oil bath. Heat the oil & take temperaturereadings at 100°C & 125°C.• Readings on the test thermocouples and standardthermometer must agree within ± 1°C.• By this process, calibrate the 12 probes of theinstrument that is used to validate sterilization cycle.
6.2 Cleaning:6.2.1 Ensure that the equipment is isolated from thepower before starting the cleaning activity.6.2.2 The outside of the autoclave should be wipedwith a wet sponge and allow to dry. All pipeconnections should be wiped with a dry sponge onceevery week.6.2.3 Clean the chamber with 0.1% SLS solution/0.5% solution of Teepol / 0.05% BenzalkoniumChloride using the sponge.6.2.4 The Doors, Trolley & Shelves should bewashed with detergent solution & rinse thoroughlywith purified water till get free from the detergent.6.2.5 The stop valves, bypass valves, gaskets,exhaust steam pipe, drain pipe & resistance
• 6.2.5 Enter the cleaning details in the log book.• 6.2.6 After cleaning is completed, the autoclavemay be operated without any load for onesterilization cycle before use of routineproduction.