SHAILENDRA S.JADIYAM.PHARM-QA (2NDSEM)CALIBRATION & CLEANING OFAUTOCLAVE & MEMBRANCEFILTERSchool Of PharmaceuticalSciences...
GOOD MORNINGTO ALL…
PROCEDURE FOR CALIBRATION &CLEANING OF AUTOCLAVE -SOP1.0. PURPOSE:This SOP provides an authorized procedure to carry outca...
6.0 Procedure :6.1 Calibration:6.1.1 Calibrate the temperature indicator,pressure gauge and probe once in a year byexterna...
CALIBRATION OF INSTRUMENTSINSTALLED ON AUTOCLAVEA. PRESSURE / VACUUM GAUGE-CALIBRATIONB. THERMOCOUPLE OF AUTOCLAVE & DHS-C...
CALIBRATION OF INSTRUMENTS INSTALLED ONAUTOCLAVEA. PRESSURE / VACUUM GAUGE-CALIBRATION• To the port in the autoclave, atta...
B. THERMOCOUPLE OF AUTOCLAVE &DHS-CALIBRATIONThese temperature indicatinginstruments should be calibrated atquarterly inte...
Master List1. Autoclave pressure gauge2. Membrane integrity pressure gauge3. Ampoules leak test apparatus vacuum gauge4. T...
C.CALIBRATION OF THERMOCOUPLE OFTEMPERATURE MEASURING DEVICES FORAUTOCLAVEProcedure for thermocouple Calibration ofThermog...
6.2 Cleaning:6.2.1 Ensure that the equipment is isolated from thepower before starting the cleaning activity.6.2.2 The out...
• 6.2.5 Enter the cleaning details in the log book.• 6.2.6 After cleaning is completed, the autoclavemay be operated witho...
CLEANING & CALIBRATION OF AUTOCLAVE
Upcoming SlideShare
Loading in...5
×

CLEANING & CALIBRATION OF AUTOCLAVE

3,006

Published on

Published in: Business, Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
3,006
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Transcript of "CLEANING & CALIBRATION OF AUTOCLAVE"

  1. 1. SHAILENDRA S.JADIYAM.PHARM-QA (2NDSEM)CALIBRATION & CLEANING OFAUTOCLAVE & MEMBRANCEFILTERSchool Of PharmaceuticalSciencesRGTU UIT Bhopal (M.P.)
  2. 2. GOOD MORNINGTO ALL…
  3. 3. 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.
  4. 4. 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.
  5. 5. CALIBRATION OF INSTRUMENTSINSTALLED ON AUTOCLAVEA. PRESSURE / VACUUM GAUGE-CALIBRATIONB. THERMOCOUPLE OF AUTOCLAVE & DHS-CALIBRATIONC.CALIBRATION OF THERMOCOUPLE OFTEMPERATURE MEASURING DEVICES FORAUTOCLAVE
  6. 6. 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.
  7. 7. 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
  8. 8. 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
  9. 9. 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.
  10. 10. 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
  11. 11. • 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.

×