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SOP For Autoclave Calibration- Detailed SOP

SOP For Autoclave Calibration: Discover the essential SOP for autoclave calibration, designed for precision in pharmaceuticals, toxicology, and scientific research. This detailed SOP outlines the procedure for calibrating temperature, pressure, and timer settings to meet regulatory standards and ensure effective sterilization.

SOP For Autoclave Calibration- Detailed SOP
SOP For Autoclave Calibration- Detailed SOP

SOP For Autoclave Calibration- Detailed SOP

Purpose- SOP for Autoclave Calibration

This SOP for Autoclave Calibration describes the procedure of calibration of autoclaves for the accurate and repeatable performance in sterilization. In pharmaceutical sciences, genetic toxicology, pharmacognosy, and pharmacology it is essential to calibrate the instruments.

Calibration is an important factor to ensure that autoclaves operate within the specified parameters, thus ensuring that the sterility of the materials is guaranteed and the compliance to regulatory standards.

Scope- SOP for Autoclave Calibration

This SOP for Autoclave Calibration is relevant to the calibration of all autoclaves used for sterilization in the lab. It includes calibration of temperature, pressure sensors, and timers which are very important for the proper functioning of the autoclave.

Responsibilities

  • Laboratory Personnel: Responsible for performing the calibration under the guidance of this SOP.
  • Quality Assurance (QA) Team: Responsible for reviewing and approving the calibration records to ensure compliance with the SOP for Autoclave Calibration.
  • Maintenance Team: Responsible for addressing any issues identified during calibration that affect the autoclave’s performance.

Materials and Equipment– SOP for Autoclave Calibration

  • Autoclave to be calibrated
  • Certified reference thermometer and pressure gauge
  • Data logger with thermocouple probes
  • Calibration logbook or software
  • Personal protective equipment (PPE)

Procedure- SOP for Autoclave Calibration

Preparation for Calibration

  1. Make sure the autoclave is empty and has been serviced recently, to ensure that it is in good working condition.
  2. Recheck the specifications of the manufacturer for temperature, pressure, and timer accuracy.
  3. Ensure that there are the required certified reference instruments which are traceable to national or international standards.

Calibration of Temperature Sensors

  1. Insert the reference thermometer and data logger with thermocouple probes into the autoclave chamber.
  2. Set the autoclave to run a standard sterilization cycle.
  3. Compare the temperature readings taken from the autoclave sensor to those taken from the reference thermometer during the cycle.
  4. As per the manufacturer instructions, adjust the autoclave temperature sensor as needed to meet the reference thermometer.

Calibration of Pressure Sensors

  1. Connect the certified reference pressure gauge to the pressure sensor port of the autoclave.
  2. Run a normal cycle and note the pressure readings from the autoclave sensor and the reference gauge.
  3. Calibrate the pressure sensor of the autoclave according to the manufacturer’s recommendations to match the readings of the reference gauge.

Calibration of Timers

  1. The accuracy of the autoclave’s timer should be checked by measuring the sterilization time against a stopwatch or another certified timer.
  2. If discrepancies are identified, adjust the timer settings of the autoclave following the manufacturer’s recommendations.

Documentation and Record-Keeping- SOP for Autoclave Calibration

  1. Keep a record of all calibration undertakings; the date, the instruments used, personnel carrying out the calibration, and the before and after readings.
  2. Record any changes made to the autoclave settings and the ultimate calibration status.
  3. Store calibration records in the laboratory’s quality assurance system to be audited.

Post-Calibration Checks

  1. After calibration, test run the autoclave with biological and chemical indicators to determine the sterilization efficiency.
  2. Sign off on the calibration process by the QA team, ensuring that the autoclave meets all the operational specifications.

Safety Precautions

  1. When using autoclaves and calibration equipment, one should wear the right PPE.
  2. Make sure that all calibration instruments are handled and used per their safety instructions to avoid injuries or damages.

Maintenance and Troubleshooting

  1. Schedule maintenance checks before calibration activities so that the autoclave is in the best condition for calibration.
  2. In case calibration adjustments do not calibrate sensors with reference instruments, then contact the autoclave manufacturer or a professional service technician for further assistance.

References and Regulatory Compliance

  1. The manufacturer’s manual should be consulted for detailed calibration procedures and specifications.
  2. Follow local and international standards for calibration of laboratory equipment such as ISO, FDA, or EMA.

Autoclave Calibration Record Form- SOP for Autoclave Calibration

Facility Information

  • Facility Name:
  • Location/Department:
  • Calibration Date:
  • Autoclave ID/Model:

Calibration Team

  • Lead Technician:
  • Team Members:
  • QA Reviewer:

Instrumentation and Reference Standards

  • Reference Thermometer ID/Model:
    • Certification Date:
    • Next Calibration Due:
  • Reference Pressure Gauge ID/Model:
    • Certification Date:
    • Next Calibration Due:
  • Data Logger & Thermocouple ID/Model:
    • Certification Date:
    • Next Calibration Due:

Calibration Procedure

Temperature Calibration

  • Set Sterilization Cycle Parameters:
    • Temperature:
    • Time:
  • Reference Temperature Reading:
  • Autoclave Sensor Reading (Before Adjustment):
  • Adjustment Made: Yes/No
  • Autoclave Sensor Reading (After Adjustment):
  • Comments:

Pressure Calibration

  • Reference Pressure Reading:
  • Autoclave Sensor Reading (Before Adjustment):
  • Adjustment Made: Yes/No
  • Autoclave Sensor Reading (After Adjustment):
  • Comments:

Timer Calibration

  • Set Timer For:
  • Actual Time Measured:
  • Adjustment Made: Yes/No
  • Comments:

Post-Calibration Verification

  • Biological Indicator Results: Pass/Fail
  • Chemical Indicator Results: Pass/Fail
  • Comments:

Approval and Sign-off

  • Calibration Performed by:
    • Signature:
    • Date:
  • Reviewed by QA:
    • Signature:
    • Date:
  • Supervisor/Manager Approval:
    • Signature:
    • Date:

Attachments

  • Calibration Certificates for Reference Instruments
  • Before and After Adjustment Data Logs
  • Post-Calibration Test Reports

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