Vacuum Oven – Operation and Calibration SOP

Standard Operating Procedure (SOP) for Operation and Calibration of vacuum oven used in quality control laboratory and R&D in pharmaceuticals.

SOP for Vacuum Oven

1.0   PURPOSE:

    • The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of Vacuum Oven.

2.0   SCOPE:

    • This SOP is applicable for the operation (Make- Thermo Scientific) and calibration of Vacuum Oven installed at the quality control department.

3.0   REFERENCES:

    • URS and analytical instrument/equipment qualification (SOP)
    • Maintenance of laboratory instruments (SOP)
    • Instrument/Equipment usage log book.
    • Preparation of Internal and External Calibration Schedule and Calibration Practices (SOP)
    • SOP for authorized personnel list and status labeling in the working area.

4.0   RESPONSIBILITY – SOP FOR VACUUM OVEN:

    • Analyst :Vacuum Oven

    • To Operate the instrument as per SOP.
    • To calibrate the instrument as per SOP.
    • Recording all documents related to calibration and preventive maintenance.
    • Quality Control Head or Designee :

    • Training to the concern before the implementation of SOP.
    • To verify the calibration and preventive maintenance followed as per schedule.
    • To ensure proper documentation as per SOP.
    • Quality Assurance :

    • To ensure the implementation of the system as per SOP.
    • Quality Head and Plant Head :

    • To review and approve the SOP.

5.0   ABBREVIATIONS USED IN SOP FOR VACUUM OVEN:

    • LOD: Loss on drying
    • NA: Not Applicable
    • QA: Quality Assurance
    • QC: Quality Control
    • SOP: Standard Operating Procedure

6.0   PROCEDURE – SOP FOR VACUUM OVEN:

  • Procedure for Operation of Vacuum Oven:

    • Turn “ON” the master switch, the green pilot light comes “ON”.
    • Change the set point with “+” and “-“
    • If the “+” or “-“ key will be pressed, the value of the setpoint in display changes.
    • Press “°C” key once more, the desired set point will be stored,
    • The display does not flash the set point but shows actual temperature value.
    • If the “°C” key will not be actuated, the old set point is maintained.
    • Open the gas ballast to rotate pointed arrow towards labeling “GB”.
    • Close the air inlet valve ( Making in vertical position)
    • Put the leaver of shutoff valve in the “OPEN” position ( Making in vertical position)
    • Switch “ON” vacuum system.
    • Apply vacuum till the desired pressure is not attained.
    • When the desired pressure is attained, start closing the knob by rotating it in the clockwise direction and then remove the vacuum oven tube followed by putting off the vacuum pump.

Note: Always Put Off the Vacuum first and then remove the tube otherwise the oil of the vacuum pump will be sucked inside the oven

    • After the test is over, open the valve of the vacuum line.
    • Slowly release the vacuum after 2 minutes.
    • Operating temperature range is 40 to 200 “°C
    • The operating pressure range is 0 to 1000m bar.
  • General Procedure for the handling of Vacuum Oven:

    • In case of any maintenance of the instrument, follow the procedure as per SOP “ Maintenance of Laboratory Instruments” (For SOP – Click here).
    • For the entry of usage of the instrument follow the procedure as per SOP “Instrument/Equipment usage logbook”
    • Affix the calibration label on the instrument as per SOP “Authorized personnel list and status labeling in the working area”.
    • Maintain the third party calibration schedule and the Internal calibration schedule for the instrument as per SOP “Preparation of Internal and External (Third Party) Calibration Schedule and Calibration Practices”
  • Calibration/ Validation of Vacuum Oven:

    • Frequency: Yearly ± 30 days by an external agency.
    • Precautions :
    • If the test sample melts at a lower temperature than that specified for the LOD test, maintain the bottle with sample for 1 to 2 hrs. at a temperature 5°C to 10°C below the melting temperature, then dry at the specified temperature.
    • Before using the instrument, ensure that the instrument shall be clean.

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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