SOP Title: Operation, Cleaning and Calibration of Vacuum Oven
- Objective:
To lay down the procedure for Operation, Cleaning and Calibration of Vacuum Oven.
- Scope:
This SOP is applicable for Operation, Cleaning and Calibration of Vacuum Oven located in Quality Control Laboratory.
- Responsibility:
- Quality Control: To prepare and review the SOP. To follow the procedures laid down for Operation, Cleaning and Calibration of Vacuum Oven as per this SOP.
- Engineering Department: To carry out preventive maintenance as per schedule and procedure defined.
- Quality Assurance Department: To review and approve the SOP and Annexures.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department
- Procedure:
| 5.1 | Safety Precautions/Instructions: | |||||||||||||||||||||||||||||||||||
| 5.1.1 | Ensure all the electrical connections are properly earthed. Ensure the power plug of the vacuum oven is fixed in the socket properly. | |||||||||||||||||||||||||||||||||||
| 5.1.2 | Wear personal protective equipments such as safety glasses, heat resistant gloves during operation of equipment. | |||||||||||||||||||||||||||||||||||
| 5.1.3 | Ensure that the ON/OFF switch is working properly by switching “ON” the vacuum oven. | |||||||||||||||||||||||||||||||||||
| 5.2 | Operation: | |||||||||||||||||||||||||||||||||||
| 5.2.1 | Switch ON the main switch. | |||||||||||||||||||||||||||||||||||
| 5.2.2 | Switch ON the ‘ON/OFF’ knob in ON position. | |||||||||||||||||||||||||||||||||||
| 5.2.3 | The main indicator red light will glow and the temperature panel display will show the temperature in oC. | |||||||||||||||||||||||||||||||||||
| 5.2.4 | Set the required temperature on the temperature panel with ‘TO SET’ key. | |||||||||||||||||||||||||||||||||||
| 5.2.5 | Adjust the required temperature with the ‘COARSE’ and ‘FINE’ keys. | |||||||||||||||||||||||||||||||||||
| 5.2.6 | Wait till the vacuum oven attains the set temperature. | |||||||||||||||||||||||||||||||||||
| 5.2.7 | The Temperature indicator green light will glow when the required temperature is reached. | |||||||||||||||||||||||||||||||||||
| 5.2.8 | Open the door of the vacuum oven by rotating the 3 screw knobs in
anti clockwise direction. |
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| 5.2.9 | Place the sample to be dried inside the vacuum oven on a stainless steel plate provided. | |||||||||||||||||||||||||||||||||||
| 5.2.10 | If the sample is placed in LOD bottle or any other closed glass apparatus, open the lid of the bottle and place in the vacuum oven. | |||||||||||||||||||||||||||||||||||
| 5.2.11 | Immediately close the door and tighten the 3 screw knobs tightly. | |||||||||||||||||||||||||||||||||||
| 5.2.12 | To apply pressure to the vacuum oven, connect the vacuum pump to the vacuum nozzle of the vacuum oven provided at the right side corner of the equipment. | |||||||||||||||||||||||||||||||||||
| 5.2.13 | For operation of vacuum pump refer SOP ‘Operation, Cleaning and Calibration of Vacuum Pump’. | |||||||||||||||||||||||||||||||||||
| 5.2.14 | Open the pressure ‘IN’ knob and start the vacuum pump. | |||||||||||||||||||||||||||||||||||
| 5.2.15 | Check the vacuum gauge dial of the equipment till the needle reaches at the required vacuum. | |||||||||||||||||||||||||||||||||||
| 5.2.16 | As soon as the required vacuum is reached, close the pressure ‘IN’ knob tightly and switch OFF the vacuum pump. | |||||||||||||||||||||||||||||||||||
| 5.2.17 | Allow the substance under test to remain under vacuum at a specified temperature and specified time as mentioned in the respective pharmacopoeia or specification. | |||||||||||||||||||||||||||||||||||
| 5.2.18 | After completion of analysis, slowly release the vacuum by opening the pressure ‘OUT’ knob till the pressure needle on vacuum gauge dial comes to zero position. | |||||||||||||||||||||||||||||||||||
| 5.2.19 | Switch OFF the ‘ON/OFF’ knob in OFF position. | |||||||||||||||||||||||||||||||||||
| 5.2.20 | Open the door of the vacuum oven, remove the sample and place it in dessicator till it attains the room temperature. | |||||||||||||||||||||||||||||||||||
| 5.2.21 | Close the door of the vacuum oven and switch OFF the mains. | |||||||||||||||||||||||||||||||||||
| 5.2.22 | Update the “Instrument/Equipment Usage Log Book” as per SOP “Calibration of Instruments and Equipments”. | |||||||||||||||||||||||||||||||||||
| 5.3 | Cleaning: | |||||||||||||||||||||||||||||||||||
| 5.3.1 | Switch OFF the mains of the vacuum oven. | |||||||||||||||||||||||||||||||||||
| 5.3.2 | Clean the inside and outside of vacuum oven with lint free cloth before and after use. | |||||||||||||||||||||||||||||||||||
| 5.4 | Calibration Procedure: | |||||||||||||||||||||||||||||||||||
| Frequency: Once in a year | ||||||||||||||||||||||||||||||||||||
| 5.4.1 | Calibration is carried out by external agency as per SOP “Calibration of Instruments and Equipments”. | |||||||||||||||||||||||||||||||||||
| 5.4.2 | Refer Annexure for calibration test to be performed and acceptance criteria.
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| 5.4.3 | Generate the A. R. No. on the “Instrument/Equipment Calibration Register” as per SOP and give requisition to QA department for calibration formats of instruments/equipments on the due date of calibration. | |||||||||||||||||||||||||||||||||||
| 5.4.4 | For issuance of calibration report refer SOP “Control of documents, Preparation, Approval, Issuance and Maintenance. | |||||||||||||||||||||||||||||||||||
| 5.5 | Preventive Maintenance | |||||||||||||||||||||||||||||||||||
| 5.5.1 | Perform the preventive maintenance as per Annexure. | |||||||||||||||||||||||||||||||||||
| 5.5.2 | If preventive maintenance activity is outsourced, the observations are to be transcribed in the Annexure, and external party certificate to be attached. | |||||||||||||||||||||||||||||||||||
| 5.5.3 | If any breakdown occurs, follow procedure as per SOP “Calibration of Instruments and Equipments”. | |||||||||||||||||||||||||||||||||||
- Definitions / Abbreviations :
- Definitions :
- Breakdown: Any activity leading to operation of instrument/equipment other than the set parameters or unusual sound or vibration observed in the instrument/equipment.
- Calibration: Tests performed to ensure that the instrument/equipment is functioning as per set parameters. These tests are performed as per predefined frequency and also after any major repair or replacement of parts.
- Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.
- Abbreviations :
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
| A. R. No | Analytical Reference Number |
| No. | Number |
| oC | Degree Celsius |
| LOD | Loss on Drying |
| PM | Preventive Maintenance |
*Note – Ready to use SOP available in “DOWNLOAD” Section.