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QC SOP

SOP Title: Operation, Cleaning and Calibration of Hot Air Oven

SOP Title: Operation, Cleaning and Calibration of Hot Air Oven

 

  1. Objective:

To lay down the procedure for Operation, Cleaning and Calibration of Hot Air Oven.

  1. Scope:

This SOP is applicable for Operation, Cleaning and Calibration of Hot Air Oven located in Quality Control Laboratory.

 

  1. Responsibility:
  • Quality Control: To prepare and review the SOP. To follow the procedures laid down for Operation, Cleaning and Calibration of Hot Air 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.
  1. Accountability:

Head Quality Control Department, Head Quality Assurance Department

  1. Procedure:
5.1           Safety Precautions/Instructions:
 5.1.1 Ensure all the electrical connections are properly earthed. Ensure the power  
  plug of the hot air oven is fixed in the socket properly.  
5.1.2 Wear personal protective equipments such as safety glasses and heat resistant gloves during operation of equipment.  
5.1.3 Ensure that the ON/OFF switch is working properly by switching “ON” the hot air oven.             
5.2      Operation:
5.2.1 Switch ON the main switch.  
5.2.2 For ‘Main Indicator’ red light will glow and “Control Indicator’ orange light will glow after switching rotary switch.  
5.2.3 Set the required temperature by rotating the ‘Temperature Controller knob’ in clockwise or anti-clockwise direction as per requirement. Temperature can be set from 50° C to 300° C with multiple of 10° C.  
5.2.4 Set the ‘Rotary Switch’ in ‘Low’, ‘Medium’ or ‘High’ as required. Main function of rotary switch to rise in temperature with speed of low / medium/ high.  
5.2.5 Hot air oven generally used for drying of laboratory glassware.  
5.2.6 Set the temperature of oven at 60° C ±5° C for drying of glassware, refer  SOP for Cleaning of Glassware’s in Quality control department and SOP for Cleaning of Used Glassware in Microbiology Section.  
5.2.7 Open the door by pulling carefully the handle and place the calibrated thermometer inside and close the door.  
5.2.8 Wait till the hot air oven attains the set temperature.  
5.2.9 When the set temperature is reached, open the door carefully and place the glassware on the racks and immediately close the door.  
5.2.10 Allow the glassware to remain inside hot air oven at a specified temperature for 1 to 2 hours.  
5.2.11 After completion of glassware drying, open the door of the hot air oven, remove the dried glassware’s and allow it to attain the room temperature. Then keep the glassware’s at designated places.  
5.2.12 Switch off the hot air oven after end of the shift or when not in use.  
5.2.13 Hot air oven also can be used for testing of samples in case of non availability of drying oven for testing of sample.  
5.2.14 Refer procedure mentioned below for sample testing:

To switch “ON” and temperature setting follow steps mention as per point no.:-5.2.1 to 5.2.4.

 
  Note: While testing of sample ensure that there is no any glassware should be dried in the oven.  
5.2.15 Set the temperature of oven as Specified in respective pharmacopeia / GTP / STP of testing sample.  
5.2.16 When the set temperature is reached, open the door carefully and place the sample for analysis on the racks and immediately close the door.  
5.2.17 Allow the sample to remain inside hot air oven at a specified temperature and specified time as mentioned in the respective pharmacopeia or STP/GTP.  
5.2.18 After completion of analysis, switch OFF the mains.  
5.2.19 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 hot air oven.  
5.3.2 Clean the inside and outside of hot air oven with lint free cloth before and after use.  
5.4           Calibration Procedure:
  Frequency:  Once in a year by external agency or after carrying out any major maintenance work.
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.

Sr. No. Tests Set value Acceptance Criteria
1. Temperature Verification 50oC ±5oC
100oC ±5oC
150oC ±5oC
200oC ±5oC
250oC ±5oC
 
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.  
5.4.5 If any breakdown occurs, follow procedure as per SOP “Calibration of Instruments and Equipments”.  

 

  1. 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.
  • Abbreviations:
Abbreviation Expansion
SOP Standard Operating Procedure
QC Quality Control
QA Quality Assurance
A. R. No Analytical Reference Number
No. Number
STP Standard Testing Procedure
GTP General Testing Procedure

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

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