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SOP for Calibration of Oven


Standard operating procedure of calibration of Oven using calibrated thermometer.

1.0 OBJECTIVE

To describe the procedure for operation and calibration of precision oven.

2.0 SCOPE

This SOP is applicable for operation and calibration of precision oven.

3.0 RESPONSIBILITY

Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 Operation

5.1.1  Ensure that temperature indicator is within due date of calibration.  
5.1.2  Switch on the precision oven.
5.1.3  Adjust the required temperature by adjusting temperature knob (soft key).
5.1.4  After attaining required temperature keep the dish and lid separately inside the oven. Close tightly the oven door.
5.1.5  Allow to hold the specified temperature.
5.1.6  Note the time of attaining specified temperature.          
5.1.7  After completion of specified time switched off the precision oven.
5.1.8  Allow to come down the temperature below 40°C.
5.1.9  After attaining to 40°C, open the door and take out the dish & replace the lid.
5.1.10  Reclose the door.
5.1.11  Take the print out of the duration used for LOD test.
5.1.12  Fill the usage log book.

5.2  Calibration

5.2.1  Calibrate the chamber temperature by calibrated thermometer.
5.2.2  Set the chamber temperature alternately 50°C, 105°C and 150°C, Standardize by calibrated thermometer. Record the observations.
5.2.3  Calibrate the temperature sensor by the external agency on annual basis.
5.2.4  Calibration frequency of chamber temperature: Quarterly.
5.3  Precautions
5.3.1  Never keep switch ON position, when not in use.
5.3.2  Clean equipment after use.
5.4  Maintenance 
5.4.1  If the instrument does not produce required results or its response is poor then it should be labeled “UNDER MAINTENANCE” and should be repaired or serviced.

6.0  ABBREVIATIONS:

6.1  SOP - Standard Operating Procedure
6.2  No. - Number
6.3  QA - Quality Assurance
6.4  NA - Not Applicable
6.5  CCF - Change control format
6.6  QC - Quality Control


                                                                       ANNEXURE-I
                                                                                                                                      Format No. 
                                                         PRECISION OVEN USAGE LOG
Date
Product/
Material Name
Batch No./ Lot No.
Time
Analyzed
by
Checked by
Remarks
Started
 at
Completed
 on








                                                         
                                                          ANNEXURE-II
                                                                                                                          Format No.
                                CALIBRATION REPORT OF PRECISION OVEN
Asset ID  No.
:

Ref.  SOP No.
:

Make
:

Model No.
:

1. Cleanliness of the Instrument:
Observation: Clean / Not Clean
Corrective action in the case of non-compliance:

2. Calibration :
Observations:
Calibrated thermometer ID No.:__________________

S. No.
Temperature
Limit
Remarks

Set
Observed

50°C

+ 2°C



105°C

+ 2°C



150°C

+ 2°C


Remarks: The instrument is calibrated as per the SOP and shows satisfactory / does not satisfactory results as per calibration procedure.
Calibrated on                    : _______________
Next Calibration Due on  :________________

Done by:                                                                                         Checked by:
Date:                                                                                               Date:
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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