1.0 OBJECTIVETo describe the procedure for operation and calibration of precision oven.
2.0 SCOPEThis SOP is applicable for operation and calibration of precision oven.
3.0 RESPONSIBILITYOfficer/ Executive - Quality Control
4.0 ACCOUNTABILITYManager - Quality Control
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.
5.2.1 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.
5.3.1 Never keep switch ON position, when not in use.
5.3.2 Clean equipment after use.
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.
6.1 SOP - Standard Operating Procedure
6.2 No. - Number
6.3 QA - Quality Assurance
6.4 NA - Not Applicable
6.5 CCF - Change control format6.6 QC - Quality Control
PRECISION OVEN USAGE LOG
Batch No./ Lot No.
CALIBRATION REPORT OF PRECISION OVEN
Asset ID No.
Ref. SOP No.
Observation: Clean / Not Clean
Corrective action in the case of non-compliance:
2. Calibration :
Calibrated thermometer ID No.:__________________
Calibrated on : _______________
Next Calibration Due on :________________
Done by: Checked by:
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.
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