Standard Operating Procedure for Using Hot Air Oven
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the hot air oven used in the manufacturing of otic dosage forms to ensure effective drying and sterilization of materials and equipment.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the hot air oven in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the hot air oven as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the drying and sterilization process and verifying results.
Maintenance Personnel: Responsible for maintaining the hot air oven in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the hot air oven is on a stable, level surface.
4.1.1.2 Check that the oven chamber is clean and free of any debris.
4.1.1.3 Verify that the oven is properly calibrated and functioning.
4.1.2 Loading the Oven
4.1.2.1 Arrange the items to be dried or sterilized in the oven trays, ensuring there is space between them for air circulation.
4.1.2.3 Close and secure the oven door.
4.1.3 Drying/Sterilization Process
4.1.3.1 Select the appropriate temperature and time settings for the drying or sterilization process.
4.1.3.2 Start the oven and monitor the cycle parameters.
4.1.3.3 Allow the cycle to complete and ensure the oven reaches the required conditions for drying or sterilization.
4.1.3.4 After the cycle is complete, allow the oven to cool down before opening the door.
4.1.4 Unloading the Oven
4.1.4.1 Open the oven door carefully to avoid burns from hot air.
4.1.4.2 Remove the dried or sterilized items using heat-resistant gloves.
4.1.4.3 Allow the items to cool before handling further.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the oven’s temperature settings and indicators.
4.2.1.2 Record the results in the equipment log.
4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the hot air oven monthly using standard test methods.
4.2.2.2 Document the calibration results and any adjustments made.
4.3 Maintenance
4.3.1 Routine Maintenance
4.3.1.1 Clean the oven chamber and all parts regularly to prevent buildup of residue.
4.3.1.2 Inspect the door gasket and replace if worn or damaged.
4.3.2 Troubleshooting
4.3.2.1 If the oven displays error messages or fails to reach the required conditions, refer to the manufacturer’s manual for troubleshooting steps.
4.3.2.2 Contact maintenance personnel if the issue cannot be resolved.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Drying/sterilization log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the hot air oven
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0