1) SOP for Operating Drying Ovens

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating drying ovens, including temperature, time, and humidity control, to ensure proper drying of pharmaceutical products.

3) Scope

This SOP applies to all personnel involved in the operation of drying ovens within the pharmaceutical manufacturing area.

4) Responsibilities

• Operators are responsible for setting up, operating, and cleaning drying ovens according to this SOP.
• Supervisors are responsible for overseeing the drying process and ensuring compliance.
• Quality Assurance (QA) personnel are responsible for verifying that procedures are followed correctly and addressing any deviations.

5) Procedure

1. Preparation
   1. Ensure the drying oven area is clean and free of contaminants.
   2. Verify the availability and quality of materials to be dried as per the batch record.
   3. Check the cleanliness and readiness of the drying oven.
2. Oven Setup
   1. Set the drying oven temperature according to the product specifications.
   2. Set the drying time as per the batch record.
   3. Adjust the humidity control settings if required.
3. Drying Process
   1. Load the materials into the drying oven.
   2. Start the oven and monitor the drying process continuously.
   3. Ensure that the temperature and humidity levels are maintained within the specified range.
   4. Document the drying conditions and any observations made during the process.
   5. Remove the dried materials once the drying cycle is complete and allow them to cool before further processing.
4. Troubleshooting
   1. If the oven malfunctions, stop the operation immediately and troubleshoot the issue.
   2. Refer to the manufacturer’s manual for troubleshooting guidelines.
   3. Document the issue and the corrective actions taken in the maintenance logbook.
   4. Resume operation once the issue is resolved and the oven is functioning properly.
5. Cleaning and Maintenance
   1. Turn off and cool down the oven before cleaning.
   2. Clean the interior and exterior of the oven thoroughly to prevent cross-contamination.
   3. Document the cleaning process in the cleaning logbook.
   4. Perform regular maintenance checks and document them in the maintenance logbook.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Batch Record
• Cleaning Logbook
• Maintenance Logbook

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s operation and maintenance manual

9) SOP Version

Version 1.0