1) SOP for Operating Sifters and Sieves

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating sifters and sieves, including guidelines for particle size analysis and documentation, to ensure consistent particle size distribution.

3) Scope

This SOP applies to all personnel involved in the operation of sifters and sieves within the pharmaceutical manufacturing area.

4) Responsibilities

• Operators are responsible for setting up, operating, and cleaning sifters and sieves according to this SOP.
• Supervisors are responsible for overseeing the sifting and sieving 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 sifting and sieving area is clean and free of contaminants.
   2. Verify the availability and quality of materials to be sifted or sieved as per the batch record.
   3. Check the cleanliness and readiness of the sifter and sieve equipment.
2. Equipment Setup
   1. Select the appropriate sieve mesh size based on the product specifications.
   2. Assemble the sifter and sieve according to the manufacturer’s instructions.
   3. Ensure that all components are securely in place and properly aligned.
   4. Set the machine parameters (e.g., vibration intensity, duration) according to the batch record.
3. Sifting and Sieving Process
   1. Load the materials into the sifter or sieve.
   2. Start the machine and monitor the sifting or sieving process continuously.
   3. Ensure that the particle size distribution meets the specified criteria by sampling and testing the output at regular intervals.
   4. Adjust the machine settings if necessary to maintain consistency.
   5. Document any observations and adjustments made during the sifting or sieving process.
4. Troubleshooting
   1. If the machine 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 machine is functioning properly.
5. Cleaning and Maintenance
   1. Turn off and disassemble the sifter or sieve according to the manufacturer’s instructions.
   2. Clean all parts 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