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