Standard Operating Procedure for Sifting and Sieving Process

Purpose

The purpose of this SOP is to establish procedures for the effective sifting and sieving of materials, ensuring particle size consistency, quality, and compliance with regulatory standards.

Scope

This SOP applies to all personnel involved in the sifting and sieving process, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for executing the sifting and sieving process according to the established procedures.
• Technicians: Responsible for monitoring and maintaining sifting and sieving equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for monitoring and ensuring compliance with the sifting and sieving SOP.

Procedure

1. Inspect the sifting and sieving equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, free from residues, and calibrated before starting the sifting and sieving process.
3. Verify that all materials to be sifted or sieved are properly labeled and approved for use.
4. Load the materials into the sifting or sieving equipment, ensuring proper quantity and distribution for effective particle separation.
5. Set the sifting or sieving parameters on the equipment, including mesh size and duration, according to the approved specifications.
6. Initiate the sifting or sieving process and monitor the equipment to ensure uniform particle size distribution and adherence to specified parameters.
7. Perform periodic checks on the sifted or sieved materials to ensure the desired particle size is achieved.
8. If adjustments to the sifting or sieving parameters are necessary, document the changes made and the reason for the adjustments.
9. Perform in-process checks, such as particle size analysis or visual inspections, to assess the quality of the sifted or sieved materials.
10. Upon completion of the sifting or sieving process, collect samples for quality control testing and analysis.
11. Submit samples to the quality control laboratory, ensuring that the sifted or sieved materials meet the predefined acceptance criteria.
12. If the materials pass quality control, proceed with further processing steps as per the formulation requirements.
13. If the materials fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
14. Complete the logbook or batch record with all pertinent information, including any adjustments made during the sifting or sieving process.
15. Clean and sanitize the sifting and sieving equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Sifting and Sieving Logbook
• Quality Control Test Results
• Maintenance and Calibration Records
• Deviation and Corrective Action Logs

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0