Standard Operating Procedure for Qualification of Powder Sieving Machines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying powder sieving machines used in pharmaceutical manufacturing. This SOP ensures that the sieving machines are correctly installed, operate according to specifications, and perform consistently under normal production conditions. The qualification process verifies the mechanical, electrical, and operational parameters of the sieving machine to ensure effective separation and classification of powders, thereby meeting the required regulatory and quality standards.
2) Scope
This SOP applies to the qualification of all powder sieving machines used in pharmaceutical manufacturing, primarily for separating particles based on size, removing foreign particles, and ensuring the uniformity of powder mixtures. It covers the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes. This SOP is applicable to both new powder sieving machines and those that have undergone major repairs, upgrades, or relocations. The qualification process ensures that the sieving machine operates effectively and efficiently to meet the required quality standards.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the powder sieving machine is operated according to the qualification protocols and that
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the powder sieving machine are carried out in compliance with this SOP and meet all regulatory requirements. QA is responsible for reviewing and approving all qualification reports and documentation.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the machine operates within the specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the powder sieving machine meets all performance criteria.
Maintenance Personnel: Ensures that the powder sieving machine is properly installed, maintained, and calibrated, and that all mechanical and electrical systems are functioning correctly during the qualification process.
4) Procedure
The following steps should be followed for the IQ, OQ, and PQ of powder sieving machines:
1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the powder sieving machine meets the necessary requirements for installation.
1.2 Verify that all required utilities (e.g., electrical power, compressed air, etc.) are available and meet the specifications required for proper machine operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, cleanliness, and space.
1.4 Confirm that all mechanical components are correctly installed, including the sieve mesh, agitators, motor, and the material handling system.
1.5 Ensure that all electrical components, including sensors, control systems, and alarms, are properly connected and functioning.
1.6 Perform a visual inspection to confirm that the equipment is installed according to the manufacturer’s instructions and that all components are intact.
1.7 Complete the IQ documentation, including checklists, equipment manuals, and relevant installation records, ensuring that all information is recorded and signed off by responsible personnel.
2. Operational Qualification (OQ):
2.1 Verify that all operational controls, such as mesh size, vibration speed, material feed rate, and reject systems, are properly set and calibrated.
2.2 Conduct a dry run of the powder sieving machine to verify that it operates without issues. Monitor key parameters such as vibration intensity, material flow rate, and uniformity during operation.
2.3 Test all control systems, ensuring that the start/stop, sieving controls, material feeding, and reject mechanisms are working correctly.
2.4 Inspect the sieving process to ensure that the powder is being effectively separated according to the desired particle size distribution.
2.5 Ensure that the sieve mesh does not become clogged during operation and that material flow is consistent.
2.6 Document the results of the OQ, noting any deviations or issues encountered and corrective actions taken.
3. Performance Qualification (PQ):
3.1 Conduct the sieving process using product or simulated product (e.g., inert powder) and monitor performance under typical production conditions.
3.2 Measure the efficiency of the sieving process by assessing the particle size distribution of the powder. Verify that the sieved powder meets the predefined particle size specifications.
3.3 Ensure that the sieve mesh is performing as expected by checking for uniform separation and minimal loss of material.
3.4 Perform sampling during the sieving process and analyze the sieved powder to determine the amount of oversized or undersized particles present.
3.5 Verify that the machine operates at the required throughput without affecting sieve performance or material quality.
3.6 Document the results of the PQ, including particle size distribution, throughput, and any process deviations. Ensure that all records are signed and reviewed by responsible personnel.
4. Documentation and Reporting:
4.1 Record all data during the IQ, OQ, and PQ processes, including batch records, equipment logs, process parameters, and inspection results for particle size, flow consistency, and sieve performance.
4.2 Ensure that all forms, reports, and certificates are completed and signed by responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the consistency and reliability of the sieving process. This analysis should confirm that the machine operates consistently within predefined parameters and meets the acceptance criteria.
4.4 Prepare a final qualification report, summarizing the results of the IQ, OQ, and PQ, including any deviations, corrective actions, and conclusions regarding the sieving machine’s performance.
5. Requalification:
5.1 Requalify the powder sieving machine if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying the sieving system.
5.2 Periodically perform requalification to ensure that the equipment continues to perform as expected and remains in compliance with regulatory requirements.
5) Abbreviations
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- QA: Quality Assurance
- SOP: Standard Operating Procedure
6) Documents
- IQ/OQ/PQ Protocol
- Equipment Manufacturer Specifications
- Installation and Setup Reports
- Calibration Records
- Sieving Process Records
- Particle Size Distribution Logs
- Rejection and Corrective Action Reports
7) Reference
- FDA Guidance for Industry: Equipment Qualification
- International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ISO 9001: Quality Management Systems – Requirements
- USP Chapter 1151: Pharmaceutical Dosage Forms
8) SOP Version
Version 1.0 – Effective Date: DD/MM/YYYY
Annexure
Template 1: IQ/OQ/PQ Test Record
| Date | Time | Operator Initials | Test Type (IQ/OQ/PQ) | Test Results | Comments |
|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | IQ/OQ/PQ | Pass/Fail | Comments |
Template 2: Sieving Efficiency Log
| Batch No. | Test Date | Efficiency (%) | Particle Size (µm) | Uniformity (Pass/Fail) | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Efficiency in % | Particle Size | Pass/Fail | Operator Name |
Template 3: Equipment Calibration and Maintenance Log
| Equipment Name | Calibration Date | Maintenance Performed | Next Calibration Date | Operator Initials |
|---|---|---|---|---|
| Sieving Machine Model | DD/MM/YYYY | Maintenance Tasks | DD/MM/YYYY | Operator Name |