Document Control Number: PQ-SM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Performance Qualification Protocol for Sigma Mixer / Kneader
Objective: To validate the performance of the Sigma Mixer / Kneader for high-viscosity mass mixing in the production of solid dosage forms.
Scope: This protocol applies to the Sigma Mixer / Kneader located in the Production/Granulation area, specifically for the mixing of high-viscosity materials impacting product quality directly.
Responsibilities:
- Validation Team: Preparation and execution of the PQ protocol.
- Quality Assurance: Review and approval of the PQ protocol and results.
- Production Personnel: Operation of the Sigma Mixer / Kneader during testing.
Prerequisites:
- Installation Qualification (IQ) completed and approved.
- Operational Qualification (OQ) completed and approved.
- Training of personnel on equipment operation.
Equipment Description: The Sigma Mixer / Kneader is designed for high-viscosity mass mixing, featuring adjustable blade speeds, temperature control, and vacuum application capabilities. It is essential for ensuring uniform mixing of materials in solid dosage form production.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-SM-01 | Verify blade speed at set points (e.g., low, medium, high). | Blade speed within specified range as per URS. | Calibration records, speed test data. |
| PQ-SM-02 | Measure temperature during mixing. | Temperature remains within defined limits as per URS. | Temperature logs, mixing records. |
| PQ-SM-03 | Check vacuum levels during operation. | Vacuum levels meet specifications as per URS. | Vacuum measurement data, operational logs. |
Detailed Test Cases:
- Test ID: PQ-SM-01
- Procedure: Set the blade speed to low, medium, and high. Record the actual speed using a tachometer.
- Acceptance Criteria: Blade speed must be within ±10% of the set point as per URS.
- Evidence: Documented speed readings and calibration status of the tachometer.
- Test ID: PQ-SM-02
- Procedure: Start the mixer and monitor the temperature throughout the mixing process.
- Acceptance Criteria: Temperature must remain within ±5°C of the specified range.
- Evidence: Temperature recording charts and logs.
- Test ID: PQ-SM-03
- Procedure: Activate the vacuum and monitor levels during operation.
- Acceptance Criteria: Vacuum must not drop below specified thresholds.
- Evidence: Vacuum gauge readings and operational logs.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed, and corrective actions must be implemented and verified.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance: ______________________ Date: ___________