Document Control:
Version: 1.0
Date: 2023-10-01
Approved by: [Name]
Performance Qualification Protocol for Powder Compounding Vessel Used in Sachet and Stick Pack Production
Objective: To validate the performance of the Powder Compounding Vessel (Jacketed SS) used for preparing bulk powder blends or granulations for sachet filling.
Scope: This protocol applies to the Powder Compounding Vessel utilized in the production area for non-sterile applications, specifically for sachets and stick packs.
Responsibilities:
- Validation Team: Ensure protocol execution and documentation.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Operate the equipment as per established procedures.
Prerequisites:
- Training on equipment operation and validation processes.
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
Equipment Description:
The Powder Compounding Vessel (Jacketed SS) is designed for mixing, blending, and granulating powders for sachet and stick pack production. It includes a jacket for temperature control and is equipped with PLC for monitoring critical parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Mixing Speed Verification | Mixing speed within specified range | PLC audit trail report |
| PQ-002 | Temperature Blending Check | Temperature maintained within specified limits | Temperature log |
| PQ-003 | Blending Time Assessment | Blending time meets defined criteria | Blend time documentation |
Detailed Test Cases:
Test Case for
- Procedure: Start the vessel and monitor the mixing speed via PLC.
- Acceptance Criteria: Mixing speed should be within the specified range.
- Evidence: Capture data from the PLC audit trail.
Test Case for PQ-002: Temperature Blending Check
- Procedure: Monitor the temperature during the blending process.
- Acceptance Criteria: Temperature should remain within defined limits.
- Evidence: Record temperature logs throughout the process.
Test Case for PQ-003: Blending Time Assessment
- Procedure: Measure the time taken for blending.
- Acceptance Criteria: Blending time should meet the defined criteria.
- Evidence: Document the blending time during the process.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions implemented as necessary.
Approvals:
Prepared by: [Name]
Reviewed by: [Name]
Approved by: [Name]
Data Integrity Checks:
- Regular audits of PLC data logs to ensure accuracy.
- Cross-verification of temperature logs with physical measurements.
- Validation of blending time against established benchmarks.