Performance Qualification Protocol for V Blender in Solid Dosage Form
Document Number: PQ-VB-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the V Blender operates within specified limits and produces consistent blending of powders/granules in compliance with the User Requirement Specification (URS).
Scope
This protocol applies to the V Blender utilized in the production area for blending solid dosage forms. This includes all activities related to the validation of the equipment’s performance.
Responsibilities
- Validation Team: Execute and document the PQ protocol.
- Quality Assurance: Review and approve the PQ protocol and results.
- Production Personnel: Assist in the execution of the protocol and provide necessary data.
Prerequisites
- Equipment must be installed and operational.
- Users must be trained on the operation of the V Blender.
- All necessary materials must be available for testing.
Equipment Description
The V Blender is designed for blending powders and granules in a production environment. It operates by rotating the blending chamber, allowing for efficient mixing of materials.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Verify RPM settings at specified load. | RPM within ±5% of target. | Calibration log and RPM measurements. |
| TP-002 | Check fill level during operation. | Fill level at 50-75% of capacity. | Visual inspection and measurement records. |
| TP-003 | Measure blending time for consistency. | Blending time ≤ 15 minutes. | Time logs and batch records. |
Detailed Test Cases
Test Case 1: RPM Verification
Procedure: Set the V Blender to the specified RPM and record the actual RPM using a calibrated tachometer. Ensure the RPM remains stable throughout operation.
Acceptance Criteria: The RPM must be within ±5% of the target value.
Evidence: RPM measurement logs and calibration certificates.
Test Case 2: Fill Level Verification
Procedure: Fill the V Blender to the specified level and visually inspect the fill level during operation.
Acceptance Criteria: The fill level must be between 50-75% of the total capacity of the blender.
Evidence: Visual inspection records and photographs.
Test Case 3: Blending Time Measurement
Procedure: Start the blending process and record the time taken to achieve the desired blend quality.
Acceptance Criteria: Blending time must not exceed 15 minutes.
Evidence: Time logs and blending quality assessment reports.
Deviations
Any deviations from the acceptance criteria must be documented, along with the rationale for the deviation and any corrective actions taken.
Approvals
Prepared by: ______________________ Date: ____________
Reviewed by: ______________________ Date: ____________
Approved by: ______________________ Date: ____________