Design Qualification Protocol for Single Screw Extruder in Solid Dosage Form
Document Number: DQ-OSD-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Objective
The objective of this Design Qualification (DQ) Protocol is to verify that the Single Screw Extruder used for the production of pellets meets the specified requirements and is suitable for its intended use.
Scope
This protocol applies to the validation of the Single Screw Extruder in the Production area for Solid Dosage Form (OSD) manufacturing. It includes the assessment of equipment performance and critical parameters.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for providing technical support and ensuring equipment is installed correctly.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved in the validation process must be trained and qualified.
Equipment Description
The Single Screw Extruder is designed for the extrusion of pellets in the Solid Dosage Form manufacturing process. Key features include adjustable screw speed, controlled feed rate, and torque measurement capabilities.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify screw speed settings | Screw speed within specified range (e.g., 50-100 RPM) | Calibration certificate, logs |
| DQ-002 | Measure feed rate | Feed rate within specified limits (e.g., 1-5 kg/h) | Measurement logs, calibration records |
| DQ-003 | Monitor torque during operation | Torque readings within acceptable range (e.g., 10-20 Nm) | Torque records, operational logs |
Detailed Test Cases
Test Case DQ-001: Verify screw speed settings by adjusting the speed to the designated RPM and recording the actual speed.
Test Case DQ-002: Measure the feed rate by running the extruder for a specified duration and weighing the output pellets.
Test Case DQ-003: Monitor the torque during extrusion by recording the torque readings at various speeds and feed rates.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be taken as necessary.
Approvals
Approved by: [Name]
Date: YYYY-MM-DD
Data Integrity Checks
- Ensure all data is recorded in real-time during testing.
- Implement audit trails for all data entries related to the DQ protocol.
- Regularly back up data to secure storage locations.