Design Qualification Protocol for High Shear Granulator in Solid Dosage Form
Document ID: DQ-HSG-OSD-001
Version: 1.0
Effective Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the High Shear Granulator (HSG) is designed, installed, and operates according to specified requirements to meet the needs of wet granulation in Solid Dosage Form production.
Scope
This protocol applies to the Design Qualification of the High Shear Granulator used in the Production/Granulation area for the direct impact on product quality.
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 ensuring the equipment is installed according to specifications.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) completion.
- Availability of relevant documentation (manuals, schematics, etc.).
Equipment Description
The High Shear Granulator (HSG) is designed for wet granulation processes. It operates by mixing powders with a binder solution to form granules. Key critical parameters include speed, time, torque, binder addition, and PLC controls.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T01 | Verify speed settings | Speed must be within specified range (e.g., 100-300 RPM) | Calibration report |
| T02 | Check time settings | Time must be accurately programmable within 1-60 minutes | Time log |
| T03 | Measure torque during operation | Torque must remain within specified limits | Torque measurement data |
| T04 | Verify binder addition rate | Binder addition must meet specified rate | Binder addition log |
| T05 | PLC functionality check | PLC must operate without faults | PLC test report |
Detailed Test Cases
Test Case T01: Verify Speed Settings
Procedure: Set the HSG to various speed settings and verify against the specified range. Document results.
Expected Outcome: Speed readings must fall within the defined range.
Test Case T02: Check Time Settings
Procedure: Program various time settings and verify accuracy. Document results.
Expected Outcome: Time settings must match programmed values.
Test Case T03: Measure Torque During Operation
Procedure: Measure torque during a granulation run and document readings.
Expected Outcome: Torque must remain within specified limits throughout operation.
Test Case T04: Verify Binder Addition Rate
Procedure: Monitor binder addition during a granulation run and document the rate.
Expected Outcome: Binder addition rate must meet specified criteria.
Test Case T05: PLC Functionality Check
Procedure: Conduct a full functionality test of the PLC during operation.
Expected Outcome: PLC must function without any faults or errors.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed for impact on product quality. Corrective actions must be taken as necessary.
Approvals
Prepared by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________