Document ID: DQ-EMS-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Name]
Approved by: [Name]
Design Qualification Protocol for Inline Emulsification System
Objective: To establish the design qualification for the Inline Emulsification System used in the production of microspheres and microcapsules.
Scope: This protocol applies to the Inline Emulsification System used in R&D and production areas for the formulation of emulsion droplets critical for microsphere and microcapsule development.
Responsibilities:
- Validation Team: Responsible for protocol execution and documentation.
- Quality Assurance: Responsible for review and approval of the protocol and results.
- Engineering: Responsible for equipment setup and maintenance.
Prerequisites:
- Completion of User Requirement Specification (URS) as per Annex 11.
- Installation Qualification (IQ) must be completed prior to this protocol.
Equipment Description:
The Inline Emulsification System is designed to produce uniform emulsion droplets for the formulation of microspheres and microcapsules. Key features include adjustable shear rates, flow temperature control, and pressure monitoring capabilities.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-EMS-001 | Verify shear rate settings during operation. | Shear rate within specified range as per URS. | Calibration records, operation logs. |
| DQ-EMS-002 | Monitor flow temperature during emulsification. | Temperature maintained within specified limits. | Temperature logs. |
| DQ-EMS-003 | Check pressure records during operation. | Pressure within acceptable limits as per URS. | Pressure logs. |
Detailed Test Cases:
- Test Case 1: Verify shear rate settings.
- Procedure: Set shear rate to the specified value and monitor during operation.
- Acceptance: Shear rate must remain within specified range.
- Evidence: Calibration records and operation logs will be collected.
- Test Case 2: Monitor flow temperature.
- Procedure: Set and monitor the temperature during emulsification.
- Acceptance: Temperature must stay within the defined limits.
- Evidence: Collect temperature logs throughout the process.
- Test Case 3: Check pressure records.
- Procedure: Monitor pressure during emulsification.
- Acceptance: Pressure must remain within acceptable limits.
- Evidence: Gather pressure logs for review.
Deviations: Any deviations from the acceptance criteria must be documented and evaluated for impact on product quality.
Approvals: This protocol must be reviewed and approved by the Quality Assurance team before execution.