Document Control
Document ID: DQ-DCB-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for Double Cone Blender
Objective
The objective of this Design Qualification (DQ) Protocol is to verify that the Double Cone Blender is designed and constructed to meet the specified requirements for blending powders and granules in the production area.
Scope
This protocol applies to the Double Cone Blender used in the production of solid dosage forms (OSD) at [Insert Facility Name]. It covers the validation of equipment used for blending operations.
Responsibilities
The following personnel are responsible for the execution and approval of this DQ Protocol:
- Validation Manager: Overall approval and oversight.
- Quality Assurance: Review and ensure compliance with regulatory standards.
- Engineering: Equipment specifications and installation verification.
Prerequisites
Before executing this DQ Protocol, the following prerequisites must be met:
- Completion of User Requirement Specification (URS).
- Installation of Double Cone Blender in designated production area.
- Availability of all necessary documentation and specifications.
Equipment Description
The Double Cone Blender is a piece of equipment designed for the blending of powders and granules. It operates by rotating the cone-shaped vessel, allowing for homogeneous mixing of materials.
Key Critical Parameters:
- RPM
- Blending Time
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify RPM settings | RPM must match URS specifications | Calibration records |
| DQ-02 | Measure blending time | Blending time must meet URS specifications | Process logs |
Detailed Test Cases
Test Case DQ-01: Verify RPM Settings
Procedure: Set the Double Cone Blender to the specified RPM and measure the actual RPM using a calibrated tachometer. Document the results.
Acceptance Criteria: The RPM must match the specifications outlined in the URS.
Expected Outcome: RPM readings fall within the acceptable range.
Test Case DQ-02: Measure Blending Time
Procedure: Start the blender and record the time taken to achieve the desired blend consistency. Stop the blender and document the time.
Acceptance Criteria: Blending time must align with the URS specifications.
Expected Outcome: Blending time meets specified limits.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be proposed and implemented as needed.
Approvals
This Design Qualification Protocol must be reviewed and approved by the designated personnel before execution.