Operational Qualification Protocol for Double Cone Blender in Solid Dosage Form
Document Number: OQ-DCB-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Double Cone Blender operates within specified limits and meets the acceptance criteria defined in the User Requirements Specification (URS).
Scope
This protocol applies to the Double Cone Blender used in the production area for blending powders and granules in the Solid Dosage Form (OSD) manufacturing process.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with regulatory requirements. The Quality Assurance (QA) department will review and approve the final report.
Prerequisites
All personnel involved in the execution of this protocol must be trained on the operation of the Double Cone Blender and the relevant SOPs. The equipment must be installed and calibrated according to the manufacturer’s specifications.
Equipment Description
The Double Cone Blender is designed for the uniform blending of powders and granules. It consists of two conical sections that rotate around a horizontal axis, ensuring thorough mixing of materials.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify RPM settings during blending. | RPM must be within specified limits as per URS. | Calibration records, RPM measurement logs. |
| OQ-02 | Measure blending time. | Blending time must meet the defined criteria in URS. | Time logs, blending reports. |
Detailed Test Cases
Test Case OQ-01: Verify RPM Settings
Procedure: Set the Double Cone Blender to the specified RPM. Use a calibrated tachometer to measure the actual RPM during operation.
Acceptance Criteria: The RPM must remain within the limits defined in the URS.
Evidence: Document the RPM readings and any deviations from the set point.
Test Case OQ-02: Measure Blending Time
Procedure: Start the blending process and record the time taken to complete the blending cycle.
Acceptance Criteria: The blending time must align with the specifications outlined in the URS.
Evidence: Time logs and blending reports must be maintained for review.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be conducted, and corrective actions must be implemented as necessary.
Approvals
This protocol requires approval from the Validation Manager and Quality Assurance before execution.