Design Qualification Protocol for Bottle Unscrambler in Packaging/Primary Area
Document Number: DQ-OSD-001
Revision Number: 1.0
Effective Date: 2023-10-01
Prepared By: [Name]
Approved By: [Name]
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the Bottle Unscrambler equipment meets the specified requirements for its intended use in the Solid Dosage Form (OSD) packaging process.
Scope
This protocol applies to the Bottle Unscrambler used in the Packaging/Primary area for feeding and orienting bottles. It covers the equipment’s critical parameters and acceptance criteria.
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 equipment specifications.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the Bottle Unscrambler.
- Availability of necessary documentation and technical specifications.
Equipment Description
The Bottle Unscrambler is designed for the efficient feeding and orientation of bottles in the packaging line. It features speed jam sensors and interlocks to ensure safe operation.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| T1 | Verify speed settings against specifications. | Speed settings must be within specified range. | Calibration report. |
| T2 | Test jam sensors for responsiveness. | Jam sensors must activate within 2 seconds. | Test log. |
| T3 | Check interlocks for proper functionality. | Interlocks must engage and disengage correctly. | Operational test report. |
Detailed Test Cases
Test Case T1: Speed Verification
Procedure: Adjust the speed settings on the Bottle Unscrambler to the specified values and record the actual speeds.
Acceptance Criteria: Speeds must be within ±5% of specified values.
Evidence: Calibration report documenting the actual speeds.
Test Case T2: Jam Sensor Testing
Procedure: Simulate a jam condition and measure the time taken for the sensor to activate.
Acceptance Criteria: Activation time must not exceed 2 seconds.
Evidence: Test log showing activation times.
Test Case T3: Interlock Functionality
Procedure: Engage and disengage the interlocks during operation to ensure proper functionality.
Acceptance Criteria: Interlocks must engage and disengage without failure.
Evidence: Operational test report confirming interlock performance.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on equipment performance and product quality. A corrective action plan must be developed as necessary.
Approvals
Prepared By: _____________________ Date: ____________
Approved By: _____________________ Date: ____________