Document Control:
Document ID: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for Bottle Washing/Rinsing Machine
Objective
The objective of this Design Qualification (DQ) Protocol is to verify that the Bottle Washing/Rinsing Machine is designed and installed in accordance with user requirements and applicable regulatory standards.
Scope
This protocol applies to the Bottle Washing/Rinsing Machine used in the production area for cleaning bottles prior to filling with IV infusions (LVP/SVP – Bags/Bottles).
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 the installation and maintenance of the equipment.
Prerequisites
- Completion of the User Requirements Specification (URS).
- Installation of the Bottle Washing/Rinsing Machine.
- Training of personnel on equipment operation.
Equipment Description
The Bottle Washing/Rinsing Machine is designed to clean and rinse bottles before filling with IV infusions. It utilizes a combination of rinse pressure and particulate removal to ensure cleanliness.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify rinse pressure settings | Rinse pressure meets specified range as per URS Annex11 | Pressure logs |
| T2 | Check particulate removal efficiency | Particulate count meets acceptable limits | Particulate analysis report |
| T3 | Review PLC logs for operational consistency | Logs show no errors or anomalies | PLC log reports |
Detailed Test Cases
Test Case T1: Verify Rinse Pressure Settings
Procedure: Measure the rinse pressure using calibrated gauges. Ensure it remains within the specified range.
Acceptance Criteria: Rinse pressure should be within the range defined in URS Annex11.
Evidence: Documented pressure readings and calibration certificates.
Test Case T2: Check Particulate Removal Efficiency
Procedure: Collect samples before and after rinsing and analyze for particulate count.
Acceptance Criteria: Particulate count should not exceed acceptable limits defined in URS Annex11.
Evidence: Analysis report from the laboratory.
Test Case T3: Review PLC Logs for Operational Consistency
Procedure: Access PLC logs to verify the operational history and check for errors.
Acceptance Criteria: No errors or anomalies should be recorded in the PLC logs.
Evidence: Printouts or digital copies of PLC logs.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented.
Approvals
This protocol must be reviewed and approved by the Quality Assurance and Validation teams prior to execution.
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