Design Qualification Protocol for Ophthalmic Bottle Washing Machine
Document Number: DQ-OBWM-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Prepared By]
Approved By: [Approved By]
Objective
The objective of this Design Qualification (DQ) protocol is to demonstrate that the Ophthalmic Bottle Washing Machine is designed, installed, and operates in accordance with user requirements and applicable regulatory standards.
Scope
This protocol applies to the Design Qualification of the Ophthalmic Bottle Washing Machine used in the production of sterile eye drops and ointments in the production area.
Responsibilities
- Validation Team: Responsible for preparing and executing the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Production Staff: Responsible for operating the washing machine in accordance with the validated procedures.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) must be completed prior to execution of this DQ.
- Training of personnel on the operation of the equipment.
Equipment Description
The Ophthalmic Bottle Washing Machine is designed to wash bottles prior to sterilization and filling. It utilizes controlled wash pressure, temperature, and particulate removal to ensure cleanliness and compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify wash pressure settings | Pressure within specified range | PLC logs |
| T2 | Verify wash temperature settings | Temperature within specified range | PLC logs |
| T3 | Check particulate removal efficiency | Particulate count below threshold | Test results |
Detailed Test Cases
Test Case T1: Verify Wash Pressure Settings
Objective: Ensure wash pressure is within specified limits.
Procedure: Monitor wash pressure using PLC logs during operation.
Acceptance Criteria: Pressure must be within the range of [Insert Range].
Evidence: PLC logs showing pressure readings.
Test Case T2: Verify Wash Temperature Settings
Objective: Ensure wash temperature is within specified limits.
Procedure: Monitor wash temperature using PLC logs during operation.
Acceptance Criteria: Temperature must be within the range of [Insert Range].
Evidence: PLC logs showing temperature readings.
Test Case T3: Check Particulate Removal Efficiency
Objective: Validate the effectiveness of the washing process in removing particulates.
Procedure: Conduct particulate count analysis post-wash.
Acceptance Criteria: Particulate count must be below [Insert Threshold].
Evidence: Test results and analysis report.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed as necessary.
Approvals
By signing below, the following individuals approve this Design Qualification Protocol:
Prepared By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________