Document Control:
- Document Number: DQ-PSWM-001
- Version: 1.0
- Effective Date: 2023-10-01
- Reviewed By: [Reviewer Name]
- Approval Date: [Approval Date]
Design Qualification Protocol for Prefilled Syringe Washing Machine
Objective: To validate the design and performance of the Prefilled Syringe Washing Machine to ensure it meets the specified requirements for washing syringes prior to sterilization.
Scope: This protocol applies to the Prefilled Syringe Washing Machine used in the production area for cleaning prefilled syringes and cartridges, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the validation protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for operating the equipment as per validated procedures.
Prerequisites:
- Completed Installation Qualification (IQ) of the Prefilled Syringe Washing Machine.
- Training of personnel on equipment operation and safety procedures.
- Availability of cleaning agents and materials required for testing.
Equipment Description:
The Prefilled Syringe Washing Machine is designed to wash prefilled syringes and cartridges using specified wash pressure, temperature, and particulate removal methods. It features a PLC for audit trail documentation.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify wash pressure settings | Within specified range | Pressure gauge readings |
| T2 | Check wash temperature | Within specified range | Temperature log |
| T3 | Evaluate particulate removal efficiency | Meets defined particulate limits | Particulate analysis report |
| T4 | Review PLC audit trail | Complete and accurate records | Audit trail report |
Detailed Test Cases:
- Test Case T1: Set wash pressure to specified level and record readings. Acceptance if within range.
- Test Case T2: Set wash temperature and monitor during operation. Acceptance if within range.
- Test Case T3: Conduct particulate analysis post-wash. Acceptance if below specified limits.
- Test Case T4: Generate and review PLC audit trail. Acceptance if all entries are accurate and complete.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be implemented where necessary.
Approvals:
- Validation Team Lead: ____________________ Date: ____________
- Quality Assurance Manager: ________________ Date: ____________
Data Integrity Checks:
- Regular backups of PLC data logs.
- Access controls to ensure only authorized personnel can modify settings or data.
- Periodic reviews of audit trails for discrepancies.