Installation Qualification Protocol for Dynamic Light Scattering Analyzer
Document Number: IQ-DLS-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Dynamic Light Scattering (DLS) Analyzer is installed and operates according to the specified requirements, ensuring accurate particle size and PDI measurements in compliance with URS Annex11.
Scope
This protocol applies to the installation and qualification of the DLS Analyzer used in the Quality Control (QC) and Research & Development (R&D) departments for the measurement of particle size and polydispersity index (PDI).
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Technical Support: Responsible for providing installation support and troubleshooting.
Prerequisites
- Completion of site preparation as per equipment specifications.
- Availability of required utilities (power, water, etc.).
- Training of personnel on equipment operation and safety protocols.
Equipment Description
The Dynamic Light Scattering (DLS) Analyzer is an analytical instrument used for measuring the size of particles in suspension through the analysis of light scattering. It provides critical parameters such as size accuracy and PDI repeatability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against manufacturer’s specifications. | All components installed as per specifications. | Installation checklist signed by technician. |
| IQ-02 | Check utility connections (power, water, etc.). | Utilities are fully operational. | Utility verification report. |
| IQ-03 | Perform initial calibration check. | Calibration within specified limits. | Calibration certificate. |
| IQ-04 | Conduct size accuracy and PDI repeatability tests. | Results meet acceptance criteria as per URS Annex11. | Test results report. |
Detailed Test Cases
Test Case IQ-01
Objective: Verify installation against manufacturer’s specifications.
Procedure: Review installation checklist and confirm all components are installed.
Acceptance Criteria: All components installed as per specifications.
Test Case IQ-02
Objective: Check utility connections.
Procedure: Inspect power and water connections for compliance.
Acceptance Criteria: Utilities are fully operational.
Test Case IQ-03
Objective: Perform initial calibration check.
Procedure: Execute calibration procedure as per manufacturer instructions.
Acceptance Criteria: Calibration within specified limits.
Test Case IQ-04
Objective: Conduct size accuracy and PDI repeatability tests.
Procedure: Measure standard reference material and record results.
Acceptance Criteria: Results meet acceptance criteria as per URS Annex11.
Deviations
Any deviations from this protocol must be documented and approved by Quality Assurance. A root cause analysis will be performed for any critical deviations affecting the results.
Approvals
Approved By: ______________________
Date: ______________________