Document ID: IQ-PSCS-001
Version: 1.0
Date: 2023-10-05
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Installation Qualification Protocol for Particle Size Classification System
This document outlines the Installation Qualification (IQ) protocol for the Particle Size Classification System used in the production of microspheres and microcapsules.
Objective: To ensure that the Particle Size Classification System is installed correctly, operates as intended, and meets the requirements outlined in the User Requirements Specification (URS).
Scope: This protocol applies to the Particle Size Classification System utilized in R&D and production for size fraction selection of microspheres and microcapsules.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Review and approval of the protocol and results.
- Engineering: Ensure the system is installed according to specifications.
Prerequisites:
- Completion of equipment installation.
- Availability of necessary documentation (URS, installation manuals).
- Personnel trained in equipment operation and validation procedures.
Equipment Description:
The Particle Size Classification System consists of sieves and an air classifier designed to select size fractions of microspheres and microcapsules. The critical parameter for this equipment is the sieve integrity cut size.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against the manufacturer’s specifications. | All components are installed as per the specifications. | Installation checklist signed by the engineering team. |
| IQ-02 | Check sieve integrity cut size using calibrated standards. | Cut size is within the specified range as per URS. | Calibration report and measurement records. |
| IQ-03 | Perform functionality test of the air classifier. | System operates without errors; airflow meets specifications. | Test run data and operational logs. |
Detailed Test Cases:
- Test Case IQ-01: Confirm that all installation components are present and correctly positioned.
- Test Case IQ-02: Measure the sieve cut size with calibrated particles to ensure compliance with the URS.
- Test Case IQ-03: Run a test cycle on the air classifier to verify that it meets the specified operational parameters.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed for any major deviations.
Approvals:
All test results must be reviewed and approved by the Quality Assurance team prior to the equipment being qualified for use.