Installation Qualification Protocol for Dust Extraction Unit in Solid Dosage Form
Document Number: IQ-LEV-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Dust Extraction Unit (LEV) is installed correctly and operates in accordance with its intended use for dust capture in the production/containment area, ensuring operator and product protection.
Scope
This protocol applies to the Dust Extraction Unit installed in the Solid Dosage Form (OSD) production area. It covers the installation verification, operational parameters, and compliance with the User Requirement Specification (URS).
Responsibilities
The following personnel are responsible for the execution and approval of this protocol:
- Validation Team: Execute and document the IQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Engineering: Ensure equipment installation meets specifications.
Prerequisites
Prior to executing this protocol, the following must be completed:
- Installation of the Dust Extraction Unit as per manufacturer specifications.
- Completion of all necessary training for personnel involved in the validation process.
- Availability of all required documentation, including User Requirement Specification (URS).
Equipment Description
The Dust Extraction Unit (LEV) is designed for dust capture during the dispensing of solid dosage forms. It operates by creating a suction effect to capture airborne particles, ensuring a safe working environment.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-LEV-01 | Verify installation against manufacturer specifications. | Installation matches specifications outlined in URS. | Installation checklist, photographs. |
| IQ-LEV-02 | Measure airflow capture velocity. | Airflow capture velocity meets specified range. | Calibration report, measurement logs. |
| IQ-LEV-03 | Perform filter integrity test. | Filter integrity confirmed with no leaks. | Test results, filter integrity report. |
Detailed Test Cases
Test Case 1: Installation Verification
Verify that the Dust Extraction Unit is installed according to the manufacturer’s specifications. Document any discrepancies.
Test Case 2: Airflow Capture Velocity Measurement
Measure the airflow capture velocity at designated points. Ensure it falls within the acceptable range as per the URS.
Test Case 3: Filter Integrity Testing
Conduct a filter integrity test to ensure there are no leaks. Document the results and any necessary actions taken.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report must be prepared and approved by Quality Assurance.
Approvals
The following individuals must approve this Installation Qualification Protocol:
- Prepared By: [Insert Name] – [Title]
- Reviewed By: [Insert Name] – [Title]
- Approved By: [Insert Name] – [Title]