Document Control Number: DQ-OSD-BIN-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Bin/IBC Washer in Solid Dosage Form
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Bin/IBC Washer is qualified for its intended use in washing IBC/bin contact parts, meeting the specified requirements and acceptance criteria.
Scope
This protocol applies to the validation of the Bin/IBC Washer used in the production area for Solid Dosage Form (OSD) manufacturing. It includes all relevant aspects of the equipment’s design, functionality, and performance.
Responsibilities
The validation team is responsible for the execution of this DQ protocol. The Quality Assurance (QA) team will review and approve the documentation.
Prerequisites
- Completion of User Requirements Specification (URS)
- Installation Qualification (IQ) completion
- Operational Qualification (OQ) completion
Equipment Description
The Bin/IBC Washer is designed to wash Intermediate Bulk Containers (IBCs) and bins used in the production of solid dosage forms. It utilizes a combination of wash temperature, time, pressure, and detergent dosing controlled by a Programmable Logic Controller (PLC) to ensure effective cleaning.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify wash temperature | Temperature maintained within specified range | Temperature log |
| DQ-02 | Verify wash time | Wash time as per defined parameters | Time log |
| DQ-03 | Verify wash pressure | Pressure maintained within specified range | Pressure log |
| DQ-04 | Verify detergent dosing | Detergent dosing meets specified criteria | Dosing log |
| DQ-05 | PLC functionality check | PLC operates as intended | PLC verification report |
Detailed Test Cases
Test Case DQ-01: Verify Wash Temperature
Procedure: Monitor the wash temperature during a full wash cycle. Compare the recorded temperature against the specified range.
Acceptance Criteria: The temperature must be maintained within the specified range as defined in the URS.
Evidence: Temperature logs must be documented and reviewed.
Test Case DQ-02: Verify Wash Time
Procedure: Record the duration of the wash cycle to ensure compliance with the defined wash time.
Acceptance Criteria: The wash time must meet the defined parameters.
Evidence: Time logs must be documented and reviewed.
Test Case DQ-03: Verify Wash Pressure
Procedure: Monitor the wash pressure throughout the wash cycle. Compare against the specified pressure range.
Acceptance Criteria: The pressure must be maintained within the specified range as defined in the URS.
Evidence: Pressure logs must be documented and reviewed.
Test Case DQ-04: Verify Detergent Dosing
Procedure: Verify the amount of detergent used during the wash cycle against the specified dosing criteria.
Acceptance Criteria: Detergent dosing must meet the specified criteria.
Evidence: Dosing logs must be documented and reviewed.
Test Case DQ-05: PLC Functionality Check
Procedure: Perform a functionality check of the PLC to ensure it operates as intended throughout the wash cycle.
Acceptance Criteria: The PLC must operate without errors.
Evidence: PLC verification report must be documented and reviewed.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions must be implemented and verified.
Approvals
Approved By: [Insert Name], [Insert Title]
Date: [Insert Date]
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