Design Qualification Protocol for Dust Collector / Bag Filter in Solid Dosage Form

Objective: To establish and document the design qualification of the Dust Collector / Bag Filter system used for dust collection from product streams in the production area.

Scope: This protocol applies to the Dust Collector / Bag Filter system utilized in the production and material transfer area for solid dosage forms, ensuring compliance with regulatory requirements and operational standards.

Responsibilities:

• Validation Team: Execute the protocol and document results.
• Quality Assurance: Review and approve the protocol and results.
• Engineering: Provide technical support and equipment specifications.

Prerequisites:

• Completion of User Requirement Specification (URS).
• Installation Qualification (IQ) completed and approved.
• Operational Qualification (OQ) plan established.

Equipment Description:

The Dust Collector / Bag Filter system is designed to collect dust from product streams during the manufacturing process. It operates by utilizing a pulse cleaning mechanism to maintain efficient filtration and minimize contamination.

Detailed Test Cases:

• Test Case DQ-01: Confirm that the Dust Collector / Bag Filter is installed according to the manufacturer’s specifications. Document any discrepancies.
• Test Case DQ-02: Measure differential pressure (DP) during pulse cleaning to ensure containment. Record all readings and compare them to acceptance criteria.
• Test Case DQ-03: Conduct a performance test during normal operation to ensure no dust is escaping the system. Document findings and any corrective actions taken.

Deviations: Any deviations from the acceptance criteria must be documented in the deviation report, including root cause analysis and corrective actions taken.

Approvals:

_________________________
Prepared by: [Your Name]
Date: ______________

_________________________
Approved by: [Approver’s Name]
Date: ______________