Bin Lifter / IBC Lifter – OQ Protocol

Document Number: OQ-001

Version: 1.0

Effective Date: 2023-10-01

Review Date: 2024-10-01

Operational Qualification Protocol for Bin Lifter / IBC Lifter

Objective: To validate the operational performance of the Bin Lifter / IBC Lifter used for IBC handling and docking in the production area.

Scope: This protocol covers the operational qualification of the Bin Lifter / IBC Lifter in the production/material handling area for solid dosage forms.

Responsibilities:

  • Validation Team: Execute the qualification protocol.
  • Quality Assurance: Review and approve the protocol and results.
  • Production Personnel: Assist in the execution of tests as needed.

Prerequisites:

  • Installation Qualification (IQ) completed and approved.
  • All necessary training for personnel involved in the qualification.
  • Access to the Bin Lifter / IBC Lifter and relevant documentation.

Equipment Description:

The Bin Lifter / IBC Lifter is designed for the safe handling and docking of Intermediate Bulk Containers (IBCs) in the production area. It has a load capacity of 1000 kg and features adjustable docking alignment mechanisms.

Test ID Procedure Acceptance Evidence
OQ-01 Verify load capacity by loading maximum weight. Load capacity meets or exceeds 1000 kg. Load test report.
OQ-02 Check docking alignment with IBC. Alignment within ±5 mm. Alignment measurement log.

Detailed Test Cases:

Test Case OQ-01: Load Capacity Verification

Objective: To ensure the Bin Lifter / IBC Lifter can handle the maximum load capacity.

Procedure: Gradually load the lifter with weights until it reaches 1000 kg. Monitor for any signs of failure.

See also  Barcode Scanner (GMP) – Equipment Validation SOP

Acceptance Criteria: The equipment should operate smoothly without any mechanical failure.

Evidence: Documented load test report detailing the weights used and observations.

Test Case OQ-02: Docking Alignment Check

Objective: To verify that the docking mechanism aligns correctly with the IBC.

Procedure: Position the IBC under the lifter and measure the alignment from multiple points.

Acceptance Criteria: The alignment should be within ±5 mm.

Evidence: Alignment measurement log with recorded values.

Deviations:

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented.

Approvals:

___________________________
Validation Team Lead

___________________________
Quality Assurance Representative

___________________________
Production Manager

Also Check:

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