Sanitary Transfer Pump (Mag Drive/Centrifugal) – IQ Protocol

Document Control:

Document ID: IQ-TP-001

Version: 1.0

Effective Date: 2023-10-01

Reviewed By: [Name]

Approval Date: [Date]

Installation Qualification Protocol for Sanitary Transfer Pump

Objective: To ensure that the Sanitary Transfer Pump is installed correctly and operates according to specified requirements, ensuring product integrity during the transfer of bulk solutions.

Scope: This protocol applies to the Installation Qualification of the Sanitary Transfer Pump used in the production area for IV infusions (LVP/SVP – Bags/Bottles).

Responsibilities:

  • Validation Team: Prepare and execute the IQ protocol.
  • Quality Assurance: Review and approve the protocol and results.
  • Maintenance Team: Assist in installation and troubleshooting.

Prerequisites:

  • Completion of equipment installation.
  • Availability of necessary documentation (URS, SOPs).
  • Training of personnel on equipment operation.

Equipment Description:

The Sanitary Transfer Pump (Mag Drive/Centrifugal) is designed for the transfer of bulk solutions in a sterile environment. It features a flow shear seal for maintaining integrity during operation.

Test ID Procedure Acceptance Criteria Evidence
IQ-TP-01 Verify pump installation according to manufacturer’s specifications. All components must be installed as per the installation manual. Photographic evidence and installation checklist.
IQ-TP-02 Check flow shear seal integrity. No leaks or pressure loss during operation. Pressure test results and inspection report.

Detailed Test Cases:

  • Test Case ID: IQ-TP-01
    • Procedure: Inspect all mechanical and electrical connections.
    • Expected Result: All connections are secure and meet specifications.
    • Actual Result: [To be filled during execution]
  • Test Case ID: IQ-TP-02
    • Procedure: Conduct a pressure test on the flow shear seal.
    • Expected Result: Seal maintains integrity under operational pressure.
    • Actual Result: [To be filled during execution]
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Deviations:

Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary.

Approvals:

__________________________
Validation Team Lead

__________________________
Quality Assurance

__________________________
Maintenance Team

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