Document Control
Document Number: OQ-001
Revision: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Solution Preparation Tank
Meta Description: This document outlines the Operational Qualification protocol for the Solution Preparation Tank used in IV Infusions, ensuring compliance with URS Annex 11 standards.
Tags: Equipment Validation, IV Infusions, Operational Qualification
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Solution Preparation Tank operates within specified limits and meets the requirements outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Solution Preparation Tank used for dissolving solids into solutions in the production area for IV Infusions (LVP/SVP – Bags/Bottles).
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for operating the equipment during the OQ testing.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of all necessary equipment and materials.
- Training of personnel on the operation of the Solution Preparation Tank.
Equipment Description
The Solution Preparation Tank is designed for the dissolution of salts and sugars into solutions, ensuring accurate concentration and homogeneity. It is equipped with temperature control, agitation mechanisms, and PLC logging capabilities.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify temperature control accuracy | ±2°C of setpoint | Temperature log |
| OQ-002 | Measure agitation time | Within specified limits | PLC logs |
| OQ-003 | Check conductivity of solution | Meets product specifications | Conductivity meter readings |
Detailed Test Cases
Test Case OQ-001: Verify Temperature Control Accuracy
Objective: To ensure the temperature control system is functioning correctly.
Procedure: Set the temperature to the desired setpoint and record the actual temperature over a specified duration.
Acceptance Criteria: The actual temperature must remain within ±2°C of the setpoint.
Evidence: Documented temperature logs must be reviewed for compliance.
Test Case OQ-002: Measure Agitation Time
Objective: To confirm that the agitation time meets the required specifications.
Procedure: Start the agitation process and record the time taken to reach the desired homogeneity.
Acceptance Criteria: Agitation time must fall within specified limits as per the URS.
Evidence: PLC logs will be used to verify the agitation duration.
Test Case OQ-003: Check Conductivity of Solution
Objective: To ensure the conductivity of the prepared solution meets product specifications.
Procedure: Measure the conductivity of the solution after complete dissolution.
Acceptance Criteria: Conductivity readings must meet the specified product requirements.
Evidence: Conductivity meter readings will be documented for review.
Deviations
Any deviations from the protocol must be documented, including the reason for the deviation and corrective actions taken.
Approvals
Prepared By: [Insert Name]
Approved By: [Insert Name]