Performance Qualification Protocol for IV Infusion Solution Preparation Tank
Document Control
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Solution Preparation Tank operates consistently and reliably within specified parameters to ensure the quality of IV infusion solutions.
Scope
This protocol applies to the Solution Preparation Tank used in the production area for the preparation of IV infusion solutions (LVP/SVP – Bags/Bottles). It covers the critical aspects of the equipment’s performance, including temperature, agitation time, conductivity, and PLC logs.
Responsibilities
The following personnel are responsible for the execution and review of this protocol:
- Validation Team: Execution of the PQ protocol
- Quality Assurance: Review and approval of the protocol
- Production Team: Operation of the Solution Preparation Tank
Prerequisites
Prior to executing this protocol, the following conditions must be met:
- The Solution Preparation Tank must be installed and calibrated.
- All operators must be trained on the equipment operation.
- All necessary materials must be available for testing.
Equipment Description
The Solution Preparation Tank is designed for the dissolution of solids (salt/sugar) into a solution for IV infusions. It features temperature control, agitation mechanisms, and PLC logging capabilities.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Verify temperature control during operation | Temperature maintained within ±2°C of set point | Temperature logs |
| TP-002 | Measure agitation time | Agitation time must be ≥ specified duration | Agitation logs |
| TP-003 | Check conductivity of the solution | Conductivity must meet specifications | Conductivity measurements |
| TP-004 | Review PLC logs for operation | Logs must show no errors during operation | PLC log reports |
Detailed Test Cases
Test Case 1: Temperature Control
Procedure: Set the temperature to the specified target and monitor the readings over a defined period.
Expected Result: Temperature remains within ±2°C of the set point throughout the test duration.
Test Case 2: Agitation Time Measurement
Procedure: Initiate agitation and record the time taken to achieve complete dissolution.
Expected Result: Agitation time must meet or exceed the duration specified in the URS Annex11.
Test Case 3: Conductivity Check
Procedure: Measure the conductivity of the solution post-dissolution.
Expected Result: Conductivity values must align with product specifications.
Test Case 4: PLC Log Review
Procedure: Analyze PLC logs for any operational errors or anomalies during the test.
Expected Result: No errors should be recorded in the PLC logs during the operation.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality.
Approvals
This protocol requires approval from the following individuals:
- Validation Manager: [Insert Name]
- Quality Assurance Manager: [Insert Name]