Operational Qualification Protocol for Purified Water Storage Tank
Document Control:
Document Number: OQ-PWST-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Operational Qualification (OQ) Protocol is to verify that the PW Storage Tank operates within specified parameters to ensure the microbial integrity and temperature levels for storing purified water.
Scope
This protocol applies to the PW Storage Tank used in the Utilities area for the storage of purified water that has a direct impact on product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with URS Annex15. The Quality Assurance team will review and approve the final report.
Prerequisites
All equipment must be installed and operational. Personnel must be trained in relevant SOPs and safety procedures.
Equipment Description
The PW Storage Tank is designed to store purified water. It is critical for maintaining the microbial integrity and temperature levels required for the quality of the stored water.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify Temperature Levels | Temperature maintained between 15°C – 25°C | Temperature logs |
| OQ-02 | Microbial Integrity Testing | No presence of microbial contaminants | Microbial test results |
Detailed Test Cases
Test Case OQ-01: Verify Temperature Levels
Procedure: Monitor the temperature of the PW Storage Tank using calibrated thermometers at specified intervals.
Acceptance Criteria: Temperature must remain between 15°C and 25°C.
Evidence: Documented temperature logs for a minimum of 24 hours.
Test Case OQ-02: Microbial Integrity Testing
Procedure: Collect water samples from the PW Storage Tank and conduct microbial testing.
Acceptance Criteria: No microbial contaminants detected in samples.
Evidence: Laboratory test results indicating microbial counts.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be initiated for any critical failures.
Approvals
Prepared by: ____________________ Date: ____________
Approved by: ____________________ Date: ____________