Operational Qualification Protocol for Non-Sterile Powder Compounding Vessel
Document Number: OQ-PCV-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Powder Compounding Vessel operates according to its intended use and meets predefined acceptance criteria for production of bulk powder blends or granulations for sachet filling.
Scope
This protocol applies to the Powder Compounding Vessel (Jacketed SS) used in the production area for non-sterile applications, specifically in the preparation of bulk powder blends for sachet and stick pack filling.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and ensuring compliance with all acceptance criteria.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Team: Responsible for providing necessary access and support during the validation process.
Prerequisites
All personnel involved in the execution of this protocol must be trained in the operation of the Powder Compounding Vessel and familiar with the validation process. All necessary equipment must be calibrated and in good working order prior to the execution of this protocol.
Equipment
The Powder Compounding Vessel is a jacketed stainless steel container designed for the mixing and blending of powders. It features temperature control capabilities, a PLC for monitoring parameters, and is utilized in the production of bulk blends for sachet filling.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify mixing speed | Mixing speed within specified range | Speed log report |
| OQ-02 | Measure temperature during blending | Temperature remains within specified limits | Temperature log report |
| OQ-03 | Verify blending time | Blending time meets specified duration | Blending time report |
| OQ-04 | Audit PLC data | PLC audit trail is complete and accurate | PLC audit report |
Detailed Test Cases
Test Case OQ-01: Verify Mixing Speed
Procedure: Set the Powder Compounding Vessel to the specified mixing speed. Record the actual speed and compare it to the acceptance criteria.
Acceptance Criteria: The mixing speed must be within the defined range of X to Y RPM.
Evidence: Provide a printout of the speed log showing the recorded mixing speed.
Test Case OQ-02: Measure Temperature During Blending
Procedure: During the blending process, monitor the temperature and record the values at specified intervals.
Acceptance Criteria: The temperature must remain within the defined limits of A to B °C.
Evidence: Submit the temperature log report detailing the monitored values.
Test Case OQ-03: Verify Blending Time
Procedure: Start the blending process and record the total time taken for blending.
Acceptance Criteria: The blending time must not exceed C minutes.
Evidence: Provide the blending time report with timestamps.
Test Case OQ-04: Audit PLC Data
Procedure: Review the PLC audit trail for completeness and accuracy during the operational qualification.
Acceptance Criteria: The PLC audit trail must show all relevant operations without discrepancies.
Evidence: Submit the PLC audit report for review.
Deviations
Any deviations from the protocol must be documented and justified. If acceptance criteria are not met, a thorough investigation must be conducted to determine the cause and corrective actions implemented.
Approvals
Validation Team Lead: ________________________ Date: ___________
Quality Assurance: ________________________ Date: ___________
Production Manager: ________________________ Date: ___________