Operational Qualification Protocol for Air Classifier Mill in Solid Dosage Form
Document Control:
Document Number: OQ-ACM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approved By: [Insert Approver Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to validate the performance of the Air Classifier Mill in the production of solid dosage forms, ensuring it meets defined specifications and acceptance criteria.
Scope
This protocol applies to the Air Classifier Mill used in the milling process within the production area for solid dosage form products.
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 ensuring the equipment is set up and maintained according to the protocol.
Prerequisites
- Completion of Installation Qualification (IQ).
- Training of personnel on equipment operation.
- Availability of necessary materials for testing.
Equipment Description
The Air Classifier Mill is designed for controlled fine milling of solid dosage forms. It utilizes airflow to classify particles based on size, ensuring a uniform particle size distribution (PSD). The critical parameters for operation include classifier speed and airflow.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify classifier speed settings. | Classifier speed within specified range as per URS. | Calibration records and test results. |
| OQ-002 | Measure airflow rates during operation. | Airflow rates meet specifications defined in URS. | Flow meter readings and logs. |
| OQ-003 | Evaluate particle size distribution (PSD). | PSD falls within acceptable limits set in URS. | PSD analysis reports. |
Detailed Test Cases
Test Case OQ-001: Classifier Speed Verification
Objective: To ensure the classifier speed is set correctly.
Procedure: Set the classifier speed to specified values and record the actual speed using calibrated equipment.
Acceptance Criteria: The actual speed must fall within the range specified in the URS.
Evidence: Documented calibration records and test results.
Test Case OQ-002: Airflow Measurement
Objective: To confirm airflow rates are within specified limits.
Procedure: Measure airflow using a calibrated flow meter during operation.
Acceptance Criteria: Airflow rates must meet the specifications defined in the URS.
Evidence: Flow meter readings and logs.
Test Case OQ-003: PSD Evaluation
Objective: To assess the particle size distribution of the milled product.
Procedure: Collect samples during operation and analyze using appropriate methods.
Acceptance Criteria: PSD must be within acceptable limits set in the URS.
Evidence: PSD analysis reports.
Deviations
Any deviations from the acceptance criteria must be documented, with appropriate justification and corrective actions outlined.
Approvals
This document requires approval from the Quality Assurance department prior to execution.