Document ID: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Bottle Blow Molding Machine
Objective: To validate the operational performance of the Bottle Blow Molding Machine used for producing IV infusion bottles, ensuring compliance with specifications outlined in the URS Annex11.
Scope: This protocol applies to the Bottle Blow Molding Machine located in the Production area, specifically for the manufacture of plastic bottles for IV infusions (LVP/SVP).
Responsibilities:
- Validation Team: Prepare and execute the OQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary support during testing.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved must be trained on the equipment and procedures.
Equipment Description:
The Bottle Blow Molding Machine is designed to manufacture plastic bottles for IV infusions. Key features include temperature control, cycle timing, dimensional control, and alarm systems for operational safety.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify temperature control settings and functionality. | Temperature within specified range (±2°C). | Temperature logs and calibration certificates. |
| OQ-02 | Measure cycle time for bottle production. | Cycle time within specified limits (±5 seconds). | Cycle time records. |
| OQ-03 | Check dimensional control of finished bottles. | Dimensions within specified tolerances. | Measurement reports. |
| OQ-04 | Test alarm functionality during operation. | All alarms activate appropriately. | Alarm test reports. |
Detailed Test Cases:
- Test ID: OQ-01
- Procedure: Set the machine to the specified temperature settings and monitor for stability.
- Acceptance Criteria: Temperature must remain within ±2°C of the set point for the duration of the test.
- Evidence: Documented temperature logs and calibration certificates.
- Test ID: OQ-02
- Procedure: Initiate a production cycle and record the time taken for completion.
- Acceptance Criteria: Cycle time must be within ±5 seconds of the defined standard.
- Evidence: Recorded cycle time data.
- Test ID: OQ-03
- Procedure: Measure the dimensions of a sample batch of bottles using calibrated measuring tools.
- Acceptance Criteria: All measurements must fall within specified tolerances.
- Evidence: Measurement reports and photographs.
- Test ID: OQ-04
- Procedure: Simulate fault conditions to test alarm systems.
- Acceptance Criteria: All alarms must activate correctly and be audible/visible.
- Evidence: Alarm test reports and observations.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Validation Team and Quality Assurance for further action.
Approvals:
- ____________________
- Validation Team Lead
- ____________________
- Quality Assurance Manager
Data Integrity Checks: Ensure that all data collected during the OQ is securely stored, backed up, and retrievable for audit purposes. Verify that all electronic records are compliant with 21 CFR Part 11 requirements.