Design Qualification Protocol for Bottle Blow Molding Machine in IV Infusions Production

Objective

The objective of this Design Qualification (DQ) Protocol is to ensure that the Bottle Blow Molding Machine meets the necessary design specifications and is suitable for the production of plastic bottles for IV infusions, in compliance with applicable regulatory requirements.

Scope

This protocol applies to the Bottle Blow Molding Machine utilized in the production area for manufacturing plastic bottles intended for IV infusions (LVP/SVP). It encompasses the validation of critical parameters and ensures that the equipment meets the defined acceptance criteria.

Responsibilities

• Validation Team: Responsible for executing and documenting the DQ protocol.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol and its results.
• Engineering: Responsible for providing technical support and documentation related to the equipment.

Prerequisites

• Completion of User Requirements Specification (URS).
• Installation of the Bottle Blow Molding Machine.
• Availability of all necessary documentation, including operation manuals and maintenance records.

Equipment Description

The Bottle Blow Molding Machine is designed to produce plastic bottles for IV infusions. It operates under controlled temperature and cycle times to ensure dimensional integrity and adherence to specified alarms for critical parameters.

Test Plan

Detailed Test Cases

Test Case T1: Temperature Verification

Procedure: Monitor the temperature settings during the operation of the Bottle Blow Molding Machine.

Acceptance Criteria: The temperature must remain within the specified limits as defined in the URS Annex11.

Evidence: Record temperature logs for the duration of the testing.

Test Case T2: Cycle Time Measurement

Procedure: Measure the time taken for the machine to produce a batch of bottles.

Acceptance Criteria: The cycle time must fall within the specified range outlined in the URS Annex11.

Evidence: Document cycle time records for review.

Test Case T3: Dimensional Control Check

Procedure: Measure the dimensions of a sample of produced bottles using calibrated measuring tools.

Acceptance Criteria: All dimensions must be within the specified tolerances set forth in the URS Annex11.

Evidence: Provide dimensional measurement records for the produced bottles.

Test Case T4: Alarm Functionality Test

Procedure: Simulate conditions that would trigger alarms and verify their functionality.

Acceptance Criteria: Alarms must trigger as specified in the machine’s operational requirements.

Evidence: Document the results of the alarm tests.

Deviations

Any deviations from the acceptance criteria must be documented and reviewed. Appropriate corrective actions must be taken to address any identified issues.

Approvals

Validation Team: _____________________ Date: ____________

Quality Assurance: ____________________ Date: ____________

Engineering: _________________________ Date: ____________

Data Integrity Checks

Data integrity checks will be implemented to ensure accuracy and reliability of the data collected during the DQ process. This includes:

• Verification of temperature log entries against machine settings.
• Cross-checking cycle time records with production logs.
• Calibration verification of measurement tools used for dimensional checks.
• Review of alarm test results against expected outcomes.