Operational Qualification Protocol for Twin Screw Extruder in Solid Dosage Form Production

Objective

The objective of this Operational Qualification (OQ) protocol is to verify that the Twin Screw Extruder operates according to the specified requirements and performs its intended function in the production of pellets and solid dispersions.

Scope

This protocol applies to the Operational Qualification of the Twin Screw Extruder used in the Production area for the manufacturing of solid dosage forms, specifically pellets.

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 providing necessary operational support during the OQ execution.

Prerequisites

• Completion of Installation Qualification (IQ) for the Twin Screw Extruder.
• Availability of necessary materials and resources for testing.
• Training of personnel on equipment operation and safety protocols.

Equipment Description

The Twin Screw Extruder is designed for the extrusion of pellets and solid dispersions. It features adjustable screw speed, multiple temperature zones, and torque measurement capabilities, ensuring precise control over the extrusion process.

Test Plan

Detailed Test Cases

Test Case 1: Screw Speed Verification

Objective: To ensure the extruder operates within the specified screw speed range.

Method: Set the extruder to the desired RPM and record the actual speed using a calibrated tachometer.

Acceptance Criteria: Actual RPM must be within ±5% of the target speed.

Expected Result: Screw speed recorded meets the acceptance criteria.

Test Case 2: Temperature Measurement

Objective: To confirm that the temperature in all zones of the extruder is within the specified limits.

Method: Use calibrated thermocouples to measure the temperature in each zone during operation.

Acceptance Criteria: Temperatures must be within ±2°C of the specified set points.

Expected Result: All temperature readings are within the acceptance criteria.

Test Case 3: Torque Monitoring

Objective: To verify that the torque readings are within acceptable limits during operation.

Method: Monitor torque readings using the built-in torque measurement system during extrusion.

Acceptance Criteria: Torque readings must not exceed the maximum specified limit.

Expected Result: Torque readings are within the acceptance criteria.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.

Approvals

By signing below, the following individuals approve this Operational Qualification Protocol:

Prepared By: ______________________ Date: __________

Reviewed By: ______________________ Date: __________

Approved By: ______________________ Date: __________

Data Integrity Checks

• Ensure all data logged during testing is time-stamped.
• Verify that all measurements are recorded in a secure electronic system with limited access.
• Conduct periodic audits of the data to ensure accuracy and completeness.