Operational Qualification Protocol for CIP Skid in the Production of Nasal & Otic Products

Objective: To validate the operational performance of the CIP Skid in cleaning tanks and pipelines for the production of Nasal and Otic products.

Scope: This protocol applies to the CIP Skid used in the Production and Cleaning areas for both Sterile and Non-Sterile Nasal and Otic products.

Responsibilities:

• Validation Team: Oversee the execution of the protocol and documentation of results.
• Quality Assurance: Review and approve the protocol and results.
• Production Team: Ensure equipment is set up and maintained for testing.

Prerequisites:

• Completion of Installation Qualification (IQ).
• Availability of necessary documentation and equipment.
• Training of personnel on OQ procedures.

Equipment Description:

The CIP Skid is a cleaning system designed to clean tanks and pipelines used in the production of Nasal and Otic products. It operates under controlled temperature and conductivity parameters, ensuring effective cleaning.

Detailed Test Cases:

1. Temperature Validation:
   • Procedure: Monitor and log temperature during CIP cycles.
   • Acceptance Criteria: Temperature must remain within ±2°C of the specified set point.
   • Evidence: Review temperature logs for compliance.
2. Conductivity Validation:
   • Procedure: Measure and record conductivity at the end of the CIP cycle.
   • Acceptance Criteria: Conductivity must be ≤ 1 µS/cm.
   • Evidence: Review conductivity logs for compliance.
3. Flow Rate Validation:
   • Procedure: Measure flow rate during CIP operations.
   • Acceptance Criteria: Flow rate must meet or exceed specified requirements.
   • Evidence: Review flow audit trail logs for compliance.

Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed if necessary.

Approvals:

____________________ Validation Team Lead

____________________ Quality Assurance

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