Design Qualification Protocol for Sterility Test Isolator in NDDS Critical Analytics

Objective: To establish the design qualification requirements for the Sterility Test Isolator used in NDDS critical analytics to ensure compliance with regulatory standards.

Scope: This protocol applies to the Sterility Test Isolator utilized in the microbiology area for sterility testing of NDDS products, impacting product quality directly.

Responsibilities:

• Validation Team: Ensure compliance with validation protocols.
• Quality Assurance: Review and approve the DQ protocol.
• Microbiology Team: Perform sterility testing and provide necessary documentation.

Prerequisites:

• Completion of User Requirement Specification (URS).
• Installation Qualification (IQ) completed.
• Training of personnel on the operation of the Sterility Test Isolator.

Equipment Description:

The Sterility Test Isolator is a controlled environment system designed for sterility testing of NDDS products. It ensures a sterile working environment through effective airflow and leak integrity, with VHP cycles for decontamination.

Detailed Test Cases:

• Test Case 1: Perform a leak integrity test using a calibrated leak detector. Document results.
• Test Case 2: Measure airflow using an anemometer to ensure compliance with specifications. Record data.
• Test Case 3: Execute a VHP cycle and verify through the audit trail that all parameters were met.

Deviations: Any deviations from the acceptance criteria must be documented and justified. A deviation report should be generated and reviewed by the Quality Assurance team.

Approvals:

• Validation Team Lead: ____________________ Date: ___________
• Quality Assurance Representative: ____________________ Date: ___________

Data Integrity Checks:

• Ensure all data recorded during testing is backed up and securely stored.
• Verify that audit trails for VHP cycles are intact and accessible.
• Cross-verify test results with electronic records for consistency.