Isolator / RABS System – DQ Protocol

Design Qualification Protocol for Isolator/RABS System in Aseptic Processing

Document Control:

Document Number: DQ-ISOLATOR-001

Version: 1.0

Effective Date: [Insert Date]

Reviewed By: [Insert Name]

Approval Date: [Insert Date]

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the Isolator/RABS System provides a suitable aseptic processing environment for the production of prefilled syringes and cartridges, meeting all specified requirements and regulatory standards.

Scope

This protocol applies to the validation of the Isolator/RABS System used in the production area for aseptic processing of prefilled syringes and cartridges. It covers the critical parameters, acceptance criteria, and testing procedures necessary for validation.

Responsibilities

  • Validation Team: Responsible for executing the DQ protocol and documenting results.
  • Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
  • Engineering: Responsible for ensuring equipment is installed and functioning as intended.

Prerequisites

  • Completion of Installation Qualification (IQ).
  • Availability of relevant documentation including User Requirements Specification (URS) and operational procedures.

Equipment Description

The Isolator/RABS System is designed to provide an aseptic processing environment for the filling of prefilled syringes and cartridges. The system features pressure integrity monitoring and a validated VHP cycle for sterilization.

Test Plan

Test ID Procedure Acceptance Criteria Evidence
DQ-01 Pressure Integrity Test Maintain pressure integrity throughout the cycle Test logs, Visual inspection report
DQ-02 VHP Cycle Audit Trail Review Complete and accurate audit trail logs Audit trail log report

Detailed Test Cases

Test Case DQ-01: Pressure Integrity Test

Objective: To verify that the Isolator/RABS System maintains pressure integrity.

See also  Dust Extraction Unit (LEV for dispensing) – DQ Protocol

Procedure: Perform a pressure integrity test as per the validated procedure. Record the pressure data over the cycle duration.

Acceptance Criteria: The system must maintain pressure integrity without any leaks.

Evidence: Documented test logs and visual inspection report.

Test Case DQ-02: VHP Cycle Audit Trail Review

Objective: To ensure the VHP cycle audit trail is complete and accurate.

Procedure: Review the audit trail logs generated during the VHP cycle for completeness and accuracy.

Acceptance Criteria: All logs must be complete and without discrepancies.

Evidence: Audit trail log report.

Deviations

Any deviations from the established procedures must be documented and reviewed. A corrective action plan should be developed and implemented for any critical deviations.

Approvals

Prepared By: [Insert Name] – [Insert Date]

Reviewed By: [Insert Name] – [Insert Date]

Approved By: [Insert Name] – [Insert Date]

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