From Exposure to Zero Risk: How This Pharmaceutical Company Achieved FDA Approval

In aseptic pharmaceutical manufacturing, the containment integrity of isolator transfer systems is critical to product sterility assurance. Per FDA Aseptic Processing Guidelines and EU GMP Annex 1, isolators must maintain a fully closed transfer environment throughout material handling. Any exposure during transfer may be deemed a critical compliance gap.

Project Background:

A global pharmaceutical manufacturer identified an exposure risk in its isolator system during utensil transfer, where part of the process occurred outside the isolator’s closed environment. This design violated FDA requirements under 21 CFR Part 211.42 (aseptic environmental controls) and FDA Aseptic Processing Guidelines (isolator containment criteria). To address sterility risks and ensure regulatory compliance, the client requested a retrofit to achieve a closed-system.

AUSTAR Solution:

System Redesign

• Integrated three-section isolator modules (dry heat sterilizer interface, moist heat sterilizer interface, and transfer tunnel) to enable end-to-end closed utensil transfer from sterilization equipment to production isolators.

• Optimized isolator docking mechanisms to eliminate exposure risks while ensuring seamless integration with existing equipment.

Validation & Implementation

• Completed design, manufacturing, and on-site installation within one month, enabling closed transfers of utensils and aluminum bottles between sterilizers and production isolators.

• Conducted FDA-aligned performance tests:

      - Pressure Holding Test: Verified isolator containment per ISO 14644-7 standards.

      - Airflow Velocity Test: Confirmed uniform laminar airflow compliance with FDA Aseptic Guidelines for Grade A zones.

      - Simulated Transfer Trials: Validated operational reliability under worst-case scenarios.

Regulatory Compliance

• Aligned with 21 CFR Part 211 and EU GMP Annex 1 requirements for closed processing, mitigating contamination risks.

AUSTAR Value Delivered:

• Regulatory Readiness: Full compliance with FDA and EU GMP standards, reducing inspection risks.

• Sterility Assurance: Eliminated exposure points, ensuring uninterrupted Grade A conditions.

• Operational Efficiency: Minimized downtime and reprocessing costs through stable system performance.

AUSTAR Technical Service provides end-to-end pharmaceutical facility management, maintenance, and compliance solutions, empowering clients to achieve operational excellence across equipment and engineering lifecycles.