Isolators & Filling Equipment Design & Qualification Services

Guiding Regulatory Frameworks

I provide specialized support for the design, commissioning, and qualification of isolator-based filling systems in full compliance with:

• EU GMP Annex 1 – Emphasizing Contamination Control Strategies (CCS) around interventions, air handling, transfer processes, and decontamination cycles.

• FDA’s Guidance for Sterile Drug Products Produced by Aseptic Processing – Emphasizing an equipment design and qualification approach to yield reliable, repeatable media fill performance.

Services Offered

1. Design Qualification (DQ) & Project Initiation

• Conceptual & Mock-up Design Verification for:

  • Operator ergonomics in equipment set-up and production phase operations

  • Compatibility of critical work surface design with first-air principles

  • Isolator chamber zoning and pressure cascade

  • Material transfer feasibility (e.g., via RTPs, MTCs, or tunnel-fed isolators)

  • Mapping of viable and non-viable particle monitoring across isolator and support zones

  • EM location mapping in compliance with Annex 1 EM expectations

  • Alignment with CCS and trend-based monitoring strategies

• Alignment with Annex 1 expectations for isolator justification and design.

2. FAT/SAT & Commissioning

• FAT/SAT verification of:

  • I/O loops, alarming, HMI functions, interlocks, and container handling.

  • Glove integrity recipes, VHP cycles, leak testing, and fixture design.

• Traceable commissioning documentation to support smooth transition into IQ/OQ.

  
  

3. Qualification Execution – IQ/OQ

• Generation and execution of IQ/OQ protocols covering:

  • HEPA airflow and filter leak integrity

  • Glove leak tests (pressure decay)

  • Air classification per ISO 14644

  • User Access & Permissions, Audit Trail, Backup & Restore, Reporting, Facility Integration

  • In-process controls (IPC) for fill weight and reject logic

  
  

4. Performance Qualification (PQ) & Media Fills

• Development & Execution of Performance Qualifications (PQ):

  • VHP decontamination coverage & efficacy

  • Static & Dynamic EMPQ

  • Container closure integrity (CCI) testing

  • Process holding and changeover scenarios

• Development & Execution of Aseptic Process Simulations (APS):

  • Simulation of worst-case interventions and batch conditions

  • Execution across multiple shifts and configurations

  • Bracket establishment to challenge representative container/closure systems and fill volumes

  • Documentation per FDA and Annex 1 expectations

5. Ancillary Program/Parameter Development:

• Isolator environmental monitoring

• Isolator glove testing

• Isolator product-contact component autoclaving and hold

• Isolator VHP sterility hold

• Routine & non-routine intervention Definition & risk assessment

• Aseptic process simulation (APS) program development

• APS bracket matrix development

System Expertise

• Optima MultiUse (Filling & Closing Systems)

• SKAN VarioSys (Modular Isolator Platforms)

• Bausch & Stroebel KSF (Modular Filling Machines)

• IMA Xtrema (High-Speed Vial/Bottle Fillers)

• Bosch (Syntegon) Filling and Barrier Technology