ISO Class 6 Vaccine Fill & Finish Suite
To support accelerated vaccine rollouts, MSV Group designed and delivered a cGMP-compliant fill-finish facility with modular cleanrooms, automated material flow and fully instrumented HVAC/BMS infrastructure.
Scope Delivered
Turnkey engineering, fabrication and qualification for high-throughput fill suites.
- ISO Class 6 core with ISO 7 support corridors and cascading gowning sequence
- Modular PUF partitions, flush vision panels and solvent-safe epoxy flooring
- Automated vial washing, filling and stoppering line integration
- Material & personnel airlocks with RFID access and differential pressure monitoring
- Cold-chain ante-rooms, QC labs and packaging zone segregation
Key Systems Installed
Fully validated utilities supporting aseptic processing and data integrity.
- EC fan coil HVAC with terminal HEPA, VFD control and particle monitoring
- CIP/SIP-ready process piping with condensate recovery
- BMS integration for temperature, humidity and differential pressure logging
- cGMP-compliant data historian with audit trails and alarm management
Project Outcomes
Higher batch throughput with complete regulatory traceability.
- Increased production capacity to 6 million vials per month
- Real-time cleanroom analytics reduced deviation response time by 22%
- Successful WFI/utility qualification and media fill campaign on first attempt
- Complete validation dossier furnished for WHO GMP and ISO inspections
Support & Training
Documentation and knowledge transfer to maintain aseptic reliability.
- Operator training on gowning, airflow discipline and aseptic interventions
- Preventive maintenance program for HVAC, HEPA integrity and utilities
- Annual support agreement covering calibration and environmental qualification
Scaling a Fill-Finish Operation?
Partner with MSV Group to design, manufacture and validate cleanroom infrastructure that meets global vaccine standards.
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