We deliver risk-based facility design fully aligned with global cGMP, EMA Annex 1, FDA, PIC/S and ISPE guidelines exclusively tailored for vaccine manufacturing workflows, including viral live vaccines, inactivated vaccines, mRNA vaccines, subunit vaccines and bacterial vaccines.
Our design framework centers on two core priorities: strict aseptic control and thorough cross-contamination prevention. We implement scientifically rational zoning of Grade A/B/C/D classified clean areas, independent segregated production suites for different strains, unidirectional segregation of personnel and material flow, and dedicated airlock transfer systems to isolate contaminated and clean zones. Specialized biosafety design features negative-pressure isolation suites, fully enclosed transfer equipment, and complete waste inactivation systems to block viral and microbial cross-spread risks.
Comprehensive GMP-compliant utility design is integrated into every scheme, covering WFI generation & distribution, pure steam circuits, CIP/SIP sanitary piping, high-efficiency HVAC filtration, differential pressure monitoring, and real-time environmental particle & microbial monitoring systems. We embed GEP and quality risk management throughout conceptual layout, 3D BIM detailed engineering and construction drawing stages, eliminating design flaws that may trigger regulatory non-compliance during audits.
Our design services cover new greenfield vaccine factories, modular pilot vaccine workshops and GMP upgrade reconstruction of existing production plants. All design documents are audit-ready and fully support subsequent CQV, regulatory inspection and commercial batch release, helping clients shorten facility launch cycles and avoid costly post-construction modifications.
