Oncology OSD & Injectable Facility, Vietnam
A greenfield oncology-focused pharmaceutical manufacturing facility engineered to support high-containment Oral Solid Dosage (OSD) and sterile injectable operations aligned with international regulatory expectations. Developed for future-facing regulated market ambitions, the project integrated contamination-controlled manufacturing environments, sterile processing infrastructure, and process-driven operational planning within a highly specialized oncology manufacturing framework.
Location
Ho Chi Minh City, Vietnam
Area
7,000 sqm
IN THIS PROJECT
Inotek was engaged to strategically review, remediate, and redevelop the facility engineering approach after identifying critical limitations within the original concept design prepared by an international consultant.
The project required a complete regulatory and process-oriented reassessment to align the facility with oncology containment philosophy, sterile injectable operational requirements, and internationally aligned GMP expectations.
The engineering strategy focused on high-containment zoning, contamination control integration, sterile processing infrastructure, HVAC pressure cascade planning, utility engineering, and operational segregation suitable for multi-product oncology manufacturing operations.
Special emphasis was placed on balancing biosafety, operator protection, sterile integrity, and manufacturing efficiency within a compact and technically demanding facility footprint.
METRICS / BRAND PHILOSOPHY SECTION
Regulatory-First Remediation Engineering
The project demanded more than conventional engineering correction. It required regulatory reinterpretation of the facility philosophy itself.
Inotek approached the project through a compliance-first remediation strategy integrating process logic, containment engineering, contamination control philosophy, and operational risk reduction into every stage of the revised engineering framework.
High-Containment Engineering Integration
The facility integrated oncology containment infrastructure, sterile injectable systems, cleanroom engineering, HVAC cascade strategy, utility coordination, and multidisciplinary engineering workflows within a unified operational framework.
Designed for long-term regulatory scalability, the project incorporated high-containment engineering principles, future-ready infrastructure planning, and operational segregation strategies aligned with EU-GMP and PIC/S-oriented expectations.
“Inotek demonstrated exceptional depth in understanding the engineering and regulatory complexities associated with oncology and sterile manufacturing environments. Their ability to reassess and strategically realign the project added significant technical and compliance value.”
Project Leadership Team, DCL
