Project Brief

KeRi led the delivery of a greenfield aseptic fill-finish manufacturing facility for the filling of vials and prefilled syringes (PFS). The project expanded the building footprint to create a fully integrated operation: manufacturing, packaging, warehousing, sampling and dispensing, quality and microbiology laboratories, and the employee support spaces around them, offices, cafeteria, and IT infrastructure. The facility was planned to meet the regulatory requirements that govern aseptic manufacture while leaving room for the operation to grow.

KeRi provided architectural, structural, MEP, and process engineering along with procurement support, delivering a highly automated aseptic environment. The design supports closed-system filling to protect product sterility and carries provisions for a future lyophilizer, so freeze-drying can be added without reworking the building. Cleanrooms were designed to cGMP requirements from ISO 8 down to ISO 5, with pressure differentials, controlled airflow, and environmental monitoring.

The manufacturing layout was planned around flow: personnel, materials, and waste each move on a clear, compliant path, which limits contamination risk and keeps the operation efficient. The aseptic suite runs solution preparation, filtration, filling, inspection, and packaging as one unidirectional sequence. Supporting it are high-performance cleanroom HVAC, a dedicated WFI generation and distribution system, and electrical power with emergency and UPS backup behind the critical process equipment. KeRi carried the work through design development and construction administration.

MEP Engineering Scope

What We Engineered

Integrated building and process systems for the greenfield fill-finish facility:

• cGMP cleanrooms from ISO 8 to ISO 5, with pressure differentials, controlled airflow, and environmental monitoring
• High-performance cleanroom HVAC serving the aseptic suite and its support spaces
• Dedicated WFI generation and distribution
• Electrical power with emergency and UPS backup behind the critical process equipment
• Closed-system filling for vials and prefilled syringes, with provisions for a future lyophilizer
• Layout planned for unidirectional personnel, material, and waste flow across manufacturing, packaging, warehousing, sampling and dispensing, and the QC and microbiology laboratories
• Procurement support, design development, and construction administration

The Challenge

A greenfield vial and PFS fill-finish operation had to bring manufacturing, packaging, warehousing, laboratories, and employee support into one compliant, highly automated building, with room to grow into it.

Our Solution

KeRi delivered the architecture, structure, MEP, and process design together with procurement support: ISO 8 to ISO 5 cleanrooms, high-performance HVAC, dedicated WFI, emergency and UPS power, and a unidirectional layout, with the future lyophilizer designed for from the start.