Isogen – Aseptic Filling Facility
This project consisted of the renovation of an existing 19,000 SF non-GMP research and development facility to a new cGMP Aseptic Filling Facility within Dupont’s Stine Haskel Facility in Newark, DE. Cyma Builders and Construction Managers were the first consultant retained during the lease due diligence period under a Pre-Construction agreement to help determine the feasibility of utilizing the existing building to create the proposed program. Cyma played a key role in evaluating the building infrastructure and determining if it could support the requirements of the filling operations. Upon negotiation of the lease, Cyma was selected as the construction manager to guide design development, assist with procurement of process and process utility systems, construct the program, and support the commissioning and qualification process. The project was constructed on an extremely fast track basis with a constrained budget. All interrelated goals of budget, schedule, quality, and safety were attained allowing for development of a sterile filling facility ready for product in record time relative to industry standards. The new program included material and personnel air locks, fill/finish suite, component prep areas, microbiology, chemistry, metrology and materials laboratories, cold storage spaces.New toilet rooms and a new mechanical and electrical system were also part of the project.
The scope of work included the complete demolition of existing lab and office areas, including MEP utility distribution. The fill/finish and component prep suites were created, utilizing a modular clean room construction approach. New process support equipment included an autoclave, clean steam generator, WFI generation system, process chiller, process humidifiers, air compressor, and process air handling unit. Utility distribution included compressed air, nitrogen, clean steam, WFI, chilled water, plant steam and condensate, condensate, chilled water, process chilled water, process waste and vent, process ductwork, lab ductwork, and office ductwork, as well as electrical systems. The existing electrical infrastructure was expanded to accommodate new loads. The existing lab and office air handling unit was overhauled and the capacities were increased. A new loading dock was constructed to accommodate product delivery. New finishes to match specific programs (clean room, labs, and offices) were implemented throughout.