Inhalable Insulin Project

MANNKIND CORPORATION Location: Danbury, Connecticut Square Footage: 252,000 Construction Cost: $163,000,000

Project Description:

This project was the design of a $163 million inhalable dosage manufacturing facility. CRB was the prime consultant for architectural and engineering design, from concept thru commissioning and turnover. The project included the renovation of an existing building and an additional 100,000 sq. ft.

of new space. CRB's scope also included technology selection for formulation, cryogenic freezing, freeze dryer load and unload, and material handling.

New and renovated space includes ISO class 7 and 8 manufacturing spaces, formulation, freeze drying, filling and packaging areas, warehousing, office and technical space. Central utilities include a 3, 600 ton chiller plant with a primary-secondary pumping system and a 900 BHP steam boiler system. A new 2,500 kW, 480V substation and emergency generator was designed to support the CUB and keep the facility online in the event of a power failure.

A validated Process Automation System and Building Automation System were included. Discreet event simulation was utilized to optimize people and material flows and layout. Detail design phase utilized a fully detailed 3D model, as well as intelligent database driven PID's.

The facility is intended to handle the manufacturing from receipt of raw materials, including active pharmaceutical ingredients, through formulation, freezing, freeze drying, powder filling and primary packaging in blisters or pouches.

In recognition of the innovative process and equipment technology in this project, the facility received the prestigious ISPE/Interphex Facility of the Year Award. While the facility itself is a striking merger of form, function, and efficiency, the judges were most impressed with the custom process line that the facility houses. Another distinguishing feature of the facility is a first-ever solid-dosage pharmaceutical adaptation of a cryopelletizer. "This is the first time in the program's history that the judges have named one project to two categories. However, the judges felt very strongly that MannKind Corporation excelled in each of these categories during the construction of its facility."
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