cGMP PRODUCTION FACILITY UPGRADES
- Project Overview
- Project Details
TOTAL SQUARE FOOTAGE:
63,000 sq. ft. of renovation between two projects.
Torcon was the Construction Manager for two simultaneous upgrade projects at the Roxane Labs production campus in Columbus, Ohio. One program, a $15,000,000 a manufacturing facility, was constructed to support the global supply of Spiriva, a new daily treatment for Chronic Obstructive Pulmonary Disease. The facility handles the product from the “conditioned storage” of raw material through to the kit packaging of this dry inhalant.
The facility features an insulated metal panel conditioned storage room, which houses a state-of-the-art Automated Storage and Retrieval System for the storage of raw materials and powder-filled capsules in a temperature and humidity controlled environment.
Two separate processing lines were provided for the encapsulation and packaging of the final product. The process suites were designed to meet European clean room standards through the use of cleanroom metal wall panel construction. The cleanroom environment is maintained through dedicated air handler systems as well as stringent dehumidification controls, 15% RH in the Capsule Pack-Out Rooms.
The major challenge on the project was the isolation and construction of the three story, 50,000 sq. ft. facility within an operating cGMP high bay warehouse. The Encapsulation Lines include isolated suites for encapsulation, drying and dispensing. The Packaging Lines include isolated suites for blister packaging, inhaler kit assembly, cartoning and dispensing. The Packaging Lines are serviced by an automated conveyor system to feed packaging materials and the removal of packaging debris. Utilities include wash rooms, DI Water to Parts Washers and COP areas and compressed air, data and power distribution to owner supplied process equipment.
The second project element was aimed at achieving cGMP compliance as well as an Electrical Classification upgrade of the 13,000 sq. ft. Liquids Manufacturing operations. The facility is utilized for the formulation of controlled substances, which require the dispensing of potent compounds and alcohol products. The upgrade provided isolation barriers and MEP systems necessary for the execution of these activities in a current regulatory and code compliant environment. Emphasis is on personnel safety, product protection as well as installation quality.
The project was challenged by the phased execution necessary to maintain adjacent cGMP compliant operation of the facility. Utility upgrades include the replacement and enhancement of existing HVAC systems, replacement of seven processor tanks ranging in size from 1,000 to 3,800 liters, and repiping of existing Distilled Water, Purified Water, Heat Transfer Fluids, Product Transfer and CIP systems.
The project also included the upgrade of two existing processors, which remained in service throughout construction with limited down time. Torcon also added a new potent compound room featuring a glove box and dedicated HEPA exhaust system.