Project Description
Critical to the success of this project was the ability to design a new formulation and finishing facility to package a highly potent active pharmaceutical ingredient for a new biotech cancer therapeutic with operator exposure level requirements of 1 microgram/m3.
Parsons performed conceptual and detailed design for the entire process, support utilities and facility to fit out an existing shell. Operations for which isolation equipment was designed included:
- Subdivision
- Granulation
- Fluid bed drying
- Milling
- Blending
- Compression
- Coating
- Filling
This process involved design, specification, and factory acceptance testing of all isolators and bulk active ingredients.
Containment was primary in the design of this facility. All dust collectors had contained handling capability. All liquid waste streams were collected in a hold tank before release into the waste treatment systems. Decontamination of operating areas and equipment was also important. Significant explosion-rated areas were required for safe solvent handling and future recovery. Adherence to good manufacturing practices ensured that Federal Drug Administration regulations were met.
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