Aging facility considerations in pharmaceutical and biopharmaceutical processing

Industrial Management Consulting
Industrial Management Consulting

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Aging facilities are a reality and are on the rise. These facilities can work smoothly without
problems, but that is often the exception and not the rule. Well-trained personnel with a process
ownership mentality make such facilities run, but it is a question of time when such personnel will
move or retire and the facility or processes see their first excursions. Facilities, processes and
analytics become obsolete and lose the necessary performance parameters. At a minimum,
improvements are required. More often the situation demands totally new innovations. If such steps are not taken, it is a matter of time when problems will arise.
In addition, some facilities may still run sufficiently, but the product, which was produced in these
dedicated processes, loses patent protection or has been replaced. These processes, if not total
facilities, are mothballed and become underutilized assets or more aptly liabilities.
The question posed here is, how can aging facilities present new opportunities instead of being a
mothballed problem?

Examples
Most facilities that are shut down are brick & mortar sites. They produce one product and are generally
not capable of anything else. When the product reaches its life-cycle and generics overtake it production of the product stops. The process and facility used to manufacture the product, often though, are product dedicated. Costs to revamp, clean, refurbish, etc. the production line, and the building infrastructure, including the HVAC system, are considerable. In such a formidable task, evidence has to be established that there is no chance of a cross-contaminating the new product with the old product.
To avoid such risk, the entire infrastructure has to be gutted and rebuilt. During that process additional
issues reveal themselves which can further increase costs and project time.

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Continue at: https://www.steqamerica.com/stequs/wp-content/uploads/G-CON-White-Paper_Aging-Facility-Considerations_August-2016.pdf

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