This article is the first in a three-part series describing an engineering approach to establishing an environmental sampling plan for a new pharmaceutical or biopharmaceutical manufacturing facility. The series assume the facility has just been built and no manufacturing of batches have been run, despite being associated with other corporate sites. Simulations of dynamic conditions analogous to producing a batch will be factored in. This article will cover phase 1 in the development of such a sampling plan, and future installments will cover phases 2 through 6.
With the development of structural, component, or subsystem pieces that are standardized and able to be assembled in virtually limitless ways, pharmaceutical companies can quickly and easily set up their manufacturing facilities. In addition to efficiency, single-use equipment and modular facility designs offer benefits including cutting costs, increasing output, and even boosting sustainability.