Design of an Environmental Monitoring Program for a New Biotechnology Facility

Abstract

A new biotechnology facility in Puerto Rico is in need of an Environmental Program to ensure the stability of room conditions for the manufacturing of their products. This environmental baseline study provided documented evidence through various testing and verification activities that the viable and non-viable environmental conditions for the Manufacturing areas and laboratories were established. Each room was monitored for viable (total CFU count) and non-viable (total particle count) during two (2) weeks. The monitoring process consisted of environmental sampling during the first (1) week for three (3) consecutives days under static conditions and the second (2) week for three (3) consecutives days under dynamic. Identification of microorganisms was performed and provided knowledge of the microbial flora collected. The result of this baseline study provided an environmental monitoring program for this new facility and assured that this one complied with the San Jose, California (main facility) established criteria.