Simulation-Based Implementation of Germicidal UV-C Light Within a GMP Setting

Germicidal UV-C light has been around for 120 years, and while it is widely utilized in the food industry, it is less implemented within the pharmaceutical industry. In this paper, we present an optical-assisted implementation process of UV-C lamps within a Good Manufacturing Practice (GMP) setting. The presented approach consists of six steps: understanding the room; optical simulations; dose, cycle and frequency; safety; maintenance plan; and installation, verification and results. Each of these steps is described by following an actual implementation example inside a class D/C Personal Airlock (PAL). The Environmental Monitoring (EM) effect is compared 12 months prior to and 12 months after the implementation of the UV-C lamps. Here, it is shown that the total number of alerts was reduced from 32 (6.0%) to 12 (2.6%), the three-in-a-row alerts were reduced from 3 to 0, while the action levels were reduced from 4 (0.8%) to 0 (0.0%). The mean Colony-Forming Unit (CFU) count decreased from 3.60 before UV-C implementation to 1.94 after implementation, corresponding to a 46% reduction. Finally, we discuss different approaches of implementation into other types of cleanrooms, and possible mitigation actions should a UV-C system underperform.