The cleanroom industry is at the crossroads of increasing demands for sustainability and the stringent requirements of regulatory frameworks. This presentation delves into the legal and scientific challenges shaping the industry's journey toward sustainable practices. As the pharmaceutical sector pushes for greater environmental responsibility, legislation such as the Corporate Sustainability Reporting Directive (CSRD) and Annex 1 of GMP guidelines introduce both opportunities and obstacles. While these regulations aim to improve sustainability, they often fail to seamlessly integrate into practical operations and rely on scientific-based targets, which are not always effectively implemented.
Traditional tools like Life Cycle Assessments (LCA) are increasingly being questioned for their limitations in addressing the unique dynamics of cleanroom environments. This session proposes alternatives rooted in scientific-based approaches, emphasizing practical, evidence-backed solutions rather than decisions guided by what simply "feels good." It also highlights how excessive bureaucracy can stifle meaningful change, advocating for a shift from rigid compliance to proactive activism. Through this lens, we aim to inspire a forward-thinking strategy for achieving sustainability in the cleanroom industry that aligns with both regulatory requirements and environmental goals.