Navigating Water Circularity in Pharma: Regulatory Perspectives and Emerging Contaminant Challenges
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 ET
Session Length: 1 hour
As the pharmaceutical industry intensifies its focus on sustainability, water circularity-particularly the reuse and recycling of water-has emerged as a critical area of concern & opportunity. This presentation explores the regulatory landscape and technical implications of water reuse in high-purity applications, including purified water (PW) and water for injection (WFI), where stringent quality standards intersect with environmental stewardship. We will present findings from a third-party (Legal) review of North American European regulations governing water reuse and recycling in pharmaceutical manufacturing. Pharmacopoeial guidance and regulations were assessed. We will also address the growing impact of emerging contaminants, specifically per and polyflouoralkuyl substances (PFAS) and active pharmaceutical ingredients (APIs), on water systems. The newly adopted Urban Wastewater Directive (2024/3019) introduces extended producer responsibility and mandates advanced treatment stages to remove micropollutants-many of which originate from pharmaceutical products. By integrating regulatory insights with environmental risk considerations, this presentation aims to foster dialog on balancing safety, regulatory compliance, and sustainable water management in the pharmaceutical sector.
Learning Objectives
- Participants will gain a better insight into how regulations are both restricting and opening opportunity for Pharma companies to address sustainability and substances of concern.
- Participants should walk away understanding that water circularity is not only accepted but is encouraged by current regulatory guidance in Pharma.
- Participants will gain insight into substances of concern and how they are being considered in regulatory and sustainability context.
