Microplastics in sustainable pharmaceutical manufacturing

Abstract

Microplastics (MPs), plastic particles smaller than 5 mm, are emerging contaminants of concern in both environmental and pharmaceutical fields. Within pharmaceutical manufacturing, MPs typically originate from the breakdown of plastic-based equipment, packaging materials, and leachates, and can enter drug products during production, handling, or storage. This review explores these contamination pathways through the perspective of sustainable manufacturing and green chemistry principles. The presence of MPs in formulations particularly liquid and semi-solid dosage forms can compromise drug efficacy by affecting the stability, solubility, and bioavailability of active pharmaceutical ingredients (APIs). MPs may also serve as carriers of toxic substances, such as heavy metals and endocrine-disrupting chemicals, increasing potential risks to human health and the environment. Incorporating bio-circular economy concepts, the review evaluates advanced detection techniques including FTIR, Raman spectroscopy, and SEM, along with sustainable sample preparation methods. It also highlights contamination control measures aligned with Good Manufacturing Practices (GMP), such as the use of non-plastic processing tools, cleanroom improvements, and eco-friendly packaging all aimed at reducing MPs contamination and supporting circular material use. This multidisciplinary approach emphasizes the need for sustainable, system-based solutions that align with the United Nations Sustainable Development Goals. To advance these efforts, future research should focus on standardizing detection methods, studying long-term impacts of MPs on drug safety, and developing real-time monitoring tools. Additionally, clear regulatory guidelines and risk assessment models specific to microplastics in pharmaceuticals are essential for guiding effective industry practices and policy decisions.