Raw Material Supply Chain and Quality Risks under Emerging PFAS Restrictions: Response Strategies in the Pharmaceutical Industry

Abstract

Per- and polyfluoroalkyl substances (PFAS) are becoming an important regulatory and tech-nical concern for the pharmaceutical industry due to their high environmental persistence, po-tential health risks, broad use across many industrial production fields and growing pressure for their regulation in consumer products. The pharmaceutical industry is particularly at risk for PFAS, due to their strict adherence to product quality and patient safety.
In response, the EU, North America (Canada and the United States) and China have gradually developed PFAS restrictions, moving from substance-specific control to a broader class-based approach. In 2023 the EU proposed a comprehensive PFAS restriction to prohibit the manufac-ture, use and import of all PFAS substances in the EU market and allow only narrowly defined and strictly justified exemptions. However, the implementation of such restriction brings chal-lenges to pharmaceutical industry.
Therefore, this thesis conducts a systematic literature review and qualitative interviews with industrial and regulation consulting experts to examine how PFAS restriction may affect the biopharmaceutical industry. This thesis identifies the main PFAS-related challenges in regulato-ry uncertainty, contamination risks, PFAS detection, analytical limitation, material substitution barriers, pharmaceutical regulatory compliance, supply chain transparency and complexity. It also evaluates how future PFAS restrictions may influence pharmaceutical compliance strate-gies, manufacturing decisions and business opportunities across the value chain.
The finding shows that PFAS regulation is shifting from substance-specific restriction to class-based control with distinct regulatory speed and implementation structure across the EU, North America and China. In biopharmaceutical production, the main PFAS contamination risks arise from direct addition and contact leakage. Interview findings further suggest that PFAS re-striction may affect upstream chemical suppliers more directly, while downstream pharmaceuti-cal companies may face indirect impacts through higher cost, supply disruption, additional qual-ification work and increasing demand for regulatory consulting support.
Overall, this thesis concludes that PFAS restriction may create significant regulatory, technical and operational challenges for the biopharmaceutical industry. Although PFAS alternatives is feasible in selected areas, large-scale replacement remains difficult due to performance require-ments, validation needs, supplier qualification and post-launch regulatory procedures. Future PFAS Management in the pharmaceutical industry might follow a phased, risk-based and sci-ence-driven strategy. Early identification of affected materials, supplier communication, alterna-tive material assessment and long-term regulatory planning would be essential. At the same time, PFAS restrictions may create strategic opportunities in the pharmaceutical value chain, especially in PFAS identification, substitution planning, compliance support and market access management.

Popular Abstract

Per- and polyfluoroalkyl substances (PFAS) are a large group of synthetic chemicals that are widely used in industrial production and consumer products. They are valued because they can help material resist chemicals, reduce sticking, improve stability and make equipment and pack-aging work more reliably. In pharmaceutical manufacturing, they may appear in many forms and are found in raw materials, processing aids, production equipment, packaging materials and laboratory consumables.
However, PFAS are extremely persistent in the environment and therefore are often called “for-ever chemicals”. Some of them may also be harmful to human health. Long-term exposure has been associated with potential effects on the immune system, endocrine function, liver function, hormones, reproduction and cancer risk. In biopharmaceutical manufacturing, PFAS may enter drug products through direct addition or contact with PFAS-containing equipment, laboratory consumables and packaging materials. This may create potential risk for drug quality and pa-tient safety. As a result, many countries have developed regulations to restrict the manufactur-ing, use and import of PFAS.
This thesis explores how tightening PFAS regulations may affect the biopharmaceutical indus-try with particular focus on the proposed comprehensive PFAS restriction in the European Un-ion (EU) through a literature review and qualitative interviews. The literature review was used to compare PFAS regulatory pathway in the EU, North America (Canada and the US) and China, and to analyze PFAS applications, contamination pathways, detection methods, alterna-tives options and regulatory challenges in biopharmaceutical manufacturing. The interviews were used to collect practical opinions from industrial and regulatory consulting experts about supply chain transparency, regulatory uncertainty, implementation barriers and business oppor-tunities.
The findings identified and grouped the challenges that the pharmaceutical industry is faced with, including identifying PFAS-containing materials across complex supply chains, detecting PFAS with low concentration, finding suitable alternatives, validation material changes and maintaining regulatory compliance. However, PFAS restrictions may also create new opportu-nities for companies that prepare early, improve supplier communication, develop more reliable alternatives and build long-term compliance strategies.

• author: Dai, Weina
• supervisor: Stephen Burleigh
• organization: Food Technology and Nutrition (M.Sc.)
• course: KLGM06 20261
• year: 2026
• type: H2 - Master's Degree (Two Years)
• subject: Medicine and Health Sciences
• keywords: PFAS, Pharmaceutical Industry, Supply Chain, Regulation, Pharmaceutical Formulation
• language: English
• id: 9230675
• date added to LUP: 2026-06-10 14:02:24
• date last changed: 2026-06-10 14:02:24