In the constantly shifting world of pharmaceutical manufacturing, every change has the potential to cause significant ripple effects across the industry. The discontinuation of a commonly used lyophilization heat transfer fluid, due to the presence of per- and polyfluoroalkyl substances (PFAS), has impacted pharmaceutical manufacturers and equipment suppliers.
The Biden-Harris Administration recently finalized the first-ever national, legally enforceable drinking water standard to protect people from these substances. PFAS has been linked to negative health and environmental impacts and this final rule has been implemented to limit exposure for approximately 100 million people.
As PFAS and other emerging contaminants continue to move to the forefront of industry conversations, increasing regulations surrounding PFAS-containing product effects are taking hold and those in the manufacturing industry are beginning to act. This shift away from PFAS-containing products not only necessitates reconfigurations in equipment but also triggers crucial considerations regarding building code compliance and environmental safety and compliance.
Industry Shifts
Pharmaceutical manufacturers heavily rely on lyophilizers to enhance product stability and extend shelf life. These specialized vessels utilize heat transfer fluids to freeze-dry pharmaceutical products. The discontinuation of a certain lyophilization heat transfer fluid, known for its superior heat transfer capabilities and non-flammability, presents a challenge. Now, the industry is faced with finding viable alternatives without compromising safety or incurring exorbitant expenses related to replacing facility equipment or insurance premium costs.
Our team recently worked with a client to proactively address these challenges. Leveraging closed-use systems to use non-PFAS-containing heat transfer fluids allowed the team to mitigate safety hazards and remain compliant with building code regulations. This approach saved costs and resolved potential safety and compliance risks associated with PFAS-containing heat transfer fluids.
Compliance and Safety
The transition from discontinued PFAS-containing lyophilization heat transfer fluids to alternatives necessitates meticulous consideration of building code implications. Some fluids and configurations pose significant hazards, potentially elevating a facility's hazard classification and incurring higher insurance premiums. However, by implementing closed-use systems, enhancing ventilation measures and proper fluid selection, manufacturers can effectively mitigate these risks, yielding a safer environment for facility occupants while maintaining compliance with regulatory standards.
Beyond immediate safety concerns, the discontinuation of PFAS-containing lyophilization heat transfer fluids underscores the broader challenges facing the pharmaceutical manufacturing industry. As manufacturers grapple with reconfigurations to accommodate alternative heat transfer fluids, yielding long-term stability and maintaining compliance remains paramount. By adopting proactive measures and leveraging innovative solutions, the industry can navigate these shifts while safeguarding both operations and the well-being of employees and consumers.
PFAS regulations are taking effect to limit exposure and promote the health and safety of communities. Learn more about these substances and how to prepare for remediation and treatment.