Understanding PFAS in Pharmaceutical Manufacturing

Introduction to PFAS

Per- and polyfluoroalkyl substances (PFAS) are a large group of man-made chemicals that have been widely used in various industries since the 1940s. These chemicals are known for their resistance to heat, water, and oil, making them valuable in numerous applications, including non-stick cookware, water-repellent clothing, firefighting foams, and even in the pharmaceutical industry.

Thermo Fisher Scientific: Understanding PFAS in Pharmaceutical Manufacturing

PFAS in pharmaceutical manufacturing

Pharmaceutical manufacturing is a complex process that involves the synthesis, formulation, and packaging of medications. PFAS can play several roles in this industry, often due to their unique chemical properties:

1. As processing aids: PFAS are used as surfactants and emulsifiers in the production of certain drugs. They help in the formation of stable emulsions and dispersions, which is crucial for the consistency and efficacy of pharmaceutical products.
2. In equipment and packaging: PFAS coatings and materials are used in manufacturing equipment and packaging to ensure non-reactivity and durability. For example, PTFE (a type of PFAS) is often used to line equipment because of its non-stick properties, which help in maintaining cleanliness and preventing contamination.
3. Analytical applications: PFAS are used in analytical chemistry within pharmaceuticals for various tests and quality control measures. Their unique properties can aid in the detection and quantification of various compounds.

Environmental and health concerns

Despite their utility, PFAS have come under scrutiny due to their persistence in the environment and potential health risks. They are often referred to as “forever chemicals” because they do not break down easily in the environment, leading to long-term contamination issues. Studies have linked PFAS exposure to various health problems, including cancer, liver damage, immune system effects, and developmental issues.

Regulatory landscape

The growing awareness of PFAS-related risks has led to increased regulatory scrutiny. Regulatory agencies around the world, including the Environmental Protection Agency (EPA) in the United States and the European Chemicals Agency (ECHA), are taking steps to limit the use of PFAS and to monitor their presence in manufacturing processes.

In the pharmaceutical industry, this means manufacturers must be vigilant in their use of PFAS. They must ensure compliance with regulations, implement robust monitoring systems, and explore alternative materials and processes that can achieve similar results without relying on PFAS.

Moving towards sustainable practices

Pharmaceutical companies are increasingly looking for sustainable alternatives to PFAS. This involves:

1. Research and development: Investing in R&D to find new materials that can replace PFAS without compromising product quality or safety.
2. Process optimization: Modifying manufacturing processes to reduce or eliminate the need for PFAS.
3. Enhanced filtration and treatment: Implementing advanced filtration and wastewater treatment technologies to capture and remove PFAS from manufacturing effluents.
4. Supplier collaboration: Working closely with suppliers to ensure that raw materials and components are free from PFAS.

Overcoming analytical challenges: detecting and quantifying PFAS in pharmaceuticals

Overcoming analytical challenges in detecting and quantifying per- and polyfluoroalkyl substances (PFAS) in pharmaceuticals is crucial due to the potential health risks these compounds pose. PFAS are highly persistent in the environment and human body, making their accurate detection essential. The unique chemical properties of PFAS, such as their resistance to degradation and their ability to exist in complex matrices, complicate the analytical processes.

Advanced techniques like high-resolution mass spectrometry coupled with liquid chromatography (LC-MS/MS) have become indispensable tools in this endeavour. These methods offer high sensitivity and specificity, enabling the detection of PFAS at trace levels. Additionally, rigorous method validation and the development of robust sample preparation protocols are essential to mitigate matrix effects and ensure reproducibility and accuracy. Overcoming these analytical challenges is fundamental to ensuring the safety and compliance of pharmaceutical products with regulatory standards.

We have developed a comprehensive LC-MS based solution for the screening and quantitation of PFAS in pharmaceutical packaging and processing materials. This approach employs the Thermo Scientific Vanquish Horizon UHPLC system coupled with the Thermo Scientific Orbitrap Exploris 120 mass spectrometer, leveraging the high sensitivity and resolution these instruments offer. The solution utilizes Thermo Scientific Chromeleon CDS for chromatographic data system management and Thermo Scientific Compound Discoverer software for advanced data analysis. This integrated approach ensures precise identification and quantification of PFAS, providing robust and reliable results that meet stringent regulatory requirements.

Key features:

• Simultaneous identification: The polarity switching Full Scan-ddMS2 method enables the identification of both known and unknown PFAS with high sensitivity and mass accuracy.
• High sensitivity quantitation: Targeted quantitation of 17 common PFAS is achieved with LOQs ranging from 0.1 to 1 ppb, using a PFAS analysis kit to minimize background interference.
• Detection at low levels: Demonstrates the ability to detect PFAS at low ppb to sub-ppb levels, including five suspected PFAS identified in non-targeted analysis.
• Delay column use: Enhances analysis by separating system peaks from sample peaks, aiding in the detection of frequent LC-MS system contaminants.

This method provides a robust and reliable approach for PFAS screening in E&L analysis and other pharmaceutical testing, helping companies stay compliant with regulations and ensure product safety. For detailed insights and methodologies, download our latest application note: “Comprehensive PFAS Screening in Pharmaceutical Packaging and Medical Devices by LC-HRAM-MS.” Stay ahead in ensuring safety and compliance in your pharmaceutical manufacturing processes.

Watch our latest webinar: “Comprehensive PFAS Screening in Pharmaceutical Packaging and Medical Devices.” Learn about cutting-edge techniques and tools to ensure safety and compliance in pharmaceutical manufacturing.

Conclusion

PFAS have played a significant role in pharmaceutical manufacturing due to their unique properties, such as chemical stability and resistance to degradation. However, their environmental persistence and potential health risks necessitate a careful and responsible approach to their use. The pharmaceutical industry must balance the benefits of PFAS with the imperative to protect human health and the environment, driving innovation towards safer and more sustainable manufacturing practices.

By staying informed, compliant, and proactive, pharmaceutical manufacturers can contribute to a healthier future while continuing to deliver safe and effective medications to the public. Utilizing advanced analytical tools, such as our comprehensive LC-MS based solution with the Vanquish Horizon UHPLC system and Orbitrap Exploris 120 mass spectrometer, ensures precise detection and quantitation of PFAS, supporting this critical balance.

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