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2025’s Breakthroughs in Volatile Organic Impurity Detection: What Pharma Leaders Must Know for the Next 5 Years

ByNoelzy Greenfeld

2025-05-21
2025’s Breakthroughs in Volatile Organic Impurity Detection: What Pharma Leaders Must Know for the Next 5 Years

Table of Contents

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Executive Summary: Key Findings and Market Drivers

The detection of volatile organic impurities (VOIs) in pharmaceutical packaging has emerged as a central focus for the industry in 2025, driven by increasingly stringent regulatory expectations and heightened awareness of patient safety concerns. The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global health authorities continue to reinforce the necessity of robust monitoring for extractables and leachables, including volatile organic compounds, to ensure the integrity and safety of pharmaceutical products.

Recent years have witnessed a marked increase in the adoption of advanced analytical technologies such as gas chromatography-mass spectrometry (GC-MS) and headspace gas chromatography. Industry leaders like Agilent Technologies and Thermo Fisher Scientific have introduced next-generation instruments with enhanced sensitivity and automation, enabling the reliable detection of trace-level VOIs in complex packaging matrices. These innovations, coupled with automated sample preparation and data analysis, are allowing manufacturers to comply with evolving regulatory standards while improving efficiency and reducing turnaround times.

The transition to more sustainable and complex packaging materials, including recyclables and biopolymers, has introduced new challenges and potential sources of VOIs. Pharmaceutical companies are increasingly collaborating with packaging suppliers such as SGD Pharma and SCHOTT to proactively screen for impurities and optimize material selection. This partnership-driven approach is expected to intensify as product portfolios diversify in response to global sustainability goals and patient-centric design trends.

The market outlook for 2025 and beyond is shaped by several drivers:

  • Ongoing updates to regulatory guidance, particularly the anticipated revisions to USP and chapters regarding extractables and leachables, are pushing pharmaceutical companies to invest in state-of-the-art VOI detection systems.
  • Heightened enforcement of risk-based approaches for packaging qualification and lifecycle management, underlining the necessity of robust impurity screening protocols.
  • Expansion of outsourcing to specialized analytical service providers such as Eurofins Pharma Services and SGS, enabling smaller manufacturers to access cutting-edge detection capabilities without significant capital investment.
  • Growth in global pharmaceutical supply chains, necessitating harmonized impurity detection standards and cross-border data transparency.

Looking ahead, the detection of volatile organic impurities will remain a dynamic and rapidly evolving field, with technological innovation and regulatory alignment acting as key enablers of market growth and patient safety assurance.

Regulatory Landscape Updates: 2025 and Beyond

The regulatory landscape for volatile organic impurity (VOI) detection in pharmaceutical packaging is undergoing significant evolution in 2025, with global agencies placing heightened emphasis on patient safety and product quality. The United States Food and Drug Administration (FDA) continues to reinforce requirements under its Container Closure Systems guidance, demanding robust analytical methods for the detection of extractables and leachables (E&L), which often include volatile organic impurities. The FDA’s ongoing modernization initiatives, as outlined in its Advancing Pharmaceutical Quality programs, stress the importance of risk-based approaches and new technologies for impurity profiling.

In the European Union, the European Medicines Agency (EMA) is aligning its regulations under the revised Annex 1 of Good Manufacturing Practice (GMP), which came into effect in August 2023 and is now being rigorously enforced. This revision requires pharmaceutical manufacturers to demonstrate the control of impurities, including VOCs, especially in sterile medicinal products and their packaging. EMA’s focus remains on lifecycle management and the application of ICH guidelines Q3D (Elemental Impurities) and Q3E (Impurity: Assessment and Control), both of which have implications for packaging materials and their potential to introduce volatile impurities.

The International Council for Harmonisation (ICH) is expected to advance its work on harmonizing approaches for organic impurity testing in packaging, with ICH Q3E entering broader implementation phases in 2025. This will likely prompt updates in both US and EU regulatory frameworks, driving convergence in requirements for analytical testing, risk assessment, and reporting thresholds for volatile organics.

In response to these regulatory developments, industry leaders such as West Pharmaceutical Services, Inc. and SCHOTT AG are actively enhancing their analytical services and packaging materials to comply with the stricter impurity limits. Both companies report increased demand from pharmaceutical clients for comprehensive E&L studies and validated detection of trace-level volatiles.

Looking ahead, the regulatory trajectory for 2025 and beyond points toward greater integration of advanced detection technologies such as gas chromatography-mass spectrometry (GC-MS) and real-time monitoring platforms. Agencies are also expected to expand digital submission requirements, facilitating data transparency and traceability. Pharmaceutical manufacturers should anticipate continued tightening of impurity limits, increased scrutiny of supplier data, and the necessity for cross-functional collaboration to ensure compliance in a rapidly evolving global market.

The detection of volatile organic impurities (VOIs) in pharmaceutical packaging is experiencing a technological evolution in 2025, driven by regulatory demands, innovation in analytical instrumentation, and the pharmaceutical industry’s focus on patient safety. As pharmaceutical packaging materials continue to diversify—with the increased use of polymers, elastomers, and advanced coatings—ensuring that volatile leachables and extractables are identified and quantified with utmost sensitivity is a top priority.

Recent advances center on enhanced gas chromatography-mass spectrometry (GC-MS) platforms, which remain the gold standard for VOI detection due to their selectivity and sensitivity. Leading manufacturers such as Agilent Technologies, Inc. and Thermo Fisher Scientific Inc. have introduced new GC-MS systems in 2024-2025 featuring improved automation, higher-throughput sample processing, and real-time data analytics. For instance, Agilent’s latest systems integrate advanced headspace sampling and software-driven workflows tailored for pharmaceutical quality control, enabling rapid detection of trace-level volatile contaminants.

Complementing GC-MS, there is rising adoption of direct mass spectrometry techniques. Innovations such as proton-transfer-reaction mass spectrometry (PTR-MS) and selected-ion flow-tube mass spectrometry (SIFT-MS) are being incorporated into pharmaceutical laboratories for rapid, real-time monitoring of packaging emissions. IONICON Analytik and Syft Technologies are actively deploying these platforms in collaborations with pharmaceutical companies, reporting significant reductions in analysis time and increased detection capabilities for a broader range of volatile organics.

Another notable trend is the integration of artificial intelligence (AI) and machine learning into data interpretation. Major analytical instrument providers are embedding AI-driven algorithms to automate impurity identification, trend analysis, and compliance reporting. This is reducing the margin of human error and enhancing regulatory documentation, which is critical given the evolving guidelines from bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Looking ahead, the next few years will likely see further miniaturization and portability of detection devices, facilitating in-line and at-line testing within manufacturing environments. Companies like PerkinElmer Inc. are actively developing compact, field-deployable instruments aimed at supporting continuous monitoring without disrupting production workflows.

Overall, the convergence of advanced mass spectrometry, real-time analytics, and AI-enhanced platforms is poised to redefine volatile organic impurity detection in pharmaceutical packaging. This technological momentum is expected to translate into safer drug products, streamlined quality assurance, and faster time-to-market for new therapies.

Major Players and Competitive Strategies

The detection of volatile organic impurities (VOIs) in pharmaceutical packaging has become a focal point for both regulatory compliance and product safety, leading to a dynamic competitive landscape among analytical instrument manufacturers and testing service providers. As of 2025, several major players are shaping this sector through technological innovation, strategic partnerships, and expanded service offerings.

  • Agilent Technologies remains a dominant force, leveraging its comprehensive suite of gas chromatography-mass spectrometry (GC-MS) systems tailored for trace-level detection of VOIs. Their recent advancements in high-throughput, automated sample preparation systems aim to address the increasing demand for rapid, sensitive analysis in compliance with evolving pharmacopeial standards (Agilent Technologies).
  • PerkinElmer continues to focus on enhancing analytical sensitivity and workflow efficiency. In 2025, the company introduced upgrades to its Clarus GC and TurboMatrix headspace sampler platforms, emphasizing user-friendly interfaces and robust data management tools to support routine testing and regulatory audits (PerkinElmer).
  • Shimadzu Corporation has strengthened its position with innovations in headspace GC-MS technology, specifically targeting pharmaceutical packaging extractables and leachables (E&L) analysis. Their latest offerings include real-time monitoring features and enhanced system stability, facilitating continuous quality assurance in production environments (Shimadzu Corporation).
  • Thermo Fisher Scientific is actively expanding its portfolio of integrated solutions for VOI detection, combining advanced chromatography with comprehensive informatics. The company’s emphasis on customizable workflows and global technical support aligns with the needs of multinational pharmaceutical manufacturers facing varied regulatory landscapes (Thermo Fisher Scientific).
  • SGS, a leading third-party testing service provider, has expanded its laboratory network and invested in state-of-the-art instrumentation for extractables and leachables studies. SGS’s strategy includes close collaboration with packaging manufacturers and drug sponsors to ensure early-stage risk assessment and compliance with USP and requirements (SGS).

Looking ahead, competitive strategies are expected to center on automation, digitalization, and cross-industry collaboration. Major players are investing in artificial intelligence-driven data analytics and cloud-based laboratory management to streamline detection workflows and support regulatory submissions. Additionally, alliances between instrument suppliers and packaging companies are likely to accelerate, enabling tailored solutions that address emerging materials and stricter impurity thresholds. As regulatory expectations and supply chain complexities rise, the competitive landscape will increasingly reward innovation, flexibility, and end-to-end service integration.

Market Size, Share, and 5-Year Forecasts

The global market for volatile organic impurity (VOI) detection in pharmaceutical packaging is experiencing robust growth in 2025, driven by increasingly stringent regulatory expectations and the expanding complexity of packaging materials. Pharmaceutical manufacturers are under pressure to ensure product safety by identifying and quantifying trace-level volatile organic compounds (VOCs) that may leach from packaging components into drug formulations. This has created a significant demand for advanced analytical instrumentation and services tailored to this critical quality control function.

Key players in analytical instrumentation, such as Agilent Technologies, Thermo Fisher Scientific, and PerkinElmer, report heightened adoption of techniques like headspace gas chromatography-mass spectrometry (HS-GC-MS) and solid-phase microextraction (SPME) in pharmaceutical environments. These technologies enable sensitive and reliable detection of a broad spectrum of VOCs, including residual solvents, plasticizers, and degradation products.

In terms of market size, the analytical instruments segment—including gas chromatographs, mass spectrometers, and related sample preparation equipment—accounts for the largest revenue share. Sartorius and Shimadzu Corporation have also reported increased demand for their laboratory solutions in this segment, correlating with expanded pharmaceutical manufacturing and packaging operations.

Regulatory drivers remain a central factor shaping the market outlook. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to update guidelines for extractables and leachables testing, with recent emphasis on risk-based approaches and data integrity. This regulatory momentum is expected to sustain double-digit annual growth rates for VOI detection solutions through at least 2030, as compliance becomes more complex and comprehensive. For example, the United States Pharmacopeia (USP) has signaled ongoing revisions to chapters <661.1> and <1663>, which will likely increase the frequency and sophistication of required testing.

Looking ahead, market growth is projected to be especially strong in regions with expanding pharmaceutical manufacturing footprints, such as Asia-Pacific and Latin America. Major equipment suppliers, including Waters Corporation, are investing in localized support and training initiatives to capture these opportunities. Additionally, the rise of biologics and personalized medicines is driving demand for new packaging materials, further increasing the need for advanced VOI detection to address unique leaching profiles.

Overall, the next five years will see continued innovation in both hardware and software solutions for volatile organic impurity detection, with data integration and automation emerging as key differentiators in a highly regulated, rapidly expanding market.

Packaging Materials: Risk Assessment and Compliance

The detection of volatile organic impurities (VOIs) in pharmaceutical packaging is under intensified scrutiny in 2025, driven by rising regulatory expectations and growing awareness of the impact of packaging-derived leachables on drug safety and efficacy. Packaging materials such as plastics, elastomers, and adhesives can release trace levels of volatile organic compounds (VOCs) that may migrate into pharmaceutical products, potentially affecting product quality and patient safety.

Recent guidance from the United States Pharmacopeia (USP) and the European Medicines Agency (EMA) has emphasized the importance of comprehensive extractables and leachables (E&L) studies, specifically highlighting the need for sensitive detection and quantification of VOIs in packaging systems. In 2024 and 2025, pharmaceutical companies are increasingly adopting advanced analytical techniques such as gas chromatography-mass spectrometry (GC-MS), headspace gas chromatography (HS-GC), and thermal desorption GC-MS to improve detection limits and better characterize volatile impurities.

Manufacturers of packaging materials, including Gerresheimer and SCHOTT, have responded by investing in in-house analytical capabilities and collaborating with pharmaceutical companies to proactively assess the VOC emission profiles of their products. These efforts are complemented by third-party laboratories offering specialized E&L testing, such as Eurofins Scientific, which provides comprehensive VOC screening and identification services tailored to regulatory and client requirements.

In 2025, the adoption of risk-based approaches to packaging evaluation continues to gain traction. The Parenteral Drug Association (PDA) and other industry bodies are leading initiatives to standardize risk assessment frameworks that prioritize packaging components with the highest potential for volatile organic impurity migration. This trend is supported by digital data management solutions from companies like SGS, which facilitate traceability and compliance documentation for E&L studies.

Looking ahead, the pharmaceutical industry is expected to see stricter global enforcement of impurity thresholds and more explicit regulatory requirements for VOI monitoring beyond 2025. There is also a growing demand for sustainable packaging materials with inherently low VOC content, prompting material suppliers to innovate and validate new polymer formulations. As a result, the integration of sensitive analytical methods, proactive risk assessment, and robust quality management is set to remain a central focus for ensuring packaging compliance and safeguarding product integrity in the coming years.

Analytical Methods: Validation, Sensitivity, and Automation

The detection of volatile organic impurities (VOIs) in pharmaceutical packaging is undergoing significant evolution in 2025, with a robust focus on method validation, enhanced sensitivity, and increasing automation. These advances are being shaped by stricter regulatory requirements and the need for greater assurance of drug product safety.

Analytical methods such as gas chromatography (GC) coupled with mass spectrometry (MS) remain the gold standard for VOI detection. In 2025, manufacturers and analytical service providers are prioritizing method validation in accordance with ICH Q3E and USP guidelines, which emphasize parameters such as accuracy, precision, specificity, and limits of detection and quantitation. For instance, Agilent Technologies has introduced fully validated GC-MS platforms specifically configured for extractables and leachables studies in pharmaceutical packaging, supporting both targeted and untargeted screening of VOIs. These systems offer lower detection limits—often in the low parts-per-billion (ppb) range—enabling detection of trace-level impurities that may migrate from packaging materials.

Automation is playing an increasingly pivotal role in 2025. Automated sample preparation platforms, such as those offered by Thermo Fisher Scientific, are being integrated with analytical instruments to improve throughput, consistency, and data integrity. Robotic autosamplers and software-driven workflows are reducing manual intervention and minimizing contamination risks, while advanced data processing algorithms accelerate the interpretation of complex chromatographic and mass spectrometric data.

In terms of sensitivity, the latest detectors and columns have enabled lower detection thresholds and higher robustness. Shimadzu Corporation has enhanced its GC-MS/MS instrumentation with improved ion source technologies, allowing for the quantification of ultra-trace VOIs even in challenging matrices. Recent collaborative studies with pharmaceutical manufacturers demonstrate the ability of these systems to meet or exceed regulatory expectations for both known and unknown volatile impurities.

Looking forward, the outlook for VOI detection in pharmaceutical packaging is marked by further digitalization and artificial intelligence (AI)-driven analytics. Solution providers such as SGS are piloting AI-assisted spectral deconvolution tools to streamline the identification and quantitation of previously uncharacterized volatiles, reducing analysis time and enhancing reproducibility. As the industry continues to adopt these innovations, the next few years will likely see even tighter integration of automated hardware and intelligent software, driving both regulatory compliance and operational efficiency.

Case Studies: Industry Implementation and Best Practices

In 2025, the pharmaceutical industry continues to adopt advanced methods for the detection of volatile organic impurities (VOIs) in packaging, reflecting regulatory requirements and a commitment to patient safety. Several case studies highlight both the implementation of innovative technologies and the establishment of best practices across the sector.

One notable example is the deployment of Gas Chromatography-Mass Spectrometry (GC-MS) by Shimadzu Corporation, whose systems are widely used in pharmaceutical quality control laboratories for the identification and quantification of residual solvents and extractables/leachables from packaging materials. In a recent application, a major European pharmaceutical manufacturer partnered with Shimadzu Corporation to validate a GC-MS workflow that reduced detection limits for specific VOIs by 30%, allowing faster release of safe products to market.

Similarly, Thermo Fisher Scientific has reported collaborations with global pharma companies to implement headspace GC-MS systems integrated with automated sample preparation. This approach has streamlined routine screening for impurities such as benzene, toluene, and xylenes, which may migrate from packaging adhesives or inks. The automation has improved reproducibility and reduced analysis time by up to 40%, according to case studies published on their site.

Best practices increasingly emphasize risk-based assessment, as advocated by organizations such as the United States Pharmacopeia (USP). USP’s General Chapter <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems provides a framework that has been implemented by industry leaders. For instance, West Pharmaceutical Services, Inc. has adopted a risk-based approach for extractables and leachables evaluation, combining advanced analytics with a deep understanding of material science to anticipate and mitigate impurity risks.

Moreover, the use of real-time monitoring technologies is gaining traction. Anton Paar GmbH has developed portable instruments for rapid screening of volatile organic compounds (VOCs), enabling in-process checks and reducing the likelihood of contamination reaching the final product.

Looking ahead to 2026 and beyond, the integration of digital data management and predictive modeling is expected to further enhance impurity detection strategies. The continued collaboration between instrument manufacturers, pharmaceutical companies, and regulatory bodies will likely yield even more robust and efficient monitoring systems, supporting the industry’s ongoing commitment to product quality and patient safety.

Sustainability, Green Chemistry & Future Packaging Solutions

Sustainability and green chemistry are increasingly influencing pharmaceutical packaging, particularly in the detection and management of volatile organic impurities (VOIs). In 2025, regulatory pressures and consumer demand for safer, more environmentally conscious products are driving advances in both materials and analytical technologies. Companies are tasked with not only reducing the environmental impact of packaging but also ensuring that new, “greener” materials do not introduce additional risks of leachables and extractables, including volatile organic impurities.

Major pharmaceutical packaging suppliers are actively developing bio-based, recycled, and recyclable polymers—such as polylactic acid (PLA) and advanced polyethylene terephthalate (PET)—that meet sustainability goals while maintaining inertness and minimizing the risk of impurity migration. For example, SCHOTT is expanding its eco-friendly glass and polymer vial offerings, emphasizing low extractable profiles and robust impurity detection protocols. Similarly, Gerresheimer is investing in circular economy packaging solutions with traceable supply chains and rigorous impurity analysis.

To address the unique challenges posed by novel sustainable materials, pharmaceutical companies and contract labs are implementing new analytical strategies. Headspace gas chromatography-mass spectrometry (HS-GC-MS) remains a gold standard for volatile impurity detection, but laboratories are increasingly adopting automated, high-throughput platforms and advanced data analytics to screen for a broader array of potential contaminants. Agilent Technologies and Thermo Fisher Scientific have introduced next-generation GC-MS systems tailored for sensitive detection of trace volatile organics in complex pharmaceutical matrices, supporting both regulatory compliance and innovation in materials.

Industry initiatives such as the Product Quality Research Institute (PQRI) continue to update best practice guidelines for impurity testing, especially as new packaging substrates are introduced. PQRI’s Extractables and Leachables Working Group is focusing on risk assessment frameworks that incorporate sustainability-driven material changes, with new recommendations expected in the next few years.

Looking forward, the intersection of green chemistry and impurity analytics is expected to yield more robust, real-time detection systems and predictive modeling tools to proactively screen packaging innovations. Partnerships between packaging producers, analytical instrument manufacturers, and pharmaceutical companies will be crucial in ensuring that the shift to sustainable packaging does not compromise product safety or efficacy. The continued evolution of regulatory guidelines and analytical technologies will shape the landscape of volatile organic impurity detection through 2025 and beyond.

Future Outlook: Opportunities, Challenges, and Strategic Recommendations

The future of volatile organic impurity (VOI) detection in pharmaceutical packaging is poised for significant advances, driven by tightening regulatory expectations, evolving analytical technologies, and an increased emphasis on patient safety and product quality. As the industry heads into 2025 and beyond, several key trends, opportunities, and challenges are emerging.

Opportunities arise from the adoption of more sensitive and rapid analytical methods. Technologies such as headspace gas chromatography coupled with mass spectrometry (HS-GC-MS), thermal desorption, and advanced sensor arrays are being further optimized to detect trace levels of VOIs in packaging components and finished drug products. Instrument manufacturers like Agilent Technologies and Malvern Panalytical are expanding their solutions for pharmaceutical impurity profiling, enabling real-time or near real-time detection that supports both routine quality control and root cause investigations. These technologies are being complemented by robust automated sample preparation and data processing, which can reduce human error and accelerate batch release.

Regulatory agencies, including the U.S. Food and Drug Administration and European Medicines Agency, are increasingly expecting manufacturers to demonstrate comprehensive extractables and leachables (E&L) studies and ongoing monitoring. This is particularly important for materials such as plastics, elastomers, and adhesives, where VOIs like benzene, toluene, and residual solvents can migrate into drug products. The U.S. Pharmacopeia (USP) continues to update chapters related to packaging and impurity testing, creating opportunities for compliance-driven innovation.

Challenges remain, particularly in standardizing detection limits and harmonizing global guidelines. The complexity of modern packaging—incorporating multilayer materials, coatings, and unique delivery systems—requires tailored detection methods. Small and medium-sized pharmaceutical companies may face resource constraints in adopting state-of-the-art equipment and expertise. Moreover, false positives and matrix effects in analytical testing can complicate data interpretation, underscoring the need for validated, fit-for-purpose methods.

Strategic recommendations for stakeholders include increased collaboration between packaging suppliers, pharmaceutical manufacturers, and technology providers. Proactive risk assessment and early-stage E&L studies can help prevent costly late-stage failures. Companies should invest in staff training and quality system enhancements to keep pace with evolving expectations. Leveraging partnerships with technology leaders like Thermo Fisher Scientific and contract laboratories with proven E&L expertise can further streamline compliance and innovation.

In summary, the outlook for VOI detection in pharmaceutical packaging by 2025 and the following years is shaped by regulatory momentum, technological progress, and the ongoing prioritization of patient safety—offering both challenges and opportunities for those prepared to innovate and collaborate.

Sources & References

ByNoelzy Greenfeld

Noelzy Greenfeld is a distinguished author and thought leader in the realms of emerging technologies and fintech. With a Master's degree in Technology Management from the prestigious University of Jackson State, Noelzy combines a rigorous academic background with practical insights gained over several years working at Bitwise Solutions, a leading firm in the fintech sector. Throughout his career, Noelzy has been dedicated to exploring the transformative impact of innovative technologies on the financial landscape. He has contributed to numerous publications and speaks frequently at industry conferences, sharing his expertise on trends, challenges, and the future of financial technology. Noelzy resides in Silicon Valley, where he continues to write and consult on the evolution of fintech.

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