Skip to content
environmental monitoring trends in aseptic manufacturing

Navigating change: Unraveling Environmental Monitoring trending in aseptic manufacturing

In the recent webinar titled “Navigating Change: Unraveling Environmental Monitoring Trending in Aseptic Manufacturing,” Vanessa Figueroa provided an insightful overview of the evolving landscape of environmental monitoring within the aseptic manufacturing sector. Her discussion highlighted the critical importance and the sophisticated development of environmental monitoring, emphasizing its indispensable role in contamination control.

This article aims to encapsulate the key points and insights shared during the webinar, offering a comprehensive look at the subject for those interested in the nuances of environmental monitoring in the pharmaceutical industry.

If you missed the webinar, you can watch it registering in the following link

Introduction to Environmental Monitoring evolution

Vanessa began by tracing the evolution of environmental monitoring, pointing out its shift towards a risk-based design program. This program focuses on the implementation and routine monitoring of various quality levels for microbial analysis in controlled and classified areas, including bio-safety cabinets and laminar flow hoods used for specialized medicinal preparation. She emphasized the industry-wide harmonization towards risk-based control, marking a significant development in environmental monitoring strategies.

Guidance documents and regulatory framework

Highlighting the importance of guidance documents in environmental monitoring, Vanessa discussed the critical role of technical reports from the PDA group, specifically TR 13 and TR 90. These reports delve into bioburden detection and the development of contamination control strategies, respectively, emphasizing the need for real-time data to prevent environmental control loss.

Additionally, she touched upon the USP chapters 1115 and 1116, which govern non-sterile and aseptic manufacturing, outlining the necessity for tailored environmental monitoring programs that cater to the specific conditions of the facility and product.

The core of Environmental Monitoring

Delving deeper, Vanessa spoke about the high-level structural elements crucial for an environmental monitoring program. She pointed out the necessity of considering the facility’s design, zoning, and the specific regulations applicable to the environment being monitored. Using a risk-based tool to establish an Environmental Monitoring (EM) program was highlighted as a vital step towards achieving a robust EM strategy.

Trending in Environmental Monitoring

One of the webinar’s core discussions centered around “trending” in environmental monitoring. Vanessa explained how trending involves analyzing various data points from the facility, process, and microbial analysis to assess if the environment is under control. She elaborated on the adaptive nature of acceptance criteria, the diversity of environments within the industry, and the different ways these environments can be analyzed to establish a control state.

Alerts, alarms, and data analysis

The discussion also covered practical aspects of environmental monitoring, such as the significance of alert and alarm levels, quantitative versus qualitative analysis, and the critical evaluation of data to detect potential trends and deviations. Vanessa stressed the importance of understanding the story behind the data, which involves scrutinizing total particulate matters, viable recoveries, and the effectiveness of personnel garments among other factors.

Conclusion and Best Practices

In concluding the webinar, Vanessa emphasized the value proposition of environmental monitoring trending. She argued that the goal is not to achieve zero recoveries but to manage, detect, and correct contamination control issues effectively. She advocated for a dynamic and robust environmental monitoring program, underpinned by rapid and accurate trending methods, to support regulatory compliance and ensure product quality.

Final Thoughts

Environmental monitoring in aseptic manufacturing is not just about adherence to regulatory requirements; it’s a critical component of product quality and safety. Vanessa Figueroa’s insights from the webinar provide a clear pathway for navigating the complexities of environmental monitoring, emphasizing the importance of a well-thought-out, risk-based approach.

As we continue to navigate changes within the industry, these principles will undoubtedly play a pivotal role in shaping the future of aseptic manufacturing practices.

For those who wish to dive deeper into the topic and explore additional insights, we encourage you to read the Q&A session we conducted on this subject. The session expands on the discussion with more detailed answers to specific questions raised by the participants. You can find the Q&A at the following link.

Vanessa Figueroa leverages her combined knowledge of the Pharmaceutical, Biotechnology and Medical Decives industries to provide manufacturers across the US, Europe and India with critical laboratory operations management and personnel training programs to ensure compliance with cGMPs as well as global regulatory standards.

Combining hands-on Quality Control, Sterility, Inspection, and Compliant Operations with an educational leadership approach and natural business acumen, Vanessa brings 17+ years of real-time experience to deliver transformational real-world results.


Vanessa Figueroa leverages her combined knowledge of the Pharmaceutical, Biotechnology and Medical Decives industries to provide manufacturers across the US, Europe and India with critical laboratory operations management and personnel training programs to ensure compliance with cGMPs as well as global regulatory standards.

Combining hands-on Quality Control, Sterility, Inspection, and Compliant Operations with an educational leadership approach and natural business acumen, Vanessa brings 17+ years of real-time experience to deliver transformational real-world results.

Vanessa Figueroa leverages her combined knowledge of the Pharmaceutical, Biotechnology and Medical Decives industries to provide manufacturers across the US, Europe and India with critical laboratory operations management and personnel training programs to ensure compliance with cGMPs as well as global regulatory standards.

Combining hands-on Quality Control, Sterility, Inspection, and Compliant Operations with an educational leadership approach and natural business acumen, Vanessa brings 17+ years of real-time experience to deliver transformational real-world results.

Back To Top