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Eco-friendly Pharma: Sterilization and Sustainable Practices

Keith W. Weseli, CPIP
Massimiliano Cesarini, MSEng
Eco-friendly Pharma: Sterilization and Sustainable Practices

In the intricate world of pharmaceuticals, where precision and safety are paramount, the marriage of innovation and sustainability is not just an aspiration—it's a necessity. Picture a scenario where the pursuit of product purity meets the responsibility to our planet. Welcome to the realm of "Eco-friendly Pharma: Sterilization and Sustainable Practices." As we embark on this exploration, imagine a future where sterile environments not only safeguard the integrity of pharmaceuticals but also dance harmoniously with the rhythms of sustainability. Today, we unravel the fascinating narrative of how cutting-edge sterilization processes and aseptic manufacturing can converge with eco-conscious practices, ushering in an era of greener pharmaceutical excellence.

Now, you might be wondering why we're tackling both Sustainability and Sterilization in a single post. Fair question. As it happens, the upcoming 2024 ISPE Aseptic Conference will feature dedicated tracks for each topic, complete with specific outlines and presentations by industry experts. However, we've decided to bring them together as sterilization processes play a fundamental role in the aseptic process. If Sustainability isn't part of that conversation, we might be missing a significant piece of the puzzle.

2023 ISPE Pharma 4.0™ and Annex 1 Conference

With that said, let's delve into the outlines of the two tracks, offering a sneak peek into what attending these sessions at the Aseptic Conference might look like. Get ready for a taste of what's to come and let the anticipation build.

Sterilization processes remove the potential for sustainability of objectionable, potentially life-threatening contaminants from aseptically produced products. The sterilization track will include three separate presentations on this centerpiece of aseptic processing. The sterility test pulls statistically based samples to control quality for the batch, after production. What if sterility could be verified during the manufacturing process? Stephan Heck, Site Quality Director from the Bracco Group will show us that parametric release secures better statistical coverage for the entire batch while it allows to speed up the release process at the same time. By setting it up right it offers a win-win situation, improving manufacturers’ productivity and strengthening patient safety at the same time. We will hear one firm’s journey on this path and the regulatory background and the practical aspects of implementation.

Sterilization processes require a variety of complex equipment for execution. The latest version of European Union EudraLex Volume 4 Annex 1 (or simply Annex 1), pharmaceutical manufacturers must evaluate maintenance of product contact equipment through cleaning and sterilization as part of the Contamination Control Strategy (CCS). According to Annex 1, the CCS includes a set of controls for microorganisms, endotoxin/pyrogens, and particles to ensure process performance and product quality. It is especially critical to define the contamination risks and identify appropriate controls for critical surfaces, namely product contact equipment that is cleaned, sterilized, and used in parenteral drug manufacturing. Aaron Merton , Senior Manager, Technical Services from Steri s will walk us through an example “life cycle” for product contact equipment, identifying potential contamination risks and mitigation solutions, to demonstrate best practices for achieving CCS implementation and regulatory compliance.

Maria Luisa Bernuzzi, Products and Application Engineer from Mesa France will dive deeply into sterilization validation by providing both the scientific background justifying the rationale of a validation approach and then proceed into a case study. The overkill approach has always been the simplest approach for the biological validation of a load, but some regulatory requirements are making it more complex to develop it. We will ultimately be given an “everyday procedure” for validating a batch of sterilized stoppers—one of the many applicable takeaways that the sterilization track will offer attendees.

Sustainability in Aseptic Processing

Incorporating sustainable practices into aseptic processing is not merely an imperative; it's a realm ripe for significant improvement. Historically, the stringent demands of contamination control have, at times, served as a veiled excuse to relegate sustainability to the sidelines in aseptic processing. However, a promising paradigm shift is underway. The industry boasts inspiring real-life examples and groundbreaking research, charting a course for a transformative approach where neither product safety nor environmental responsibility takes a backseat. The interventions are diverse, spanning from energy consumption reduction to the adoption of reusable materials.

As we look forward to the Sustainability track at the 2024 ISPE Aseptic Conference in Vienna, Austria on 12-13 March 2024, anticipation builds. Our sessions will feature thought leaders such as Christopher Berridge, Global Technical Consultant from Bioquell and Don Singer, Senior Microbiology Technical Consultant, North America from Ecolab, guiding us through the sustainability nuances of biodecontamination systems. Matt Hall, Technical Affairs Director from Corning Pharmaceutical Technologies will offer a fresh perspective on the Life Cycle Assessment of Glass Packaging. Jochen Schmidt-Nawrot, Fellow Process Utilities from CRB Group will delve into water systems and their role in enhancing sustainability attributes. Finally, Markus Burkert, Product Manager Sustainability from Syntegon Technology will unravel initiatives aimed at achieving CO2 neutral status, right down to the level of machine operations and raw materials. These sessions promise to be a captivating exploration of the forefront of sustainability in aseptic processing.

Get ready for insightful discussions and a glimpse into the future of eco-friendly pharmaceutical practices!

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