Unlock the Future of Aseptic Processing at the 2025 ISPE Aseptic Conference
The pharmaceutical industry continues to face increasing demands for more efficient and effective manufacturing processes, particularly when it comes to aseptic processing. With an emphasis on safety, sterility, and the quality of biologics and injectables, the field of aseptic processing is critical for delivering life-saving medications. ISPE invites all pharmaceutical professionals to join the 2025 ISPE Aseptic Conference, where industry leaders will gather to share insights, innovations, and solutions that will shape the future of aseptic processing.
One of the most anticipated tracks at this year’s conference is the Sterilization and Release track, which focuses on the latest developments in sterilization technologies and decontamination techniques. This session will provide valuable insights for anyone working in aseptic processing, helping to ensure that pharmaceutical products are both safe and high-quality.
Sterilization and Release Track – Part One: Focus on Analytics – New Solutions and Methods, CCI, and Rapid Micro
This track will offer deep insights into the advanced analytics methods used in aseptic processing, focusing on solutions for sterility testing, container closure integrity (CCI), and the application of rapid microbiological methods.
1. Package Integrity: A Sensitive Dye Ingress Application
Alexandra Heussner, Laboratory Manager at Vetter Pharma, will present a session on package integrity testing using a sensitive dye ingress application. This technique is critical in ensuring that pharmaceutical products remain sterile throughout the packaging and distribution process. Heussner will explore how this innovative testing method improves package integrity assessment and ensures product safety.
2. Sterility Testing in Cell and Tissue Therapies
With the increasing use of cell and tissue therapies in the pharmaceutical industry, sterility testing methods must evolve to meet new challenges. Anthony Thatcher and Prethib Arumugam from Sumitomo Pharma America will present the latest advancements in sterility testing for these complex products, highlighting the unique considerations and protocols necessary to maintain sterility during the production of cell and tissue-based therapies.
3. ATP-based Alternative Microbial Methods for Product Quality Assessment of Biologic Drug Products
In this presentation, Talia Faison and Mada Arias with the US Food and Drug Administration (US FDA) will discuss adenosine triphosphate (ATP)-based microbial testing methods for assessing the quality of biologic drug products. This innovative approach allows for faster and more efficient microbial assessments, enabling quicker decision-making in the quality control process while maintaining the safety and efficacy of the products.
Sterilization and Release Track – Part Two: Focus on Sterilization – Decon
1. Theoretical Analysis of UltraSonic Aerosol Dispersion
The first presentation in this track will explore the theoretical underpinnings of ultrasonic aerosol dispersion. Presented by Koji Kawasaki from Airex and Hirokazu Sugiyama, PhD, from the University of Tokyo, Department of Chemical System Engineering, this session will delve into how ultrasonic technology can be used to improve sterilization and decontamination processes by dispersing aerosols in a controlled manner. Attendees will gain a deeper understanding of the potential applications of this cutting-edge technology in enhancing sterility within production zones.
2. Integrated Vaporized Hydrogen Peroxide (VHP) Technology for Production Zones/Restricted Access Barrier Systems (RABS)
Next, Bruno Aze from STERIS will discuss the integration of VHP technology in production zones and RABS. VHP is widely used for sterilization due to its effectiveness in eliminating microbial contamination. In this session, Aze will examine how integrating VHP technology into production zones can streamline the decontamination process, reduce downtime, and improve overall operational efficiency.
3. Can We In-situ Steam in Place (SIP) Indirect Contact Items (Bowls/Lanes)?
The final presentation in this track will feature Geert Vandenbossche, PhD, from C&E Solutions BV, who will explore the feasibility of in-situ SIP for indirect contact items such as bowls and lanes in aseptic processing environments. This innovative approach could significantly reduce the need for disassembly during cleaning and sterilization, improving the overall efficiency of the process and minimizing the risk of contamination.
This track offers a unique opportunity to dive deep into the latest sterilization and decontamination technologies. If you're looking to stay ahead of the curve in aseptic processing, this session is a must-attend. Register now to secure a spot and gain valuable knowledge that will help optimize operations and maintain the highest standards of sterility.
Why Professionals Should Attend
The 2025 ISPE Aseptic Conference offers attendees the chance to gain in-depth knowledge and practical strategies from industry leaders and experts. With presentations on the latest innovations in sterilization, contamination control, regulatory compliance, and sterility testing, this conference is a valuable opportunity for professionals to stay ahead of the curve.
Attendees will:
- Gain expert insights on emerging trends and technologies shaping aseptic processing
- Learn best practices for overcoming industry challenges such as contamination control and process consistency
- Stay informed on the latest regulatory developments and compliance standards
- Network with other professionals in the pharmaceutical and biotech industries
This is an opportunity attendees won’t want to miss—register today and secure a seat at this pivotal event for aseptic processing professionals!
