IMA Life at A3P Barrier Technologies – Lyophilization • 25-26 June 2025

IMA Life is pleased to take part in the 2025 A3P Barrier Technologies – Lyophilization. The event will address the future challenges facing the industry through technical and regulatory issues, and provide answers through practical applications.

Visit IMA tabletop #11 in the exhibition area to meet our experts and do not miss IMA Life presentations.

• 25 June 2025 at 12:00 – Speaker: Giacomo Guidi R&D Isolation Technology at IMA Life

Design Strategies for Annex 1 Compliant Aseptic Filling Lines and Innovative Transfer Solutions for RTU Components

The new revised GMP Annex 1 introduces stricter requirements for the design of aseptic filling lines and related barrier solutions. A key aspect involves the handling of Ready-To-Use (RTU) components, where No-Touch Transfer (NTT) methods are preferred to prevent contamination during introduction into Grade A zones. As alternative surface decontamination solutions, such as Nebula HC-VHP, could be considered. This presentation outlines compliant design strategies for aseptic processes, aligned with Annex 1, highlighting technologies that support sterility assurance and regulatory adherence.

• 25 June 2025 at 14:30 – Speaker: Philippe Selsis – Area Manager at IMA France

Next Generation Freeze Dryer Cooling

The next generation of refrigeration technologies for freeze dryers is focused on reducing environmental impact while ensuring optimal performance. With growing concerns about climate change and the phase-out of high global warming potential (GWP) refrigerants, there is a significant push towards alternative solutions. Lower GWP refrigerants, such as natural refrigerants and newer synthetic options, will be discussed.  Air-based refrigeration systems, which utilize ambient air as a cooling medium, present a promising direction, especially for energy-conscious operations. Additionally, liquid nitrogen, known for its low temperature capabilities, remains a proven solution with high reliability, low maintenance and outstanding performance.  This abstract highlights the innovations in refrigeration for freeze dryers, addressing both sustainability and operational efficiency, while paving the way for environmentally responsible and energy-efficient solutions in the future.

• 26 June 2025 at 10:30 – Speaker: Giacomo Guidi R&D Isolation Technology at IMA Life

 Advanced Robotic Solutions for Aseptic Filling: Design and case studies of Multi-Role Line for vials and PFS

This presentation outlines the implementation of a fully robotic and automated solutions for aseptic fill-finish operations. Injecta system enables fully automatic no-touch-transfer handling of RTU components through the use of robotic arms and it is designed with a modular and flexible architecture. it supports multi-purpose configurations suitable for different container types and production scales, from clinical trials to high-volume manufacturing. A specific case study will be presented, focusing on a multi-role filling line for both vials and pre-filled syringes, including freeze-dried products. The line is designed to manage high-potent and biohazardous compounds, integrating appropriate containment measures and barrier technologies to ensure both operator safety and product sterility.

• 26 June at 12:00 – Speaker: Philippe Selsis – Area Manager at IMA France

 Kryoseq controlled nucleation – unlocking the power of unmatched control

Lyophilization plays a pivotal role in the stabilization of pharmaceutical compounds, making the control and repeatability of the lyophilization process critical to ensuring consistent, high-quality products. While the primary and secondary drying phases are often well-controlled, the lack of precise control over the ice nucleation temperature, the point at which freezing begins, can lead to variations in product uniformity, resulting in suboptimal freeze-drying cycles. KRYOSEQ® Nucleation is an innovative, advanced controlled nucleation technology that overcomes these challenges by generating sterile cryogenic ice fog and circulating it within the lyophilizer chamber, ensuring consistent and timely top-down nucleation of vial-contained pharmaceutical formulations at the optimal temperature.

Location

Tours Convention Center

26 Boulevard Heurteloup 37000 Tours

France