IMA Life is pleased to take part in the 2024 ISPE Aseptic Conference.

Recent advancements in aseptic processing, such as advanced isolators, robotics, and increased automation, have transformed the industry whilst simultaneously reducing the risks of contamination for sterile products. However, modern therapies, innovative, targeted treatments that result in small-batch aseptic products, require faster speeds to market and present unique sterilization and handling challenges. This dichotomy presents unique challenges for the industry to address.

Moreover, the updated Annex 1 is impacting the manufacturing of sterile products, necessitating updated requirements such as Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems.

Programme highlights for the 2024 ISPE Aseptic Conference include:

• Regulatory Key Notes from the German and Austrian Authorities
• Industry Key Notes from the Austrian Pharma Association
• Technical discussions around the implementation of Annex 1
• Automation, use of robots
• A track on gloveless isolators with a moderated discussion with a large number of suppliers
• An international regulatory panel

The 2024 ISPE Aseptic Conference will provide an ideal opportunity for participants to share progress, success stories, best practices, and lessons learned. Get ahead of the game with a focus on novel therapies, emerging technologies, and aseptic processing.

We look forward to seeing you in Vienna, Austria!

Visit our tabletop n. 45 and do not miss IMA Life presentation on March 13^th at 2:30 PM, given by Giacomo Guidi, specialist for isolation technologies at IMA Life R&D department.

Title of the presentation
High Concentrated VPHP for Continuous Decontamination

Abstract of the presentation
An innovative decontamination system is presented where highly concentrated vapour phase hydrogen peroxide (HC-VPHP) is injected at high temperature into an open tunnel, suitable for 6-log high speed continuous decontamination of RTU material. The management of chamber pressures allows H₂O₂ to be kept confined and, in the same time, to achieve a robust killing effect in few seconds. The system qualification strategy is described: the CFD simulations and tests performed to ensure containment effectiveness are presented, as the outcomes of challenges on the microbiological abatement capacity of HC-VPHP. H₂O₂ residues studies on vials and syringes are another important presentation focus. A final discussion is provided concerning how this new continuous approach can be connected to aseptic fill-finish plants and what kind of advantages it can produce in terms of performance, operational flexibility and sterility assurance.