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The need to take advantage of new technologies and explore new ways for process control and efficiency permeates all areas of pharmaceutical manufacturing. Recent emerging technologies in aseptic processing such as advanced isolators, robotics, and increased automation have changed the industry and reduced contamination risks for sterile products. Simultaneously, modern therapies - new, targeted approaches to treatment resulting in small-batch aseptic products - are proving more difficult to sterilize and handle and requiring faster speeds to market. Furthermore, the updated Annex 1 will impact the manufacture of sterile products, setting new requirements for Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems. The requirement to re-think the existing standards is becoming more urgent.

Thus, as we slowly navigate to the post-COVID world and return to the new normal, ISPE’s Aseptic Conference wants to realign our focus. We welcome you to participate at the 2023 ISPE Aseptic Conference to learn and share progress, success stories, best practices and lessons learned. For more information visit the ISPE website.

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