IMA Life at PDA Italy Event “Excellence on Manufacturing Process: from API to Filling”

IMA Life is pleased to announce its participation in the PDA Italy Chapter event “Excellence on Manufacturing Process: from API to Filling”, taking place on April 22–23, 2026, at the Stabilimento Chimico Farmaceutico Militare (SCFM) in Florence, Italy.

The two-day conference, organized by PDA Italy Chapter, will bring together industry experts, regulators, academia, and technology providers to discuss current and emerging practices across the pharmaceutical manufacturing chain – from API production to aseptic fill-finish. The agenda will focus on regulatory updates, engineering solutions, automation, and advanced technologies for sterile and parenteral drug manufacturing, with particular attention to high-speed and robotic aseptic filling systems.

Technical Presentation by IMA Life

As part of the conference program, Sergio Manera, from the R&D Department of IMA Life, will deliver a technical presentation entitled: “Scaling Up Aseptic PFS Manufacturing: A Case Study on Full Robotic High-Speed Filling Lines”

Abstract

High-speed aseptic filling lines for ready-to-use (RTU) pre-filled syringes (PFS) present significant challenges in terms of sterility assurance, layout complexity, and regulatory compliance, particularly when production rates exceed 300 containers per minute. This presentation describes the implementation of full robotic architectures in high-speed fill-finish systems for RTU syringes, where the entire aseptic process is performed within an isolated environment and managed exclusively by anthropomorphic robots. The proposed system design demonstrates a significant improvement in sterility assurance, achieved through intrinsic alignment with the requirements of the revised Annex 1, while maintaining high operational flexibility and a target productivity of up to 36,000 containers per hour. Computational Fluid Dynamics (CFD) analyses confirm compliance with the first air principle, despite high process speeds and compact equipment layouts. A case study of high-speed RTU syringe filling lines is presented, focusing on the technical and regulatory challenges. The architecture supports large-scale manufacturing processes facing regulatory challenges, high product sensitivity, and stringent operational requirements to maintain target productivity, enabling the production of large batches that may exceed one million PFS. The presentation also addresses downstream inspection systems capable of accurately detecting defects related to plunger presence and positioning.

IMA Life looks forward to contributing to the technical discussion and sharing its expertise in advanced robotic solutions for aseptic fill-finish processes. The event will represent an important opportunity to exchange knowledge with industry peers and regulators, and to explore innovative approaches to meet evolving regulatory and market requirements.