How Did It Go

The Pharmapack Symposium organized by Stevanato Group was held for the first time in Dublin, Ireland, on June 21st at The Spencer Hotel with the title: “Primary Packaging and Drug Delivery Trends for Injectables”.

Dr. Fabiano Nicoletti, Honorary President of the International Commission on Glass, chaired it and 25 top-representatives from Pharmaceutical companies based in Ireland and UK attended it.

The presentations provided by 12 industry experts around the various technologies & solutions for aseptic manufacturing gave the audience the possibility to learn more about the ready-to-use systems, including two real case studies from two major companies. The audience was also actively engaged in the Q&A sessions with the presenters.

The Symposium was sponsored by Stevanato Group, Nelson Labs, KeyPlants, West, IMA Life, Merck and Ypsomed.

The first speech gave a good overview of regulatory requirements, especially in the domain of sterile packaging and analytical test methods that has become more and more stringent (such ISO 11040-4 and ISO 11040-7, ISO 11040-8, ISO DIS 21881 and ISO DIS 21882). The second presenter explored how the use of technologies such as modular production facilities, single-use and ready to use materials are lowering some of the historic barriers of producing vaccines and biologics in dynamic countries such as Africa.

A PharmaCo presented its case study covering various aspects taken into account while introducing its state of the art aseptic filling line: from conceptual design through to PPQ manufacture using the ASTM validation approach.

 

The symposium then followed with a presentation showing how analytical testing labs need to be on the forefront with expertise in the field of extractables and leachables testing and state-of –the art technology to face the reality of the ever-evolving regulatory landscape.  Also with regards to the analytical services, a presentation on how to assure the drug quality and stability through a comprehensive set of laboratory tests on glass primary packaging was delivered.

A presentation analyzed different packaging options for Ready-to-Sterilize and Ready-to-Use components adapted to the customer needs and provided insights on the impact of different sterilization methods on extractable profiles or functionality.

The last part of the symposium was dedicated to the manufacturing side with a presentation on

how modularization and off-site construction can be the most flexible solutions for the next generation of “plug & play” solutions-based facilities. In this sense an overview of the most state-of-the-art flexible filling technology was provided

It was also offered an holistic view on how a combined set of capabilities, from project management to manufacturing assets through device integration, can help mitigate the risk associated to the development challenges. The symposium ended with a few presentations on the current solutions in terms of larger volume injection devices including patch-injectors, addressing the demand for smart injection devices that operate within connected healthcare ecosystems as well as with a presentation of single use technologies to mitigate the risk during final fill assembly design, manufacturing, and use and integrated engineering capabilities for the manufacture of drug delivery systems.