IMA Life at the Pharma Microbiology Congress | 8-9 November 2023 (virtual) and 14 November 2023 (Milan, Italy)

IMA Life is pleased to take part in the Pharma Microbiology Congress, the European annual meeting point of professionals involved in the sterile manufacturing of medicinal products and medical device.

A full immersion on the latest regulatory updates, new technologies for the detection and containment of contamination, best practice and strategies to improve the sterility assurance of the manufacturing and control of sterile medicines.

Do not miss IMA Life presentations.

November 9, 2023 at 9:25 AM (CEST)

PRESENTATION TITLE AND ABSTRACT
Validation approach for a biodecontamination technology of pre-sterilised RTU (ready to use) containers in the aseptic filling line

In the next years there will be a great increase of Pre-sterilised RTU (Ready to use) containers such as syringes, vials and cartridges due to the growing of biological products, personalized medicines and investigational medicinal products. So the challenge will be introduce these systems into aseptic filling line with methods that avoid the contamination and follow main guidelines. This presentation will describe the methodology approach to validate a biodecontamination technology introduction in aseptic filling line for pre-sterilised RTU (Ready to use) containers.

SPEAKER

Alessandra Benassi Alessandra holds a Pharmacy degree from the University of Bologna. She deals with sterility assurance within IMA Life and also follows the validation of VHP cycles in isolated aseptic lines. She joined IMA Life in 2013; previously she worked in the field of quality assurance in a pharmaceutical company.

November 9, 2023 at 11:35 AM (CEST)

PRESENTATION TITLE AND ABSTRACT
INJECTA: full robotic solution for flexible and high-speed vials and syringes filling

The presentation describes how it is possible to apply “full robotic” solutions to high-speed filling systems, where the entire fill-finish process, on nested vials or syringes, takes place through the use of anthropomorphic robots. Unlike the current state of the art, the robots manage both the handling of nested containers, from their introduction into the isolated aseptic area to their extraction, and the filling operations. It is presented how this approach, core of the IMA Injecta filling systems, improves sterility assurance by adapting the system design to the requirements of the new GMP Annex 1 and at the same time provides high operational flexibility in handling different formats, while maintaining a production target up to 36000 containers/hour. Containers, vials or PFS, for large volumes or pharmaceutical specialties with high costs, required in case of advanced biologics or innovative therapies, can coexists with high-speed fillings of small volumes in classic PFS formats for large market distribution.

SPEAKER

Stefano Specchia

He is currently Product Manager for Aseptic Processing Solutions at IMA Life, a division of IMA S.p.A.
His main focuses in his current position are on robotized machines for aseptic filling of RTU containers and on freeze dryer automatic loading/unloading systems.
He joined IMA group in 2010 as Technical Engineer on automatic machines and then as Project Engineer of aseptic filling lines.