Project: New production process for medical bags based on RadioFrequency sterilization and ICT

The project proposes the study and the prototype realization of a new sterilization treatment and related prototype for the production of bags for pharmaceutical solutions where we adopt a quite innovative radio-frequency (RF) sterilization treatment._x000D_The sterilization of these bags is typically carried out by thermal treatment in autoclave. The bags are placed on undercarriages inserted in a steam or heated water autoclave: the pharmaceutical solution is carried to a temperature higher than 120 °C and it is COtained at this temperature for about 20 minutes._x000D_The autoclave processing introduces several limits to the production system, because it requires plastic materials with good thermal resistance characteristics, it is not compatible with bags filled with thermally sensitive pharmaceutical solutions, and the production must be a batch process, with consequent inefficiencies due to energy consumption, to productivity slowdown (because of intermediate storage areas), and to reduced safety because of risks of human errors in the production cycle. Others sterilization processes based on chemical solutions or gamma-ray are affected by serious problems about work safety, and they do not represent valid alternative solutions._x000D_In this project we propose an alternative solution for the sterilization of bags, based on RF fields that is effective against pathogenic agents and is approved by international health authorities. This solution guarantees several improvements at level of technology, production process, and industrial plant. _x000D_At the technological level, the innovative RF sterilization treatment is able to heat the material to be sterilized to high temperature in a short period of time. Moreover, the higher penetration of the electromagnetic fields ensures a uniform temperature within the entire bag and reduces the heating time. Furthermore, these RF fields can act on the mechanical properties of the cellular membranes, thus augmenting the sterilization effects with a combination of thermal and RF effects._x000D_The potential of RF sterilization in pharmaceutical contexts is known: theoretical studies demonstrate the effectiveness of RF sterilization for several pathogenic agents, like spores, bacteria, bacillus and some kinds of viruses, with exposition time of about 10 minutes. However, nobody has applied the theoretical results to industrial processes. In accordance with the new RF sterilization treatment, we plan to design and develop new plastic bags that are able to resist to RF electromagnetic fields exposure during the sterilization. It is important that the RF sterilization treatment will be continuously monitored and (locally and remotely)controlled through an innovative ICT system that has never been adopted in similar plants._x000D__x000D_The novel RF sterilization introduces significant changes to the bag production process that will pass from a batch production process with offline sterilization and storage areas that are managed by human operators, to a continuous production process where RF sterilization is applied to each bag. In the new process, all phases of welding, filling, identification and sterilization are embedded into the same automatic line where storage comes at the end of the entire treatment that does not require human intervention. The new system increases the productivity because the sterilization treatment is integrated into the production cycle and works without interruptions. The shorter sterilization time reduces energy consumption and, even more important, can extend the types of pharmaceutical solutions to the products that are thermally sensitive and unsuitable to the traditional sterilization mechanism._x000D_The new production process requires a new generation of ICT SCADA systems that are able to monitor and control every parameter of the plant, possibly from a remote location. The new production process controlled by innovative ICT solutions improve the quality and the safety of the final product. Indeed, traditional batch production processes with intermediate storages are prone to human errors with possibly fatal consequences. The fully automated production process, with bag-by bag sterilization and control, avoids human interventions and guarantees that for every bag the sterilization treatment conforms to the settled parameters._x000D__x000D_At the level of industrial plant, the simplification of the production process reduces the necessary facilities for plant installation. For example, traditional storage areas and autoclaves with their facilities for steam production are no longer necessary. The novel plant occupies a minor space, simplifies installation and COtenance, and decreases initial and periodic costs. _x000D_

Acronym SterilMed (Reference Number: 5049)
Duration 01/10/2009 - 31/03/2012
Project Topic The project aims to propose a new process to produce bags for pharmaceutical solutions. The new production plant is integrated with ICT and with an innovative sterilization system based on RF that combines rapid heating and amplification for the disruption of bacterial masses.
Project Results
(after finalisation)
It is a medical thermoplastic compound suitable to produce semi-finished products with which obtain flexible containers for pharmaceutical. The compound formulation has been optimised to produce sterilisation bags with radiofrequency sterilisation plants._x000D_The experiments that has been done highlighted by the way the great behaviour of the new compound if subject to the traditional sterilisation process. The new compound has the following characteristics:_x000D_- High workability that allows to obtain film with extrusion processes and tri dimensional components with injection printing processes_x000D_- It does not release components to the pharmaceutical solutions which it goes in contact with_x000D_- Weldable with the most common processes_x000D_- Recyclable_x000D_- Biocompatible_x000D_- Shrinkages inferior than to the one of the films actually in use_x000D_- Perfectly transparent to the electromagnetic fields_x000D_With the new compound have been developed a new series of intravenous bags of volume 100-250-500-1000 ml
Network Eurostars
Call Eurostars Cut-Off 3

Project partner

Number Name Role Country
3 SIPPEX SA Partner France
3 Università di Modena e Reggio Emilia, Centro di Ricerca Interdipartimentale sulla Sicurezza Partner Italy