Cold Plasma Sterilization of Medical Devices – PLASSTER

The effect of cold plasma treatment on materials will be treated as follows:
1. Collection of materials to be analyzed, identifying specifications, preparation of test specimens and samples.
2. Characterization of the materials before and after cold plasma sterilization treatment
3. Characterization of the packaging container before and after sterilization by cold plasma
4. After the process optimization stage, a characterization of preselected materials after cold plasma sterilization in the optimized conditions will be performed.
The microbiological study will check the efficiency of plasma against bacteria, spores and viruses. The used techniques include: the spores and bacterial enumeration and titration for the virus. The physiology of microorganisms will be processed in order to study the mechanisms lethality induced plasma. Analysis by scanning electron microscopy and fluorescence will be developed. The study of the impact of cold plasma on bacterial toxins will verify of the absence of toxicity or inflammatory reaction generated by cold plasma sterilization.
Characterization of cold plasma will be mainly performed by plasma spectroscopy (UV-Visible) through the sterilization pouch. In the presence of contaminated DM, research will be oriented in the identification of indicators that enables the monitoring of treatment process.
In the end an interfacing with the control of the prototype will be implemented. As the final objective of the project is the realization of a demonstrator, the drafting of the specifications of this demonstrator will be based on the results of studies on the plasma interaction with microorganisms and materials of the medical devices

Performing a Cold plasma sterilization prototype whose effectiveness has been validated. The sterile state is maintained because the plasma is generated goshawks the DM that is pre-packaged.

TRL7 to TRL9

Z. Ben Belgacem, F. Velard, D. Laurent-Maquin, J.M. Popot, B. Cauwe , M. Boudifa, S. Gangloff, M.P. Gellé. « New sterilization process by non thermal plasma discharge inside disposable bag ». In 19th International Conference on Plasma Processes with IVC-19, Paris, September 9-13, 2013.

The Plas'ster project concerns the sterilization of materials and biomaterials used in medical devices. In the medical field, the most commonly used methods for sterilization of implantable or non implantable devices are steam sterilization (autoclave), ionizing radiation (gamma radiation) and ethylene oxide. The evolution of medical techniques and technologies and the emergence of new materials have led to great advances in medicine.
Medical devices are listed in four categories and represent a very heterogeneous set ranging from wheelchair, eye lenses, pacemakers, biological glues, to bone filling products ? Application fields are wide and include among other orthopedics, ophthalmology, dentistry, nephrology, general surgery ... However, the sterilization of some of these new devices presents some difficulty linked to their vunerability to sterilizing agents (physical or chemical). Thus, new ways of sterilization are studied at present.
One of the most promising methods is the cold plasma sterilization.
This technique is based on the ionisation of a gas or gas mixture.
Many studies have demonstrated the efficacy of a plasma on microorganisms inactivation. However, the possibility for preservation of sterility through this technique was rarely studied, and, in addition, there are few studies on the effects of plasma on materials and/or biocompatibility in the case of implantable devices.
The project is based on the development of a sterilization process by cold plasmas and conservation of the sterilization state of delicate medical devices, meaning sensitive to temperature, humidity or radiation. Conservation of the sterilization will be guarenteed by direct treatment inside the transport pouch.
Based on the combined experience of CRITT-MDTS, EA " Biomaterials and Inflammation in Bone Site" (EA 4691, ex INSERM UMR-S 926) and GREMI, this project will allow a multi-disciplinary approach. This will cover different aspects: the compliance with standards for sterilization of medical devices; conservation and integrity of the characteristics of devices subject to the plasmas, the integration of organic devices by checking the absence of toxicity or inflammatory reaction generated by the sterilization, the characterization of plasma species.
Validating key data and conceptualization of an apparatus able to reach the main objective meaning sterilization and conservation of sterile condition, this project will lead to the industrialization of the plasma sterilization process for applications in hospitals or production sites while satisfying the regulations from health authorities.