Six participating project partners (FEP, IBMT, ITEM, IVV/AVV, IZFP, and IZI) are working in the future-oriented project “SteriHealth” on the development of new sterilization methods and highly-effective hygiene assurance processes to supply sterile packaged medicine products to hospitals, doctor’s offices, and nursing homes.

In Germany alone, the health care costs due to secondary infections are estimated at up to 7 billion Euros annually. Some the largest risk factors in medical treatment are postoperative and nosocomial infections as well as the increasing presence of antibiotic resistant pathogens. According to current numbers, it is assumed that 800,000 patients per year (incl. about 40,000 deaths) are infected in hospitals. Safe and flexible hygiene procedures are the basis for minimizing infection risks.

In particular, thermolabile micro- and tube systems, instruments, implants, and cell-therapeutic agents cannot be sterilized using the current hospital practice of hot steam sterilization methods. This is because of the high temperatures that are necessary for a long period. New sterilization technologies can thus reduce the enormous psychological and physical burden on affected patients. In addition, they can lead to high cost savings in health care.

An important part of the project is the development of a “mini-sterilizer” based on physical sterilization technologies at the Fraunhofer FEP. The Fraunhofer IBMT is contributing its competence in the area of design, development, and production of medical equipment. The test of the successful sterilization will be done using “challenge-tests” on clinically relevant micro-organisms and endotoxins at the Fraunhofer ITEM and IVV/AVV. At the same time, new packaging concepts will be developed at the Fraunhofer IVV/AVV to fulfil the high sterilization, processing, and storage process, as well as handling demands.

The Fraunhofer IBMT, ITEM, and IZI will evaluate the biocompatibility of radiated products to make their use for in vitro/in vivo as well as clinical applications (e.g. in regenerative medicine) possible. Another subproject at the Fraunhofer IZI deals with the use of highly efficient antibiotic peptides and plant ingredients which so far have not been applied clinically. They will minimize the risk of infecting the recipient with human pathogens from the donor material. To optimize the safety and to document the sterilization success, an integrated measuring and monitoring system in packaging and processing is planned at the Fraunhofer IZFP.

  • Supply of highly effective hygiene assurance processes specifically for thermolabile medicine products and cell therapeutic agents
  • Development/validation of the “mini-sterilizer” for quick and safe on-site sterilization
  • Development of new technologies and standards in medical technology

Fraunhofer-Institute for Toxicology and Experimental Medicine ITEM,
Nikolai-Fuchs-Straße 1,
30625 Hannover
Fraunhofer-Institute for Biomedical Engineering IBMT,
Ensheimer Straße 48,
66386 St. Ingbert
Fraunhofer-Institute for Cell Therapie and Immunology IZI,
Perlickstr. 1,
04103 Leipzig
Fraunhofer-Institute for Electron Beam and Plasma Technology FEP,
Winterbergstr. 28,
01277 Dresden
Fraunhofer-Institute for Process Engineering and Packaging IVV,
Giggenhauser Str. 35,
85354 Freising
Fraunhofer-Application Center for Processing Machinery and Packaging Technology AVV,
Heidelberger Str. 20,
01189 Dresden
Fraunhofer-Institute for Non-Distructive Testing IZFP,
Maria-Reiche-Str. 2,
01109 Dresden