Fraunhofer Institute for Process Engineering and Packaging IVV
Microbiological validation of sterilization processes
The hygienic and safe packing of food and cosmetic products is often challenging. This process step largely determines the quality and shelf-life of the final product. Foods that are fresh or foods that easily spoil such as milk and dairy products and cosmetic products must be packaged under sterile or near-sterile conditions. In order to achieve this, the packaging is sterilized just before being filled with the products. Industry uses a variety of machine concepts and sterilization methods for this based on chemical or physical technologies. These must have precise and reproducible effects.
Determination of the efficiency of sterilization methods in filling plants
We perform microbiological validations in the form of challenge tests. These measure the effectiveness of the sterilization systems in your filling plants. Using defined methods such as artificially contaminated foods, cosmetics and packaging materials, we identify possible weak spots in your filling process and evaluate the overall effectiveness of your sterilization system. Based on the results we give you advice about process optimization and plant design. Simultaneously we offer validation of microbiological efficiency in accordance with VDMA recommendations and technical bulletins.
With controlled germinated packaging materials using standardized testing organisms, we assess filling processes for possible hazard points.
The results of the microbiological validation are used to assess how safe the disinfection and sterilisation processes used are.
We evaluate the efficiency of new physical disinfection processes, such as plasma technology.
Effective design of packaging processes for microbiological safety
Our offer
- Verification and quantification of the effectiveness of different sterilization methods in accordance with VDMA recommendations
- Identification of potential points of microbiological risk in the process chain in the development phase and also on start up on-site and for re-validation purposes
- Monitoring plant sterilization (sterilization-in-place)
- On-site validation of the effectiveness of sterilization
- Development of specific, resistance-tested bioindicators
- Microbiological tests on packaging materials
- Assessment of the overall hygienic state of production areas
- Evaluation of complex cases of contamination
- Advice on the development of sterilization systems