Fraunhofer Institute for Process Engineering and Packaging IVV
Microbiological validation of sterilization processes
Increase the safety of your products with microbiological validation
Filling food and cosmetics hygienically and safely is a challenge in many cases, but is crucial to the quality and shelf life of the end product. To support you in this, we offer comprehensive microbiological validation of your sterilization processes so that packaging and filling processes can be designed safely and resource-efficiently.
Microbiological challenge tests reveal weak points in the sterilization process
We use microbiological challenge tests to validate the effectiveness of your disinfection process and identify potential weaknesses or areas for improvement. We use process-specific bioindicators that are individually generated using special disinfection processes and resistance-checked test organisms. In this way, we create the basis for meaningful results.
Validation of sterilization processes for packaging and systems
We perform microbiological validations in the form of challenge tests to determine the performance of your filling system's sterilization processes. From the development phase to on-site commissioning and revalidation, we can help you identify potential microbiological weaknesses in your process chain.
We also advise on process optimization and system design
Using defined test organisms, we precisely quantify the inactivation efficiency of your packaging and machine sterilization. For this purpose, bioindicators (artificially contaminated carrier materials such as packaging or machine parts) are introduced into the real process. Based on the results of the microbiological validation, we advise you on process optimization and system design. At the same time, we provide you with microbiological proof of efficacy in accordance with the recommendations and information sheets of the VDMA.
Regular tests and inspections help to assess the functionality of filling systems and to identify potential weak points. They also provide transparent evidence for audits and documentation.
Our service portfolio for validation
- Verification and quantification of the performance of different disinfection processes in accordance with VDMA recommendations
- Identification of potential microbiological hazards in the process chain as early as the development phase, during commissioning on site and during revalidations
- Inspection of system sterilization (sterilization-in-place)
- Location-resolved verification of sterilization performance
- Development of specific, resistance-tested bioindicators
- Microbiological packaging material tests
- Advice on the development of sterilization systems
Challenge tests for the validation of heating processes
We use microbiological challenge tests as an important tool to validate and verify the effectiveness of heating processes in food production. In this way, we ensure that potentially pathogenic microorganisms are reduced to a safe level by heating and that product safety and shelf life are guaranteed. The product is specifically inoculated with relevant microorganisms (e.g. Salmonella, Listeria) under controlled conditions to test the inactivation of these pathogens by the specific heating process in the specific matrix.
Influence of food properties
The need for microbiological challenge tests arises from the fact that the composition and properties of the food (such as pH, sugar content, salt content, protein content, etc.) can strongly influence the D and z values of microorganisms. A challenge test examines the mortality behavior of microorganisms in the food matrix under standardized, practical conditions.
Challenge tests result in critical control points
The results (D and z values) of a challenge test provide information on the temperature and duration of the heating process required to achieve the desired microbial reduction. The data obtained helps to define critical control points as part of HACCP concepts and to confirm that the heating process is sufficiently robust to minimize potential microbiological risks. It is also possible to optimize oversized heating processes to save energy.
Our service portfolio for challenge tests
- Isolation and identification of microbial contaminants
- Support in determining the cause of microbial contamination
- Determination of D and z values of relevant microorganisms in the product matrix
- Artificial bacterial contamination of food products for challenge testing, including apathogenic surrogates
- Evaluation of heating processes for packaged products on a laboratory scale by practical simulation of the real heating process
- Identification of potential microbiological hazards in the process chain during development, on-site commissioning and revalidation
- Assessment of the overall hygienic condition of the operating rooms
- Determination of the causes of complex failures