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Zawartość zarchiwizowana w dniu 2024-06-18

Light-based technologies for the decontamination of powdered infant formula

Final Report Summary - BABY-SAFE (Light-based technologies for the decontamination of powdered infant formula)

Executive Summary:
Powdered infant formula (PIF) is the most widespread and established alternative to the breastfeeding of the newborn. Despite preservation steps during production, cases of contaminated formula as a result of Salmonella spp. and Cronobacter sakazakii have been reported, which can lead to brain damage or death in babies and infants.
A European consortium of 9 members counting small, medium and large enterprises of the dairy industry, as well as research centres, have participated in the BABYSAFE project to develop a novel system for the reduction of microbial contamination of infant formula by using a processing system based on calculated exposure to continuous UV-C light in combination with a fluidised bed system. Such a system enables the mixing and transport of the powdered infant formula, whilst exposing the powder to the bactericidal effect of the light. The BABYSAFE technology provides infant formula manufacturers with an additional unit operation, which can be included downstream in the manufacturing process (blending and packing) to reduce the levels of pathogenic and other microorganisms as well as reducing the risk of infant formula recontamination; without compromising the quality of the product. The system has been designed to be safe, effective, affordable, energy efficient, and environmentally friendly.

Today’s challenge
PIF is not a sterile product and can be contaminated with bacteria during the manufacturing process or if not handled properly, potentially threatening the health of babies and infants when it reaches the market. The use of high temperatures during processing is effective in ensuring the safety of the product but can cause protein denaturation and loss of nutritive value. Due to compositional differences, cows milk, the usual base for infant formula, is normally supplemented with a range of bioactive ingredients including heat sensitive vitamins and proteins such as Lactoferrin in order to resemble breast milk more closely. Such additional steps can lead to recontamination of the PIF after thermal processing. As such, there is a need to provide manufacturers with a reliable treatment method that reduces the microbial load and yet does not diminish the nutritional quality of the formula.
Past research showed the effectiveness of light technologies for surface decontamination in packaging, for treatment of various beverages, and for the decontamination of vegetative microorganisms. The first year of the BABYSAFE project built on past research to design a PIF decontamination system that could reduce the levels of pathogenic microorganisms, without compromising the nutritional quality of the product. During the second year of the project, a reliable pre-competitive prototype was built and its effectiveness validated in industrial-like conditions (i.e. working in continuous for a long periods of time). .
The project has proven the BABYSAFE concept and demonstrated the system to the industry, however the results are at precompetitive scale, and further scale up work and demonstration effort is required now in a post-project phase. Such developments could make the technology accessible to European SMEs, whereby they will benefit from being able to differentiate their products and market them as a value added commodity. The impact of the BABYSAFE technology for the health and safety of babies and infants, for increased consumer confidence / product and brand security and peace of mind, coupled with the reduced risk of costly product recalls are significant. Moreover, the BABYSAFE process can be extended to safeguard other powdered ingredients which can be treated to reduce microbial / pathogenic contamination. Moreover, this solution has the potential to extend to other product ranges where powdered ingredients or particulate are to be treated to reduce the microbial contamination.

Project Context and Objectives:
The overall objective of the BABYSAFE project was to develop a pre-competitive system for the treatment and decontamination of PIF based on continuous UV and pulsed high intensity light technologies combined with a fluidised bed.

In order to achieve the above, the technical and operational objectives that needed to be fulfilled are provided below:
1. To carry out in depth consultations with a representative sample of infant formula manufacturers to establish their requirements in terms of product decontamination, and to establish the regulatory requirements for the introduction of a processing step such as the one proposed by BABYSAFE.
2. To use the findings of previous consultations, as well as those of an in-depth literature and market research, to define the specifications of the BABYSAFE system.
3. To assemble a laboratory test rig (batch unit) that will enable UCD to investigate several operating conditions.
4. To carry out antimicrobial trials in the lab on formula that has been purposely contaminated with microorganisms of concern and at different light dosage and microbial contamination, in order to assess the efficacy of the technology to inactivate microorganisms.
5. To identify the optimum processing conditions that can ensure retention of the nutritional and organoleptic properties of the product (e.g. protein quality and content, fatty acid profile).
6. To evaluate the nutritional, quality and shelf-life performance of the lab scale produced products.
7. To define the parameters from the data from the laboratory batch system that will feed into the design and manufacturing of the pre-commercial BABYSAFE prototype.
8. To draw up industrial designs for the BABYSAFE precompetitive prototype in keeping with specifications defined as a result of consultations with industry in WP1 and in keeping with the parameters defined from the laboratory work carried out in WP2.
9. To build a precompetitive BABYSAFE prototype following the designs from objective 8 above and to integrate the system software and controls.
10. To install and test the functionality of the BABYSAFE system in a real industrial environment.
11. To validate the BABYSAFE prototype, by carrying out tests on powdered product that has been treated with it and by comparing the results with those of powdered infant formula produced following current industrial practice (WP4, achieved).
12. To facilitate the uptake of the BABYSAFE results by the participating SMEs of the consortium, as well as a wider audience of SMEs and stakeholders from the food supply and value chains (WP5, WP6, achieved).
13. To carefully outline scaling-up rules and development work towards a fully commercial system so that the SMEs are provided with the knowledge that they need to exploit the results in the market.

Project Results:
As part of WORK PACKAGE 1, the project started by gaining in-depth understanding of the technological needs of the European PIF and ingredient producers, as well as perceptions in terms of product safety and quality. This was done in order define the industrial specifications of the BABYSAFE decontamination technology. A semi-structured questionnaire was prepared to serve as a basis for direct in-depth consultations with industry representatives. Some of these consultations were made via plant visits, whereas others were made via personal or phone interviews. In total 7 in-depth consultations were made to manufacturers in Austria, Ireland, Spain and Turkey.
As an addition to the consultations, a comprehensive literature, patent and legislation review was carried out, in order to update the state-of-the-art in terms of surface decontamination using light technologies, and to identify relevant patents and legislation that had to be considered for the definition of the specifications of the system. As a result of the information gathered in WP1, the overall system specifications and performance characteristics of the BABYSAFE system were defined. The overall and individual component specifications will be key to the design of the industrial prototype.

In parallel to the previous work package, WORK PACKAGE 2 started by IRIS designing and building a test-rig needed by UCD to perform laboratory analysis planned under this WP. Before conducting any experimental work, a detailed characterisation of the two light technologies was performed in terms of the a) energy delivered and consequently absorbed by the product and b) the temperature profiles during processing. Preliminary results in clear liquid suspensions showed that HILP and continuous UV-C technologies have a strong potential to inactivate three vegetative bacteria of public health significance that can be found in PIF (Salmonella spp., Cronobacter sakazakii and L. innocua as a surrogate for L. monocytogenes). A further set of experiments demonstrated the ability of these technologies to inactivate bacteria in a dry state model (i.e. soda lime glass and polytetrafluoroethylene beads), which is the environment they will encounter in PIF. The next step was to assess microbial inactivation in PIF with the BABYSAFE test-rig. Different fluidisation approaches were tested and based on the results obtained, the Consortium decided to focus on the ability of HILP and continuous UV-C light treatments to inactivate microorganisms in a thin layer of PIF, which enhanced the level of sample exposure. Under such conditions, both technologies have the capability to improve the safety of PIF. The next step was to assess the physico-chemical properties (proximate analysis, moisture, colour, powder particle size and viscosity of the reconstituted formula), lipid oxidation and the enzymatic degradation of the powder infant formula exposed to different ‘mild’ and ‘severe’ light treatments. Sensory tests were also performed to gather information on consumer’s opinion. Based on the knowledge gained and results obtained in WP2, design recommendations were made for BABYSAFE technology-scale up, including exposure time, emission wavelength, location of the lamps, building materials and air and moisture considerations.

Initial work in WORK PACKAGE 3 resulted in a range of conveying system design concepts that were subjected to discussion among RTDs (especially IRIS and UCD) and the industrial partners. Since the treatment of thin layers of powder had been proven to be efficient at lab scale, concepts based on this idea (e.g. plaster-printing inspired approach, conveyor belt approach, etc) were included in the discussions, however these had to be discarded later due to the complexity in the integration of such a system in an actual production line.
It was finally decided to use a fluidised bed as conveying system (as originally written in the DoW). A commercially available fluidised bed, with some adaptations that would allow to meet the project needs, was found to be the most suitable and reliable way to face this challenge. The processing capacity of the pre-competitive prototype had to be downscaled (as compared to the original system specifications defined in WP1) to fit within the prototype´s budget limitations.
Technical advances and findings in the project suggested that continuous UV-C coupled with a fluidised bed was the technology the Consortium may decide to adopt (as opposed to the original idea of combining continuous UV-C and HILP lights with a fluidised bed). Since continuous UV-C light on its own had proven to be able to provide sufficient microbial kill in WP2, the final prototype design included a continuous UV-C light lamp integrated into the chamber of a fluidised bed, placed in such a way that all the particles moving within the chamber would receive an appropriate light dose.
A commercially available small scale bench-top fluidised bed unit was purchased and modified. It comprises a perforated plate with a mesh to fluidise the PIF, a decompression chamber where the powder moves around the UV-C light and blow back filters to prevent the powder from coming out of the system. The system includes a pneumatic vibration system to prevent powder from sticking to the chamber walls, as well as an inspection window to easily check how the powder behaves inside the decompression chamber. UV-C light is supplied by low pressure mercury lamp placed vertically in the centre of the decompression chamber, which acts as the treatment chamber. The fluidised bed comprises a control system, accessible through a control panel, which is ready to precisely control air flow, pressure and temperature, as well as blow back intervals. The UV-C lamp is powered by an electronic ballast, while a power monitor ensures that the lamp is working within the desired parameters.
The functionality tests performed at IRIS allowed for optimal operating and process parameters to be identified prior to starting industrial-like validation trials.

WORK PACKAGE 4 started by agreeing on the set of safety and quality parameters that would be evaluated during the validation process. Such parameters were based on legal provisions, as well as on inputs given by participating companies. Selected parameters were compiled in a catalogue of requirements, including default parameter values and acceptable deviations.
A cross-validation of PIF that had been light-treated at lab scale (under four sets of conditions: HILP and UV-C at ‘mild’ and ‘severe’ conditions) was performed with the aim of evaluating the quality and safety of such products. The examined samples did not showed indications of significant adverse effects of light treatments on PIF immediately after treatment. This leads to the conclusion that, by choosing an appropriate energy level, nutritional values can be preserved and the safety and quality of the PIF assured.
Expanded shelf-life tests of samples from laboratory trials were also performed, where the objective was to investigate the stability of the formula at microbial, nutritional and physico-chemical quality level. The samples were analysed after treatment with the batch system operating at laboratory scale and subsequent storage. In general the examined nutritional parameters were affected only to a little extent by the UV-C light treatment over time, and test results merely deviated within anticipated statistical tolerances. Samples having undergone HILP processing showed significant losses in some nutritional parameters. Microbiological examination resulted in a positive assessment of the hygienic status of all analysed samples processed either with under UV-C or HILP conditions over the whole storage period.
Finally, the analysis of samples treated with the BABYSAFE prototype at industrial-like conditions (i.e. working in continuous for long periods of time) was performed in this WP. The examination of selected parameters resulted in the assessment of the BABYSAFE treatment as mild regarding preservation of the nutrient content, colour and whey proteins. For every species of pathogenic microorganisms for which legal requirements are set up, BABYSAFE treatment has fulfilled the respective demands, i.e. the values for Bacillus cereus, as well as Salmonella spp., Cronobacter sakazakii and Listeria monocytogenes were found to comply with legislation in the examined samples.
The choice of treatment temperature and duration allows for the setting of an appropriate BABYASAFE treatment energy level, which serves for the improvement of the microbiological safety of the product and preservation of nutritional quality.

In WORK PACKAGE 5, the Consortium decided that the industrial trials would take place at IRIS. This allowed for an extended functionality evaluation at lab scale, as well as for industrial-like trials (i.e. working in continuous for a long periods of time) performed with non-inoculated PIF samples (i.e. samples produced following current industrial practice, results reported in WP4) and with inoculated PIF samples (i.e. samples that posed an additional challenge to the technology). The latter trials have been performed in addition to the tasks originally planned in the work programme.
Samples were inoculated with microorganisms for which legal requirements are set up and previously selected in WP2. Listeria and Salmonella resulted to be the most sensitive species to BABYSAFE treatments and Bacillus the most resistant one.
Statistical analysis elaborated from the results obtained show increasing microbial inactivation with increasing BABYSAFE treatment intensity (i.e. treatment time and air temperature). The most effective treatment among those tested would be compatible with industrial scenarios.
All in all, the industrial-like validation trials demonstrated that the BABYSAFE technology can contribute to increasing the safety of powdered infant formula without significantly altering their nutritional and quality characteristics.

As part of WORK PACKAGE 6, training activities were performed throughout project to ensure a profitable knowledge transfer from the RTDs to the technical and managerial staff of the industrial partners of the Consortium. Training activities consisted of a complementary approach based on written documentation, two on-site training sessions and a video clip for the Consortium members. Such activties were fundamental to facilitate acceptance and future uptake and exploitation of the results of the BABYSAFE project by the participant SMEs.

In WORK PACKAGE 7, knowledge management-related matters that have emerged from the project have been managed. The aspects of the foreground and their novelty have been presented and discussed during the project meetings based on the results of the RTD work. A Joint Exploitation Agreement has been negotiated and agreed by all partners, which outlines the way in which the SMEs will protect, own, share and exploit the foreground. A dissemination strategy has been in place to ensure that non-confidential BABYSAFE information is disseminated as widely as possible. A project website (http://www.babysafe-fp7.eu) was created and used to inform the public and interested parties on the basics of the technology, latest news and the progress of the project insofar as it can be disseminated without threatening the proper protection of the developed IP. Project poster and leaflet were prepared, printed and distributed to raise the awareness of BABYSAFE both in industry and in the public domain. Overall, 77 dissemination activities have been carried out throughout 24 months. The project has been disseminated among the scientific community via oral presentations and posters at conferences.

Potential Impact:
The BABYSAFE process results in a safer product which is critical to manufacturers of this premium, highly emotive and sensitive product.
- Additional unit operation - that can be seamlessly included downstream in the manufacturing process to reduce microbial contamination / (re)contamination risk in the finished product.
- Increased product safety - a very powerful selling point in the market place, which will be well received by shareholders (brand security) consumers and retailers, stimulating market demand, sales, turnover and growth.
- Longer shelf-life - the shelf-life of the product will be extended. Shelf-life is intrinsic with product safety and is a key facilitator for international trade to distant markets where a low shelf life product may not be acceptable. Longer shelf life gives manufacturers additional security with high volume / high value stocks.
- Quality and nutritional profile will be safeguarded - the system will reduce the requirement for the use of excessive temperatures, thereby reducing the risk of protein denaturation.
- Reduced risk of contaminated product reaching the market, which often translates into financial loss and potentially catastrophic brand damage.
- Market differentiation- “Food safety is one of the criteria by which consumers judge quality”. By uptaking BABYSAFE technology, manufacturers will gain a competitive edge in a market where safeguarding the health and safety of babies is the primary and most fundamental concern.

List of Websites:
www.babysafe-fp7.eu

Dr. Edurne Gaston Estanga
IRIS SL
+34935570111
egaston@iris.cat