Filling Technology

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					                       14th Workshop on the Developments in the Italian PhD Research on
                       Food Science Technology and Biotechnology - University of Sassari
                                      Oristano, September 16 – 18, 2009




 Innovative aseptic filling technology prototype for pouches without spout:
                          development and validation
                                Rossana Borgese (rossana.borgese@jbtc.com)
            Department of Industrial Engineering, Food Technology Area, University of Parma, Italy
                                         Tutor: Prof. Roberto Massini

This PhD thesis was carried out in JBT Food Tech Company leader in food processing machinery. The thesis
focused on the development of a new aseptic filling technology prototype for γ-ray pre-sterilized spoutless
pouch, designed for high and low acid food and, especially, for diphase (sol-liq) or particulates food products. It
has been developed an aseptic process for the sterilization of external pouch and for its opening, filling and
ultrasound closing in aseptic conditions. It has been optimized microbial challenge tests for the validation of all
the operative phases relevant for the filler asepsis: direct and indirect contact surfaces thermal pre-sterilization of
the pouch sterilization chamber, the filling chambers, and of the filling valve;, chemical sterilization of the pouch
outer layer; and asepticity maintenance within the filling chamber by sterile air overpressure. Moreover, a direct
validation of the aseptic filler with tomato pulp (high acid product) has been carried out.

 Tecnologia innovativa di riempimento asettico per sacchetti senza bocchello: sviluppo e
                                     validazione
Questa tesi di dottorato ha riguardato lo sviluppo di una nuova riempitrice asettica prototipale per sacchi senza
bocchello presterilizzati con raggi γ, progettata per il riempimento di prodotti ad alta e bassa acidità
prevalentemente bifasici o particolati. E’ stato sviluppato un processo che permette di sterilizzare la superficie
esterna della busta e, successivamente, di aprirla, riempirla e richiuderla ad ultrasuoni in condizioni asettiche.
Sono stati ottimizzati i challenge test microbiologici per validare tutte le fasi operative che determinano l’asepsi
della confezionatrice garantire sul prototipo dei metodi di analisi microbiologica per la validazione della
asetticità della riempitrice: la presterilizzazione termica delle superfici a contatto diretto e indiretto con il
prodotto della camera dove avviene la sterilizzazione della busta, della camera dove avviene il suo riempimento
e della valvola di dosaggio del prodotto; la sterilizzazione chimica della superficie esterna della busta e il
mantenimento della asetticità della camera di riempimento con sovrapressione di aria sterile. E’ stata inoltre
effettuata una validazione diretta della riempitrice con polpa di pomodoro, il prodotto ad alta acidità.

Keywords: aseptic filling, spoutless pouch.

1. Introduction
The advantages of aseptic processing in terms of reduced processing time, longer shelf life and improved quality
has been known to the industry for many years. The almost traditional bag in box aseptic technology is currently
limited to liquid product applications due to the small 1 inch spout aperture. Now by using spoutless pouches the
opening size has been increased to fill particulate aseptically as well. This new aseptic technology can be applied
profitably to the institutional package sizes with significant savings in package cost and capability to process
particulates. The elimination of the spout permits significant saving in the use of plastic packaging material and
thus results in a more environmental friendly operation. The reduction of aseptic surfaces also reduces both the
risk of contamination and the chemical disinfectant consumption, with further saving and low environmental
impact.

2. Materials and Methods
The present and patented invention relates to a process and an apparatus for the aseptic packaging of food
products in presealed and internally γ-ray presterilized pouches. The apparatus (see Figure 1) comprises an
aseptic filling chamber positioned above the pouches sterilization pre-chamber. Within the filling chamber a
device is arranged which allows the pouches to be knife opened and properly held to be filled and finally
ultrasound sealed.
The first part of the research project has been focused on the compliance analysis with requirements concerning
the food contact material, the hygienic design and construction, and the effective control of all the pre-processing
and processing critical parameters.
                         14th Workshop on the Developments in the Italian PhD Research on
                         Food Science Technology and Biotechnology - University of Sassari
                                        Oristano, September 16 – 18, 2009

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Figure 1 Functional layout of the new aseptic filler.

1.a - Compliance analysis of materials in contact with food products was based on the Italian and European law
requirements, on the metals and alloys European Guidelines, on specific EHEDG Guidelines, and also on the
NSF-ANSI standard for the exportation to USA.
1.b - Compliance analysis on fundamental requisitions to hygienic design and construction referring to all the
jointed components of the technology and to technical drawing for unjointed components in accordance with
requisitions of Italian and European laws, the European Guidelines and VDMA Documents, the Codex
Alimentarius and to Code of Federal Regulations of USA.
1.c - Compliance analysis on the way to guarantee the controll of process parameters with drawing analysis of
critical controll points of the process, the inspection of the controll system installed in the machine and the
verification of the functionality of controll scheme in case of system deviation for each critical point. All these
analysis have been carried out referring to European laws, the European Guidelines and VDMA Documents, the
Good manufacturing Practice of Codex Alimentarius, the guidelines from Center for Food Safety and Applied
Nutritional of Food and Drug Administration.
The second part of the project has been focused on the aseptic validation of the filling machine.
As target micro organism for low acid food (and all the more so for high acid products) Geobacillus
stearothermophiulus (formerly Bacillus stearothermophiulus) was chosen, because their spores are quite thermal
peroxide resistant. To respect the B. subtilis mesophilic spores commonly used for aseptic filler challenge tests,
the strict thermophilic G. stearothermophiulus inoculation allows a quite simple handling. Moreover, only for G.
stearothermophiulus spores is reported a correlation of the peroxide resistance with C. botulinum ones, which
allows to calculate the correspondent of the safety botulinum cook (12D).
A 107 cfu/ml suspension of G. stearothermophiulus spores (BIOLOGIK s.r.l.) was directly or indirectly
inoculated on previously identified critical points of surfaces to be sterilized. After the processing recovered
inocula were 5 days incubated at 55°C and the applied number of reductions were calculated taking recovery rate
into account.
2.a - Validation tests of filling equipment sterilization with pressurized saturated steam focused on all the
components in systematic or occasional contact with food product.
2.b - Validation tests of the sterilization of the pouch sanitization chamber and filling chamber with pressurized
saturated vapor focused.
2.c - Validation tests on asepticity mainteinance in filling chamber with sterile air overpressure.
2.d - Validation tests on pouch sterilization with chemical germicide. Several peroxide solutions and surfactant
compounds were tested.
The third part of the project has been focused on the direct validation of filling process.
3. - Performance tests carried out by filling tomato pulp, an high acid particulate product, during running tests of
the prototypal aseptic filler.

3. Results and discussions
1.a) All the materials used in the filler construction, with specific reference to elastomers and stainless steels,
were complying to all the European and International legislations.
                        14th Workshop on the Developments in the Italian PhD Research on
                        Food Science Technology and Biotechnology - University of Sassari
                                       Oristano, September 16 – 18, 2009

1.b Referring to EHEDG guideline n°8 on “Product contact surface” the filling machine showed some
     hygienic design and construction lacks. However, after cleaning tests, not even one of this formal
     nonconformity proved to be critical. For example the valve stem shows a conical pit where the cleaning
     could be not very efficient in removing residual product. But cleaning tests have been showed to be
     efficient when rinsing water flow is correctly controlled during CIP.
1.c Critical control points of process have been identified as:
-      sterilization of the filler, which must be controlled by temperature monitoring in the cold point of the
       machine.
-      sterilization of pouch external surface, which must be controlled by monitoring: first of all the amount,
       concentration, and temperature of chemical germicide, as well as the hot sterile air temperature; secondly
       by monitoring the air humidity for the disinfectant activation and the contact time between external
       surface of the pouch with the chemical agent.
-      Pouch sealing, which must be controlled by monitoring time, pressure and temperature of ultrasound
       sealing device. Obviously, the pouch integrity after filling and sealing operations must be verified.
-      Aseptic maintenance of product before filling, which must be controlled by internal overpressure and
       steam barriers on all the jointed components of the product pipe and the filling valve.
-      Aseptic maintenance in filling and sterilizing chambers, which must be controlled by monitoring the
       sterile air flow and the correct functionality of vapour barrier on moving components. Obviously, air
       sterility must be controlled by using an effective microfilter and by measuring their pressure drop.
2.a Sterilizability of the filling equipment
     Tests have been carried out in the most critical points of the filling valve for its sterilizability (direct
     product contact): on the top of the gasket (external part), on the top gasket (internal part) and on the bottom
     gasket. The results showed that al least 5 log reduction of Geobacillus stearothermophiulus spores are
     obtained.
2. b Sterilizability of pouch sanitization chamber and filling chamber
     Tests have been carried out in the most critical points to be reached from the steam during sterilisation
     process. The results obtained showed an average of 4,71 log reduction.
2. c Validation tests on asepticity mainteinance in filling chamber with sterile air overpressure.
     The test was carried out after sterilisation process of the filler. Several pouches were preliminarily filled
     with a small volume of sterile bacteria growing media and re-closed excluding the air within a laboratory
     laminar flow cabinet. The pouches were feed into the aseptic filler, opened in the filling chamber and
     maintained open for 1.5 hours; then the pouches were sealed and ejected from the filler. After 30 days
     incubation at 30°C, none microbial contamination has been found.
2. d Validation tests on pouch sterilization with chemical disinfectant
     Several challenge tests with different chemical and wetting agents have been carried out in order to reach
     the goal of external pouch sterilisation in a very short time. For both side of the bags, the final result
     showed 5 log reduction of G. stearothermothilus spores on most of the points where the inocula were
     applied.
3. Validation with high acid product: tomato pulp
     A filling test of 5000 pouches with tomato pulp has been carried out. Filled pouches were stored for 1
     month at 25°C and none shoved blowing signs. Microbial analysis was carried out on 50 pouches and the
     results obtained showed no contamination by micro-organisms commonly present within a tomato cannery:
     moulds, yieasts, lactobacillus, enterococcus and Bacillus caougulans.

4. Conclusions
Thanks to the scientific approach applied during the design phase and to the operational parameters and control
measures identified by the challenge and direct performance test, the new aseptic filling system represents a safe
and efficient technology to be used to produce products or beverage with particulates.

5. References
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3)“Antiseptics and disinfectants: Activity, Action and Resistance”, G. McDinnel and A. D. Russel, Clinical Microbiology
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    Martins, BioMed Central, BMC Infectious Diseases.
                         14th Workshop on the Developments in the Italian PhD Research on
                         Food Science Technology and Biotechnology - University of Sassari
                                        Oristano, September 16 – 18, 2009

6) “Determination of decimal reduction time (D value) of chemical agents used in hospitals for disinfection purposes”, T. C.
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20) EHEDG Guidelines: Doc 18 Passivation of stainless steel. Doc 23 Production and use of food-grade lubricants. Doc 32
     Materials of Construction for equipment in contact with food.
21) NSF International Standard/American National Standard 51 - 2007 Food equipment material.
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22) Directive 2006/42/EC on machinery, and amending Directive 95/16/EC (recast), which will be operative on 29 december
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23) UNI EN 1672-2:1997 Primary concepts — Parte 2: Hygienic requirements.
24) EN ISO 14159:2002 - Safety of machinery – Hygiene requirements for the design of machinery.
25) EHEDG Guidelines: Doc. 3 Microbiologically safe aseptic packing of food products, 1993. Doc. 8 Hygienic equipment
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     products, 1993; Doc. 14 Hygienic design of valves for food processing, 2004; Doc. 16 Hygienic pipe couplings, 1997;
     Doc. 25 Design of mechanical seals for hygienic and aseptic applications, 2002.
26) Verband Deutscher Maschinenund Anlagenbau e.V. (German Engineering Federation). Food Processing Machinery and
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31) CAC/RCP 40-1993 – Code of Hygienic Practice for Aseptically Processed and Packaged Low-Acid Foods. 7.5.2.3.2
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     systems. 8.1 Processing and Production Records.
32) 21 CFR Part 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. Subpart C
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     filling, and closing operation.
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