Background Art Milk or juice is often packaged in cartons that have been sterilized to prolong shelf life of the contents under refrigeration. When milk or juice is being packaged under aseptic packaging conditions, the content are capable of being stored for a substantial period of time at room temperature without spoilage.

Both of these packaging processes require effective sterilization of the packaging material prior to filling of a container formed from the packaging material. For example, a container, such as a gable-top container, that has previously been formed may have its interior surfaces sterilized prior to being filled with product.

U.S. Patent No. 4,375,145, discloses a packaging machine having a conveyor on which pre-formed cartons advance under ultraviolet germicidal solution, such as hydrogen peroxide, passing under the ultraviolet lamps.

U.S. Pat. No. 4,289,728, discloses a method for sterilization of the surfaces of food containers and other materials by applying a hydrogen peroxide solution, followed by ultraviolet radiation. This patent indicates that the peak intensity of ultraviolet radiation occurs at a wavelength of 254 nm. The concentration of the

hydrogen peroxide solution is less than 10% by weight, and furthermore, the hydrogen peroxide solution is heated during or subsequent to irradiation.

UV sterilization has been shown to be suitable for sterilization of flat films but has been found to have limited applicability to preformed, angular containers (Maunder, 1977) due to the geometric and physical constraints associated with UV light. If a simple UV lamp is placed in close proximity above a preformed, such as a gable top carton, the sterilization effectiveness is severely limited due to several reasons. The total light flux entering the carton is restricted to light that can be directed through the carton opening, which in case of typical gable top cartons are 55 x 55 mm, 70 x 70 mm or 95 x 95 mm. Unreflected light emitted from a line source UV lamp decreases in intensity with the square distance from the light source. Thus, as the depth of the carton increases, the light intensity falls off.

Another problem in sterilizing these cartons with UV light is that the light enters the top of the carton and radiates toward the bottom substantially parallel to the sides of the carton. The germicidal effect of the light that impinges on the side is very low because of the high angle incidence. Thus, the sides of the cartons are the most difficult surfaces to sterilize, especially for tall cartons. When the cartons are positioned on the conveyor, two sides of the carton lie in a plane that is parallel to the axis of the lamp, while the other two sides are transverse to the axis of the lamp. Since the lamp is elongated, radiation impinges on the transverse sides of the carton at a higher angle of incidence than it does on parallel sides of the carton. In the case of a single UV lamp source above the center of a 70 x 70 x 250 mm rectangular carton, the effective light intensity at the bottom of the carton would be reduced to 13.9% of the maximum intensity at that distance from the

source. The carton sides transverse to the lamp axis receive light from the entire length of the bulb. Light originating from the lamp reflector on the side opposite the parallel carton wall will have a minimum incident angle and thus have an intensity equal to 27.0% of the lamp intensity.

One ultraviolet lamp assembly that is designed to address, among other things, the problem of effective irradiation of pre- formed packages is disclosed in U.S. Patent No. 5,433,920, to Sizer et al. In accordance with one aspect of the invention disclosed therein, an ultraviolet reflector for use with an ultraviolet lamp is utilized to effectively irradiate the sides as well as the bottom of the container.

Another problem with current sterilization practices is the limitation of concentration of hydrogen peroxide which may be used on packaging material for food. Only a.minute quantity of hydrogen peroxide residue may be found on the packaging which limits most applications to less than 1% concentration.

Yet another problem with sterilization of cartons is the ability to properly sterilize those portions of the cartons which are "shadowed" by the folds of the folded bottom panels of the carton. One solution of the prior art is disclosed in U.S. Patent No. 4,683,701 to Rangwala et al. Rangwala et al nebulizes a sterilant fog into the interior of a carton as the carton blank is being erected between the magazine and mandrel. This is the only sterilization that a carton receives as it is filled and sealed on a machine.

Yet another problem is disinfecting or maintaining the sterility of the mandrel cap of the mandrel wheel on which the carton is bottom folded prior to placement on a linear conveyor.

Disclosure of the Invention On aspect of the present invention is a method for sterilization of packaging at a sterilization station on a form, fill and seal machine. The first step of the method is providing a carton blank. The next step is erecting the carton blank and placing it on mandrel of an indexing mandrel wheel. The next step is subjecting the interior of the carton bottom panels to a predetermined quantity of a sterilant at a bottom prefolding station thereby creating an interior carton bottom coated with a thin layer of the sterilant. The next step is heating the coated carton bottom at a bottom heating station. The next step is removing the folded and sealed carton from the mandrel. Another aspect of the present invention is an apparatus for sterilizing the interior bottom of a carton at the bottom forming station on a form, fill and seal machine.

It is a primary object of the present invention to provide a method and apparatus for providing an extended shelf life packaging.

It is an additional object of the present invention to provide a method and apparatus for sterilizing the interior bottom of a carton on a form, fill and seal packaging machine.

It is an additional object of the present invention to sterilize the mandrel cap of a mandrel of an indexing mandrel wheel.

It is an additional object of the present invention to provide a method and apparatus for creating a shelf stable liquid food product.

Brief Description of the Drawings There is illustrated in FIG. 1 a schematic view of a mandrel wheel of the present invention; There is illustrated in FIG. 1 A a cut-away section view of the prefolding station of the mandrel wheel of FIG. 1; There is illustrated in FIG. 1B a cut-away section view of the bottom heating station of the mandrel wheel of FIG. 1; There is illustrated in FIG. 1 C a perspective view of the final folding and sealing station of the mandrel wheel of FIG. 1; There is illustrated in FIG. 1D a plan view of the interior bottom of carton; There is illustrated in FIG. 2 schematic view of apparatus of the present invention integrated on linear form, fill and seal packaging machine; There is illustrated in FIG. 3 a schematic view of the vapor delivery system of the present invention; There is illustrated in FIG. 4 a cross-sectional view of prior art sterilization using liquid hydrogen peroxide; There is illustrated in FIG. 5 a perspective view of a carton capable of being sterilized by the present invention; Best Mode(s) For Carrying Out The Invention The present invention applies to the sterilization of a partially formed carton, undergoing fabrication to a container having an extended shelf life. Such a container may take the form of a fiberboard carton such as a TETRA REXB

gable top carton. An application of the present invention is with containers fabricated along a horizontal conveyance system on a multiple station form, fill and seal packaging machine such as the TETRA REXW packaging machine available from Tetra Pak. Although application of the present invention has been described in reference to fabrication with the above-mentioned containers and on the above-mentioned machine, those skilled in the pertinent art will recognize that the application of the present invention with the fabrication of other containers are well within the scope of the present invention.

As shown in FIG. 1, the indexing mandrel wheel assembly 10 includes a plurality of mandrels 11 which rotate about a central turret 12. Each of the mandrels 11 rotate from station to station at a predetermined indexed time which usually corresponds to the most time consuming station on the entire packaging machine. Usually, the most time consuming station is the top sealing station.

An erected carton is placed on a mandrel 11 at a placement station 13. The carton blank is fed from a magazine, not shown, and erected in transit to the mandrel 11. From the placement station 13, the mandrel 11 is rotated to a bottom prefolding station 14. At the bottom prefolding station 14, the bottom end panels of are "broken", that is the end panels of the carton are folded along specific score lines for facilitated sealing at a final folding and sealing station 18. At the prefolding station 14, a spray nozzle 15 sprays a predetermined amount of sterilant such as vapor phase hydrogen peroxide onto the end panels 21 and the mandrel cap 23, as further illustrated in FIG. 1 A. Other possible sterilants include ozone, liquid phase hydrogen peroxide, and other peroxides. The introduction of a sterilant at the prefolding station allows for the end panels 22 to be sterilized before the end panels 22 are folded on top of each other to form the bottom of the

carton 20. Once the end panels 22 are folded and sealed, sterilization is only effective on those end panels 22 which are exposed on the interior of the carton 20. Also, the introduction of sterilant at the prefolding station 11 allows for the sterilization of the mandrel cap 23 which further enhances the hygienic nature of the present invention.

From the prefolding station 11, the mandrel 11 is rotated to a bottom heating station 17. The bottom heating station heats the end panels to allow to facilitate heat sealing of the panels at the final folding and sealing station 18. The heating also activates or enhances the disinfecting action of the sterilant on the end panels 21 and the mandrel cap 23. FIG. 1B illustrates the heater 25 in relation to the end panels 21 and the mandrel cap 23.

From the bottom heating station 17, the mandrel 11 is rotated to the final folding and sealing station 18. At this station 18, the end panels 21 are folded and heat sealed together to form the bottom of the carton 20. FIG. 1C illustrates the carton after having been folded and heat sealed at the final folding and sealing station 18 by folder 27. One end panel 21A is folded on top of another end panel 21B which is folded on top of end panels 21C-D illustrated by dashed lines.

Thus, after final folding, only the exposed portions of the end panels 21 on the interior of the carton 20 may be sterilized. As illustrated in FIG. 1D, end panels 21C and 21D are folded on top of end panels 21A and 21B thereby preventing sterilization of the covered portions of these end panels 21 after the bottom is formed on the mandrel wheel 10. The sterilization of the end panels 21 allows for a more thoroughly sterilized carton than provided by the prior art sterilization methods.

Referring to FIG. 2, the cartons 20 usually have a square bottom which, as mentioned above, is formed and heat sealed on the mandrel wheel 10, and then placed on a conveyor 24 which advances at a predetermined interval (indexing) to the right as viewed in FIG. 2. The cartons 20 are placed equidistant apart and advance a predetermined number of carton positions during each periodic advancing step of the conveyor. Between each advancing step of the conveyor 24, the cartons 20 generally remain stationary for processing for the predetermined interval. The predetermined interval usually corresponds to the slowest process on the line in the fabrication of the carton. The slowest process is usually the sealing of the top of the carton after filling with a desired product. A carton 20 will wait for the predetermined interval, then proceed toward the next station.

As illustrated in FIG. 2, a series of cartons 20 are partially formed on a mandrel 22 on which an end of the carton, usually the bottom, is sealed thereby by providing a carton with sidewalls, a sealed bottom and an hollow interior. The cartons 20 then proceed to a fitment applicator station 26. Other machines may not have a fitment applicator, or may apply the fitment post-processing. In such situations, the cartons 20 proceed directly to the sterilization chamber 28. If a fitment is applied, various applicators may be employed.

Once conveyed inside the sterilization chamber 28, each of the series of cartons are subjected to vapor-phase hydrogen peroxide from an applicator 30.

The applicator 30 may be a nozzle for dispensing the hydrogen peroxide gas onto the carton 20, and in a preferred embodiment is a continuous flowing applicator.

The applicator 30 flows the gas over and around the carton during the predetermined interval. The hydrogen peroxide gas condenses on the carton 20 thereby coating the carton 20 with a thin layer of hydrogen peroxide. A vaporizer

32 is disposed above of the applicator 30. The vaporizer 32 transforms a solution of hydrogen peroxide into the vapor phase by heating the solution above the gas temperature of hydrogen peroxide, 175 ° C. The hydrogen peroxide applicator 30 and vaporizer 32 will be further described below. Next, a pre-breaker 34 for bending the carton 20 is optionally provided, however, a pre-breaker 34 is not necessary to practicing the present invention. Next, a hot air distributor 36 may optionally be provided for drying the coated carton 20 before entering the next substation. However, another embodiments may not have a hot air distributor 36, and such is not necessary for practicing the present invention.

Next, each of the cartons 20 is conveyed to the ultraviolet (UV) radiation chamber 38. The chamber 38 irradiates the coated carton 20 with UV radiation thereby providing a synergistic sterilization effect between UV radiation and hydrogen peroxide. As shown in FIG. 2, the UV chamber 38 is has a length of approximately three cartons 20 on the conveyor 24. Thus, as shown, the carton 20 is subjected to UV radiation for three predetermined intervals of time. The UV radiation may be UV-C, excimer UV light, or the like. A possible reflector for dispersing the UV radiation is described in U.S. Patent 5,433,920.

Next, each of the cartons 20 is conveyed to a hot air distributor 40 for drying the cartons 20 and for flushing/removing any hydrogen peroxide residue from the cartons 20. Again, this hot air distributor 40 is optional. Once the each of the cartons 20 exits the sterilization chamber 28, only 0.5 parts per million (ppm) should be present in the cartons 20. Each of the cartons 20 are next conveyed to a filling station 42 for filling the carton with a desired product such as milk or juice. Then to a heat sealing station 44 for sealing the end of the cartons 20, usually the top, which was not sealed previously thereby creating an extended

shelf life product having a defect rate of less than 1 in a thousand. Defectives is measured by spoiled product.

FIG. 3 shows the vapor delivery system of the present invention. The vapor delivery system consists of the applicator 30 and the vaporizer 32. The vaporizer 32 may be a heat exchanger 50 which receives air and hydrogen peroxide through a conduit 52. The conduit is in flow communication with a hydrogen peroxide source 54 and an air supply 56. As the liquid solution of hydrogen peroxide enters the chamber 58 of the vaporizer 32, it is heated to a temperature in excess of 175 ° C, the vaporization temperature of hydrogen peroxide. In an alternative embodiment, the vaporizer may transform the solution of hydrogen peroxide into vapor through increasing the pressure instead of the temperature.

The vapor phase hydrogen peroxide flows through a second conduit 59 to the applicator 30 where it is sprayed onto a carton 20 as illustrated by arrows 60.

The applicator may be a nozzle with a distribution of openings sufficient to widely disperse the gas. When the gas exits the applicator, its temperature has decreased to 80-90 ° C. The flow of hydrogen peroxide is continuous in a preferred embodiment, however, it is within the scope of the present invention to have intermittent spraying of the hydrogen peroxide gas.

The hydrogen peroxide gas enters and condenses on the opened interior 64 of the carton 20, the exposed exterior of the carton 20, and also condenses on the fitment 62. The condensation temperature for hydrogen peroxide is 60 ° C. As previously stated, the carton is stationary for the predetermined interval during which a predetermined amount of hydrogen peroxide gas condenses on the carton 20. For example, the predetermined interval may be 1.2 seconds.

Notable the present invention sterilizes the interior portion of the spout assemblies/fitment 64. In this respect, it is noted in FIG. 4 that each spout assembly may be functionally comprised of two sections: an exterior section 66, that, upon application to the respective carton 20 is disposed toward the exterior of the carton 20; and, an interior section 68 that, upon application to the respective carton 20 is disposed toward the interior of the carton 20. Generally, as illustrated in FIG 4, sterilization of the interior sections of the spout assemblies/fitments 64 is neglected in that the interior sections 68 are difficult to access once the spout assemblies/fitments 64 have been attached to the respective carton 20. For example, a dispersion of liquid hydrogen peroxide, illustrated with arrows 70, fails to reach certain interior portions of the spout assembly/fitment 64. Such regions effectively become "shadowed" regions that do not receive an application of hydrogen peroxide. Accordingly, post-attachment container sterilization with liquid hydrogen peroxide frequently leaves substantial portions of the spout assembly in a septic state that may contaminate the contents of the carton, and thereby lowering its effective shelf life. By spraying gaseous hydrogen peroxide into and around the carton, such problems are reduced or eliminated.

There is shown in FIG. 5 a fully formed, sealed and filled gable top carton 20 fabricated using the present invention. The carton has the familiar gable top 72 which is accented by the top fin 74. The top fin is either heat sealed or ultrasonically sealed to prevent contamination of the carton 20 and the desired product contained therein. The fitment 62 is provided to access the contents of this carton 20, however, more traditional cartons would have an integrated pour spout accessed by tearing open a portion of the gable top 72.

The present invention will be described in the following examples which will further demonstrated the efficacy of the novel sterilization method and apparatus, however, the scope of the present invention is not to be limited by these examples.

Test Methodology A. Spore Reduction Test A 50 cm2 area in the bottom of the second panel was used to spread 10 pL of 107 spores/ml. A swab application and recovery method was used for this test.

A sterile carton swab was dipped in sterile phosphate buffer, squeezed against the side of the test tube, and used to spread the 10 pL drop over the selected area.

The inoculated cartons were allowed to dry for at least two hours under the laminar flow hood. One wet and one dry sterile cotton swabs were used to recover the spores from the test cartons after the treatment, in a similar manner. The test tubes containing the buffer and the swabs were vortexed and allowed to sit for one hour before sampling. Appropriate dilutions were plated using Plate Count Agar (PCA) and incubated at 32 for 48 hours.

B. Inoculated Pack Test Procedure 1. Inoculate cartons by spray method with appropriate log load.

2. Run test cartons through filling machine and fill with sterile milk.

3. Incubate inoculated filled cartons at 32 for ten days.

4. Streak 10 pL of product from each package on PCA plates.

5. Measure pH of inoculated samples and inspect for off odors and/or curdling.

6. Incubate PCA plates for 24 to 48 hours at 32 C.

7. A positive is a streak with confirmed BsA growth.

Test Results Table 1. Spore reduction test results Test Conditions Log Reduction* No. of Cartons 35% H2O2 vapor + hot air (no UV) 3.5 - not a total kill 20 35% H2O2 + UV + hot air >4.5 20 35% H2O2 + hot air + UV >4.5 10 15% H2O2 + hot air + UV >4.5 10 2% H2O2 + hot air + UV >4.5 10 2% H2O2 + UV + hot air >4.5 10 0.5 % H2O2 + UV + hot air 4 4 - not a total kill 10 * Each variable had ten cartons Average recovery from ten positive controls is 4.5 log Table 2. Inoculated pack test results Test # Test Conditions Log Load Results 1 Non-screw cap, 35% H2O2 2 No positives Vapor1 Hot air after UV light 2 Screw cap, Same as #1 2 No positives 3 Non-screw cap, same as #1 3 No positives 4 Screw cap, Same as #1 3 No positives 5 Non-screw cap, Same as #1 4 6/20 positives 6 Screw cap, same as #1 4 6/20 positives 7 Non-screw cap, same as #1 5 17/20 positives 8 Non-screw cap, 2% H2O2 4 12/18 vapor positives Hot air after UV on-screw cap, 35% H2O2 2 No positives vapor Hot air before UV 0 Non-screw cap, same as #9 3 No positives 11 Non-screw cap, same as #9 4 4/10 positives

Statistical Analysis A. Results from 2, 3 and 4 log tests Log Cycle Reduction (LCR) 4.5 Lower limit 4.4 Higher limit 4.8 Confidence interval 9.5% Maximum probability 3.127 Likelihood (> 95% is meaningful result 30%

B. Results using 2, 3,4 and 5 log tests LCR (95% confidence level) 4.6 Lower limit 4.5 Higher limit 4.8 Likelihood (very significant) 69.3% These results show that 35% H2O2 Vapor and UV System is capable of delivering a 4.5 log reduction on Bacillus subtilis A spores. This is the first time ever the results were meaningful and very significant with > 95% confidence level.

Summary Existing H202 - UV System on Tetra Rex machines was improved by changing over to vapor instead of liquid H2O2. Vapor introduces improved and uniform coverage throughout the cartons. Droplets and excess peroxide in the package are eliminated. This improves the sterilization capability of the system which could be noticed by comparing 0.5% H202 vapor versus liquid.

It is clear that it is the total number of H202 molecules available for reaction which is critical. Hence, higher concentration ofH2O2 than 0.5% can be used at a lower flow rate to obtain a similar or better log reduction. The results obtained from hot air before and after UV exposure did not show any significant difference. This is because the spore load applied was not high enough to obtain a difference. The interesting thing is that hot air applied before UV could remove the excess H202 (if there is any) and let UV light produce free radicals from H202 penetrated/attached to the spores. This could be effective since the radicals are generated closer or inside the spores to inactivate them in a short time.

These tests show that the results obtained from spore reduction tests are different from (lower than) inoculated pack tests. Inoculated pack test with milk is a tough test for refrigerated or ESL products. However, it is a realistic test because Tetra Rex cartons have shadow areas and cracks. Applying spores in one flat area and treating the carton does not challenge the UV - H202 System appropriately. Inoculated pack test with proper statistical analysis should be used as a final test for gable-top cartons to determine a conservative log reduction.

The results also show that there is no limit on concentration of H202 for spore inactivation as reported in a few earlier research papers. Absorption of UV by (high concentration) H202 and/or multiple spore layers could be the reason for reduced or no kill results. This was previously proven by applying UV light from the opposite side of the spore + H202 side of high transmittance polyethylene materials. A linear relationship was developed between concentration H202 (up to 35%) and log spore reduction This result can be used to conclude that a thin layer of H202 is required for effective sporicidal action of H202 - UV System. Current study using H202 vapor for an application of thin layer confirms that increased spore reduction can be achieved by increasing the concentration.