JP2020070087A - Validation method for electron beam sterilization facility - Google Patents

Abstract

To provide a validation method for an electron beam sterilization facility capable of enhancing verification accuracy of whether or not an inner face of a preform body is appropriately sterilized.SOLUTION: There is provided a validation method for an electron beam sterilization facility comprising a holding device for holding a preform body P from inside, and an electron beam emission nozzle 4 by which an inner face of the preform body P after being held with the holding device is exposed to electron beams E. The validation method comprises a verification electron beam irradiation step of emitting the electron beams E from the electron beam emission nozzle 4 in such a manner that a dose i8 of the electron beams E to which a verification part f8 that is any of those other than a history-present part is exposed from inside becomes each dose i1 to i7 or less of the electron beams to which f1 to f7 other than the verification part are exposed, on the inner face of the verification preform body P whose inner face has an identical shape to that of the preform body P. The validation method further comprises a verification step of verifying whether or not the dose i8 of the electron beams to which the verification part f8 is exposed exceeds a sterilization reference.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a validation method for electron beam sterilization equipment.

  As a sterilization of PET bottles by an electron beam sterilization facility, a method of sterilizing a PET bottle itself or a preform body which is a raw material body before being blow-molded into the PET bottle by irradiation with an electron beam is adopted. In the electron beam sterilization facility, validation is required to verify whether a PET bottle or a preform body (a sterilization target object having a mouth) is properly sterilized.

  An electron beam sterilization facility has been proposed which adopts a method of sterilizing a container by irradiating an electron beam, including the above-mentioned verification, and irradiates an electron beam with more accurate intensity (for example, paragraphs [0023] and [0023] of Patent Document 1). 0037]).

Japanese Patent No. 5554524

  By the way, in the verification in the electron beam sterilization equipment of Patent Document 1, the dose of the electron beam applied to the inner surface of the container is measured by the dose film attached to the inner surface of the target container.

  However, before sterilizing the inner surface of the container, the mouth of the container may be held from the inside when sterilizing the outer surface of the container. In this case, if the dose film attached to the mouth of the container is damaged by the holding, the dose of the electron beam applied to the mouth of the container may not be accurately measured in the verification. If the dose of the electron beam applied to the inner surface of the container is not accurately measured, the accuracy of the verification will be reduced.

  Therefore, an object of the present invention is to provide a method for validating electron beam sterilization equipment, which can improve the accuracy of verification of whether the inner surface of a sterilization target having a mouth is properly sterilized.

In order to solve the above problems, the method for validating an electron beam sterilization equipment according to the first invention is an electron beam sterilization equipment for sterilizing an inner surface of a sterilization object having a mouth portion by irradiating an electron beam. A validation method to verify whether the inner surface is properly sterilized,
The electron beam sterilization equipment,
A holding device for holding the sterilization target from the inside,
An electron beam irradiation device for irradiating the inner surface of the object to be sterilized after being held by the holding device with an electron beam,
The electron beam irradiation device,
Having an electron beam emission nozzle that emits an electron beam by being inserted into the sterilization target,
For verification of the inner surface of the sterilization target having the same shape as the sterilization target, the dose of the electron beam irradiated to the verification portion other than the portion held from the inside by the holding device is for the verification. A verification electron beam irradiation step of emitting an electron beam from the electron beam emission nozzle so that the dose is equal to or less than the dose of the electron beam emitted to a portion other than the portion,
And a verification step of verifying whether or not the dose of the electron beam applied to the verification portion exceeds a standard for sterilization.

  The validation method of the electron beam sterilization equipment according to the second aspect of the invention is the verification electron beam irradiation step in the validation method of the electron beam sterilization equipment according to the first aspect of the invention, for verification on the inner surface of the verification sterilization object. The electron beam is emitted from the electron beam emission nozzle so that the dose of the electron beam with which the part is irradiated is less than the dose of the electron beam with which the part other than the verification part is irradiated.

  Furthermore, the validation method of the electron beam sterilization equipment according to the third invention is the validation method of the electron beam sterilization equipment according to the first or second invention, wherein the portion of the verification sterilization target held inside by the holding device is , The mouth of the verification sterilization target.

  In addition, the validation method of the electron beam sterilization equipment according to the fourth aspect of the present invention is the validation method of the electron beam sterilization equipment according to the third aspect of the invention, wherein in the verification electron beam irradiation step, the electron beam emission nozzle is a verification sterilization target. The rate at which objects are inserted or removed is constant.

  The validation method of the electron beam sterilization equipment according to the fifth aspect of the present invention is the validation method of the electron beam sterilization equipment according to the third aspect of the present invention, wherein the verification electron beam irradiation step uses an electron beam emission nozzle as a verification sterilization target object. The speed of inserting into and / or retracting from is lower at a position corresponding to the mouth portion than at a position corresponding to a portion other than the mouth portion.

  The validation method for an electron beam sterilization facility according to a sixth aspect is the validation method for an electron beam sterilization facility according to any one of the third through fifth aspects, wherein the verification electron beam irradiation step comprises an electron beam emission nozzle. The depth of inserting the item into the verification sterilization target is 75% to 90% of the depth of the verification sterilization target.

  According to the validation method of the electron beam sterilization equipment, even if the dose of the irradiated electron beam cannot be accurately measured in a part other than the verification part, it is sufficient if it can be accurately measured in the verification part. The accuracy of verification whether the inner surface of the object is properly sterilized can be improved.

It is a schematic structure figure of an electron beam sterilization equipment concerning an embodiment of the invention, and shows the state where the inside of a preform object is held by a holding device. It is a schematic block diagram of the same electron beam sterilization equipment, and shows the state in which the electron beam is irradiated to the inner surface of the preform body after being held by the holding device. It is a schematic block diagram for demonstrating the validation method of the same electron beam sterilization equipment. It is a schematic block diagram of the test machine of the electron beam sterilization equipment which concerns on the Example of this invention. It is a schematic block diagram which shows the dose of the electron beam measured by the irradiation dose measuring device for test machines of the same test machine. FIG. 4 is a schematic configuration diagram for explaining the operation of the electron beam sterilization equipment, showing a state in which the preform body is held from the inside and the outer surface is sterilized. It is a schematic block diagram for explaining the operation of the same electron beam sterilization equipment, and shows a state in which the preform body is transferred from the inner holding device to the relay device. FIG. 4 is a schematic configuration diagram for explaining the operation of the electron beam sterilization equipment, showing a state in which the preform body is delivered from the relay device to the outer holding device. It is a schematic block diagram for explaining the operation of the same electron beam sterilization equipment, and shows a state in which the inner surface of the preform body is sterilized and the dose of the electron beam irradiated for that purpose is measured. It is a longitudinal cross-sectional view of a preform body in which the same validation method is used. It is a longitudinal cross-sectional view of a preform body having another shape in which the same validation method is used.

  Hereinafter, a method for validating an electron beam sterilization facility according to an embodiment of the present invention will be described with reference to the drawings.

  First, an outline of the electron beam sterilization equipment will be described with reference to FIGS. 1A and 1B. In order to simplify the description, a preform body will be described below as an example of an object to be sterilized by the electron beam sterilization equipment. Of course, the object to be sterilized is not limited to the preform body, as long as it has a mouth portion, it includes containers such as PET bottles and bottles.

  As shown in FIG. 1A and FIG. 1B, the electron beam sterilization equipment 1 uses an electron beam for the inner surface of the preform body P, that is, the inner surface of the test tube-shaped raw material body P before being molded into a PET bottle by blow molding. It is sterilized by irradiation of the line E. Therefore, the electron beam sterilization equipment 1 includes a holding device 2 (hereinafter, referred to as an inner holding device 2) that holds the preform body P from the inside, and a preform body after being held by the inner holding device 2. An electron beam irradiation device 3 for irradiating the inner surface of P with the electron beam E is provided. The electron beam irradiation device 3 has an electron beam emission nozzle 4 which is inserted into the preform body P and emits an electron beam E. The preform body P when the inner surface is irradiated with the electron beam E is after being held by the inner holding device 2, so that, for example, a separate holding device 5 (hereinafter referred to as the outer holding device 5) from the outside can be used. It may be held, or may not be held if holding is unnecessary.

  In order to measure the dose of the electron beam E applied to the inner surface of the preform body P, on the inner surface of the preform body P, a large number (eight in FIG. 2) of dose films f1 as shown in FIG. f8 is pasted along the axial direction of the preform body P. Of these dose films f1 to f8, the portions f1 and f2 held by the inner holding device 2, that is, the ones f1 and f2 attached to the portions “holding history from the inside” shown in FIG. May be damaged by contact with 2. Even in such a case, the gist of the present invention is a method capable of increasing the accuracy of verification whether the inner surface of the preform body P is properly sterilized.

  Hereinafter, the validation method of the electron beam sterilization equipment 1 which is the gist of the present invention will be described.

  The validation method does not use the regular preform bodies P, that is, the regular preform bodies P that are sterilized by the electron beam sterilization facility 1 and then blow molded into PET bottles. Before P, a verification preform P that is sterilized in the electron beam sterilization equipment 1 is used. The verification preform body P has the same shape as at least the inner surface of the regular preform body P. Of course, the verification preform body P may have the same shape as the regular preform body P as a whole. Hereinafter, when it is not necessary to distinguish between the regular preform body P and the verification preform body P, it is simply described as the preform body P, and when it is necessary to distinguish between them, the regular preform body P is used. Alternatively, the verification preform P will be described.

  On the inner surface of the verification preform body P, any part other than the part held from the inner side by the inner holding device 2 is used as the verification part. In the example shown in FIG. 2, a portion of the dose film f8 attached to the innermost side of the verification preform body P is shown as a verification portion. The validation method includes a verification electron beam irradiation step of irradiating the inner surface of the verification preform P with an electron beam E, and a verification step of performing verification from the result of the verification electron beam irradiation step.

  The verification electron beam irradiation step is a step of emitting the electron beam E from the electron beam emission nozzle 4 so that the dose of the verification portion is equal to or less than the dose of the electron beam E that is irradiated to a portion other than the verification portion. .. That is, in the example shown in FIG. 2, in the verification electron beam irradiation step, the dose i8 applied to the dose film f8 stuck at the innermost side is the dose i1 to i7 applied to the other dose films f1 to f7. An electron beam E is emitted from the electron beam emission nozzle 4 as described below.

  The verification step is a step of verifying whether or not the dose of the electron beam E applied to the verification portion exceeds a standard for sterilization. That is, in the example shown in FIG. 2, the verification step verifies whether or not the dose i8 applied to the dose film f8 attached to the innermost part exceeds the standard for sterilization. Since the electron beam E having a dose equal to or higher than the dose of the electron beam E applied to the verification portion (the dose film f8 stuck on the innermost side) is applied to the portions other than the verification portion (other dose films f1 to f7) If the dose i8 of the electron beam E applied to the verification portion exceeds the reference, it can be said that the doses i1 to i7 of the electron beam E applied to the portions other than the verification portion also exceed the reference. ..

  As described above, according to the validation method of the electron beam sterilization equipment 1, even if the dose of the irradiated electron beam E cannot be accurately measured in a portion other than the verification portion, it is sufficient if it can be accurately measured in the verification portion. The accuracy of verification as to whether the inner surface of the preform body P is properly sterilized can be improved.

  Hereinafter, a method for validating the electron beam sterilization equipment 1 according to an example showing the above embodiment more specifically will be described with reference to the drawings. In the present example, description will be given focusing on the configuration omitted in the above-described embodiment, and the same configuration as that in the above-described embodiment will be denoted by the same reference numeral and description thereof will be omitted.

  In the validation method of the electron beam sterilization equipment 1 according to the present embodiment, not only the electron beam sterilization equipment 1 but also a test machine of the electron beam sterilization equipment 1 is used. This test machine sets the conditions for use in the electron beam sterilization equipment 1 so that the verification portion in the electron beam sterilization equipment 1 has a dose equal to or less than the dose of the electron beam E irradiated to the portion other than the verification portion. It is equipment for making decisions.

  As shown in FIG. 3, the test machine 100 includes a test machine outer holding device 105 for holding the preform body P from the outside, and a preform body P held from the outside by the test machine outer holding device 105. An electron beam irradiation device 103 for a test machine that irradiates the electron beam E is provided. This test machine electron beam irradiation device 103 has a test machine electron beam emission nozzle 104 that is inserted into the preform body P and emits an electron beam E. Further, the test machine 100 includes a test machine elevating device 107 that elevates and lowers the test machine outer holding device 105 in order to insert and withdraw the test machine electron beam emission nozzle 104 into and from the preform body P. Further, the tester 100 controls the tester electron beam irradiation device 103 and the tester lifting device 107, and the tester controller 108 controls the electron beam E irradiated on the inner surface of the preform P. An irradiation dose measuring device 109 for a test machine that measures a dose in the axial direction from the mouth to the bottom of the preform body P. The mouth and bottom of the preform body P are as shown in FIG. 6, and in order to measure the electron beam dose in the axial direction from the mouth to the bottom, for example, the dose films f1 to f8 shown in FIG. used.

  The object of control by the test machine control device 108 will be specifically described. The output of the electron beam E emitted from the test machine electron beam irradiation device 103 and the outside of the test machine by the test machine lifting device 107. This is the operation of the holding device 105. Here, the operation of the outside holding device 105 for a test machine includes the amount and speed of the outside holding device 105 for a test machine that is raised and lowered by the lifting and lowering device 107 for a test machine, and the change in the speed.

  As shown in FIG. 4, the dose of the electron beam E with which the inner surface of the preform body P is irradiated by the irradiation dose measuring device 109 for the test machine is “verification portion i8 ≦ other than the verification portion i1 to i7”. If so, the conditions used in the control by the test machine control device 108 at that time are recorded. Here, the measured doses i1 to i8 may have an allowable error (permissible error). These tolerances are shown in FIG. 4 by inclining the tips (right ends) of the bar graphs i1 to i8 corresponding to the respective doses. In this case, the maximum value i8max including the allowable error in the measured dose i8 in the verification portion f8 has the allowable error in the smallest dose i7 among the measured doses i1 to i7 in the portions other than the verification portion f1 to f7. If the included minimum value i7min or more, it is considered that "verification part i8≤i1 to i7 other than the verification part". These conditions in the test machine 100 are used by control by a control device (described later) of the electron beam sterilization equipment 1. That is, even in the electron beam sterilization equipment 1, the same condition as that of the test machine 100 is used, so that the dose of the electron beam E applied to the inner surface of the verification preform body P is “verification portion ≦ verification portion concerned”. Other than the part ".

  Next, the electron beam sterilization equipment 1 according to the present embodiment will be described with reference to the drawings.

  As shown in FIG. 5A, the electron beam sterilization equipment 1 includes an electron beam irradiation device 3 (hereinafter, referred to as an electron beam irradiation device 3 having an inner holding device 2, an outer holding device 5, and an electron beam emission nozzle 4) as in the above-described embodiment. Inner surface electron beam irradiation device 3). The electron beam sterilization equipment 1 also includes an outer surface electron beam irradiation device 6 that sterilizes the outer surface of the preform body P held from the inner side by the inner side holding device 2 by irradiation of the electron beam E. Further, the electron beam sterilization equipment 1 also includes a relay device 10 that receives the preform body P from the inner holding device 2 and transfers it to the outer holding device 5, as shown in FIGS. 5B and 5C. In addition, the electron beam sterilization equipment 1 also includes an elevating device 7, a control device 8, and an irradiation dose measuring device 9, as shown in FIG. 5D. The lifting device 7 and the control device 8 have the same configuration as the test device lifting device 107 and the test device control device 108 of the test machine 100. The irradiation dose measuring device 9 may have the same configuration as the irradiation dose measuring device 109 for a test machine, and if the dose of the electron beam E irradiated to at least the verification portion can be measured, the irradiation dose measurement for a test machine is possible. A configuration different from that of the device 109 may be used. This is because the irradiation dose measuring device 9 measures the dose of the electron beam E with which the verification portion is irradiated, so that the dose of the electron beam E with which the area other than the verification portion is irradiated is estimated in the subsequent verification process. Because it will be. Further, as shown in FIG. 5D, the electron beam sterilization facility 1 also includes a verification device 11 that verifies whether or not the dose of the electron beam E applied to the verification portion exceeds a standard for sterilization. ..

  Next, a validation method of the electron beam sterilization equipment 1 will be described.

  First, as shown in FIG. 3, in the tester 100, the inner surface of the preform body P is irradiated with the electron beam E. If the dose of the irradiated electron beam E is “verification part ≦ other than the verification part”, the conditions used in the control by the test machine control device 108 at that time are recorded. The control condition is used by the control device 8 of the electron beam sterilization equipment 1.

  Then, as shown in FIGS. 5A to 5D, the verification preform P is sterilized by the electron beam sterilization equipment 1 and validation is performed.

  Specifically, as shown in FIG. 5A, the outer surface of the verification preform body P whose inner side is held by the inner side holding device 2 is sterilized by irradiation with the electron beam E by the outer surface electron beam irradiation device 6.

  Next, as shown in FIG. 5B, the relay device 10 receives the verification preform P whose outer surface is sterilized. The verification preform P received by the relay device 10 is transferred from the relay device 10 to the outer holding device 5, as shown in FIG. 5C.

  After that, as a verification electron beam irradiation step, the verification preform body P transferred to and held by the outer holding device 5 has the electron beam E on the inner surface under the control conditions described above, as shown in FIG. 5D. It is irradiated and is moved up and down by the lifting device 7. On the other hand, the dose of the electron beam E with which the verification portion is irradiated is measured by the irradiation dose measuring device 9. Then, as a verification step, the verification device 11 verifies whether or not the dose of the electron beam E with which the verification portion is irradiated exceeds the standard for sterilization. As a result of this verification, if the dose of the electron beam E applied to the verification portion exceeds the standard, it is determined that the electron beam E having a dose equal to or higher than the standard is irradiated to all the inner surfaces of the verification preform body P. To be judged.

  As described above, according to the validation method of the electron beam sterilization equipment 1 according to the present embodiment, the electron beam sterilization equipment 1 for sterilizing the outer surface and the inner surface of the preform body P also has the effects described in the above embodiment.

  Moreover, since a separate tester 100 is used in advance to determine the conditions for use in the electron beam sterilization equipment 1, the accuracy of verification can be further enhanced.

  By the way, in the said embodiment and Example, although the dose of the electron beam E with which the inner surface of the preform body P is irradiated was demonstrated as "verification part <= other than the verification part", "verification part <related It is preferably "other than the verification portion". With this, even if an error occurs in the measurement of the dose, the result of the verification is unlikely to be affected, so that the accuracy of the verification can be further improved. In particular, when the dose of the electron beam E applied to the verification portion is 80% to 90% of the dose of the electron beam E applied to other than the verification portion, the verification accuracy can be further improved. The non-uniformity of the electron beam E with which the inner surface of the preform body P is irradiated can be reduced.

  Further, in the above-described embodiments and examples, the part held inside by the inside holding device 2 was not specifically described, but as shown in FIG. 6, it may be the mouth of the preform body P. preferable. Since the mouth portion is a portion that is easily held from the inside, problems are less likely to occur during the holding of the preform body P from the inside and the subsequent steps, and as a result, the accuracy of verification can be further improved.

  Further, in the above-described embodiment and examples, the speed at which the electron beam emission nozzle 4 is inserted into and withdrawn from the preform body P is not specifically described, but a portion held from the inside (with a holding history from the inside) When the (part) is the mouth, it is preferably constant. Since the speed is constant (that is, constant speed), as shown in FIG. 6, the dose of the electron beam E irradiated to the bottom of the preform body P and the lower part of the body (the lower part of the body) is minimized ( In other words, it tends to become a verification part). As a result, the setting of the verification portion can be simplified. On the other hand, it is also preferable that the speed is lower at a position corresponding to the mouth than at a position corresponding to a portion other than the mouth. With such a speed, not only the preform body P as shown in FIG. 6 but also the preform body P'having a much larger diameter as shown in FIG. Since the portion is sufficiently irradiated with the electron beam, the dose of the electron beam E with which the bottom portion and the lower portion of the body portion are irradiated is likely to be the minimum (that is, the verification portion). As a result, the setting of the verification portion can be simplified even for the preform P ′ shown in FIG. 7.

  In addition, in the above-described embodiments and examples, the depth of inserting the electron beam emission nozzle 4 into the preform body P was not specifically described, but 75% to 90% of the depth of the preform body P was described. Is preferred. With such an insertion depth, the dose of the electron beam E applied to the bottom of the preform body P and the lower portion of the body tends to be minimized (that is, the verification portion). As a result, the setting of the verification portion can be simplified.

  Moreover, in the said Example, although the control apparatus 8 and the inner surface electron beam irradiation apparatus 3 which were installed in the ground were shown one by one in FIGS. 5A-5D, they may be more than one. When the control device 8 and the inner surface electron beam irradiation device 3 are plural, the plurality of control devices 8 and the inner surface electron beam irradiation device 3 are the electron beams because the regular preform P is continuously sterilized. It is preferable that the sterilization equipment is arranged separately at equal intervals on the periphery of the turntable.

  Further, in the above-described embodiment, the verification process is performed by the verification device 11 shown in FIG. 5D, but an operator may perform the verification process.

  Further, in the above-described embodiment, the preform body P moves up and down toward the electron beam emitting nozzle 4 when inserting and retracting the electron beam emitting nozzle 4 in the preform body P, but the electron beam emitting nozzle 4 is described. May be moved up and down toward the preform body P.

  Further, the above-described embodiments and examples are illustrative in all points and not restrictive. The scope of the present invention is shown not by the above description but by the claims, and is intended to include meanings equivalent to the claims and all modifications within the scope. Of the configurations described in the above-described embodiments and examples, the configurations other than the configuration described as the first invention in "Means for solving problems" are arbitrary configurations and can be appropriately deleted and changed. Is.

1 Electron beam sterilization equipment 2 Holding device (inside holding device)
3 Electron beam irradiation device (inner electron beam irradiation device)
4 Electron Beam Ejection Nozzle 5 Outer Holding Device 6 External Electron Beam Irradiation Device 7 Lifting Device 8 Control Device 9 Irradiation Dose Measuring Device 10 Relay Device 11 Verification Device 100 Test Machine 103 Electron Beam Irradiation Device for Test Machine 104 Electron Beam Emission for Test Machine Nozzle 105 Outside holding device for test machine 107 Lifting device for test machine 108 Control device for test machine 109 Irradiation dose measuring device for test machine

Claims (6)

In the electron beam sterilization equipment to sterilize the inner surface of the sterilization object having a mouth by irradiation of an electron beam, a validation method for verifying whether the inner surface of the sterilization object is properly sterilized,
The electron beam sterilization equipment,
A holding device for holding the sterilization target from the inside,
An electron beam irradiation device for irradiating the inner surface of the sterilization target after being held by the holding device with an electron beam,
The electron beam irradiation device,
Having an electron beam emission nozzle that emits an electron beam by being inserted into the sterilization target,
For verification of the inner surface of the sterilization target having the same shape as the sterilization target, the dose of the electron beam irradiated to the verification portion other than the portion held from the inside by the holding device is for the verification. An electron beam irradiation step for verification in which an electron beam is emitted from the electron beam emission nozzle so that the dose is equal to or less than the dose of the electron beam emitted to a portion other than the portion,
And a verification step of verifying whether or not the dose of the electron beam applied to the verification portion exceeds a standard for sterilization.   The verification electron beam irradiation step is performed so that the dose of the electron beam irradiated to the verification portion on the inner surface of the verification sterilization target is less than the dose of the electron beam irradiated to other than the verification portion. The method for validating electron beam sterilization equipment according to claim 1, wherein an electron beam is emitted from an emission nozzle.   The validation method for electron beam sterilization equipment according to claim 1 or 2, wherein the portion of the verification sterilization target held inside by the holding device is a mouth of the verification sterilization target.   The method of validating electron beam sterilization equipment according to claim 3, wherein in the verification electron beam irradiation step, a speed at which the electron beam emission nozzle is inserted into or withdrawn from the verification sterilization target is constant.   In the verification electron beam irradiation step, the speed at which the electron beam emission nozzle is inserted into and / or withdrawn from the verification sterilization target is set to be lower at the position corresponding to the mouth portion than at the position other than the mouth portion. The method for validating electron beam sterilization equipment according to claim 3, which is characterized in that. In the verification electron beam irradiation step, the depth at which the electron beam emission nozzle is inserted into the verification sterilization target is 75% to 90% of the depth of the verification sterilization target. 6. The method for validating electron beam sterilization equipment according to any one of items 1 to 5.

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