JP6920268B2 - Validation method of electron beam sterilization equipment - Google Patents

Description

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

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

An electron beam sterilization facility that irradiates an electron beam with a more accurate intensity by adopting the method of sterilizing a container by irradiating an electron beam including the above verification has been proposed (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 facility of Patent Document 1, the dose of the electron beam irradiated to the inner surface of the container is measured by the dose film attached to the inner surface of the target container.

However, it is also possible to hold the mouth of the container from the inside, such as when sterilizing the outer surface of the container before sterilizing the inner 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 irradiated to the mouth of the container may not be accurately measured in the verification. If the dose of the electron beam irradiated 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 validation method for electron beam sterilization equipment that can improve the accuracy of verification of whether the inner surface of a sterilization object having a mouth is properly sterilized.

In order to solve the above-mentioned problems, the validation method of the electron beam sterilization equipment according to the first invention is performed in an electron beam sterilization equipment for sterilizing the inner surface of a sterilization object having a mouth by irradiation with an electron beam. A validation method that verifies that the inner surface is properly sterilized.
The electron beam sterilization equipment
A holding device that holds the mouth of the sterilized object from the inside,
An electron beam irradiating device for irradiating the inner surface of the object to be sterilized after being held by the holding device with an electron beam is provided.
The electron beam irradiation device is
It has an electron beam emitting nozzle that is inserted into the sterilized object and emits an electron beam.
On the inner surface of the verification object having the same inner surface as the sterilization object, the dose of the electron beam irradiated to the verification portion other than the mouth held from the inside by the holding device is the verification. A verification electron beam irradiation step in which an electron beam is emitted from the electron beam emitting nozzle so that the dose of the electron beam is equal to or less than the dose of the electron beam irradiated to the portion other than the part to be used.
It includes a verification step for verifying whether or not the dose of the electron beam irradiated to the verification portion exceeds the standard for sterilization.

Further, in the method for validating the electron beam sterilization equipment according to the second invention, the verification electron beam irradiation step in the validation method for the electron beam sterilization equipment according to the first invention is for verification on the inner surface of the object to be sterilized for verification. The electron beam is emitted from the electron beam emitting nozzle so that the dose of the electron beam irradiated to the portion is less than the dose of the electron beam irradiated to the portion other than the verification portion.

Further , 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, and the verification electron beam irradiation step sterilizes the electron beam emitting nozzle for verification. The speed at which it inserts or exits the object is constant.

In addition , the validation method of the electron beam sterilization equipment according to the fourth invention is the validation method of the electron beam sterilization equipment according to the first or second invention, and the verification electron beam irradiation step is for verification of the electron beam emitting nozzle. The rate of insertion and / or exit from the object to be sterilized is lower at the position corresponding to the mouth than at the position corresponding to the part other than the mouth.

Also, validation process of electron beam sterilization equipment according to the fifth invention, in the first through the validation process of electron beam sterilization equipment according to a fourth invention of any one of verification for electron beam irradiation process, an electron beam emitted nozzle Is inserted into the verification sterilization object at a depth of 75% to 90% of the depth of the verification sterilization object.

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

It is a schematic block diagram of the electron beam sterilization equipment which concerns on embodiment of this invention, and shows the state which the inside of the preform body is held by the holding device. It is a schematic block diagram of the electron beam sterilization equipment, and shows the state which the electron beam is irradiating 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 electron beam sterilization equipment. It is a schematic block diagram of the test machine of the electron beam sterilization equipment which concerns on Example of this invention. It is a schematic block diagram which shows the dose of the electron beam measured by the irradiation dose measuring apparatus for the test machine of the same test machine. It is a schematic block diagram for demonstrating the operation of the electron beam sterilization equipment, and shows the state which is held from the inside of the preform body and the outer surface is sterilized. It is a schematic block diagram for demonstrating the operation of the electron beam sterilization equipment, and shows the state which the preform body was handed over from an inner holding device to a relay device. It is a schematic block diagram for demonstrating the operation of the electron beam sterilization equipment, and shows the state which the preform body was handed over from a relay device to an outer holding device. It is a schematic block diagram for demonstrating the operation of the electron beam sterilization equipment, and shows the state which the inner surface of a preform body is sterilized, and the dose of the electron beam irradiated for that purpose is measured. It is a vertical sectional view of the preform body in which the same validation method is used. It is a vertical cross-sectional view of the preform body of another shape in which the same validation method is used.

Hereinafter, the validation method of the electron beam sterilization equipment according to the embodiment of the present invention will be described with reference to the drawings.

First, the outline of the electron beam sterilization equipment will be described with reference to FIGS. 1A and 1B. In the following, for the sake of simplicity, the preform body will be described as an example of the sterilization object to be sterilized by the electron beam sterilization equipment. Of course, the object to be sterilized is not limited to the preform body, but may have a mouth, and thus includes a container such as a PET bottle or a bottle.

As shown in FIGS. 1A and 1B, the electron beam sterilizer 1 has an electron electron on the inner surface of the preform body P, that is, the inner surface of the test tube-shaped raw material P before being molded into a PET bottle by blow molding. It is sterilized by irradiation with line E. For this purpose, the electron beam sterilization equipment 1 includes a holding device 2 (hereinafter referred to as an inner holding device 2) for holding the preform body P from the inside, and a preform body after being held by the inner holding device 2. An electron beam irradiating device 3 for irradiating the inner surface of P with an electron beam E is provided. The electron beam irradiating device 3 has an electron beam emitting nozzle 4 that is inserted into the preform body P and emits an electron beam E. Since the preform body P when the inner surface is irradiated with the electron beam E is held by the inner holding device 2, for example, it is held by a separate holding device 5 (hereinafter referred to as the outer holding device 5) from the outside. It may be retained and may not be retained if retention is not required.

In order to measure the dose of the electron beam E applied to the inner surface of the preform body P, a large number (eight in FIG. 2) of dose films f1 to be shown on the inner surface of the preform body P. f8 is attached over 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, those affixed to the portion "having a history of holding from the inside" shown in FIG. 2, are the inner holding devices f1 and f2. It may be damaged due to contact with 2. Even in such a case, a method capable of improving the accuracy of verification that the inner surface of the preform body P is properly sterilized is the gist of the present invention.

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

In the validation method, the regular preform body P, that is, the preform body P which is sterilized in the electron beam sterilization facility 1 and then blow-molded into a PET bottle is not used, but these regular preform bodies P. Before P, a verification preform body P that is sterilized by the electron beam sterilization facility 1 is used. The verification preform body P has at least the same inner surface as 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, it will be described as a verification preform body P.

On the inner surface of the verification preform body P, any portion other than the portion held from the inside by the inner holding device 2 is used as the verification portion. In the example shown in FIG. 2, the portion of the dose film f8 attached to the innermost part of the verification preform body P is shown as the verification portion. The validation method includes a verification electron beam irradiation step of irradiating the inner surface of the verification preform body 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 an electron beam E from the electron beam emitting nozzle 4 so that the verification portion is equal to or less than the dose of the electron beam E irradiated to other than the verification portion. .. That is, in the example shown in FIG. 2, in the verification electron beam irradiation step, the dose i8 irradiated on the dose film f8 attached to the innermost part is the dose i1 to i7 irradiated on the other dose films f1 to f7. The electron beam E is emitted from the electron beam emitting nozzle 4 as follows.

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

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 except for the verification portion, it is sufficient if the dose can be accurately measured at the verification portion. It is possible to improve the accuracy of verification that the inner surface of the preform body P is properly sterilized.

Hereinafter, the validation method of the electron beam sterilization equipment 1 according to the embodiment in which the embodiment is shown more concretely will be described with reference to the drawings. In this embodiment, the description will be focused on the configuration omitted in the above-described embodiment, and the same components as those in the above-described embodiment will be designated by the same reference numerals and the 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 the test machine of the electron beam sterilization equipment 1 is used. In this test machine, the conditions of use in the electron beam sterilization equipment 1 and the like are set so that the verification portion in the electron beam sterilization equipment 1 is equal to or less than the dose of the electron beam E irradiated to the portion other than the verification portion. It is a facility for deciding.

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. It is provided with an electron beam irradiation device 103 for a test machine that irradiates the electron beam E. The electron beam irradiation device 103 for a test machine has an electron beam emission nozzle 104 for a test machine that is inserted into the preform body P and emits an electron beam E. Further, the test machine 100 includes a test machine lifting device 107 that raises and lowers the test machine outer holding device 105 in order to insert and exit the test machine electron beam emitting nozzle 104 into the preform body P. Further, the test machine 100 includes a test machine control device 108 that controls the test machine electron beam irradiation device 103 and the test machine lifting device 107, and an electron beam E that irradiates the inner surface of the preform body P. The preform body P is provided with an irradiation dose measuring device 109 for a test machine that measures the dose from the mouth to the bottom of the preform body P in the axial direction. The mouth and bottom of the preform body P are as shown in FIG. 6, and in order to measure the dose of the electron beam in the axial direction from the mouth to the bottom, for example, the dose films f1 to f8 shown in FIG. 3 are used. used.

Specifically, the objects of control by the control device 108 for the test machine are the output of the electron beam E emitted by the electron beam irradiation device 103 for the test machine and the outside for the test machine by the elevating device 107 for the test machine. This is the operation of the holding device 105. Here, the operation of the test machine outer holding device 105 includes the amount and speed of raising and lowering by the test machine lifting device 107 of the test machine outer holding device 105, and a change in the speed.

As shown in FIG. 4, in the irradiation dose measuring device 109 for the test machine, the dose of the electron beam E irradiated on the inner surface of the preform body P is “verification portion i8 ≦ i1 to i7 other than the verification portion”. 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 (margin of error). These margins of error are shown in FIG. 4 by inclining the tip (right end) of the bar graphs i1 to i8 corresponding to each dose. In this case, the maximum value i8max including the tolerance in the measured dose i8 in the verification portion f8 sets the tolerance in the smallest dose i7 among the measured doses i1 to i7 in f1 to f7 other than the verification portion. If it is the minimum value i7min or more including it, it is regarded as "verification part i8 ≤ i1 to i7 other than the verification part". These conditions in the test machine 100 are used in the control by the control device (described later) of the electron beam sterilization equipment 1. That is, even in the electron beam sterilization equipment 1, by using the same conditions as the test machine 100, the dose of the electron beam E irradiated on the inner surface of the verification preform body P is "verification portion ≤ the verification". Other than the part ".

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

As shown in FIG. 5A, the electron beam sterilization equipment 1 has an inner holding device 2, an outer holding device 5, and an electron beam irradiating device 3 (hereinafter referred to as an electron beam emitting nozzle 4), as in the above embodiment. It is equipped with an inner electron beam irradiation device 3). The electron beam sterilization equipment 1 also includes an outer surface electron beam irradiating device 6 that sterilizes the outer surface of the preform body P held from the inside by the inner holding device 2 by irradiating the electron beam E. Further, as shown in FIGS. 5B and 5C, 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 delivers it to the outer holding device 5. In addition, the electron beam sterilization equipment 1 also includes an elevating device 7, a control device 8, and an irradiation dosimetry device 9, as shown in FIG. 5D. The elevating device 7 and the control device 8 have the same configuration as the test machine elevating device 107 and the test machine control device 108 of the test machine 100. The irradiation dose measuring device 9 may have the same configuration as the test machine irradiation dose measuring device 109, and at least if the dose of the electron beam E irradiated to the verification portion can be measured, the test machine irradiation dose measurement The configuration may be different from that of the device 109. This is because the irradiation dose measuring device 9 measures the dose of the electron beam E irradiated to the verification portion, and then estimates the dose of the electron beam E irradiated to the portion other than the verification portion by the subsequent verification step. Because it will be. Further, as shown in FIG. 5D, the electron beam sterilization equipment 1 also includes a verification device 11 for verifying whether or not the dose of the electron beam E irradiated to the verification portion exceeds the standard for sterilization. ..

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

First, as shown in FIG. 3, in the test machine 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 portion ≤ other than the verification portion", the conditions used in the control by the control device 108 for the test machine at that time are recorded. This control condition is used in the control by the control device 8 of the electron beam sterilization equipment 1.

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

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

Next, as shown in FIG. 5B, the relay device 10 receives the verification preform body P whose outer surface is sterilized. The verification preform body P received by the relay device 10 is delivered 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 an electron beam E on the inner surface under the above-mentioned control conditions as shown in FIG. 5D. At the same time as being irradiated, it is moved up and down by the lifting device 7. On the other hand, the dose of the electron beam E irradiated to the verification portion 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 irradiated to the verification portion exceeds the standard for sterilization. As a result of this verification, if the dose of the electron beam E irradiated to the verification portion exceeds the standard, it is said that the entire inner surface of the verification preform body P is irradiated with the electron beam E having a dose equal to or higher than the standard. Judged.

As described above, according to the validation method of the electron beam sterilization equipment 1 according to the present embodiment, the effect described in the above-described embodiment is also obtained in the electron beam sterilization equipment 1 that sterilizes the outer surface and the inner surface of the preform body P.

Further, since a separate test machine 100 is used in advance to determine the conditions of use in the electron beam sterilization equipment 1, the accuracy of verification can be further improved.

By the way, in the above-described embodiments and examples, the dose of the electron beam E irradiated on the inner surface of the preform body P has been described as "verification portion ≤ other than the verification portion", but "verification portion <the relevant portion". It is preferable that it is "other than the verification part". As a result, even if an error occurs in the dose measurement, it is unlikely to affect the verification result, so that the accuracy of the verification can be further improved. In particular, if the dose of the electron beam E irradiated to the verification portion is 80% to 90% of the dose of the electron beam E irradiated to the portion other than the verification portion, the verification accuracy can be further improved. , The non-uniformity of the electron beam E irradiated on the inner surface of the preform body P can be reduced.

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

Further, in the above-described embodiments and examples, the speed at which the electron beam emitting nozzle 4 is inserted into and exits from the preform body P has not been specifically described, but a portion held from the inside (with a history of holding from the inside). When the portion) is the mouth, it is preferably constant. Since the velocity is constant (that is, constant velocity), 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 (lower part in the body) is minimized (that is, the dose of the electron beam E is minimized (that is, the lower part in the body). In other words, it tends to be a verification part). This makes it possible to simplify the setting of the verification part. On the other hand, it is also preferable that the speed is set at a position corresponding to the mouth portion and lower than a position corresponding to a portion other than the mouth portion. By setting such a speed, not only the preform body P as shown in FIG. 6 but also the preform body P'in which the mouth portion as shown in FIG. 7 has a much larger diameter than the other parts is the mouth. Since the electron beam is sufficiently irradiated to the portion, the dose of the electron beam E irradiated to the bottom portion and the lower portion of the body portion tends to be minimized (that is, to the verification portion). As a result, the setting of the verification portion can be simplified even for the preform body P'shown in FIG. 7.

In addition, in the above-described embodiments and examples, the depth at which the electron beam emitting nozzle 4 is inserted into the preform body P has not been specifically described, but 75% to 90% of the depth of the preform body P. Is preferable. By setting the insertion depth in this way, the dose of the electron beam E applied to the bottom portion and the lower portion of the body portion of the preform body P tends to be minimized (that is, to the verification portion). This makes it possible to simplify the setting of the verification part.

Further, in the above embodiment, in FIGS. 5A to 5D, the control device 8 and the inner surface electron beam irradiation device 3 installed on the ground are shown one by one, but the number may be plural. When there are a plurality of control devices 8 and internal electron beam irradiating devices 3, these plurality of control devices 8 and internal electron beam irradiating devices 3 are used to continuously sterilize the regular preform body P. It is preferable that the sterilization equipment is arranged at an equal pitch on the peripheral edge of the turntable separately provided.

Further, in the above embodiment, it has been described that the verification step is performed by the verification device 11 shown in FIG. 5D, but the verification step may be performed by an operator.

Further, in the above embodiment, it has been described that the preform body P moves up and down toward the electron beam emitting nozzle 4 in order to insert and exit the electron beam emitting nozzle 4 into the preform body P. May be raised and lowered toward the preform body P.

Moreover, the above-described embodiments and examples are exemplary in all respects and are not restrictive. The scope of the present invention is shown by the scope of claims rather than the above description, and is intended to include all modifications within the meaning and scope equivalent to the scope of claims. Of the configurations described in the above-described embodiments and examples, the configurations other than those described as the first invention in "Means for Solving Problems" are arbitrary configurations and can be appropriately deleted or changed. Is.

1 Electron beam sterilization equipment 2 Holding device (inside holding device)
3 Electron beam irradiation device (inner surface electron beam irradiation device)
4 Electron beam emission nozzle 5 Outside holding device 6 External electron beam irradiation device 7 Elevating device 8 Control device 9 Irradiation dose measurement device 10 Relay device 11 Verification device 100 Test machine 103 Test machine electron beam irradiation device 104 Test machine electron beam emission 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 (5)

This is a validation method for verifying whether the inner surface of the sterilized object is properly sterilized in an electron beam sterilization facility that sterilizes the inner surface of the sterilized object having a mouth by irradiating it with an electron beam.
The electron beam sterilization equipment
A holding device that holds the mouth of the sterilized object from the inside,
An electron beam irradiating device for irradiating the inner surface of the object to be sterilized after being held by the holding device with an electron beam is provided.
The electron beam irradiation device is
It has an electron beam emitting nozzle that is inserted into the sterilized object and emits an electron beam.
On the inner surface of the verification object having the same inner surface as the sterilization object, the dose of the electron beam irradiated to the verification portion other than the mouth held from the inside by the holding device is the verification. A verification electron beam irradiation step in which an electron beam is emitted from the electron beam emitting nozzle so that the dose of the electron beam is equal to or less than the dose of the electron beam irradiated to the portion other than the part to be used.
A method for validating an electron beam sterilization facility, which comprises a verification step for verifying whether or not the dose of the electron beam irradiated to the verification portion exceeds the standard for sterilization. In the verification electron beam irradiation step, the dose of the electron beam irradiated to the verification portion on the inner surface of the verification object to be sterilized is less than the dose of the electron beam irradiated to the portion other than the verification portion. The method for validating an electron beam sterilization facility according to claim 1, wherein an electron beam is emitted from an emission nozzle. The method for validating an electron beam sterilization facility according to claim 1 or 2 , wherein the verification electron beam irradiation step is characterized in that the speed at which the electron beam emitting nozzle is inserted into or exits from the verification sterilization object is constant. In the verification electron beam irradiation step, the speed at which the electron beam emitting nozzle is inserted into and / or exits from the verification object to be sterilized is lower at the position corresponding to the mouth than at the position corresponding to the part other than the mouth. The method for validating an electron beam sterilization facility according to claim 1 or 2, wherein the method is characterized. Claim 1 of the verification electron beam irradiation step is characterized in that the depth at which the electron beam emitting nozzle is inserted into the verification sterilization object is 75% to 90% of the depth of the verification sterilization object. The method for validating an electron beam sterilization facility according to any one of 4 to 4.

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