JP3767486B2 - Packaging material sterilization method and packaging material sterilization apparatus - Google Patents

Description

[0001]
[Technical field to which the invention belongs]
The present invention relates to a packaging material sterilization method and a packaging material sterilization apparatus, and in particular, after hydrogen peroxide is used to sterilize a packaging material, hydrogen peroxide remaining in the packaging material is decomposed and removed. The present invention relates to a packaging material sterilization method and a packaging material sterilization apparatus.
[0002]
[Prior art]
For products that require high quality control, such as pharmaceuticals, the product itself is sterilized to a sterile state, and the packaging material filled with the product is sterilized in advance, and a sealed isolator (aseptic Various processes such as a filling process and a plugging process must be performed in an aseptic environment such as inside the chamber).
[0003]
For sterilization of the packaging material as described above, hydrogen peroxide may be used, but when the packaging material is sterilized with hydrogen peroxide, the hydrogen peroxide is removed before filling the packaging material with the product. Must. In particular, in the case of a resin packaging material, hydrogen peroxide used for sterilization penetrates into the inside, and therefore, it is necessary to decompose and remove hydrogen peroxide as quickly as possible.
[0004]
In order to decompose and remove hydrogen peroxide remaining in the packaging material after sterilization, conventionally, heated air or hot water is used alone or in combination depending on the application.
[0005]
[Problems to be solved by the invention]
However, since the hot water cleaning requires equipment for producing hot water, there is a problem in that the line is enlarged and the equipment cost and running cost are high, and improvement has been desired. Moreover, in the conventional hydrogen peroxide removal method, it takes time to decompose and remove hydrogen peroxide, and it has been difficult to improve the sterilization ability of the packaging material.
[0006]
As a method for decomposing and removing hydrogen peroxide used for sterilization, a technique using ferrous oxide has been proposed (Japanese Patent Laid-Open No. 2-98520). However, decomposition of hydrogen peroxide using ferrous sulfate generates sulfur, which is not preferable for sterilization of packaging materials such as pharmaceuticals.
[0007]
The present invention has been made to solve the above-mentioned problems, and can quickly perform the decomposition and removal treatment of hydrogen peroxide, can improve the sterilization treatment capacity of the packaging material, is compact, An object of the present invention is to provide a packaging material sterilization method and a packaging material sterilization apparatus that can be sterilized by a cost-effective apparatus and that can be safely used for sterilizing packaging materials such as pharmaceuticals.
[0008]
[Means for Solving the Problems]
The method for sterilizing a packaging material according to the invention of claim 1 includes a sterilization step of sterilizing the packaging material with hydrogen peroxide, and a decomposition step of decomposing hydrogen peroxide by attaching ozone to the sterilized packaging material. And a rinsing step of bringing a sterile medium into contact with the packaging material in which the hydrogen peroxide has been decomposed.
[0009]
Since the conventional packaging material sterilization method has various problems as described above, the inventors of the present invention have invented a sterilization method for decomposing and removing hydrogen peroxide remaining in the packaging material using ozone. This is because both hydrogen peroxide and ozone are the same oxidizing agent, but hydrogen peroxide acts as a reducing agent when the partner is a strong oxidizing agent, and by applying ozone with a higher oxidation-reduction potential. Residual hydrogen peroxide can be removed from an object to be sterilized (packaging material) in a very short time. Therefore, by using this sterilization method, the sterilization capacity of the packaging material can be improved. In addition, since the decomposition treatment is performed using ozone, there is no problem in the safety of the product as in the conventional configuration using ferrous sulfate, and it is safe to use for packaging materials such as pharmaceuticals.
[0010]
The invention method according to claim 2 is characterized in that, after the sterilization step, an aeration step of spraying a sterile medium onto the sterilized packaging material to drive out hydrogen peroxide in the packaging material is performed. is there.
[0011]
According to the method of the present invention, after the hydrogen peroxide in the packaging material is discharged, the decomposition step using ozone is performed, so that the remaining hydrogen peroxide can be more reliably decomposed and removed.
[0012]
Furthermore, the invention method according to claim 3 is characterized in that the amount of ozone supplied in the decomposition step is made larger than the amount of hydrogen peroxide supplied in the sterilization step.
[0013]
In the method of the present invention, since the amount of ozone supplied is larger than the amount of hydrogen peroxide, the remaining hydrogen peroxide can be decomposed and removed more reliably.
[0014]
Further, the packaging material sterilization apparatus according to the invention of claim 4 includes a sterilizing means for sterilizing the packaging material with hydrogen peroxide, an ozone supply means for attaching ozone to the sterilized packaging material, and the ozone. Rinsing means for bringing a sterile medium into contact with the attached packaging material.
[0015]
In the packaging material sterilization apparatus according to the present invention, the hydrogen peroxide remaining in the packaging material can be rapidly decomposed and removed, and the sterilization capacity of the packaging material can be improved. Further, the configuration is simpler than the conventional configuration, and the equipment cost and running cost can be reduced.
[0016]
Further, the packaging material sterilization apparatus according to claim 5 is provided with a sterile medium spraying means for spraying an aseptic medium to the packaging material sterilized by the sterilizing means to drive out hydrogen peroxide in the packaging material. It is what.
[0017]
In the packaging material sterilization apparatus according to the present invention, hydrogen peroxide is expelled from the sterilized packaging material by performing an aeration process in which a sterile medium such as sterile air is blown by the sterile medium blowing means. Ozone is sprayed on to decompose and remove hydrogen peroxide, so that it can be completely decomposed and removed.
[0018]
A technique for sterilizing a packaging material using ozone water and hydrogen peroxide is already known (Japanese Patent No. 2793728). An object of the invention of this publication is to increase the sterilizing power by reacting ozone with hydrogen peroxide to generate hydroxy radicals (.OH).
[0019]
On the other hand, the present invention aims to reduce the residual value by decomposing and removing hydrogen peroxide used in the sterilization process. Therefore, after the packaging material is sterilized with hydrogen peroxide, it is decomposed by the action of ozone, and thereafter, it is completely removed by the action of sterile air (sterile medium) in the rinsing step. Moreover, you may make it perform the aeration process which drives out the hydrogen peroxide which remains in a packaging material between a sterilization process and the decomposition process which makes ozone act.
[0020]
DETAILED DESCRIPTION OF THE INVENTION
The present invention will be described below with reference to embodiments shown in the drawings. FIG. 1 is a schematic configuration diagram of a packaging material sterilization apparatus according to an embodiment of the present invention. The entire sterilization apparatus is a sterilization chamber 2, and the sterilization chamber 2 performs chambers 14, 16, 18, 20, 22, 24 in which each processing step is performed by partition plates 4, 6, 8, 10, 12. It is divided into different atmospheres.
[0021]
On the inlet side wall surface 26 of the aseptic chamber 2, the partition plates 4, 6, 8, 10, 12 and the outlet side wall surface 28 partitioning the chambers 14, 16, 18, 20, 22, and 24, respectively, Openings 26a, 4a, 6a, 8a, 10a, 12a, and 28a through which the resin container (packaging material) 30 used in the above can pass are formed. These resin containers 30 are sequentially transported in the chambers 14, 16, 18, 20, 22, and 24 by a container transport conveyor (transport means) 32, and each process is performed.
[0022]
Of the chambers, the most upstream chamber 14 is an introduction chamber, and the container 30 introduced from the outside into the introduction chamber 14 is carried into the subsequent processing chambers and sequentially processed. The next second chamber 16 is a sterilization chamber, and a plurality of hydrogen peroxide gas injection nozzles 36 are provided in the chamber 16 above the mouth of the container 30 continuously conveyed by the container conveying conveyor 32. It has been. These injection nozzles 36 are supplied with hydrogen peroxide gas from a hydrogen peroxide gas generating means 38, and sterilization is performed by blowing hydrogen peroxide gas from the injection nozzle 36 onto the container 30.
[0023]
The third chamber 18 is an aeration chamber, and a sterile air injection nozzle 40 is also provided in the chamber 18 above the mouth of the container 30 conveyed by the container conveying conveyor 32. An air supply means 44 is connected to these aseptic air injection nozzles 40 via a filter 42, and aseptic air (sterile medium) supplied from the air supply means 44 is being conveyed through the injection nozzle 40. The hydrogen peroxide gas staying inside the container 30 is ejected out of the container 30 by being injected into the container 30. In this aeration process, it is more effective to heat the air blown to the container 30.
[0024]
A fourth chamber 20 following the aeration chamber 18 is an ozone chamber, and an ozone injection nozzle 46 for blowing ozone onto the container 30 being conveyed by the conveying means 32 is provided in the ozone chamber 20. Ozone gas generating means 48 is connected to the ozone injection nozzle 46, and the hydrogen peroxide adhering to the inner surface and outer surface of the container 30 is blown onto the container 30 by the ozone gas supplied from the ozone gas generating means 48. Decompose gas.
[0025]
The fifth chamber 22 is a rinsing chamber, and a sterile air injection nozzle 50 for injecting sterile air (sterile medium) to the container 30 being transported is provided in the chamber 22. An air supply means 54 is connected to the aseptic air injection nozzle 50 via a filter 52, and aseptic air supplied from the air supply means 54 is blown onto the container 30 being conveyed, the container 30 The reaction product of the adhering ozone gas and hydrogen peroxide gas is removed. Also in this rinsing step, as in the aeration step, the aseptic air blown to the container 30 is preferably heated air. In this rinsing process, air is blown for a longer time than in the aeration process.
[0026]
The last chamber 24 is a discharge chamber, and the container 30 that has been sequentially processed in each of the chambers 16, 18, 20, and 22 is discharged to the outside of the sterilization apparatus through the discharge chamber 24, and is sent to the next step. Sent.
[0027]
A sterilization method using the packaging material sterilization apparatus according to the above configuration will be described. In this embodiment, sterilization of the resin container 30 used for filling medicine as a container is performed. The containers 30 are continuously conveyed by a container conveying conveyor 32 and are first introduced into the introduction chamber 14 from the inlet of the sterilization chamber 2 (the opening 26a of the inlet side wall surface 26).
[0028]
Subsequently, it is carried into the sterilization chamber 16 through the opening 4 a provided in the partition plate 4 on the outlet side of the introduction chamber 14. In the sterilization chamber 16, the hydrogen peroxide gas supplied from the hydrogen peroxide gas generating means 38 is injected from above the container 30 being conveyed via the hydrogen peroxide gas injection nozzle 36. Sterilize the outer surface. Note that the inside of the sterilization chamber 16 is controlled at a positive pressure and higher than the pressure in the upstream introduction chamber 14 and the downstream aeration chamber 18, and an external atmosphere enters the sterilization chamber 16. It is supposed not to.
[0029]
The container 30 sterilized in the sterilization chamber 16 is subsequently carried into the aeration chamber 18. In the aeration chamber 18, heated aseptic air supplied from the air supply means 44 through the filter 42 is injected from the aseptic air injection nozzle 40 and blown into the container 30. Aseptic air is blown into the container 30, the hydrogen peroxide gas remaining after being blown into the container 30 by the sterilization process in the sterilization chamber 16 is pushed out of the container 30. In this embodiment, heated aseptic air is ejected in the aeration process, but it is not necessarily limited to heated air.
[0030]
The container 30 in which aseptic air is blown in the aeration step and the hydrogen peroxide gas remaining inside is discharged is carried into the next ozone chamber 20. In the ozone chamber 20, the ozone gas supplied from the ozone gas generating means 48 is sprayed from the ozone injection nozzle 46 onto the container 30, adheres to the inner and outer surfaces of the container 30, and adheres to the container 30 in the sterilization process. It decomposes by reacting with the hydrogen peroxide gas brought into the chamber 20.
[0031]
When ozone gas is jetted and acted on the hydrogen peroxide gas adhering to the container 30 in the sterilization step, the reaction occurs as follows.
O ₃ + H ₂ O ₂ → .OH + O ₂ + O ₂ H
By reacting as described above, the hydrogen peroxide gas is decomposed and can be reliably removed. According to an experiment in which the decomposition process of hydrogen peroxide gas with ozone gas was conducted, hydrogen peroxide gas with a concentration of 8,000 ppm was blown into the container, and then aerated with normal temperature compressed air to obtain a residual value of hydrogen peroxide gas. The residual value of hydrogen peroxide gas in a resin container which was made to contact ozone resin with a concentration of about 35,000 ppm for several seconds and finally aerated with compressed air at room temperature was 0.5 ppm. It was the following.
[0032]
The container 30 that has undergone the decomposition step of decomposing hydrogen peroxide gas by blowing ozone gas is then sent to the rinsing chamber 22. In this rinsing chamber 22, heated aseptic air supplied from the air supply means 54 via the filter 52 is injected from the aseptic air injection nozzle 50 onto the container 30 being conveyed. By injecting aseptic air into the container 30, the product by the reaction of ozone gas and hydrogen peroxide gas adhering to the container 30 in the decomposition step is removed. In this rinsing step, the reaction product of ozone gas and hydrogen peroxide adhering to the container 30 can be completely removed by blowing air for a longer time than in the aeration step.
[0033]
The container 30 introduced into the sterilizer and subjected to the sterilization process, the aeration process, the decomposition process by ozone injection and the rinsing process is carried out of the sterilization apparatus via the discharge chamber 24. Thus, in the packaging material sterilization method according to the present embodiment, hydrogen peroxide can be quickly decomposed and removed by a simple process using an apparatus having a simple structure. Sterilization capacity can be improved. Further, since it is not necessary to produce hot water as in the prior art, the apparatus is downsized and simplified, and the cost is low.
[0034]
Furthermore, in this embodiment, the case where the resin-made container 30 used for pharmaceuticals is sterilized has been described as an example. However, the use is not limited to pharmaceuticals, such as food containers, beverage bottles or milk cartons. Packaging materials may be used. Moreover, it is applicable not only to the resin container 30 but also to a glass container or the like. However, in the case of a glass container, hydrogen peroxide does not permeate into the interior, and since there is no restriction on heating unlike the resin container, the removal of hydrogen peroxide is easy. Therefore, the present invention is particularly effective for packaging materials such as resin containers. Furthermore, the packaging material is not limited to the container 30 as shown in the figure, and a packaging material such as a blister pack for packaging a syringe or the like is also applicable. Further, the packaging material is not limited to a molded product, and can be applied to a packaging material before molding.
[0035]
In the above embodiment, sterilization is performed using hydrogen peroxide gas. However, the present invention is not limited to gas, and hydrogen peroxide water may be used. Also, ozone is not limited to ozone gas, and ozone water can be used. However, when hydrogen peroxide gas is used in the sterilization process, it is preferable to use ozone gas in the decomposition process. When hydrogen peroxide water is used, it is preferable to use ozone water. In particular, when hydrogen peroxide gas is used in the sterilization process and ozone gas is used in the decomposition process, the entire sterilization process in the sterilization apparatus is completed in a dry environment. Furthermore, in the case of ozone gas, the effect can be enhanced by humidifying with steam or the like.
[0036]
Further, the number of nozzles such as the hydrogen peroxide gas injection nozzle 36, the sterile air injection nozzle 40, the ozone injection nozzle 46, and the sterile air injection nozzle 50 is not limited and is set as appropriate. Further, the conveying means is not limited to the container conveying conveyor 32, and may be other conveying forms such as a rotary neck conveying. In addition, this apparatus is not limited to continuous operation, and may be intermittent operation or batch processing.
[0037]
【The invention's effect】
As described above, the packaging material sterilization method according to the first aspect of the present invention includes a sterilization step of sterilizing a packaging material with hydrogen peroxide, and ozone is attached to the sterilized packaging material to generate hydrogen peroxide. Since it includes a decomposition step for decomposing and a rinsing step for bringing a sterile medium into contact with the packaging material in which the hydrogen peroxide has been decomposed, the hydrogen peroxide used for sterilization of the packaging material can be quickly removed. And the sterilization capacity of the packaging material can be improved.
[0038]
The packaging material sterilization apparatus according to the invention described in claim 4 includes a sterilizing means for sterilizing the packaging material with hydrogen peroxide, an ozone supply means for attaching ozone to the sterilized packaging material, and the ozone. By including the rinsing means for bringing the sterilized medium into contact with the attached packaging material, the hydrogen peroxide can be removed quickly and the sterilization capacity of the packaging material can be improved. Moreover, since the structure is simple, the equipment cost and running cost can be reduced without increasing the size of the line as in the conventional apparatus using hot water.
[Brief description of the drawings]
BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a diagram showing a simplified overall configuration of a packaging material sterilization apparatus according to an embodiment of the present invention.
[Explanation of symbols]
30 Packaging materials (containers)
36 Sterilization means (hydrogen peroxide gas injection nozzle)
38 Sterilization means (hydrogen peroxide gas generation means)
40 Aseptic medium spraying means (sterile air injection nozzle)
44 Aseptic medium spraying means (air supply means)
46 Ozone supply means (ozone injection nozzle)
48 Ozone supply means (ozone gas generation means)
50 Rinsing means (sterile air injection nozzle)
54 Rinsing means (air supply means)

Claims (5)

A sterilization step of sterilizing the packaging material with hydrogen peroxide, a decomposition step of decomposing hydrogen peroxide by attaching ozone to the sterilized packaging material, and a sterile medium in contact with the packaging material from which the hydrogen peroxide has been decomposed And a rinsing step for sterilizing the packaging material. 2. The packaging material sterilization method according to claim 1, wherein after the sterilization step, an aeration step is performed in which a sterile medium is sprayed on the sterilized packaging material to drive out hydrogen peroxide in the packaging material. The packaging material sterilization method according to claim 1 or 2, wherein the amount of ozone supplied in the decomposition step is larger than the amount of hydrogen peroxide supplied in the sterilization step. Sterilizing means for sterilizing the packaging material with hydrogen peroxide, ozone supply means for attaching ozone to the sterilized packaging material, and rinsing means for bringing an aseptic medium into contact with the packaging material to which the ozone is attached A packaging material sterilizer characterized by the above. 5. The packaging material sterilization apparatus according to claim 4, further comprising: a sterile medium spraying unit that sprays an aseptic medium onto the packaging material sterilized by the sterilizing unit to drive out hydrogen peroxide in the packaging material.

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