JP5603700B2 - Continuous decontamination, sterilization apparatus and method - Google Patents

Description

  The present invention relates to a decontamination and sterilization of an exterior surface of a package containing sterilized articles, and this decontamination, continuous decontamination, and a sterilization apparatus and method for transporting the sterilized package to a work room in an aseptic environment. It is.

  Pre-filled syringes and vials filled with pharmaceuticals are manufactured in advance for convenience in the medical field. The operation of filling these syringes and vials with medicines is performed in a filling work room (hereinafter referred to as an aseptic work room) in an aseptic environment. Syringes and vials used for this operation are small one by one, and a large quantity to be processed is required. Therefore, these syringes and vials are sterilized by γ-ray irradiation, electron beam irradiation, EOG (ethylene oxide gas), etc. at each manufacturing stage, and are transported into a sterile working room in a state where a predetermined number is stored in a package. The

  As this package, for example, there is a medical instrument package proposed in the following Patent Document 1 or described as the prior art. These packages are commonly referred to as peel-open packages, with plastic tabs shaped to the shape of articles such as syringes and vials housed inside and gas permeable top seals. It has. For this top seal, a non-woven fabric made of high-density polyethylene ultrafine fibers, Tyvek (trademark) is generally used. Gas permeation into the plastic tab is possible through the micropores of the Tyvek (trademark). Intrusion is blocked.

  The package thus configured is further distributed and transported by being wrapped in a packaging bag on the outside. However, the outer surface of the plastic tab and the top seal is contaminated during distribution and transportation, or when the plastic bag is taken out of the packaging bag for delivery into the aseptic work chamber. Therefore, the contaminated exterior surface cannot be carried into the aseptic work room unless it is decontaminated or sterilized. Therefore, the plastic tab and the outer surface of the top seal are decontaminated or sterilized by a decontamination device or sterilization device connected to the aseptic work chamber and then transported to the aseptic work chamber. The seal is peeled off, and the filling operation is performed on the sterilized syringe or vial inside.

  In these decontamination equipment and sterilization equipment, various methods such as EOG (ethylene oxide gas), hydrogen peroxide low-temperature gas, ozone gas, plasma, γ-ray irradiation, ultraviolet irradiation, or electron beam irradiation are adopted according to the purpose. Yes. Among these, one of the most common methods is a decontamination method using a hydrogen peroxide low-temperature gas.

  The method using the hydrogen peroxide cold gas can achieve the required level of decontamination effect, but it takes some processing time to decontaminate the entire package. When entering the inside of the plastic tab through the top seal made of (trademark), there is a problem that it takes time to remove the hydrogen peroxide condensed inside.

  Therefore, in a decontamination apparatus or a sterilization apparatus that needs to process a large number of articles per unit time as in the production of a prefilled syringe, a method having a high decontamination and sterilization effect in a short time is desired. Therefore, the following Non-Patent Document 1 discloses a small electron beam as a safe device that has a higher sterilization effect than a device using a general hydrogen peroxide low-temperature gas and that has high productivity and no residual substances. Sterilizers incorporating an irradiation device (small electronic accelerator) have been introduced.

  This sterilizer is actually operated to process the package containing the prefilled syringe. The package containing the pre-sterilized syringe is sterilized with an electron beam on its exterior surface and transported to the aseptic work room by a conveyor. Is done. This apparatus irradiates the entire surface of the package from three directions with three small electron accelerators arranged at an angle of 120 degrees.

  In this apparatus, the plastic tab and the upper surface seal can be sterilized efficiently by controlling the dose of the electron beam to be irradiated. According to the following non-patent document 1, this apparatus can process as many as 3,600 syringes per hour, and realizes high productivity.

Patent No. 4,237,489

Japan Radiation Utilization Promotion Association, Radiation Utilization Technology Database, Data No .: 010306 (Creation: 2007/10/03, Masayuki Sekiguchi)

  By the way, in the sterilization apparatus of the said nonpatent literature 1, in order to sterilize the whole exterior surface of a medical instrument package, the three small electronic accelerators each arrange | positioned at an angle of 120 degree | times operate simultaneously. This small electron accelerator is expensive in price per unit, and has a use limit (life) due to its accumulated use time. Therefore, there has been a problem that the initial cost and the maintenance cost of the apparatus are increased by operating three units simultaneously.

  In addition, when the usage limit (lifetime) of small electronic accelerators arrives irregularly every three units, not only does the work of sterilization significantly decrease, requiring considerable time for replacement, but also the reliability of the sterilization effect. There was a problem that sex and safety were hindered. It is conceivable to deal with this problem and replace three units at the same time during a predetermined usage time. However, in this case, there is a problem that the maintenance cost is further increased.

  Therefore, the present invention addresses the above-mentioned problems, and has a high decontamination and sterilization effect and high productivity when decontaminating and sterilizing the exterior surface of the package and transporting the package to an aseptic work room. It is another object of the present invention to provide a continuous decontamination and sterilization apparatus and method that can maintain high reliability and safety of decontamination and sterilization effects and can keep the initial cost and maintenance cost of the apparatus low. To do.

  Here, “decontamination” means according to “Guidelines for the production of aseptic pharmaceuticals by aseptic manipulation” (so-called Japanese version of aseptic manipulation guidelines) that “removable microorganisms and fine particles are removed in a reproducible manner or in advance. "Decrease to a specified level".

  On the other hand, “sterilization” means that, according to the above Japanese version of Aseptic Operation Guidelines, “all kinds of microorganisms, whether pathogens or non-pathogens, are killed or removed. It is defined as “a method for obtaining a state in which no microorganism is present”.

However, since the number of bacteria cannot be reduced to zero from a stochastic concept, a sterility assurance level (SAL: Sterility Assurance Level) is adopted in practice. Therefore, in view of the above object, in the present invention, “decontamination” means to reduce viable microorganisms from the exterior part of the container, and guarantee a level of SAL ≦ 10 ⁻⁶ . As a decontamination method that can guarantee this level, for example, a method using hydrogen peroxide gas can be used.

On the other hand, “sterilization” in the present invention means that all kinds of microorganisms are killed or removed from the exterior of the container, and a level of SAL ≦ 10 ⁻¹² is guaranteed. As a sterilization method that can guarantee this level, for example, a method of setting a required dose to 25 kGy in electron beam irradiation (see ISO-13409) can be used.

  In solving the above problems, the present inventors, as a result of diligent research, combined sterilization by electron beam irradiation and decontamination by hydrogen peroxide gas treatment, and the plastic tab of the package and the top seal part were combined in different ways. By efficiently decontaminating and sterilizing, it was found that high-productivity safe decontamination and sterilization can be performed without using a plurality of expensive small electronic accelerators, and the present invention has been completed.

That is, the continuous decontamination and sterilization apparatus according to the present invention is as described in claim 1.
The exterior of the storage body (10) that is connected to the aseptic work chamber (200) and stores sterilized articles is decontaminated and sterilized, and the storage body is transported into the aseptic work chamber. In continuous decontamination and sterilization equipment (100),
A decontamination chamber (120) for decontaminating the bottom and side exterior parts of the container,
A sterilization chamber (130) for sterilizing the upper surface exterior of the container;
Transport means (20, 70) for transporting the storage body to the aseptic work chamber via the decontamination chamber and the sterilization chamber,
The decontamination chamber is
A plurality of chambers (40) circulating inside the decontamination chamber along the conveying means;
A circulation means (50) comprising an accommodation mechanism (53) for accommodating the bottom surface and side surface exterior part of the housing body and an extraction mechanism (54) for taking out the inside of the chamber while circulating the plurality of chambers;
A decontamination gas supply means (G) for supplying decontamination gas to the bottom surface and the side surface exterior part housed in the chamber;
The sterilization chamber is
An electron accelerator (60, 61) for irradiating an electron beam is provided on an upper surface exterior portion of the storage body.

  According to the above configuration, the continuous decontamination and sterilization apparatus is divided into a decontamination chamber and a sterilization chamber, and includes a transport unit that transports the storage body via both chambers. Thus, the plurality of storage bodies are transported by the transport means, and are continuously transported from the outside of the aseptic working chamber to the inside of the aseptic working chamber via the decontamination chamber and the sterilizing chamber.

During this time, in the decontamination chamber, the bottom and side exterior parts of each container are decontaminated with the decontamination gas. The bottom and side exterior parts of the container are made of a plastic molded product and the like, and in the subsequent chemical liquid filling process, the portion does not directly affect sterility assurance after filling, so SAL ≦ 10 ^−6. Decontamination is performed to guarantee the level of

  In this decontamination chamber, first, a plurality of chambers provided therein accommodate the bottom surface and the side surface exterior portion of each storage body. Thereafter, the bottom surface and the side surface exterior portion of each container are sufficiently decontaminated with the decontamination gas. At this time, unlike the conventional decontamination apparatus, the decontamination gas is not supplied to the entire decontamination chamber, and the decontamination gas is locally supplied to each chamber. Thereby, the supply and exhaust efficiency of the decontamination gas is good, and high productivity can be maintained. In addition, since only the bottom surface and the side surface exterior part of the storage body are processed, even if the cover (top seal etc.) of the storage body has a fine hole, the inside of the storage body is passed through this lid (top seal etc.). Decontamination gas does not enter.

Subsequently, in the sterilization chamber, the upper surface exterior portion of each container is sterilized by electron beam irradiation. The upper surface exterior portion of the container may be made of a material having micropores, and in the subsequent chemical solution filling step, it is a portion that directly affects sterility assurance after filling, so SAL ≦ 10 ⁻ Sterilization is performed to guarantee a level of ¹² .

  In this sterilization room, the upper surface exterior part of the container taken out from the chamber is sufficiently sterilized by electron beam irradiation. In this way, since only the upper surface exterior part of the housing needs to be irradiated with an electron beam, the number of operating electron accelerators is one, the initial cost of the apparatus is low, and the replacement work is simplified and the maintenance cost is reduced. Can be kept cheap. In addition, since this single electron accelerator can be fully used up to the use limit (life), the maintenance cost is low, and the reliability and safety of the decontamination effect can be kept high.

  Furthermore, while being irradiated with an electron beam in this sterilization chamber, it can also serve as aeration for removing the decontamination gas used in the previous decontamination chamber, so the overall processing time can be shortened, High productivity can be maintained.

  Therefore, the present invention has high decontamination, sterilization effect, and high productivity when decontaminating and sterilizing the exterior surface of the package and transporting the package to an aseptic work room. It is possible to provide a continuous decontamination and sterilization apparatus that can maintain high reliability and safety of the effect and can keep the initial cost and maintenance cost of the apparatus low.

Moreover, according to the description of claim 2, the continuous decontamination and sterilization apparatus according to the present invention,
The exterior of the storage body (10) that is connected to the aseptic work chamber (200) and stores sterilized articles is decontaminated and sterilized, and the storage body is transported into the aseptic work chamber. In continuous decontamination and sterilization equipment (150),
Decontamination of the bottom and side exterior parts of the container, as well as decontamination and sterilization chamber (170) for sterilizing the top exterior part of the container,
Transporting means (20) for transporting the container to the aseptic work chamber via the decontamination and sterilization chamber,
The decontamination and sterilization room
A plurality of chambers (40) circulating inside the decontamination chamber along the conveying means;
A circulation means (50) comprising an accommodation mechanism (53) for accommodating the bottom surface and side surface exterior part of the housing body and an extraction mechanism (54) for taking out the inside of the chamber while circulating the plurality of chambers;
A decontamination gas supply means (G) for supplying a decontamination gas to the bottom surface and the side surface exterior part housed in the chamber;
An electron accelerator (62) for irradiating an electron beam is provided on an upper surface exterior portion of the storage body.

  According to the above configuration, in the continuous decontamination and sterilization apparatus, decontamination and sterilization are simultaneously performed in the same chamber without partitioning a decontamination chamber where decontamination is performed and a sterilization chamber where sterilization is performed. That is, while the bottom surface and the side surface exterior portion of the storage body are decontaminated, the top surface exterior portion of the storage body is sterilized at the same time. As a result, the processing time for decontamination and sterilization overlaps, so that the container can be decontaminated and sterilized in a shorter time, and high productivity can be exhibited. Therefore, the invention described in claim 2 can achieve the same effects as those of the invention described in claim 1.

According to the description of claim 3, the present invention is the continuous decontamination and sterilization apparatus according to claim 1 or 2,
The decontamination gas is a hydrogen peroxide gas or a gas containing hydrogen peroxide.

  The hydrogen peroxide gas used in the above configuration has a good balance as a decontamination agent among various decontamination gases, and can sufficiently decontaminate the bottom and side exterior parts of the container. Therefore, in the invention described in claim 3, it is possible to further achieve the same effect as that of the invention described in claim 1 or 2.

According to the description of claim 4, the present invention is the continuous decontamination and sterilization apparatus according to claim 3,
The temperature of the hydrogen peroxide gas or the gas containing hydrogen peroxide to be supplied to the bottom and side exterior parts is in the range of 40 ° C to 60 ° C.

  Usually, the hydrogen peroxide gas used for decontamination is a low temperature gas, and the temperature thereof is about room temperature. According to the above configuration, a high temperature hydrogen peroxide gas or hydrogen peroxide of 40 ° C. to 60 ° C. It is possible to decontaminate the bottom surface and the side surface exterior portion of the container using a gas containing.

  A value representing a decontamination effect or a sterilization effect includes a sterilization (decontamination) processing unit: D value (Decimal reduction value). Here, the D value is the concentration / temperature / time of the hydrogen peroxide gas necessary to reduce the initial number of bacteria to 1/10. For example, when the concentration is constant, hydrogen peroxide at room temperature is used. The D value (treatment time) with hydrogen peroxide gas at 40 ° C. to 60 ° C. is smaller than the D value with gas (treatment time). As a result, the hydrogen peroxide gas for decontaminating the bottom surface and side surface outer surface of the container or the temperature of the gas containing hydrogen peroxide is set to 40 ° C. to 60 ° C., so that more effective and shorter time removal can be achieved. Dyeing is possible. Therefore, in the invention described in claim 4, it is possible to further achieve the same effect as that of the invention described in claim 3.

Moreover, according to the description of claim 5, the continuous decontamination and sterilization method according to the present invention,
Storage during a transporting process of transporting a storage body configured of a plastic tab and a gas permeable top seal and storing sterilized articles to the interior of the aseptic work chamber via the interior of the decontamination chamber In the continuous decontamination and sterilization methods to decontaminate and sterilize the exterior part of the body,
Made from the decontamination chamber box body whose upper surface portion circulates inside is opened, and the use of a chamber for accommodating the bottom and side surfaces exterior of the container therein to receive a said container from below By the accommodating step of forming a space in which the inner wall portion of the chamber and the bottom and side exterior portions of the storage body are closed ,
A decontamination step of supplying decontamination gas to the closed space formed in the storage step and decontaminating the bottom surface and the side surface exterior of the storage body ;
An extraction step of taking out the bottom and side exterior parts of the container after decontamination from the inside of the chamber,
And a sterilization step of sterilizing the upper surface exterior portion by irradiating the upper surface exterior portion of the container made of the gas permeable upper surface seal with an electron beam.

  According to the above configuration, for the same reason as described in the first and second aspects, when the package is decontaminated and sterilized and the package is transported to the aseptic work chamber, a high decontamination and sterilization effect can be obtained. Providing a continuous decontamination and sterilization method that has high productivity, maintains high reliability and safety of decontamination and sterilization effects, and can keep the initial cost and maintenance cost of equipment low. be able to.

According to the description of claim 6, the present invention is the continuous decontamination and sterilization method according to claim 5,
The decontamination gas is a hydrogen peroxide gas or a gas containing hydrogen peroxide.

  Also in the above configuration, the same effect as that of the invention according to the fifth aspect can be further achieved for the same reason as described in the third aspect.

According to the description of claim 7, the present invention is the continuous decontamination and sterilization method according to claim 6,
The temperature of the hydrogen peroxide gas or the gas containing hydrogen peroxide to be supplied to the bottom and side exterior parts is in the range of 40 ° C to 60 ° C.

  Also in the above configuration, the same effect as that of the invention described in claim 6 can be further achieved for the same reason as described in claim 4.

  In addition, the code | symbol in the bracket | parenthesis of each said means shows the correspondence with the specific means as described in embodiment mentioned later.

It is a longitudinal cross-sectional view which shows the outline | summary of 1st Embodiment of the continuous decontamination and sterilization apparatus concerning this embodiment. It is a longitudinal cross-sectional view which shows the outline | summary of 2nd Embodiment of the continuous decontamination and sterilization apparatus concerning this embodiment.

Hereinafter, each embodiment of the continuous decontamination and sterilization apparatus according to the present invention will be described with reference to the drawings.
(First embodiment)
As shown in FIG. 1, the continuous decontamination and sterilization apparatus 100 according to the first embodiment is connected to an aseptic work chamber 200. This continuous decontamination and sterilization apparatus 100 is a box composed of a wall portion made of a stainless steel metal plate, and the interior is divided into a front chamber 110, a decontamination chamber 120, and a sterilization chamber 130 by each wall portion. Has been.

  A shutter 110 a that can be opened and closed in the vertical direction is provided on the front wall of the front chamber 110. A common wall between the front chamber 110 and the decontamination chamber 120 is provided with a shutter 120a that can be opened and closed in the vertical direction. A common wall portion between the decontamination chamber 120 and the sterilization chamber 130 is provided with a shutter 130a that can be opened and closed in the vertical direction. In addition, a shutter 130 b that can be opened and closed in the vertical direction is provided on a common wall portion between the sterilization chamber 130 and the aseptic work chamber 200.

  Each chamber of the continuous decontamination and sterilization apparatus 100 and the aseptic work chamber 200 maintain a sterilized state that is shut off from the external environment. In particular, the invasion of bacteria into the aseptic work chamber 200 where the filling operation is performed is performed. In order to prevent, the internal air pressure of each chamber is adjusted by intake air from an intake device (not shown). That is, the air pressure of the aseptic work chamber 200 is high, and the air pressure is gradually reduced toward the front chamber 110 so that the aseptic work chamber 200> the sterilization chamber 130> the decontamination chamber 120> the front chamber 110 is maintained.

  Inside the front chamber 110 and the decontamination chamber 120, a transfer lift 20 that moves over both chambers is provided, and the front chamber 110 is held by opening the shutter 110a of the front chamber 110 and holding the package 10 that is carried in. To the decontamination chamber 120. The transfer lift 20 is installed so as to maintain the shielding between the front chamber 110 and the decontamination chamber 120 without hindering the opening and closing of the shutter 120a.

  The package 10 includes a rectangular cylindrical polyethylene tab having an open upper surface and an upper surface seal made of Tyvek (trademark) covering the released upper surface, and the polyethylene tab and the upper surface seal are sealed by heat sealing. Has been. A large number of syringes (not shown) are housed in the package 10 in a sterilized state.

  The front chamber 110 includes the transfer lift 20 and the HEPA filter 30 described above, and the HEPA filter 30 is provided in an upper portion of the front chamber 110 to purify air sucked from an intake device (not shown), and One-way air flowing from the upper side to the lower side in the chamber 110 is formed. This one-way air flows along the exterior portion of the package 10 carried into the front chamber 110 and is exhausted from an exhaust port (not shown) provided in the lower portion of the front chamber 110.

  The decontamination chamber 120 includes the above-described transfer lift 20, the HEPA filter 31, a plurality of chambers 40, a circulation mechanism 50 that circulates these chambers 40, and an excess of decontamination gas that is supplied into each chamber 40. And a hydrogen oxide gas supply mechanism G (not shown).

  The HEPA filter 31 is provided in the upper part of the decontamination chamber 120, purifies the air sucked from the intake device (not shown), and is a one-way flow that flows from the upper side to the lower side of the decontamination chamber 120. Air is formed. This one-way air flows along the exterior of the package 10 carried into the decontamination chamber 120 from the front chamber 110 and exhausts from an exhaust port (not shown) provided in the lower portion of the decontamination chamber 120. Is done.

  The chamber 40 is a box made of a stainless steel metal plate whose upper surface is opened, receives each package 10 from below, and accommodates the bottom surface and side surface exterior of each package 10 therein. In this state, the bottom surface and the side surface exterior portion of the package 10 form a closed space inside the package 10 together with the inner wall portion of the chamber 40. Further, on the side surface of each chamber 40, there are a seal-type air supply port and a seal-type exhaust port (both not shown) into which a supply nozzle (not shown) of the hydrogen peroxide gas supply mechanism G is inserted. Is provided.

  The circulation mechanism 50 includes two conveyors 51 and 52 and two chamber elevators 53 and 54. The upper conveyor 51 conveys the chamber 40 in a state where the package 10 is received from below in the left direction in the figure. The lower conveyor 52 conveys the chamber 40 in a state where the package 10 is not received in the right direction in the figure.

  The two chamber elevators 53 and 54 respectively include receiving members 53a and 54a that receive the lower end portion of the chamber 40 and movable members 53b and 54b that move the receiving members 53a and 54a up and down. The front chamber elevator 53 is located in front of the shutter 120a in front of the decontamination chamber 120 and transfers the chamber 40 sent from the lower conveyor 52 to the upper conveyor 51. The rear chamber elevator 54 is located in front of the shutter 130 a at the rear of the decontamination chamber 120 and delivers the chamber 40 sent from the upper conveyor 51 to the lower conveyor 52. Thus, the plurality of chambers 40 each circulate in the decontamination chamber 120 counterclockwise in the figure.

  The hydrogen peroxide gas supply mechanism G includes a supply nozzle and an aeration nozzle (both not shown). The supply nozzle is supplied from a hydrogen peroxide gas generator (not shown) disposed outside the decontamination chamber 120. The hydrogen peroxide gas to be sent is supplied to a closed space formed in each chamber 40. The aeration nozzle supplies air when the hydrogen peroxide gas after decontamination is discharged from the closed space. The hydrogen peroxide gas generator may be a normal one, and generally includes an evaporator, a chemical tank, and a blower.

  As described above, the closed space is formed by the bottom and side exterior parts of the package 10 and the inner wall part of the chamber 40, and the bottom and side exteriors of the package 10 by the supplied hydrogen peroxide gas. Department is decontaminated. Specifically, the hydrogen peroxide gas is supplied to the inside of the chamber 40 at the position A on the upper conveyor 51, exhausted from the inside of the chamber 40 at the position B, and aerated.

  The sterilization chamber 130 includes two electronic accelerators 60 and 61 and a transport mechanism 70 that transports the package 10 carried into the sterilization chamber 130 from the decontamination chamber 120. Further, in the sterilization chamber 130, aeration for sucking the internal air downward is performed. By this aeration, the hydrogen peroxide gas decontaminated on the bottom surface and side surface exterior of the package 10 is completely removed, and the remaining hydrogen peroxide gas is prevented from entering the aseptic work chamber 200.

  The two electron accelerators 60 and 61 are located from the upper part of the sterilization chamber 130 with the irradiation surface facing downward, and two of the same type are provided in series. One electron accelerator 60 is an operating device, and the other electron accelerator 61 is provided as a spare device when the operating electron accelerator 60 reaches the use limit (life). As these electron accelerators 60 and 61, what is generally referred to as a small or low energy type may be used. For example, a radiation source: 40 to 200 kV, 3.5 to 5 mA may be used.

  The transport mechanism 70 is provided with a conveyor 71 and two package transfer machines 72 and 73. The conveyor 71 is below the irradiation surface of the electron accelerators 60 and 61, and conveys the package 10 in the left direction in the figure. The electron beam irradiated from the electron accelerator 60 or 61 during this conveyance sterilizes the upper surface exterior portion of the package 10.

  The two package reloading machines 72 and 73 respectively hold gripping members 72a and 73a that hold the side wall of the package 10 and move the package 10 in the front-rear direction, and a movable member 72b that moves the gripping members 72a and 73a up and down. 73b. The front package loader 72 is located in front of the shutter 130a at the front of the sterilization chamber 130 and transfers the package 10 from the rear of the decontamination chamber 120 onto the conveyor 71 in the sterilization chamber 130. The rear package loader 73 is in front of the shutter 130b at the rear of the sterilization chamber 130, and transfers the package 10 after sterilization by electron beam irradiation from the rear of the sterilization chamber 130 onto the conveyor 81 in the aseptic work chamber 200.

  Here, the exterior part of the package 10 is decontaminated and sterilized using the continuous decontamination and sterilization apparatus 100 according to the first embodiment configured as described above, and the package 10 after decontamination and sterilization is aseptic. An operation for carrying in the work chamber 200 will be described.

  In FIG. 1, the aseptic work chamber 200 is in an aseptic environment, and a prefilled syringe filling operation (not shown) is performed therein. At this time, the shutter 130b is closed, and the aseptic working chamber 200 and the continuous decontamination / sterilization apparatus 100 are hermetically shut off. Further, the shutters 110a, 120a and 130a provided on the respective wall portions of the continuous decontamination and sterilization apparatus 100 are closed, and the front chamber 110, the decontamination chamber 120 and the sterilization chamber 130 are shut off in an airtight manner. ing.

  Here, an operator in the external environment opens the shutter 110a of the front chamber 110 and causes the transfer lift 20 in the front chamber 110 to grip the package 10. Thereafter, the shutter 110a is closed. The package 10 in the front chamber 110 is conveyed toward the decontamination chamber 120 as the transfer lift 20 moves.

  Next, the shutter 120a between the front chamber 110 and the decontamination chamber 120 is opened, and the package 10 reaching the rear of the front chamber 110 is conveyed into the decontamination chamber 120 as the transfer lift 20 moves. . Thereafter, the shutter 120a is closed. Further, it is preferable that the opening and closing of the shutter 120a and the opening and closing of the shutter 110a are linked in terms of movement of the package 10.

  Next, in the front part of the decontamination chamber 120, the movable member 53b of the front chamber elevator 53 is in a position where it is lowered, and the receiving member 53a receives the lower end of the chamber 40 sent from the lower conveyor 52. I accept. From this state, when the movable member 53b rises upward, the package 10 moved from the front chamber 110 to the decontamination chamber 120 is received by the rising chamber 40, and the exterior portion of the polyethylene tab of the package 10 is the chamber. 40.

  Next, the chamber 40 moves to the upper conveyor 51 while receiving the package 10. In this state, hydrogen peroxide gas is supplied to the inside of the chamber 40 that reaches the position A in the figure. The hydrogen peroxide gas is supplied by inserting a supply nozzle (both not shown) of the hydrogen peroxide gas supply mechanism G into an air supply port on the side wall of the chamber 40. Thus, the exterior portion of the polyethylene tab is decontaminated with hydrogen peroxide gas.

  Here, the concentration of the hydrogen peroxide solution evaporated by the hydrogen peroxide gas supply device is usually 30 to 35%, but a high concentration hydrogen peroxide solution of 40 to 60% may be used. . The hydrogen peroxide gas generated from such high-concentration hydrogen peroxide water has a high gas concentration, a small D value (treatment time), and a high decontamination effect can be obtained in a short time. In addition, the temperature of the hydrogen peroxide gas supplied to the chamber 40 is preferably 40 to 60 ° C. in order to further reduce the D value (processing time).

As described above, the hydrogen peroxide gas usually used for decontamination is a low-temperature gas, and the temperature is approximately room temperature. As in the first embodiment, decontamination using a high-temperature hydrogen peroxide gas of 40 ° C. to 60 ° C. enables more effective and short-time decontamination. For example, when the temperature of the hydrogen peroxide gas discharged from the supply nozzle is 40 to 60 ° C., the outer portion of the polyethylene tab in the chamber 40 has a level of SAL ≦ 10 ⁻⁶ within 1 minute. It was confirmed that there was a decontamination effect.

  Next, the chamber 40 that has received the package 10 while being decontaminated with hydrogen peroxide gas is conveyed in the left direction in the figure through the interior of the decontamination chamber 120 as the upper conveyor 51 moves. . Thereafter, aeration is performed to remove the hydrogen peroxide gas from the inside of the chamber 40 that reaches the position B in the figure. This aeration is performed by inserting an aeration nozzle (not shown) into the air supply port on the side wall of the chamber 40 and supplying clean air. At this time, the hydrogen peroxide gas is discharged from the exhaust port of the side wall portion of the chamber 40, and the hydrogen peroxide gas is removed from the exterior portion of the polyethylene tab.

  Next, in the rear part of the decontamination chamber 120, the movable member 54 b of the rear chamber elevator 54 is in a position where it is raised upward, and the receiving member 54 a receives the lower end portion of the chamber 40 sent from the upper conveyor 51. . From this state, the movable member 54b descends downward, whereby the package 10 held by the transfer lift 20 is taken out from the descending chamber 40. The lowered chamber 40 moves to the lower conveyor 52. Thus, each of the plurality of chambers 40 circulates inside the decontamination chamber 120 in the counterclockwise direction in the figure.

  Next, the shutter 130a between the decontamination chamber 120 and the sterilization chamber 130 is opened, and the package 10 on the receiving member 54a of the rear chamber elevator 54 is transferred to the conveyor 71 of the sterilization chamber 130 by the front package refiller 72. Transshipped to That is, the front package reloading machine 72 is in a state where the movable member 72b is lowered with the front side of the gripping member 72a facing the decontamination chamber 120. When the movable member 72b is lifted from this state, the gripping member 72a grips the side wall portion of the package 10 and releases it from the gripping state of the transfer lift 20.

  Next, the front package loader 72 drives the gripping member 72a while gripping the package 10, and moves the package 10 into the sterilization chamber 130 on the rear side of the gripping member 72a. Next, when the movable member 72 b is lowered, the package 10 is released from the gripping member 72 a and moves onto the conveyor 71. Thereafter, the shutter 130a is closed. At this time, the opening / closing of the shutter 130a and the opening / closing of the shutter 120a may be linked.

Next, the package 10 is conveyed in the left direction in the figure in the sterilization chamber 130 as the conveyor 71 moves. During this conveyance, the exterior portion of the top seal of the package 10 is sterilized with an electron beam irradiated from the electron accelerator 60. Here, the level of SAL ≦ 10 ⁻¹² can be guaranteed by adjusting the dose of the electron beam applied to the exterior portion of the top seal to 25 kGy.

  Next, the shutter 130b between the sterilization chamber 130 and the sterilization chamber 200 is opened, and the package 10 that has reached the rear of the sterilization chamber 130 is transferred onto the conveyor 81 of the sterilization chamber 200 by the rear package transfer machine 73. In other words, the rear package reloader 73 is in a state in which the movable member 73b is lowered with the gripping member 73a facing the sterilization chamber 130 side. When the movable member 73b is lifted from this state, the gripping member 73a grips the side wall portion of the package 10.

  Next, the rear package transfer machine 73 drives the gripping member 73a while gripping the package 10, and moves the package 10 into the aseptic working chamber 200 on the rear side of the gripping member 73a. Next, when the movable member 73 b is lowered, the package 10 is released from the gripping member 73 a and moves onto the conveyor 81. Thereafter, the shutter 130b is closed. At this time, the opening / closing of the shutter 130b and the opening / closing of the shutter 130a may be interlocked, and the operation of the front package re-sending machine 72 and the operation of the rear package re-sending machine 73 may be interlocked.

  In the aseptic work chamber 200 in which the package 10 is thus transported, the top seal is peeled off from the polyethylene tab of the package 10, and the filling operation is performed on the sterilized syringe inside.

As described above, in the continuous decontamination and sterilization apparatus 100 according to the first embodiment, first, in the decontamination chamber, the bottom surface of the package and the side surface exterior portion, that is, the exterior portion of the polyethylene tab are hydrogen peroxide. Decontaminated with gas. At this time, decontamination is performed to guarantee a level of SAL ≦ 10 ⁻⁶ .

  In this decontamination chamber, first, it is sufficiently decontaminated locally with hydrogen peroxide gas in a state where the exterior portions of the polyethylene tabs accommodated in each of the plurality of chambers provided therein are accommodated. . Therefore, unlike the conventional decontamination apparatus, hydrogen peroxide gas is not supplied to the entire decontamination chamber, the decontamination efficiency is high, and high productivity can be maintained.

  The hydrogen peroxide gas used as the decontamination gas has a good balance as a decontamination agent among various decontamination gases, and can sufficiently decontaminate the exterior portion of the polyethylene tab. Further, the hydrogen peroxide gas used for normal decontamination is a low temperature gas, and the temperature thereof is about room temperature. In the first embodiment, a high temperature hydrogen peroxide gas of 40 ° C. to 60 ° C. Can be used. Thus, by using a high-temperature hydrogen peroxide gas of 40 ° C. to 60 ° C., a high decontamination effect can be obtained with a short period of decontamination.

  Furthermore, since only the exterior portion of the polyethylene tab is processed, hydrogen peroxide gas does not enter the inside of the polyethylene tab through the upper surface seal made of Tyvek (trademark) having fine holes.

In the subsequent sterilization chamber, the exterior part of the top seal of each package is sterilized by electron beam irradiation. The top seal is composed of Tyvek (trademark) having micropores, and in the subsequent chemical filling process, it is a part that directly affects sterility assurance after filling, so that the level of SAL ≦ 10 ⁻¹² Sterilization is performed to ensure that.

  In this sterilization room, it is only necessary to irradiate the exterior part of the top seal of the package taken out from the chamber, so the number of operating electron accelerators is one, the initial cost of the apparatus is low, and replacement Work is simplified and maintenance costs are kept low. In addition, since this single electron accelerator can be fully used up to the use limit (life), the maintenance cost is low, and the reliability and safety of the decontamination effect can be kept high.

  In the first embodiment, a spare electron accelerator is arranged in series with the operating electron accelerator. As a result, even when the life of the electron accelerator reaches its lifetime, the operation can be quickly switched to the spare electron accelerator without requiring time for the replacement work. Therefore, the reliability and safety of the sterilization effect can be maintained high.

  Furthermore, while being irradiated with an electron beam in this sterilization chamber, it can also serve as aeration for removing the hydrogen peroxide gas used in the previous decontamination chamber, so the overall processing time can be shortened, High productivity can be maintained.

Thus, in the first embodiment, when decontaminating and sterilizing the exterior surface of the package and transporting the package to the aseptic work chamber, the package has high decontamination, sterilization effect, and high productivity. Further, it is possible to provide a continuous decontamination and sterilization apparatus and method that can maintain high reliability and safety of decontamination and sterilization effects and can keep the initial cost and maintenance cost of the apparatus low.
(Second Embodiment)
As shown in FIG. 2, the continuous decontamination and sterilization apparatus 150 according to the second embodiment is connected to the aseptic work chamber 200. The continuous decontamination / sterilization apparatus 150 is a box composed of a wall portion made of a stainless steel metal plate, and the inside thereof is partitioned into a front chamber 160 and a decontamination / sterilization chamber 170.

  The front wall portion of the front chamber 160 is provided with a shutter 160a that can be opened and closed in the vertical direction. A common wall portion between the front chamber 160 and the decontamination / sterilization chamber 170 is provided with a shutter 170a that can be opened and closed in the vertical direction. In addition, a shutter 170 b that can be opened and closed in the vertical direction is provided on a common wall portion between the decontamination / sterilization chamber 170 and the aseptic work chamber 200.

  The continuous decontamination, sterilizer 150, and aseptic work chamber 200 maintain aseptic conditions that are isolated from the external environment, but in particular to prevent bacteria from entering the aseptic work chamber 200 where the filling operation is performed. In addition, the internal air pressure of each chamber is adjusted by intake air from an intake device (not shown). That is, the air pressure in the aseptic work chamber 200 is high, and the air pressure is gradually lowered toward the front chamber 160 so that the aseptic work chamber 200> decontamination and the sterilization chamber 170> front chamber 160 are maintained.

  Inside the front chamber 160 and the decontamination and sterilization chamber 170 is provided a transfer lift 20 that moves across both chambers, and the package 10 that is carried in with the shutter 160a of the front chamber 160 opened (the first embodiment described above). A structure similar to the form) is grasped and decontaminated from the front chamber 160 and conveyed toward the sterilization chamber 170. The transfer lift 20 is installed so as to maintain the shielding between the front chamber 160 and the decontamination / sterilization chamber 170 without obstructing the opening and closing of the shutter 170a.

  The front chamber 160 includes the transfer lift 20 and the HEPA filter 30 described above, and the HEPA filter 30 is provided in an upper portion of the front chamber 160 to purify air sucked from an intake device (not shown) and One-way air flowing in the chamber 160 from the upper side to the lower side is formed. This one-way air flows along the exterior portion of the package 10 carried into the front chamber 160 and is exhausted from an exhaust port (not shown) provided in the lower portion of the front chamber 160.

  The decontamination and sterilization chamber 170 includes the transfer lift 20, the HEPA filter 31, a plurality of chambers 40 (the same structure as that of the first embodiment), a circulation mechanism 50 that circulates these chambers 40, Hydrogen peroxide gas supply mechanism G (not shown) for supplying decontamination gas into the chamber 40, one electron accelerator 62 (the same type as in the first embodiment), and one package transshipment Machine 74 (the same structure as that of the first embodiment).

  The HEPA filter 31 is provided in the upper part of the first half of the decontamination and sterilization chamber 170, purifies the air sucked from the intake device (not shown), and lowers the first half of the decontamination and sterilization chamber 170 from above. It forms a one-way air that flows toward This one-way air flows from the front chamber 160 along the exterior of the package 10 decontaminated and carried into the sterilization chamber 170, and the exhaust port (not shown) provided in the lower portion of the decontamination and sterilization chamber 170. )).

  The circulation mechanism 50 includes two conveyors 51 and 52 and two chamber elevators 53 and 54. Similarly to the first embodiment, the plurality of chambers 40 are respectively decontaminated and the interior of the sterilization chamber 170 is disposed. Circulate counterclockwise as shown.

  Similar to the first embodiment, the hydrogen peroxide gas supply mechanism G supplies hydrogen peroxide gas to the closed space formed by the bottom and side exterior portions of the package 10 and the inner wall portion of the chamber 40, and the package 10. Decontaminate the bottom surface 10 and the side surface exterior.

  The electron accelerator 62 is positioned with the irradiation surface facing downward from the upper part of the second half of the decontamination / sterilization chamber 170, and irradiates the upper surface exterior portion of the package 10 conveyed by the transfer lift 20 with an electron beam. Sterilize the exterior.

  The package transfer machine 74 is in front of the shutter 170b at the rear part of the decontamination / sterilization chamber 170, decontaminates the package 10 after decontamination / sterilization, and on the conveyor 81 in the aseptic work chamber 200 from the rear part of the sterilization chamber 170. Transship to

  Here, the exterior part of the package 10 is decontaminated and sterilized using the continuous decontamination and sterilization apparatus 150 according to the second embodiment configured as described above, and the package 10 after this decontamination and sterilization is aseptic. An operation for carrying in the work chamber 200 will be described.

  In FIG. 2, the aseptic working chamber 200 is in an aseptic environment as in the first embodiment, and a filling operation (not shown) of a prefilled syringe is performed therein. At this time, the shutter 170b is closed and the aseptic working chamber 200 and the continuous decontamination / sterilization apparatus 150 are hermetically shut off.

  Here, an operator in the external environment opens the shutter 160a of the front chamber 160 and causes the transfer lift 20 inside the front chamber 160 to grip the package 10. Thereafter, the shutter 160a is closed. The package 10 in the front chamber 160 is transported toward the decontamination and sterilization chamber 170 as the transfer lift 20 moves.

  Next, the shutter 170a between the front chamber 160 and the decontamination / sterilization chamber 170 is opened, and the package 10 reaching the rear of the front chamber 160 is decontaminated as the transfer lift 20 moves. It is conveyed to. Thereafter, the shutter 170a is closed. In addition, it is preferable in terms of movement of the package 10 that the opening and closing of the shutter 170a and the opening and closing of the shutter 160a are interlocked.

  Next, in the front part of the decontamination and sterilization chamber 170, the movable member 53b of the front chamber elevator 53 is in a position where it is lowered, and the receiving member 53a is sent from the lower conveyor 52 to the lower end of the chamber 40. Is accepted. From this state, when the movable member 53b rises upward, the package 10 moved to the decontamination and sterilization chamber 170 from the front chamber 160 is received by the rising chamber 40, and the exterior portion of the polyethylene tab of the package 10 is received. Is accommodated in the chamber 40.

  Next, the chamber 40 moves to the upper conveyor 51 while receiving the package 10. In this state, hydrogen peroxide gas is supplied to the inside of the chamber 40 that reaches the position A in the figure. The hydrogen peroxide gas is supplied by inserting a supply nozzle (both not shown) of the hydrogen peroxide gas supply mechanism G into an air supply port on the side wall of the chamber 40. Thus, the exterior portion of the polyethylene tab is decontaminated with hydrogen peroxide gas. Here, the concentration and temperature of the hydrogen peroxide gas supplied from the hydrogen peroxide gas supply mechanism G to the chamber 40 are performed in the same manner as in the first embodiment.

  Next, in a state where decontamination with hydrogen peroxide gas is being performed, the chamber 40 that has received the package 10 is decontaminated as the upper conveyor 51 moves, and the inside of the sterilization chamber 170 is conveyed in the left direction in the figure. Is done. Thereafter, aeration is performed in the same manner as in the first embodiment in order to remove the hydrogen peroxide gas from the inside of the chamber 40 that reaches the position B in the figure.

The package 10 that has been decontaminated with the hydrogen peroxide gas is sterilized with an electron beam that is irradiated from the electron accelerator 62 on the outer surface of the top seal while being conveyed by the conveyor 51. Here, the level of SAL ≦ 10 ⁻¹² can be guaranteed by adjusting the dose of the electron beam applied to the exterior portion of the top seal to 25 kGy.

  Next, in the rear part of the decontamination / sterilization chamber 170, the movable member 54b of the rear chamber elevator 54 is in a position where it is raised upward, and the receiving member 54a receives the lower end of the chamber 40 sent from the upper conveyor 51. I accept. From this state, the movable member 54b descends downward, whereby the package 10 held by the transfer lift 20 is taken out from the descending chamber 40. The lowered chamber 40 moves to the lower conveyor 52. In this manner, the plurality of chambers 40 circulate in the counterclockwise direction in the drawing inside the decontamination and sterilization chamber 170, respectively.

  Next, the shutter 170b between the decontamination / sterilization chamber 170 and the sterilization chamber 200 is opened, and the package 10 that has reached the rear of the decontamination / sterilization chamber 170 is transferred to the conveyor of the sterilization chamber 200 by the package transfer machine 74. It is transshipped to 81. That is, the package reloading machine 74 is in a state where the movable member 74b is lowered while the gripping member 74a is decontaminated and directed toward the sterilization chamber 170 side. When the movable member 74b is lifted from this state, the gripping member 74a grips the side wall of the package 10 and releases it from the gripping state of the transfer lift 20.

  Next, the package loader 74 drives the gripping member 74a while gripping the package 10, and moves the package 10 into the aseptic working chamber 200 on the rear side of the gripping member 74a. Next, when the movable member 74 b is lowered, the package 10 is released from the gripping member 74 a and moves onto the conveyor 81. Thereafter, the shutter 170b is closed. At this time, the opening / closing of the shutter 170b and the opening / closing of the shutter 170a may be linked.

  In the aseptic work chamber 200 in which the package 10 is thus transported, the top seal is peeled off from the polyethylene tab of the package 10, and the filling operation is performed on the sterilized syringe inside.

As described above, in the continuous decontamination and sterilization apparatus 100 according to the second embodiment, hydrogen peroxide gas is supplied to the exterior portion of the polyethylene tab in the decontamination and sterilization chamber, and SAL ≦ 10 ⁻⁶ . The decontamination that guarantees the level is performed, and the exterior portion of the top seal is irradiated with an electron beam, and sterilization that guarantees the level of SAL ≦ 10 ⁻¹² is performed. As a result, decontamination and sterilization of the exterior portion of the package can be efficiently performed, the entire processing time can be shortened, and high productivity can be maintained.

  Thus, also in the second embodiment, when decontaminating and sterilizing the exterior surface of the package and transporting the package to the aseptic work room, the package has high decontamination, sterilization effect, and high productivity. Further, it is possible to provide a continuous decontamination and sterilization apparatus and method that can maintain high reliability and safety of decontamination and sterilization effects and can keep the initial cost and maintenance cost of the apparatus low.

In carrying out the present invention, not only the above-described embodiments but also the following various modifications can be mentioned.
(1) In the first embodiment, two electron accelerators of the same type are provided in series and one is used as a spare. However, the invention is not limited to this, and a spare device may not be provided.
(2) In each of the above embodiments, the number of packages carried into the front chamber from the outside is one, but the number of packages is not limited to this, and a plurality of packages may be carried simultaneously.
(3) In each of the above embodiments, the number of packages transported from the front chamber to the decontamination chamber or decontamination / sterilization chamber is one, but the number of packages is not limited to this. You may make it do. When transporting a plurality of chamber elevators simultaneously, the number of chambers that can be received by the chamber elevator is increased, or a plurality of chamber elevators are arranged in parallel.
(4) In the first embodiment, the number of packages transported from the decontamination chamber to the inside of the sterilization chamber is one. However, the number of packages is not limited to this, and a plurality of packages may be transported simultaneously. Good. When transporting a plurality of chambers at the same time, the number of chambers that can be received by the chamber elevators can be increased, or a plurality of chamber elevators can be arranged in parallel and can be transshipped by the front package transfer machine. Try to increase the package quantity.
(5) In each of the above embodiments, the number of packages transferred from the sterilization chamber or decontamination / sterilization chamber to the inside of the aseptic work chamber is one. However, the number of packages is not limited to this. You may make it do. In the case of transporting a plurality of packages at the same time, the number of packages that can be reloaded by the package loader is increased.

  100, 150 ... Continuous decontamination, sterilizer, 110, 160 ... front chamber, 120 ... decontamination chamber, 130 ... sterilization chamber, 170 ... decontamination, sterilization chamber, 110a, 120a, 130a, 130b, 160a, 170a, 170b ... Shutter, 200 ... Aseptic working room, 10 ... Package, 20 ... Transfer lift, 30, 31 ... HEPA filter, 40 ... Chamber, 50 ... Circulation mechanism, 51, 52 ... Conveyor, 53, 54 ... Chamber elevator, 60, 61 62 ... Electronic accelerator, 70 ... Conveying mechanism, 71 ... Conveyor, 72, 73, 74 ... Package transshipment machine, 81 ... Conveyor.

Claims (7)

Continuous decontamination and sterilization device connected to an aseptic work chamber, decontaminating and sterilizing the exterior of a storage body containing sterilized articles, and transporting the storage body into the aseptic work chamber In
A decontamination chamber for decontaminating the bottom and side exterior parts of the container;
A sterilization chamber for sterilizing the upper surface exterior of the container;
Transporting means for transporting the storage body to the aseptic work chamber via the decontamination chamber and the sterilization chamber;
The decontamination chamber is
A plurality of chambers circulating inside the decontamination chamber along the conveying means;
Circulation means comprising an accommodation mechanism for accommodating the bottom surface and the side surface exterior part of the housing body and an extraction mechanism for taking out the interior of the chamber while circulating the plurality of chambers;
A decontamination gas supply means for supplying a decontamination gas to the bottom and side exterior parts housed in the chamber;
The sterilization chamber is
An apparatus for continuous decontamination and sterilization, comprising an electron accelerator for irradiating an electron beam on an upper surface exterior portion of the container. Continuous decontamination and sterilization device connected to an aseptic work chamber, decontaminating and sterilizing the exterior of a storage body containing sterilized articles, and transporting the storage body into the aseptic work chamber In
While decontaminating the bottom and side exterior parts of the container, decontamination to sterilize the top exterior part of the container, a sterilization chamber,
Transporting means for transporting the container to the aseptic work chamber via the decontamination and sterilization chamber,
The decontamination and sterilization chamber is
A plurality of chambers circulating inside the decontamination chamber along the conveying means;
Circulation means comprising an accommodation mechanism for accommodating the bottom surface and the side surface exterior part of the housing body and an extraction mechanism for taking out the interior of the chamber while circulating the plurality of chambers;
A decontamination gas supply means for supplying a decontamination gas to the bottom and side exterior parts housed in the chamber;
A continuous decontamination and sterilization apparatus, comprising: an electron accelerator that irradiates an electron beam to an upper surface exterior portion of the container.   The continuous decontamination and sterilization apparatus according to claim 1, wherein the decontamination gas is a hydrogen peroxide gas or a gas containing hydrogen peroxide.   4. The continuous decontamination according to claim 3, wherein a temperature of the hydrogen peroxide gas or a gas containing hydrogen peroxide supplied to the bottom surface and the side exterior portion is in a range of 40 ° C. to 60 ° C. 5. , Sterilizer. Storage during a transporting process of transporting a storage body configured of a plastic tab and a gas permeable top seal and storing sterilized articles to the interior of the aseptic work chamber via the interior of the decontamination chamber In the continuous decontamination and sterilization methods to decontaminate and sterilize the exterior part of the body,
The use of a chamber in which the decontamination chamber interior consists circulation box body whose upper surface portion is opened, and to receive a said container from below to accommodate the bottom and side surfaces exterior of the container in its interior By the accommodating step of forming a space in which the inner wall portion of the chamber and the bottom and side exterior portions of the storage body are closed ,
A decontamination step of supplying decontamination gas to the closed space formed in the storage step to decontaminate the bottom surface and the side surface exterior of the storage body ;
An extraction step of taking out the bottom and side exterior parts of the container after decontamination from the inside of the chamber,
A continuous decontamination and sterilization method comprising: a sterilization step of sterilizing the upper surface exterior portion by irradiating the upper surface exterior portion of the container made of the gas permeable upper surface seal with an electron beam.   6. The continuous decontamination and sterilization method according to claim 5, wherein the decontamination gas is a hydrogen peroxide gas or a gas containing hydrogen peroxide.   The continuous decontamination according to claim 6, wherein the temperature of the hydrogen peroxide gas or the gas containing hydrogen peroxide supplied to the bottom surface and the side surface exterior portion is within a range of 40 ° C to 60 ° C. , Sterilization method.

Images