JP2000334028A - Method for sterilizing medical supplies by electron beam - Google Patents
Method for sterilizing medical supplies by electron beamInfo
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- JP2000334028A JP2000334028A JP11146282A JP14628299A JP2000334028A JP 2000334028 A JP2000334028 A JP 2000334028A JP 11146282 A JP11146282 A JP 11146282A JP 14628299 A JP14628299 A JP 14628299A JP 2000334028 A JP2000334028 A JP 2000334028A
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- irradiation
- electron beam
- distribution
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- medical
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Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、医療用品に電子線
を照射して滅菌する、医療用品の電子線による滅菌方法
に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for sterilizing medical supplies by irradiating an electron beam to the medical supplies.
【０００２】[0002]
【従来の技術】近時、血液透析に用いられるダイアライ
ザ等の医療用品を、電子線の照射によって滅菌すること
が提案されている。（特開平８−２７５９９１号公報等
参照）これによれば、エチレンオキサイドガス法等のガ
ス滅菌法のように残留毒性の虞がなく、内容物の湿潤状
態における耐熱性に問題があって高圧蒸気によるオート
クレーブ法を使用できないような対象品にも適用でき
る。2. Description of the Related Art Recently, it has been proposed to sterilize medical supplies such as a dialyzer used for hemodialysis by irradiation with an electron beam. According to this method, there is no danger of residual toxicity unlike gas sterilization methods such as an ethylene oxide gas method and the like, and there is a problem in heat resistance in a wet state of contents, and high pressure steam is used. Can also be applied to products for which the autoclave method cannot be used.
【０００３】[0003]
【発明が解決しようとする課題】しかしながら、電子線
の照射による吸収線量は、電子線照射部位の単位面積当
たりの質量に依存するものであり、照射医療用品がダイ
アライザのように複雑な形状のものに対して全ての部位
で均一な吸収線量が得られるように照射することは極め
て困難なものであった。However, the absorbed dose due to electron beam irradiation depends on the mass per unit area of the electron beam irradiation site, and the irradiation medical supplies have a complicated shape like a dialyzer. However, it was extremely difficult to irradiate so as to obtain a uniform absorbed dose at all sites.
【０００４】このため、最も単位面積当たりの質量の大
きな（面重量の大きな：最も肉厚の厚い）部位に対して
必要な吸収線量が得られるように全体を照射することが
考えられるが、これによれば滅菌は可能であるものの単
位面積当たりの質量の小さな（通常肉厚の薄い）部位で
は吸収線量が過剰となり、その結果、材質に劣化を生じ
てしまう場合がある。For this reason, it is conceivable to irradiate the entire part so as to obtain a necessary absorbed dose to a site having the largest mass per unit area (large surface weight: thickest wall). According to this method, although sterilization is possible, the absorbed dose becomes excessive in a portion having a small mass per unit area (usually thin), and as a result, the material may be deteriorated.
【０００５】尚、特開平８−２７５９９１号公報には、
対象医療用具の滅菌可能な照射量分布に基づいて、当該
医療用具を梱包する箱の内側又は外側に電子線の透過率
を調整するシールドを設け、電子線の照射分布を小さく
した医療用具が開示されている。しかし、この構成で
は、医療用具の照射分布と対応する梱包箱の位置に、そ
の照射量の差と対応した電子線透過率のシールドを設け
る必要があり、シールドの形成や装着が面倒であって滅
菌の作業効率が低いものである。しかも、大量の医療用
具に対して滅菌照射を行う場合は、一個一個の医療用品
や梱包箱に対してシールドを設けなければならず、設備
コストが増大する。Japanese Patent Application Laid-Open No. 8-275991 discloses that
Disclosed is a medical device in which a shield for adjusting the transmittance of electron beams is provided inside or outside a box for packaging the medical device based on the sterilizable irradiation dose distribution of the target medical device, and the electron beam irradiation distribution is reduced. Have been. However, in this configuration, it is necessary to provide a shield of the electron beam transmittance corresponding to the difference in the irradiation amount at the position of the packing box corresponding to the irradiation distribution of the medical device, and the formation and mounting of the shield are troublesome. Sterilization work efficiency is low. In addition, in the case where sterilization irradiation is performed on a large number of medical devices, shields must be provided for individual medical supplies and packaging boxes, which increases equipment costs.
【０００６】本発明は、上記問題に鑑みてなされたもの
であって、ダイアライザのように複雑な形状の照射医療
用品に対しても、電子線を全体的に均一な吸収線量とな
るように照射して滅菌することができ、効率的で低コス
トな医療用品の電子線による滅菌方法を提供することを
目的とする。The present invention has been made in view of the above-mentioned problems, and irradiates an electron beam to a uniform absorbed dose as a whole even to an irradiation medical article having a complicated shape such as a dialyzer. It is an object of the present invention to provide an efficient and low-cost method for sterilizing medical supplies by using an electron beam.
【０００７】[0007]
【課題を解決する為の手段】上記目的を達成する本発明
の医療用品の電子線による滅菌方法は、医療用品に電子
線を滅菌し得る均一な吸収線量となる照射分布で照射し
て滅菌する方法であって、前記医療用品の全体に対して
前記照射分布の最小域と対応する電子線照射を均一に行
う全体照射工程と、前記最小域を電子線を遮断する遮蔽
部材で覆って前記医療用品の全体に対して電子線照射を
行って前記最小域以外の領域に電子線を照射する部分遮
蔽照射工程と、によって前記電子線照射分布と対応した
照射を行うことを特徴とする。According to the method of the present invention for achieving the above object, a method for sterilizing medical supplies by using an electron beam is performed by irradiating the medical supplies with an irradiation distribution having a uniform absorption dose capable of sterilizing the electron beam. A method of uniformly irradiating an electron beam corresponding to the minimum area of the irradiation distribution to the entire medical article, and covering the medical area by covering the minimum area with a shielding member that blocks an electron beam. A partial shielding irradiation step of irradiating the whole of the article with an electron beam and irradiating an area other than the minimum area with an electron beam, thereby performing irradiation corresponding to the electron beam irradiation distribution.
【０００８】また、上記医療用品を電子線照射装置によ
る電子線照射域を通過させることで行い、該電子線照射
域を複数回通過させることで上記照射分布で照射するこ
とを特徴とする。The medical supplies are passed through an electron beam irradiation area by an electron beam irradiation device, and the medical supplies are irradiated with the irradiation distribution by passing through the electron beam irradiation area a plurality of times.
【０００９】また、上記全体照射工程及び上記部分遮蔽
照射工程における電子線の照射は、上記医療用品を電子
線照射装置による電子線照射域を通過させることで行
い、前記電子線照射装置の電子線照射域の通過毎の通過
速度を変えることで上記照射分布と対応した照射を行う
ことを特徴とする。The irradiation of the electron beam in the whole irradiation step and the partial shielding irradiation step is performed by passing the medical supplies through an electron beam irradiation area by an electron beam irradiation device. It is characterized in that irradiation corresponding to the above-mentioned irradiation distribution is performed by changing the passing speed for each passage through the irradiation area.
【００１０】また、上記全体照射工程と、上記部分遮蔽
照射工程とを、同一の電子線照射装置によって行うこと
を特徴とする。Further, the whole irradiation step and the partial shielding irradiation step are performed by the same electron beam irradiation apparatus.
【００１１】また、上記全体照射工程と、上記部分遮蔽
照射工程とを、それぞれ別々の電子線照射装置によって
行うことを特徴とする。Further, the whole irradiation step and the partial shielding irradiation step are performed by separate electron beam irradiation devices.
【００１２】また、上記医療用品を搬送する搬送手段の
搬送方向に所定間隔で少なくとも２台の電子線照射装置
が並設されたラインを用い、前記搬送手段によって搬送
される前記医療用品に対して、上記全体照射工程と、上
記部分遮蔽照射工程とを、それぞれ別々の電子線照射装
置によって行うことを特徴とする。[0012] In addition, a line in which at least two electron beam irradiation devices are arranged at predetermined intervals in the transport direction of the transport means for transporting the medical supplies is used for the medical supplies transported by the transport means. The whole irradiation step and the partial shielding irradiation step are performed by separate electron beam irradiation devices.
【００１３】また、上記２台の電子線照射装置はその電
子線出力が同一であり、それらの電子線照射域の通過速
度を変えることで照射を調整して上記照射分布を得るこ
とを特徴とする。The two electron beam irradiators have the same electron beam output, and adjust the irradiation by changing the passing speed of the electron beam irradiation area to obtain the irradiation distribution. I do.
【００１４】[0014]
【発明の実施の形態】以下、添付図面を参照して本願発
明の実施の形態について説明する。Embodiments of the present invention will be described below with reference to the accompanying drawings.
【００１５】図１（Ａ）は本願発明に係る医療用品の電
子線による滅菌方法の一例を適用して滅菌する医療用品
であるダイアライザの平面図である。FIG. 1A is a plan view of a dialyzer, which is a medical product to be sterilized by applying an example of a method for sterilizing a medical product by an electron beam according to the present invention.
【００１６】図示ダイアライザ１０は、中間の円筒部１
１の両端にヘッダ１２，１３が螺着されて全体が略円柱
状を呈しており、円筒部１１の内部に中空糸が充填さ
れ、ヘッダ１２，１３にそれぞれ突設された血液ポート
１２Ａ，１３Ａ間を流れる血液から、円筒部１１のヘッ
ダ１２，１３と隣接する位置にそれぞれ突設された透析
ポート１１Ａ，１１Ｂ間を流れる透析液に老廃物を透析
するようになっているものである。The illustrated dialyzer 10 has an intermediate cylindrical portion 1.
Headers 12, 13 are screwed to both ends of 1, and have a substantially columnar shape as a whole. Hollow fibers are filled inside cylindrical portion 11, and blood ports 12 A, 13 A protruding from headers 12, 13 respectively. Waste blood is dialyzed from the blood flowing between the dialysate flowing between the dialysis ports 11A and 11B protruding at positions adjacent to the headers 12 and 13 of the cylindrical portion 11, respectively.
【００１７】その全体の外枠はポリカーボネートによっ
て、また、内部の中空糸はセルロースにより形成されて
おり、図示平面図に対して紙面と直交する上側から電子
線を照射する場合、ヘッダ１２，１３の螺着部は肉厚大
径となって単位面積当たりの質量が最も大きくなる。こ
のため、滅菌し得る最低限で均一な吸収線量を全ての部
位で得るには、図１（Ｂ）に示すような照射分布が必要
となる。即ち、この例では、ヘッダ１２，１３の螺着部
が照射分布の最大域（高照射部位：Ｈ）であってこの部
位に、他の部位（照射分布の最小域：低照射部位：Ｌ）
の２倍の照射量が必要となっている。尚、ここで言う照
射線量とは、電子線のエネルギー×照射時間で表される
ものとする。The entire outer frame is made of polycarbonate, and the inner hollow fiber is made of cellulose. When irradiating an electron beam from an upper side perpendicular to the plane of the drawing with respect to the plan view in FIG. The threaded portion has a large thickness and a large diameter, and has the largest mass per unit area. For this reason, in order to obtain a minimum and uniform absorbed dose that can be sterilized at all sites, an irradiation distribution as shown in FIG. 1B is required. That is, in this example, the screwed portions of the headers 12 and 13 are the maximum area of the irradiation distribution (high irradiation area: H) and this area is connected to another area (the minimum area of the irradiation distribution: low irradiation area: L).
Is required twice as large. Note that the irradiation dose here is represented by electron beam energy × irradiation time.
【００１８】このようなダイアライザ１０に対し、全体
に対して均一に電子線を照射する全体照射工程と、低照
射部位：Ｌを電子線を完全に遮蔽する遮蔽部材としての
マスキング材２０で遮蔽した状態で全体に対して均一に
電子線を照射して高照射部位：Ｈのみに電子線を照射す
る部分遮蔽照射工程と、の最低２回の照射工程を行っ
て、上記のごとき全体に均一な吸収線量を得る照射分布
で電子線を照射する。また、全体照射工程と部分遮蔽照
射工程の間には、電子線照射側から見てダイアライザ１
０の表裏を反転させる工程を挟む。このように全体照射
工程と部分遮蔽照射工程の間でダイアライザの表裏を反
転させるのは、ダイアライザ１０の高照射部位（ヘッダ
ー）：Ｈの深さ方向の吸収線量を均一化するためであ
る。The entire irradiation step of uniformly irradiating the whole of the dialyzer 10 with an electron beam, and a low irradiation portion: L is shielded by a masking material 20 as a shielding member for completely shielding the electron beam. Irradiation of the electron beam uniformly to the whole in the state is performed. At least two irradiation steps of a high irradiation part: a partial shielding irradiation step of irradiating the electron beam to only H, and a uniform irradiation as described above are performed. The electron beam is irradiated with the irradiation distribution to obtain the absorbed dose. Between the whole irradiation step and the partial shielding irradiation step, the dialyzer 1 is viewed from the electron beam irradiation side.
A step of inverting the front and back of 0 is inserted. The reason why the dialyzer is reversed between the whole irradiation step and the partial shielding irradiation step is to make the absorbed dose in the depth direction of the high irradiation part (header): H of the dialyzer 10 uniform.
【００１９】つまり、上記のごとく低照射部位：Ｌに要
する照射量がｙ、高照射部位：Ｈに要する照射量が２ｙ
である場合、全体照射工程では照射量：ｙとなるように
電子線を全体に対して照射し、ダイアライザ１０の表裏
を反転させた後、更に部分遮蔽照射工程で低照射部位：
Ｌを遮蔽して照射量：ｙとなるように電子線を全体に対
して照射して高照射部位：Ｈに対してのみ照射量：ｙの
追加照射を行い、これによって低照射部位：Ｌを照射
量：ｙ，高照射部位：Ｈを照射量：２ｙとし、全体に亘
って均一な吸収線量を得る照射分布で電子線を照射する
ものである。しかも、全体照射工程と部分遮蔽照射工程
の間で表裏反転工程によってダイアライザ１０の表裏を
反転させて高照射部位：Ｈのみに対する追加照射を初め
の全体照射工程とは反対側から行うことで、高照射部
位：Ｈの深さ方向の吸収線量の均一化も図ることができ
る。That is, as described above, the irradiation amount required for the low irradiation site: L is y, and the irradiation amount required for the high irradiation site: H is 2y.
In the whole irradiation step, the entire body is irradiated with an electron beam so that the irradiation amount becomes y, and the dialyzer 10 is turned upside down.
The entire area is irradiated with an electron beam so as to block L and the irradiation amount: y, and the additional irradiation of the irradiation amount: y is performed only on the high irradiation part: H, whereby the low irradiation part: L The irradiation amount: y, the high irradiation area: H is set to the irradiation amount: 2y, and the electron beam is irradiated with an irradiation distribution that obtains a uniform absorbed dose over the whole. In addition, by turning over the dialyzer 10 between the whole irradiation step and the partial shielding irradiation step by the front / back inversion step, the additional irradiation for only the high irradiation part: H is performed from the side opposite to the first whole irradiation step, thereby increasing the height. Irradiation site: The absorbed dose in the depth direction of H can be made uniform.
【００２０】次に、このような照射を可能とする具体例
を説明する。Next, a specific example that enables such irradiation will be described.
【００２１】即ち、図２（Ａ）に平面図，（Ｂ）に正面
図を示すように、ダイアライザ１０を搬送移動するコン
ベア３０の延設方向に対して２台の電子線照射装置（一
次照射装置４１，二次照射装置４２）が直列に配設され
ると共にそれらの間にダイアライザ表裏反転工程部４５
がが配設され、コンベア３０がこれら電子線照射装置４
１，４２の電子線照射域を通過して所定速度で移動する
ように構成された滅菌装置1を用い、ダイアライザ１０
をコンベア３０によって所定速度で搬送し、電子線照射
装置４１，４２によって電子線を照射する。That is, as shown in the plan view of FIG. 2A and the front view of FIG. 2B, two electron beam irradiation devices (primary irradiation The device 41 and the secondary irradiation device 42) are arranged in series, and a dialyzer front / back reversing process unit 45 is arranged between them.
Is provided, and the conveyor 30 is connected to these electron beam irradiation devices 4.
The sterilizer 1 is configured to move at a predetermined speed after passing through the electron beam irradiation areas 1 and 42, and the dialyzer 10 is used.
Is conveyed at a predetermined speed by a conveyor 30, and is irradiated with electron beams by electron beam irradiation devices 41 and 42.
【００２２】両電子線照射装置４１，４２はそれぞれ例
えばエネルギーが１０ＭｅＶで同一の電子線出力（例え
ば１ｋｗ）となっており、また、この電子線照射装置４
１，４２による電子線出力とコンベア３０の搬送速度の
関係は、搬送されるダイアライザ１０に照射量：ｙとな
るように電子線を照射するように設定されている。The two electron beam irradiation devices 41 and 42 have the same electron beam output (for example, 1 kW) at an energy of, for example, 10 MeV.
The relationship between the electron beam output of the conveyors 1 and 42 and the conveying speed of the conveyor 30 is set so that the dialyzer 10 to be conveyed is irradiated with an electron beam so that the irradiation amount becomes y.
【００２３】このような滅菌装置１を用い、コンベア３
０にダイアライザ１０を載置し、コンベア３０の駆動に
よって一次照射装置４１の照射域を通過させることで全
体に照射量：ｙの照射を行う（全体照射工程）。次に、
ダイアライザ表裏反転工程部４５においてダイアライザ
１０の電子線照射側から見た時の表裏を反転すると共
に、二次照射装置４２に至る前に、図３（Ａ）に平面
図，（Ｂ）に縦断面図を示すようにダイアライザ１０に
低照射部位：Ｌを遮蔽して高照射部位：Ｈのみ露出する
開口部２１を有するマスキング材２０を被せ、二次照射
装置４２の照射域を通過させることで更に全体に照射
量：ｙの照射を行う（部分遮蔽照射工程）。この二次照
射装置４２による照射時、マスキング材２０によって覆
われていない高照射部位：Ｈに対してのみ全体照射工程
時とは反対側から照射量：ｙの照射が成され、その結
果、低照射部位：Ｌでは照射量：ｙ，高照射部位：Ｈで
は照射量：２ｙとなって全体に亘って均一な吸収線量を
得る照射分布で照射することができるものである。この
とき、高照射部位：Ｈでは表裏両側より照射量：ｙづつ
照射されるので、深さ方向の吸収線量の均一化も図れ
る。Using such a sterilizer 1, a conveyor 3
The dialyzer 10 is placed at 0, and the conveyor 30 is driven to pass through the irradiation area of the primary irradiation device 41, thereby performing irradiation with the irradiation amount: y (whole irradiation step). next,
In a dialyzer front / back reversing process section 45, the front / back as viewed from the electron beam irradiation side of the dialyzer 10 is reversed, and before reaching the secondary irradiation device 42, a plan view is shown in FIG. As shown in the figure, a masking material 20 having an opening 21 that shields the low irradiation site: L and exposes only the high irradiation site: H is placed on the dialyzer 10, and further passes through the irradiation area of the secondary irradiation device 42. Irradiation with the irradiation amount: y is performed on the whole (partial shielding irradiation step). At the time of irradiation by the secondary irradiation device 42, irradiation of the irradiation amount: y is performed only on the high irradiation portion: H that is not covered by the masking material 20 from the side opposite to that in the entire irradiation step. Irradiation site: L: irradiation amount: y, high irradiation region: H: irradiation amount: 2y, so that irradiation can be performed with an irradiation distribution that obtains a uniform absorbed dose over the whole. At this time, in the high irradiation area: H, the irradiation amount: y is applied from both the front and back sides, so that the absorbed dose in the depth direction can be made uniform.
【００２４】マスキング材２０は、電子線を完全に遮蔽
する所定厚の金属素材等によって形成され、当該マスキ
ング材２０によるダイアライザ１０の低照射部位：Ｌの
遮蔽は、マスキング材２０をダイアライザ１０に被せて
も、コンベア３０へのダイアライザ１０の載置位置を規
定すると共にコンベア３０にその移動と同期して所定位
置（ダイアライザ表裏反転工程部４５と二次照射装置４
２の間）でダイアライザ１０の上側にマスキング材２０
が位置するよう構成しても何れでも良いものである。The masking material 20 is formed of a metal material or the like having a predetermined thickness for completely shielding the electron beam. The masking material 20 shields the low irradiation area (L) of the dialyzer 10 by covering the masking material 20 with the dialyzer 10. However, the position at which the dialyzer 10 is placed on the conveyor 30 is defined, and at the same time the conveyor 30 is synchronized with the movement of the dialyzer 10 at a predetermined position (the dializer front / back reversing section 45 and the secondary irradiation device 4).
2), the masking material 20 is placed on the upper side of the dialyzer 10.
May be arranged or any of them may be used.
【００２５】尚、上記例は一次照射装置４１によって全
体照射工程を行うと共にその後二次照射装置４２によっ
て部分遮蔽照射工程を行うものであるが、全体照射工程
と部分遮蔽照射工程の順序を逆としても良い。つまり、
平面図である図４に示すように、一次照射装置４１によ
って部分遮蔽照射工程を行うと共にその後二次照射装置
４２によって全体照射工程を行っても良いものである。In the above example, the whole irradiation step is performed by the primary irradiation device 41 and the partial shielding irradiation step is performed thereafter by the secondary irradiation device 42. However, the order of the whole irradiation step and the partial shielding irradiation step is reversed. Is also good. That is,
As shown in FIG. 4 which is a plan view, the primary irradiation device 41 may perform the partial shielding irradiation process, and then the secondary irradiation device 42 may perform the entire irradiation process.
【００２６】また、上記例の滅菌装置は２台の電子線照
射装置４１，４２を備えてそれぞれの電子線照射装置で
一次照射及び二次照射を行うものであるが、１台の電子
線照射装置によって行うことも可能である。Further, the sterilizer of the above example has two electron beam irradiation devices 41 and 42 and performs primary irradiation and secondary irradiation with each electron beam irradiation device. It is also possible to carry out by a device.
【００２７】即ち、図５に平面図を示すようにダイアラ
イザ１０を搬送移動するコンベア３０が電子線照射装置
４３の電子線照射域を通過して所定速度で移動するよう
に構成された滅菌装置１′を用い、コンベア３０にダイ
アライザ１０を載置し、コンベア３０の駆動によって電
子線照射装置４３の照射域を通過することで全体照射工
程を行い。その後、ダイアライザ１０を電子線照射装置
４３の照射域より上流側のコンベア３０上に移動させる
と共にダイアライザ表裏反転部４５でダイアライザ１０
の表裏を反転し、それにマスキング材２０を被せ、電子
線照射装置４３の照射域を再度通過させることで部分遮
蔽照射工程を行うものである。That is, as shown in the plan view of FIG. 5, the conveyor 30 for transporting and moving the dialyzer 10 passes through the electron beam irradiation area of the electron beam irradiation device 43 and moves at a predetermined speed. ′, The dialyzer 10 is placed on the conveyor 30, and the entire irradiation process is performed by driving the conveyor 30 and passing the irradiation area of the electron beam irradiation device 43. Thereafter, the dialyzer 10 is moved onto the conveyor 30 on the upstream side of the irradiation area of the electron beam irradiation device 43, and the dialyzer 10
Is turned over, the masking material 20 is put on it, and the partial shielding irradiation step is performed by passing the masking material 20 again through the irradiation area of the electron beam irradiation device 43.
【００２８】尚、この場合でも、平面図である図６に示
すように、全体照射工程と部分遮蔽照射工程を前後逆と
しても良いものである。In this case, as shown in FIG. 6 which is a plan view, the whole irradiation step and the partial shielding irradiation step may be reversed.
【００２９】上記例における医療用品であるダイアライ
ザ１０では、滅菌に要する電子線吸収線量となる電子線
の照射分布の最小域と最大域の比（低照射部位：Ｌと高
照射部位：Ｈの照射量の比）が１：２であり、従って、
図２や図４に示す滅菌装置１，１′のように同一出力の
電子線照射装置に対して一定速度で搬送移動するコンベ
アによってダイアライザを搬送しつつ電子線を照射する
ことで全体に亘って均一な吸収線量を得る照射分布で照
射することができる。In the dialyzer 10 which is a medical product in the above example, the ratio of the minimum area to the maximum area of the electron beam irradiation distribution, which is the electron beam absorption dose required for sterilization (low irradiation area: L and high irradiation area: H, Ratio) is 1: 2, thus:
By irradiating the electron beam while conveying the dialyzer by the conveyor which conveys and moves at a constant speed to the electron beam irradiation device of the same output like the sterilizers 1 and 1 'shown in FIG. 2 and FIG. Irradiation can be performed with an irradiation distribution that provides a uniform absorbed dose.
【００３０】ここで、照射分布の最小域と最大域の比が
１：２以外である場合、例えば図７（Ａ）に平面図，
（Ｂ）に照射分布を示す対象品１０′のように１：３
や、図８（Ａ）に平面図，（Ｂ）に照射分布を示す対象
品１０″のように２：３である場合には、 （１）．コンベアの搬送速度は一定とし、全体照射工程
と部分遮蔽照射工程とで電子線照射装置の出力を変え
る。Here, when the ratio of the minimum area to the maximum area of the irradiation distribution is other than 1: 2, for example, FIG.
(B) 1: 3 like the target product 10 'showing the irradiation distribution
Or, when the ratio is 2: 3 as shown in the plan view of FIG. 8A and the target product 10 ″ whose irradiation distribution is shown in FIG. 8B, (1). The output of the electron beam irradiator is changed between and the partial shielding irradiation step.
【００３１】（２）．電子線照射装置の出力は一定と
し、コンベアの搬送速度を全体照射工程と部分遮蔽照射
工程とで変える。(2). The output of the electron beam irradiation device is fixed, and the conveyor speed of the conveyor is changed between the whole irradiation step and the partial shielding irradiation step.
【００３２】（３）．コンベアの搬送速度及び電子線照
射装置の出力共に一定とし、全体照射工程と部分遮蔽照
射工程の何れかの照射量を基準として複数回照射を繰り
返す。特にこの方法では、照射分布の最大域の実効厚が
電子の飛程（エネルギーで決まる）に比べて大きい場合
には適宜表裏反転させることで医療用品の深さ（厚み）
方向の吸収線量の均一化を図る。(3). The conveying speed of the conveyor and the output of the electron beam irradiation device are both constant, and the irradiation is repeated a plurality of times based on the irradiation amount in either the entire irradiation step or the partial shielding irradiation step. In particular, in this method, when the effective thickness in the maximum region of the irradiation distribution is larger than the range of the electrons (determined by the energy), the depth (thickness) of the medical article is appropriately inverted by reversing the surface.
To make the absorbed dose uniform in each direction.
【００３３】等の方法により対応可能である。尚、上記
方法を組み合わせても良いものである。The above method can be used. Incidentally, the above methods may be combined.
【００３４】以下、各方法を説明する。Hereinafter, each method will be described.
【００３５】即ち、（１）のコンベアの搬送速度は一定
とし、全体照射工程と部分遮蔽照射工程とで電子線照射
装置の出力を変える方法では、照射分布の最小域と最大
域の比が１：３の場合には、全体照射工程における電子
線照射装置の電子線出力を基準として部分遮蔽照射工程
における電子線照射装置の電子線出力を２倍とすること
で対応できる。また、照射分布の最小域と最大域の比が
２：３である場合には、全体照射工程における電子線照
射装置の電子線出力を基準として部分遮蔽照射工程にお
ける電子線照射装置の電子線出力を１／２とすることで
対応できる。これによれば、コンベアの搬送速度は一定
で良いために搬送管理が容易である。That is, in the method (1) in which the conveyor conveyance speed is constant and the output of the electron beam irradiation apparatus is changed between the entire irradiation step and the partial shielding irradiation step, the ratio of the minimum area to the maximum area of the irradiation distribution is 1 : 3, the electron beam output of the electron beam irradiation apparatus in the partial shielding irradiation step can be doubled based on the electron beam output of the electron beam irradiation apparatus in the entire irradiation step. When the ratio of the minimum area to the maximum area of the irradiation distribution is 2: 3, the electron beam output of the electron beam irradiation apparatus in the partial shielding irradiation step is based on the electron beam output of the electron beam irradiation apparatus in the entire irradiation step. Is reduced to 1/2. According to this, since the conveyor speed of the conveyor may be constant, the conveyance management is easy.
【００３６】（２）の電子線照射装置の出力は一定と
し、コンベアの搬送速度を全体照射工程と部分遮蔽照射
工程とで変える方法では、照射分布の最小域と最大域の
比が１：３の場合には、全体照射工程の搬送速度を基準
として部分遮蔽照射工程の搬送速度を１／２とすること
で対応できる。また、照射分布の最小域と最大域の比が
２：３である場合には、全体照射工程の搬送速度を基準
として部分遮蔽照射工程の搬送速度を２倍とすることで
対応できる。これによれば、面倒な電子線照射装置の出
力変更する必要が無く、また、電子線照射装置を複数備
えるものでも同一仕様の電子線照射装置で良いためにコ
ストの低減化が可能である。In the method of (2) in which the output of the electron beam irradiation apparatus is fixed and the conveyor speed of the conveyor is changed between the entire irradiation step and the partial shielding irradiation step, the ratio of the minimum area to the maximum area of the irradiation distribution is 1: 3. In the case of (1), the transfer speed in the partial shielding irradiation step can be reduced by half with respect to the transfer speed in the entire irradiation step. When the ratio between the minimum area and the maximum area of the irradiation distribution is 2: 3, it can be dealt with by doubling the transport speed of the partial shielding irradiation process with reference to the transport speed of the entire irradiation process. According to this, it is not necessary to change the output of the electron beam irradiating device, and even if a plurality of electron beam irradiating devices are provided, the electron beam irradiating device of the same specification can be used, so that cost can be reduced.
【００３７】（３）のコンベアの搬送速度及び電子線照
射装置の出力共に一定とし、一回の照射量を基準として
複数回照射を繰り返す方法では、照射分布の最小域と最
大域の比が１：３の場合には、最小域の照射量を基準
（一回の照射量）とし、全体照射工程を１回とすると共
に部分遮蔽照射工程を２回繰り返すことで対応できる。
また、照射分布の最小域と最大域の比が２：３である場
合には、最小域と最大域の差の照射量を基準（一回の照
射量）とし、全体照射工程を２回繰り返すと共に部分遮
蔽照射工程を一回とすることで対応できるものである。
つまり、照射分布の最大公約数的な一回の照射量を基準
として設定し、これを複数回繰り返すことで照射分布と
対応する照射を行うものである。そしてこの時、適宜表
裏反転させることで必要な照射分布の最大域の実効厚が
電子の飛程に比べて大きい場合にも、深さ（厚み）方向
の吸収線量の均一化を図ることができる。これによれ
ば、コンベアの搬送速度は一定で良いために搬送管理が
容易であると共に、面倒な電子線照射装置の出力変更を
行う必要が無く、また、電子線照射装置を複数備えるも
のでも同一仕様の電子線照射装置で良いためにコストの
低減化が可能である。In the method (3) in which the conveyor speed and the output of the electron beam irradiator are both constant and the irradiation is repeated a plurality of times based on one irradiation amount, the ratio of the minimum area to the maximum area of the irradiation distribution is 1 : 3, the irradiation amount in the minimum region is set as a reference (one irradiation amount), the entire irradiation step is set to one time, and the partial shielding irradiation step is repeated twice.
When the ratio between the minimum area and the maximum area of the irradiation distribution is 2: 3, the irradiation amount of the difference between the minimum area and the maximum area is set as a reference (one irradiation amount), and the entire irradiation step is repeated twice. In addition, this can be dealt with by performing the partial shielding irradiation step once.
In other words, the irradiation amount corresponding to the irradiation distribution is set by setting the irradiation amount, which is the greatest common denominator of the irradiation distribution, as a reference, and repeating this several times. At this time, even if the effective thickness in the maximum region of the required irradiation distribution is larger than the range of the electrons, the absorbed dose in the depth (thickness) direction can be made uniform by appropriately inverting the surface. . According to this, the conveying speed of the conveyor may be constant, so that the conveying management is easy, and there is no need to perform troublesome changes in the output of the electron beam irradiation device. The cost can be reduced because an electron beam irradiator with specifications is sufficient.
【００３８】尚、上記各例は、医療用品の照射分布が最
小域と最大域の２領域に分割されているものであるが、
照射分布が３領域以上に分割されているものにも適用可
能であることは言うまでもない。In each of the above examples, the irradiation distribution of the medical article is divided into two areas, a minimum area and a maximum area.
It goes without saying that the present invention can be applied to the case where the irradiation distribution is divided into three or more regions.
【００３９】[0039]
【発明の効果】以上述べたように、本発明に係る医療用
品の電子線による滅菌方法によれば、医療用品の全体に
対して照射分布の最小域と対応する電子線照射を均一に
行う全体照射工程と、最小域を電子線を遮断する遮蔽部
材で覆って医療用品の全体に対して電子線照射を行って
最小域以外の領域に電子線を照射する部分遮蔽照射工程
と、によって電子線照射分布と対応した照射を行うこと
により、ダイアライザのように複雑な形状であって滅菌
し得る均一な吸収線量とするために電子線の照射分布を
有する照射医療用品に対しても、照射分布と対応した照
射を行うことが可能となって、全体的に均一な電子線吸
収線量となるように照射して滅菌することができ、単位
面積当たりの質量の小さな部位の吸収線量過剰に起因す
る材質劣化を回避できると共に、照射対象の医療用品毎
にシールドを設ける必要がないために滅菌の作業効率の
向上，設備コストの低減が可能となるものである。As described above, according to the method for sterilizing medical supplies by electron beam according to the present invention, the entirety of the medical supplies are uniformly irradiated with the electron beam corresponding to the minimum area of the irradiation distribution. An irradiation step, and a partial shielding irradiation step of irradiating the entire medical article with an electron beam by covering the minimum area with a shielding member that blocks the electron beam and irradiating the area other than the minimum area with the electron beam. By performing irradiation corresponding to the irradiation distribution, even for irradiation medical supplies having an electron beam irradiation distribution in order to obtain a uniform absorption dose that can be sterilized with a complicated shape like a dialyzer, the irradiation distribution and Corresponding irradiation can be performed, irradiation can be sterilized so as to have a uniform electron beam absorbed dose as a whole, and materials caused by excessive absorbed dose at a site with a small mass per unit area Avoid degradation Together kill, improve the working efficiency of sterilization is not necessary to provide a shield for each medical supply of irradiation target, in which reduction of the equipment cost can be reduced.
【００４０】また、医療用品を電子線照射装置による電
子線照射域を通過させることで行い、該電子線照射域を
複数回通過させることで照射分布で照射することによ
り、電子線照射による滅菌作業のライン化が可能とな
り、高い効率で滅菌作業を行うことが可能となる。Further, the medical supplies are passed through an electron beam irradiation area by an electron beam irradiation apparatus, and the medical supplies are irradiated with an irradiation distribution by passing through the electron beam irradiation area a plurality of times, so that sterilization work by electron beam irradiation can be performed. And sterilization work can be performed with high efficiency.
【００４１】また、全体照射工程及び部分遮蔽照射工程
における電子線の照射は、医療用品を電子線照射装置に
よる電子線照射域を通過させることで行い、電子線照射
装置の電子線照射域の通過毎の通過速度を変えることで
照射分布と対応した照射を行うことにより、より細かな
照射分布に対応することが可能となる。The irradiation of the electron beam in the whole irradiation step and the partial shielding irradiation step is performed by passing the medical supplies through the electron beam irradiation area of the electron beam irradiation apparatus. By performing irradiation corresponding to the irradiation distribution by changing the passing speed for each, it becomes possible to cope with a finer irradiation distribution.
【００４２】また、全体照射工程と、部分遮蔽照射工程
とを、同一の電子線照射装置によって行うことにより、
高価な電子線照射装置を複数用いることなく低コストで
電子線照射による滅菌が行える。Further, by performing the whole irradiation step and the partial shielding irradiation step by the same electron beam irradiation apparatus,
Sterilization by electron beam irradiation can be performed at low cost without using a plurality of expensive electron beam irradiation devices.
【００４３】また、全体照射工程と、部分遮蔽照射工程
とを、それぞれ別々の電子線照射装置によって行うこと
により、滅菌作業を一つのラインで行うことが可能とな
り、滅菌作業を高い効率で行うことができる。Further, since the whole irradiation step and the partial shielding irradiation step are performed by separate electron beam irradiation devices, the sterilization operation can be performed in one line, and the sterilization operation can be performed with high efficiency. Can be.
【００４４】また、医療用品を搬送する搬送手段の搬送
方向に所定間隔で少なくとも２台の電子線照射装置が並
設されたラインを用い、搬送手段によって搬送される医
療用品に対して、全体照射工程と、部分遮蔽照射工程と
を、それぞれ別々の電子線照射装置によって行うことに
より、滅菌作業を高い効率で合理的に行うことが可能と
なる。[0044] Further, using a line in which at least two electron beam irradiators are arranged at predetermined intervals in the transport direction of the transport means for transporting the medical supplies, the medical supplies conveyed by the transport means are entirely irradiated. By performing the step and the partial shielding irradiation step using separate electron beam irradiation apparatuses, it is possible to perform the sterilization operation rationally with high efficiency.
【００４５】また、２台の電子線照射装置はその電子線
出力が同一であり、それらの電子線照射域の通過速度を
変えることで照射を調整して照射分布を得ることによ
り、より細かな照射分布に対応した滅菌作業を高い効率
で合理的に行うことが可能となる。Further, the two electron beam irradiation devices have the same electron beam output, and by changing the passage speed of the electron beam irradiation area to adjust the irradiation to obtain an irradiation distribution, a finer irradiation distribution can be obtained. Sterilization work corresponding to the irradiation distribution can be performed rationally with high efficiency.
【図１】本願発明に係る医療用品の電子線による滅菌方
法の一例を適用して滅菌する医療用品であるダイアライ
ザを示し、（Ａ）は平面図，（Ｂ）は照射分布を示す図
である。FIG. 1 shows a dialyzer which is a medical product to be sterilized by applying an example of a method for sterilizing a medical product by an electron beam according to the present invention, wherein (A) is a plan view and (B) is a diagram showing an irradiation distribution. .
【図２】滅菌装置を示し、（Ａ）は平面図，（Ｂ）は正
面図である。FIGS. 2A and 2B show a sterilizer, wherein FIG. 2A is a plan view and FIG. 2B is a front view.
【図３】マスキング材を示し、（Ａ）は平面図，（Ｂ）
は縦断面図である。FIG. 3 shows a masking material, (A) is a plan view, (B)
Is a longitudinal sectional view.
【図４】異なる滅菌工程を説明する平面図である。FIG. 4 is a plan view illustrating different sterilization steps.
【図５】異なる構成の滅菌装置の平面図上に滅菌工程を
説明する図である。FIG. 5 is a diagram illustrating a sterilization step on a plan view of a sterilization apparatus having a different configuration.
【図６】異なる滅菌工程を説明する平面図である。FIG. 6 is a plan view illustrating different sterilization steps.
【図７】異なる照射分布の対象品を示し、（Ａ）は平面
図，（Ｂ）は照射分布を示す図である。7A and 7B show target products having different irradiation distributions, where FIG. 7A is a plan view and FIG. 7B is a diagram showing an irradiation distribution.
【図８】異なる照射分布の対象品を示し、（Ａ）は平面
図，（Ｂ）は照射分布を示す図である。8A and 8B show target products having different irradiation distributions, where FIG. 8A is a plan view and FIG. 8B is a diagram showing an irradiation distribution.
１ 滅菌装置 １０ ダイアライザ（医療用品） １０′，１０″ 対象品（医療用品） ２０ マスキング材（遮蔽部材） ３０ コンベア ４１ 一次照射装置（電子線照射装置） ４２ 二次照射装置（電子線照射装置） ４３ 電子線照射装置 ４５ ダイアライザ表裏反転工程部 Ｌ 低照射部位（照射分布の最小域） Ｈ 高照射部位（照射分布の最大域） DESCRIPTION OF SYMBOLS 1 Sterilizer 10 Dialyzer (medical supplies) 10 ', 10 "Target item (medical supplies) 20 Masking material (shielding member) 30 Conveyor 41 Primary irradiation device (electron beam irradiation device) 42 Secondary irradiation device (electron beam irradiation device) 43 Electron beam irradiator 45 Dializer front / back inversion process section L Low irradiation area (minimum area of irradiation distribution) H High irradiation area (maximum area of irradiation distribution)
───────────────────────────────────────────────────── フロントページの続き (72)発明者 小田島 克彦 神奈川県横浜市磯子区新中原町１番地 石 川島播磨重工業株式会社横浜エンジニアリ ングセンター内 (72)発明者 白川 忠秀 東京都江東区豊洲三丁目１番15号 石川島 播磨重工業株式会社東二テクニカルセンタ ー内 (72)発明者 生越 満 東京都江東区豊洲三丁目１番15号 石川島 播磨重工業株式会社東二テクニカルセンタ ー内 Ｆターム(参考） 4C058 AA12 AA17 BB06 KK03 KK33 KK42 4C077 AA05 BB01 EE01 EE03 KK09 LL07 ────────────────────────────────────────────────── ─── Continuing from the front page (72) Katsuhiko Odashima, Inventor, 1st place, Shin-Nakahara-cho, Isogo-ku, Yokohama-shi, Kanagawa Ishikawashima-Harima Heavy Industries, Ltd. Inside the Yokohama Engineering Center (72) Inventor, Tadahide Shirakawa Toyosu, Koto-ku, Tokyo No. 1-115, Ishikawajima-Harima Heavy Industries, Ltd., Toji Technical Center (72) Inventor Mitsuru Mitsukoshi 3-1-1, Toyosu, Koto-ku, Tokyo Ishikawajima-Harima Heavy Industries, Ltd. 4C058 AA12 AA17 BB06 KK03 KK33 KK42 4C077 AA05 BB01 EE01 EE03 KK09 LL07
Claims (7)
線量となる照射分布で照射して滅菌する方法であって、 前記医療用品の全体に対して前記照射分布の最小域と対
応する電子線照射を均一に行う全体照射工程と、前記最
小域を電子線を遮断する遮蔽部材で覆って前記医療用品
の全体に対して電子線照射を行って前記最小域以外の領
域に電子線を照射する部分遮蔽照射工程と、によって前
記電子線照射分布と対応した照射を行うことを特徴とす
る医療用品の電子線による滅菌方法。1. A method for irradiating a medical product with an irradiation distribution having a uniform absorbed dose capable of sterilizing an electron beam with an electron beam, and sterilizing the medical product, wherein the whole of the medical product corresponds to a minimum area of the irradiation distribution. An entire irradiation step of uniformly performing electron beam irradiation, and covering the minimum area with a shielding member that blocks an electron beam, performing electron beam irradiation on the entire medical article, and applying an electron beam to a region other than the minimum area. A method for sterilizing medical supplies with an electron beam, wherein irradiation corresponding to the electron beam irradiation distribution is performed by a partial shielding irradiation step of irradiation.
程における電子線の照射は、上記医療用品を電子線照射
装置による電子線照射域を通過させることで行い、該電
子線照射域を複数回通過させることで上記照射分布で照
射することを特徴とする請求項１に記載の医療用品の電
子線による滅菌方法。2. The irradiation of an electron beam in the whole irradiation step and the partial shielding irradiation step is performed by passing the medical article through an electron beam irradiation area by an electron beam irradiation device, and the electron beam irradiation area is subjected to a plurality of times. The method for sterilizing a medical article by an electron beam according to claim 1, wherein the medical article is irradiated with the irradiation distribution by passing through.
程における電子線の照射は、上記医療用品を電子線照射
装置による電子線照射域を通過させることで行い、前記
電子線照射装置の電子線照射域の通過毎の通過速度を変
えることで上記照射分布と対応した照射を行うことを特
徴とする請求項１に記載の医療用品の電子線による滅菌
方法。3. The method according to claim 1, wherein the irradiation of the electron beam in the whole irradiation step and the partial shielding irradiation step is performed by passing the medical supplies through an electron beam irradiation area of an electron beam irradiation apparatus. The method according to claim 1, wherein the irradiation is performed in accordance with the irradiation distribution by changing a passing speed of each passing through the irradiation area.
程とを、同一の電子線照射装置によって行うことを特徴
とする請求項２又は３に記載の医療用品の電子線による
滅菌方法。4. The method for sterilizing medical supplies with an electron beam according to claim 2, wherein the whole irradiation step and the partial shielding irradiation step are performed by the same electron beam irradiation apparatus.
程とを、それぞれ別々の電子線照射装置によって行うこ
とを特徴とする請求項２又は３に記載の医療用品の電子
線による滅菌方法。5. The method according to claim 2, wherein the whole irradiation step and the partial shielding irradiation step are performed by separate electron beam irradiation devices.
向に所定間隔で少なくとも２台の電子線照射装置が並設
されたラインを用い、前記搬送手段によって搬送される
前記医療用品に対して、上記全体照射工程と、上記部分
遮蔽照射工程とを、それぞれ別々の電子線照射装置によ
って行うことを特徴とする請求項２又は３に記載の医療
用品の電子線による滅菌方法。6. A medical device according to claim 1, wherein at least two electron beam irradiators are arranged side by side at predetermined intervals in a transport direction of said transport means for transporting said medical supplies. 4. The method according to claim 2, wherein the whole irradiation step and the partial shielding irradiation step are performed by separate electron beam irradiation devices.
力が同一であり、それらの電子線照射域の通過速度を変
えることで照射を調整して上記照射分布を得ることを特
徴とする請求項６に記載の医療用品の電子線による滅菌
方法。7. The two electron beam irradiation apparatuses have the same electron beam output, and adjust the irradiation by changing the passing speed of the electron beam irradiation area to obtain the irradiation distribution. A method for sterilizing a medical article according to claim 6 by an electron beam.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11146282A JP2000334028A (en) | 1999-05-26 | 1999-05-26 | Method for sterilizing medical supplies by electron beam |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11146282A JP2000334028A (en) | 1999-05-26 | 1999-05-26 | Method for sterilizing medical supplies by electron beam |
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| Publication Number | Publication Date |
|---|---|
| JP2000334028A true JP2000334028A (en) | 2000-12-05 |
Family
ID=15404196
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP11146282A Pending JP2000334028A (en) | 1999-05-26 | 1999-05-26 | Method for sterilizing medical supplies by electron beam |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2000334028A (en) |
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