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JP6164957B2 - Steam sterilization automatic on / off valve for high-pressure fluid circuit and sterilization apparatus using the valve - Google Patents

Steam sterilization automatic on / off valve for high-pressure fluid circuit and sterilization apparatus using the valve Download PDF

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JP6164957B2
JP6164957B2 JP2013141086A JP2013141086A JP6164957B2 JP 6164957 B2 JP6164957 B2 JP 6164957B2 JP 2013141086 A JP2013141086 A JP 2013141086A JP 2013141086 A JP2013141086 A JP 2013141086A JP 6164957 B2 JP6164957 B2 JP 6164957B2
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中島 淳
淳 中島
謙一 原島
謙一 原島
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Sugino Machine Ltd
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Description

本発明は、例えば微粒化装置等の高圧流体回路を維持し、食品および医薬品業界においてGMP基準を満たすことを目的として、適切な条件下で滅菌を行うために使用される蒸気滅菌自動オンオフバルブ、該バルブを備えた滅菌装置に関するものである。   The present invention is a steam sterilization automatic on / off valve used to perform sterilization under appropriate conditions for the purpose of maintaining high pressure fluid circuits such as atomizers and meeting GMP standards in the food and pharmaceutical industry, The present invention relates to a sterilizer equipped with the valve.

従来より、一般的な高圧蒸気滅菌法の滅菌条件としては、115〜118℃、30分間や、121〜124℃、15分間等(日本薬局方より)であり、例えば微粒化装置の滅菌方法としては、(1) 装置を分解し、分解後の部品を各々滅菌する方式や、(2) 装置を分解せず、滅菌を要する箇所の内表面にガスまたは液体滅菌剤を接触させることで滅菌する方式(SIP(Sterilization-in-Place):定置滅菌)が採用されていた。   Conventionally, sterilization conditions of a general high pressure steam sterilization method are 115 to 118 ° C., 30 minutes, 121 to 124 ° C., 15 minutes, etc. (from the Japanese Pharmacopoeia). (1) Disassemble the device and sterilize the parts after disassembly, or (2) Sterilize by contacting a gas or liquid sterilant with the inner surface of the part that requires sterilization without disassembling the device. The system (SIP (Sterilization-in-Place): stationary sterilization) was adopted.

しかしながら、(1) 分解後の部品を滅菌する方式では、滅菌後の組付けの段階で菌に触れてしまう可能性がある。(2) また、SIP(定置滅菌)方式では、滅菌を要する箇所(装置の流路内)に蒸気を供給することによって、流路内を滅菌するが、滅菌を行う際、単に蒸気を供給するだけでは、蒸気が流路内に接触することによって、蒸気が凝集(液状化)し、外部へ排出し難くなるとともに、供給された蒸気が排出されず、流路内部で滞留してしまう。加えて、(3) 蒸気滅菌を行う流路のどの箇所においても、適切な温度、時間などの滅菌条件を満たす必要がある等の課題がある。   However, (1) In the method of sterilizing the parts after decomposition, there is a possibility that the bacteria may be touched at the stage of assembly after sterilization. (2) Also, in the SIP (stationary sterilization) system, the flow path is sterilized by supplying steam to the place where sterilization is required (in the flow path of the device). As a result, when the vapor comes into contact with the flow path, the vapor is condensed (liquefied) and is difficult to be discharged to the outside, and the supplied vapor is not discharged and stays inside the flow path. In addition, (3) there is a problem that it is necessary to satisfy sterilization conditions such as appropriate temperature and time in any part of the flow path for steam sterilization.

これに対して、本出願人は、滅菌状態の管理を行うことができる蒸気滅菌手段を備えた湿式微粒化装置(特許文献1参照)を提案している。この蒸気滅菌手段を備えた湿式微粒化装置では、流路内部空間における蒸気の凝結および滞留を抑制することによって、滅菌を効果的に行うことができるとともに、定期的に滅菌条件を測定することによって、滅菌状態の管理を効果的に行うことができるものであったが、手動で蒸気を投入し、接液回路を蒸気滅菌できることが開示されている。   On the other hand, the present applicant has proposed a wet atomization apparatus (see Patent Document 1) provided with steam sterilization means capable of managing a sterilized state. In the wet atomization apparatus equipped with this steam sterilization means, it is possible to effectively perform sterilization by suppressing condensation and retention of steam in the internal space of the flow path, and by periodically measuring the sterilization conditions. However, it has been disclosed that the sterilization state can be managed effectively, but steam can be manually injected to sterilize the wetted circuit.

また、食品等の粉粒体を高圧の過熱水蒸気を使用して連続的に殺菌処理する定置洗浄可能な粉粒体殺菌装置が開示されている(特許文献2参照)。   In addition, a powder sterilization apparatus capable of stationary cleaning that continuously sterilizes a granular material such as food using high-pressure superheated steam is disclosed (see Patent Document 2).

特開2013−42814号公報JP 2013-42814 A 特開2011−78493号公報JP 2011-78493 A

特許文献1では、高圧噴射回路を要しつつ、かつ、その回路内に蒸気も通すことができる装置を提案した。しかしながら、高圧流体回路の維持が可能であり、尚且つ、滅菌用の蒸気を高圧流体回路外に自動的にオンオフして逃がす自動バルブは従来存在しなかった。そのため、高圧処理する医薬品製造装置が少ない状態の中で、更なる高圧状態で回路内を蒸気滅菌できる(高圧回路に蒸気を通せる)装置も存在しなかった。   Patent Document 1 proposes a device that requires a high-pressure injection circuit and can also pass steam into the circuit. However, there has been no automatic valve that can maintain a high-pressure fluid circuit and that automatically turns on and off sterilization vapor outside the high-pressure fluid circuit. For this reason, there is no device capable of steam sterilizing the circuit in a higher pressure state (steam can be passed through the high pressure circuit) in a state where there are few pharmaceutical manufacturing apparatuses that perform high pressure processing.

尚、医薬品製造装置では、特に注射剤用途では、蒸気滅菌が必須であり、しかも、蒸気を通すときに手動でバルブを開閉することは、実際には許容する場合もあるが、基本的に認められていない。   In pharmaceutical production equipment, steam sterilization is indispensable, especially for injections, and it may be allowed to open and close the valve manually when passing steam. It is not done.

また、特許文献2は、高圧流体回路に適用することが想定されていない。特に、高圧流体回路を形成する場合には、高圧状態をシールすることが困難であり、さらにそのバルブに蒸気の流入出切替機能を持たせ、それをエア駆動等により自動で行うには複雑な機構が必要となる。   Patent Document 2 is not supposed to be applied to a high-pressure fluid circuit. In particular, when forming a high-pressure fluid circuit, it is difficult to seal a high-pressure state. Furthermore, it is complicated to provide a steam inflow / outlet switching function for the valve and perform it automatically by air drive or the like. A mechanism is required.

従って、本発明は、上記課題を鑑み、高圧処理と自動蒸気滅菌処理とを切り替えられるバルブを開発すること、蒸気を自動で安定的に流路内に供給および排出することで、滅菌を効果的に行うことができる高圧流体回路用蒸気滅菌自動オンオフバルブ装置、このバルブを用いた滅菌装置を得ることを目的とする。   Therefore, in view of the above problems, the present invention develops a valve that can switch between high-pressure processing and automatic steam sterilization processing, and supplies and discharges steam into and out of the flow path automatically and effectively. It is an object of the present invention to provide a steam sterilization automatic on / off valve device for a high-pressure fluid circuit that can be used in the same manner, and a sterilizer using this valve.

請求項1に記載された発明に係る高圧流体回路用蒸気滅菌自動オンオフバルブは、大径ピストン部及びその上部に形成された小径ピストン部を有する段付きピストンと、
この段付ピストンの前記大径ピストン部が内部に摺動可能に挿入される大径シリンダ部及び前記小径ピストン部が内部に摺動可能に挿入される小径シリンダ部を有する段付きシリンダと、
前記段付きシリンダ内に挿入された段付きピストンを往復動させるピストン往復動手段とを備え、
前記小径シリンダ部の上端には100〜245MPaの高圧流体回路からの流路に連通する連通孔を有し、
前記段付きピストンが小径ピストン部方向に摺動した際に前記連通孔を閉塞し、前記段付きピストンが大径ピストン部方向に摺動した際に前記連通孔を開放する閉塞片が前記小径ピストン部上に形成されており、
前記ピストン往復動手段が、
前記段付きピストンを小径ピストン部方向に押圧する押圧バネと、
大径シリンダ部内の大径ピストン部の下側シリンダ空間に流体を供給して段付きピストンを小径ピストン部方向に押圧する第1流体供給手段と、
大径シリンダ部内の大径ピストン部の上側シリンダ空間に流体を供給して段付きピストンを大径ピストン部方向に押圧する第2流体供給手段と、
前記第1流体供給手段と第2流体供給手段とを切換える切換手段とを備え、
前記第1流体供給手段と押圧バネとによる押圧力が、高圧流体回路内の流体圧による押圧力以上であり、
前記第2流体供給手段による押圧力が、前記押圧バネによる押圧力よりも大きいことを特徴とするものである。
A steam sterilization automatic on / off valve for a high-pressure fluid circuit according to the invention described in claim 1 includes a stepped piston having a large-diameter piston portion and a small-diameter piston portion formed thereon.
A stepped cylinder having a large diameter cylinder portion into which the large diameter piston portion of the stepped piston is slidably inserted and a small diameter cylinder portion into which the small diameter piston portion is slidably inserted;
Piston reciprocating means for reciprocating a stepped piston inserted into the stepped cylinder,
At the upper end of the small diameter cylinder portion, there is a communication hole communicating with a flow path from a high pressure fluid circuit of 100 to 245 MPa ,
When the stepped piston slides in the direction of the small-diameter piston portion, the communication hole is closed, and when the stepped piston slides in the direction of the large-diameter piston portion, a closing piece that opens the communication hole is the small-diameter piston. Formed on the part ,
The piston reciprocating means is
A pressing spring that presses the stepped piston toward the small-diameter piston portion;
First fluid supply means for supplying fluid to the lower cylinder space of the large-diameter piston portion in the large-diameter cylinder portion and pressing the stepped piston toward the small-diameter piston portion;
A second fluid supply means for supplying fluid to the upper cylinder space of the large-diameter piston portion in the large-diameter cylinder portion and pressing the stepped piston toward the large-diameter piston portion;
Switching means for switching between the first fluid supply means and the second fluid supply means,
The pressing force by the first fluid supply means and the pressing spring is not less than the pressing force by the fluid pressure in the high-pressure fluid circuit;
The pressing force by the second fluid supply means is larger than the pressing force by the pressing spring .

請求項に記載された発明に係る高圧流体回路用蒸気滅菌自動オンオフバルブを用いた滅菌装置は、請求項1に記載の高圧流体回路用蒸気滅菌自動オンオフバルブを用いた滅菌装置であって、
原料を100〜245MPaで加圧する増圧機と、
前記原料を投入するための供給口から前記増圧機のハウジング内部へ原料を供給する第1流路と、
前記増圧機のハウジング内部から加圧された原料が流通する第2流路と、
前記第1流路、第2流路又は前記ハウジング内部に蒸気を吹き込む蒸気供給装置と、
前記第2流路又は前記増圧機のハウジング内部に接続され、蒸気の排出量を調整する前記蒸気滅菌自動オンオフバルブ装置とを備えたことを特徴とするものである。
A sterilization apparatus using the steam sterilization automatic on / off valve for high pressure fluid circuit according to the invention described in claim 2 is a sterilization apparatus using the steam sterilization automatic on / off valve for high pressure fluid circuit according to claim 1 ,
A pressure intensifier that pressurizes the raw material at 100 to 245 MPa ;
A first flow path for supplying the raw material from the supply port for charging the raw material to the inside of the housing of the pressure intensifier;
A second flow path through which pressurized raw material flows from inside the housing of the pressure intensifier;
A steam supply device for blowing steam into the first flow path, the second flow path or the housing;
The steam sterilization automatic on / off valve device that is connected to the second flow path or the inside of the housing of the pressure intensifier and adjusts the discharge amount of steam is provided.

本発明は、蒸気を自動で安定的に流路内に供給および排出することで、滅菌を効果的に行うことができる高圧流体回路用蒸気滅菌自動オンオフバルブ装置、これを用いた微粒化装置を得ることができるという効果がある。   The present invention relates to a steam sterilization automatic on / off valve device for a high-pressure fluid circuit capable of effectively performing sterilization by automatically and stably supplying and discharging steam into and from a flow path, and a atomization device using the same. There is an effect that can be obtained.

本発明の高圧流体回路用蒸気滅菌自動オンオフバルブの一実施例の構成を示す説明図であり、高圧処理時の高圧流体回路との遮断状態を示す。It is explanatory drawing which shows the structure of one Example of the steam sterilization automatic on / off valve for high pressure fluid circuits of this invention, and shows the interruption | blocking state with the high pressure fluid circuit at the time of a high pressure process. 図1のバルブの蒸気滅菌時の動作を示す説明図である。It is explanatory drawing which shows the operation | movement at the time of steam sterilization of the valve | bulb of FIG. ピストンの戻し力と押圧バネ力の関係を示す線図である。It is a diagram which shows the relationship between the return force of a piston, and a press spring force. エア圧力が0.4MPaの時のバルブを蒸気滅菌経路に組み込んだ湿式微粒化装置の概略配管図である。It is a schematic piping diagram of the wet atomization apparatus which incorporated the valve | bulb when an air pressure is 0.4 Mpa in the steam sterilization path | route. 図4の蒸気滅菌時の概略配管図である。It is a schematic piping diagram at the time of steam sterilization of FIG. 図4に示した高圧噴射型微粒化装置での高圧処理時における高圧噴射圧力波形を示す線図である。FIG. 5 is a diagram showing a high-pressure injection pressure waveform at the time of high-pressure processing in the high-pressure injection type atomizer shown in FIG. 4. 図4に示した高圧噴射型微粒化装置での蒸気滅菌時における増圧機43の入口温度と高圧シリンダ蒸気ドレン口の温度推移を示す線図である。It is a diagram which shows the temperature transition of the inlet temperature of the pressure booster 43 at the time of steam sterilization in the high pressure injection type atomizer shown in FIG. 4, and the high pressure cylinder steam drain port.

本発明においては、大径ピストン部及びその上部に形成された小径ピストン部を有する段付きピストンと、この段付ピストンの前記大径ピストン部が内部に摺動可能に挿入される大径シリンダ部及び前記小径ピストン部が内部に摺動可能に挿入される小径シリンダ部を有する段付きシリンダと、前記段付きシリンダ内に挿入された段付きピストンを往復動させるピストン往復動手段とを備え、前記小径シリンダ部の上端には高圧流体回路からの流路に連通する連通孔を有し、前記段付きピストンが小径ピストン部方向に摺動した際に前記連通孔を閉塞し、前記段付きピストンが大径ピストン部方向に摺動した際に前記連通孔を開放する閉塞片が前記小径ピストン部上に形成されているものである。これにより、蒸気を自動で安定的に流路内に供給および排出することで、滅菌を効果的に行うことができる。   In the present invention, a stepped piston having a large-diameter piston portion and a small-diameter piston portion formed thereon, and a large-diameter cylinder portion into which the large-diameter piston portion of the stepped piston is slidably inserted. And a stepped cylinder having a small diameter cylinder portion into which the small diameter piston portion is slidably inserted, and a piston reciprocating means for reciprocating the stepped piston inserted into the stepped cylinder, At the upper end of the small diameter cylinder part, there is a communication hole communicating with the flow path from the high pressure fluid circuit, and when the stepped piston slides in the direction of the small diameter piston part, the communication hole is closed. A closing piece that opens the communication hole when sliding in the direction of the large-diameter piston portion is formed on the small-diameter piston portion. Thereby, sterilization can be effectively performed by supplying and discharging | emitting vapor | steam in a flow path automatically and stably.

より詳しくは、本発明の高圧流体回路用蒸気滅菌自動オンオフバルブは、例えば、200MPa以上の高圧流体回路の一部を構成し、尚且つ、蒸気滅菌を自動で行うため、121℃の蒸気を通す蒸気供給路を自動で切り換えるオンオフバルブである。200MPa以上の高圧流体回路を形成する高圧噴射型微粒化装置において、蒸気滅菌を手動切替でなく自動で行えるため、組みあがった状態で装置の高圧状態を維持する接液回路を蒸気滅菌でき、医薬品装置対象でのSIP(非分解定置滅菌)が可能となった。   More specifically, the steam sterilization automatic on / off valve for a high pressure fluid circuit according to the present invention constitutes a part of a high pressure fluid circuit of, for example, 200 MPa or more, and passes steam at 121 ° C. in order to perform steam sterilization automatically. This is an on / off valve that automatically switches the steam supply path. In a high-pressure injection atomizer that forms a high-pressure fluid circuit of 200 MPa or more, steam sterilization can be performed automatically instead of manual switching, so that the wetted circuit that maintains the high-pressure state of the device in the assembled state can be steam sterilized, SIP (non-decomposition stationary sterilization) on the device target has become possible.

本発明における段付きピストンとしては、大径ピストン部と小径ピストン部とを有するものであれば良く、また、本発明における段付きシリンダとしては、大径ピストン部及び小径ピストン部が各シリンダ内部に摺動可能に挿入されるものであれば良い。大径シリンダ部内の大径ピストン部にかかる圧力を小径ピストン部に伝達することにより、大径シリンダ部内の大径ピストン部における小さな圧力が、最終的には閉塞片にかかる大きな力となる。   As the stepped piston in the present invention, any stepped piston may be used as long as it has a large diameter piston portion and a small diameter piston portion. In addition, as the stepped cylinder in the present invention, a large diameter piston portion and a small diameter piston portion are provided inside each cylinder. What is necessary is just to be inserted so that sliding is possible. By transmitting the pressure applied to the large-diameter piston portion in the large-diameter cylinder portion to the small-diameter piston portion, the small pressure in the large-diameter piston portion in the large-diameter cylinder portion eventually becomes a large force applied to the closing piece.

本発明における小径シリンダ部には、高圧処理の際には、高圧流体回路との連通流路を確実に閉塞し、蒸気滅菌の際には、蒸気を高圧流体回路の流路に供給又は排出する経路が形成されればよく、具体的には、段付きピストンが小径ピストン部方向に摺動した際に小径シリンダ部に対向する位置に形成された高圧流体回路に連通する連通孔を閉塞し、段付きピストンが大径ピストン部方向に摺動した際に前記連通孔を開放する閉塞片を小径シリンダ部内の小径ピストン部側に備えればよい。   In the small-diameter cylinder portion of the present invention, the communication channel with the high-pressure fluid circuit is securely closed during high-pressure processing, and the steam is supplied to or discharged from the channel of the high-pressure fluid circuit during steam sterilization. The path only needs to be formed. Specifically, when the stepped piston slides in the direction of the small diameter piston portion, the communication hole communicating with the high pressure fluid circuit formed at a position facing the small diameter cylinder portion is closed, What is necessary is just to equip the small diameter piston part side in a small diameter cylinder part with the obstruction | occlusion piece which open | releases the said communicating hole when a stepped piston slides in the large diameter piston part direction.

本発明におけるピストン往復動手段としては、段付きシリンダ内に挿入された段付きピストンを往復動させるものであれば良い。例えば、体積の減少しない液体又は体積の減少を生じる気体を大径シリンダ部内の段付き部側又は他端部側に供給し、段付きピストンを大径ピストン部方向又は小径ピストン部方向に摺動させるものであれば良い。液体としては油圧駆動のように作動油を用いることができるが、食品や医薬品の製造の際に油圧駆動で行うことは不純物の混入事故を考慮すると、空気等の気体で作動させる方が望ましい。   The piston reciprocating means in the present invention may be any means that reciprocates the stepped piston inserted into the stepped cylinder. For example, liquid that does not decrease in volume or gas that causes a decrease in volume is supplied to the stepped part side or the other end side in the large diameter cylinder part, and the stepped piston is slid toward the large diameter piston part or the small diameter piston part. Anything can be used. As the liquid, hydraulic oil can be used as in the case of hydraulic drive. However, it is preferable to operate with a gas such as air in consideration of an accident of contamination of impurities when hydraulically driven in the production of foods and pharmaceuticals.

具体的には、ピストン往復動手段が、段付きピストンを小径ピストン部方向に押圧する押圧バネと、大径シリンダ部内の大径ピストン部の下側シリンダ空間に流体を供給して段付きピストンを小径ピストン部方向に押圧する第1流体供給手段と、大径シリンダ部内の大径ピストン部の上側シリンダ空間に流体を供給して段付きピストンを大径ピストン部方向に押圧する第2流体供給手段と、前記第1流体供給手段と第2流体供給手段とを切換える切換手段とを備え、更に具体的には、第1流体供給手段と押圧バネとによる押圧力が、100〜245MPaの高圧流体回路内の流体圧による押圧力以上であるため、連通孔を閉塞片を介して閉塞する。 Specifically, the piston reciprocating means supplies a fluid to the lower cylinder space of the large-diameter piston portion in the large-diameter cylinder portion by pressing the stepped piston in the direction of the small-diameter piston portion and the stepped piston. First fluid supply means for pressing in the direction of the small diameter piston portion, and second fluid supply means for supplying fluid to the upper cylinder space of the large diameter piston portion in the large diameter cylinder portion and pressing the stepped piston in the direction of the large diameter piston portion. And a switching means for switching between the first fluid supply means and the second fluid supply means, and more specifically, a high-pressure fluid circuit in which a pressing force by the first fluid supply means and the pressing spring is 100 to 245 MPa. Since it is more than the pressing force by the fluid pressure inside, the communication hole is closed through the closing piece.

これにより、流体を供給させることにより、段付きピストンを往復動させることができ、小さい圧力の流体を供給することにより、大きな圧力で閉塞片を高圧流体回路に連通する連通孔に押圧して閉塞することができる。例えば、0.4MPaのエア駆動であっても、200MPa以上の高圧流体回路に連通された連通孔を閉塞することが可能となる。尚、エア駆動については、0.4MPaを例示したが、0.2〜0.6MPaの範囲で変更可能であり、このエア駆動圧力に応じて、他の諸条件も変更される。   Accordingly, the stepped piston can be reciprocated by supplying the fluid, and by supplying the fluid with a small pressure, the blocking piece is pressed against the communication hole communicating with the high-pressure fluid circuit with a large pressure. can do. For example, even if the air drive is 0.4 MPa, the communication hole communicated with the high-pressure fluid circuit of 200 MPa or more can be closed. In addition, about air drive, although 0.4 MPa was illustrated, it can change in the range of 0.2-0.6 MPa, and other various conditions are also changed according to this air drive pressure.

本発明の高圧流体回路用蒸気滅菌自動オンオフバルブで用いる材質としては、少なくとも閉塞片自体が高圧流体回路の流路を形成するに耐えるものであり、この閉塞片を押圧する段付きシリンダや段付きピストン等が高圧流体回路の圧力に耐えるものであればよく、加えて、蒸気滅菌の圧力及び温度に耐えられる素材であればよい。シリンダやピストン等は金属製であれば、高圧流体回路の圧力に耐え、蒸気滅菌の圧力及び温度に耐えられるものとなり、例えば高強度ステンレス、高強度アルミニウム等が使用できる。   The material used in the steam sterilization automatic on / off valve for the high-pressure fluid circuit of the present invention is such that at least the closing piece itself can withstand the formation of the flow path of the high-pressure fluid circuit. It is sufficient that the piston or the like can withstand the pressure of the high-pressure fluid circuit, and in addition, any material that can withstand the pressure and temperature of steam sterilization may be used. If the cylinder, piston or the like is made of metal, it can withstand the pressure of the high-pressure fluid circuit and withstand the pressure and temperature of steam sterilization. For example, high-strength stainless steel, high-strength aluminum, or the like can be used.

後述する実施例に示した具体的なバルブとしては、270MPaの耐圧高圧シールと、その1.5倍想定の衝撃圧が加わった高圧流体をシールし、かつ装置に組み込むための極力の小型化を達成するために最適なピストン径とバネ力を用い、シリンダ壁に接するようにピストンの周囲に配されるシール材としては、121℃〜140℃の蒸気温度に耐えられる材質であればよく、例えば、ポリテトラフルオロエチレン(PTFE)やフッ素ゴム等を用いた。   As specific valves shown in the embodiments described later, a 270 MPa pressure-resistant high-pressure seal and a high-pressure fluid to which an impact pressure assumed to be 1.5 times that of the high-pressure fluid is sealed, and miniaturization as much as possible is incorporated. As a sealing material disposed around the piston so as to be in contact with the cylinder wall using an optimum piston diameter and spring force to achieve, any material that can withstand a steam temperature of 121 ° C. to 140 ° C. may be used. Polytetrafluoroethylene (PTFE), fluororubber or the like was used.

また、エア駆動圧とバネで、衝撃も含めた高圧が加わった流体をシールさせ、そのバルブ内に蒸気を通す流路を設け、高圧をシールするための最小のピストン径を用いた。具体的には、ピストン径が94〜127mm、バネ補助力が10〜2600Nとした。尚、上記では270MPaの耐圧高圧シールと、その1.5倍想定の衝撃圧が加わった高圧流体をシールすることとしたが、1.4〜2倍想定の衝撃圧が加わった高圧流体をシールすることを想定した設計も行われる。   In addition, a fluid to which high pressure including impact was applied was sealed with an air driving pressure and a spring, a flow path for passing steam was provided in the valve, and the minimum piston diameter for sealing high pressure was used. Specifically, the piston diameter was 94 to 127 mm, and the spring assist force was 10 to 2600 N. In the above description, the pressure-resistant high-pressure seal of 270 MPa and the high-pressure fluid to which the impact pressure assumed to be 1.5 times are applied are sealed. However, the high-pressure fluid to which the impact pressure assumed to be 1.4 to 2 times is applied is sealed. It is also designed to do this.

本発明の滅菌装置は、前述の高圧流体回路用蒸気滅菌自動オンオフバルブを用いるものであれば良い。具体的には、原料を加圧する増圧機と、前記原料を投入するための供給口から前記増圧機のハウジング内部へ原料を供給する第1流路と、前記増圧機のハウジング内部から加圧された原料が流通する第2流路と、前記第1流路、第2流路又は前記ハウジング内部に蒸気を吹き込む蒸気供給装置と、前記第2流路又は前記増圧機のハウジング内部に接続され、蒸気の排出量を調整する前記蒸気滅菌自動オンオフバルブ装置とを備える。これにより、蒸気を自動で安定的に流路内に供給および排出することで、滅菌を効果的に行うことができる。本発明の滅菌装置としては、具体的には湿式微粒化装置が挙げられる。   The sterilization apparatus of the present invention only needs to use the above-described steam sterilization automatic on / off valve for a high-pressure fluid circuit. Specifically, a pressure booster that pressurizes the raw material, a first flow path for supplying the raw material from the supply port for charging the raw material to the inside of the housing of the pressure booster, and a pressure from the inside of the housing of the pressure booster. A second flow path through which the raw material flows, a steam supply device that blows steam into the first flow path, the second flow path or the housing, and the second flow path or the pressure booster housing, The steam sterilization automatic on / off valve device for adjusting the discharge amount of steam. Thereby, sterilization can be effectively performed by supplying and discharging | emitting vapor | steam in a flow path automatically and stably. Specific examples of the sterilization apparatus of the present invention include a wet atomization apparatus.

1.高圧流体回路用蒸気滅菌自動オンオフバルブの構成
図1は本発明の高圧流体回路用蒸気滅菌自動オンオフバルブの一実施例の構成を示す説明図であり、高圧処理時の高圧流体回路との遮断状態を示す。図2は図1のバルブの蒸気滅菌時の動作を示す説明図である。
1. Diagram 1 of a high pressure fluid circuit for steam sterilization automatic on-off valve is an explanatory diagram showing the structure of an embodiment of a high-pressure fluid circuit for steam sterilization automatic on-off valve of the present invention, cut-off state between the high pressure fluid circuit of the high-pressure treatment Indicates. FIG. 2 is an explanatory view showing the operation of the valve of FIG. 1 during steam sterilization.

本実施例の高圧流体回路用蒸気滅菌自動オンオフバルブ10は、大径ピストン部12及び小径ピストン部13を有する段付きピストン11と、この段付ピストン11の大径ピストン部12が内部に摺動可能に挿入される大径シリンダ部14および小径ピストン部13が内部に摺動可能に挿入される小径シリンダ部15を有する段付きシリンダ16とを備える。大径ピストン部12及び小径ピストン部13の側壁部には、側壁を一周する溝が形成されており、シリンダ壁に接するように各々フッ素ゴム製のシール材23が配されている。   The steam sterilization automatic on / off valve 10 for a high-pressure fluid circuit according to this embodiment includes a stepped piston 11 having a large-diameter piston portion 12 and a small-diameter piston portion 13, and a large-diameter piston portion 12 of the stepped piston 11 sliding inside. And a stepped cylinder 16 having a small diameter cylinder portion 15 into which a large diameter cylinder portion 14 and a small diameter piston portion 13 are slidably inserted. Grooves are formed around the side walls of the large-diameter piston portion 12 and the small-diameter piston portion 13, and a fluororubber seal material 23 is disposed so as to contact the cylinder wall.

段付きシリンダ16内に挿入された段付きピストン11を往復動させるピストン往復動手段として、段付きピストン11を小径ピストン部13方向に押圧する押圧バネ17と、大径シリンダ部14内の大径ピストン部12の下側シリンダ空間に流体を供給して段付きピストン11を小径ピストン部13方向に押圧する第1エア供給口18と、大径シリンダ部14内の大径ピストン部12の上側シリンダ空間に流体を供給して段付きピストン11を大径ピストン部12方向に押圧する第2エア供給口19と、第1エア供給口18と第2エア供給口19とに供給されるエアを切換えるエア切換手段20とを備える。   As piston reciprocating means for reciprocating the stepped piston 11 inserted into the stepped cylinder 16, a pressing spring 17 that presses the stepped piston 11 toward the small diameter piston portion 13 and a large diameter in the large diameter cylinder portion 14. A first air supply port 18 that supplies fluid to the lower cylinder space of the piston portion 12 to press the stepped piston 11 toward the small-diameter piston portion 13, and an upper cylinder of the large-diameter piston portion 12 in the large-diameter cylinder portion 14 The air supplied to the space is switched to the second air supply port 19 that presses the stepped piston 11 toward the large-diameter piston portion 12, and the air supplied to the first air supply port 18 and the second air supply port 19 is switched. Air switching means 20.

小径シリンダ部15には、段付きピストン11が小径ピストン部13方向に摺動した際に小径シリンダ部15に対向する位置に形成された高圧流体回路30から分岐する流路に連通する連通孔31を閉塞し、段付きピストン11が大径ピストン部12方向に摺動した際に連通孔31を開放する閉塞片21が小径ピストン部13上に形成されている。連通孔31が開放された際には、小径シリンダ部15は高圧流体回路30内と連通し、高圧流体回路30内に充満される水蒸気又は/及びドレンが蒸気排気ドレン口22から排出される。   The small-diameter cylinder portion 15 has a communication hole 31 that communicates with a flow path that branches from the high-pressure fluid circuit 30 formed at a position facing the small-diameter cylinder portion 15 when the stepped piston 11 slides in the direction of the small-diameter piston portion 13. A closing piece 21 is formed on the small-diameter piston portion 13 to open the communication hole 31 when the stepped piston 11 slides in the direction of the large-diameter piston portion 12. When the communication hole 31 is opened, the small-diameter cylinder portion 15 communicates with the inside of the high-pressure fluid circuit 30, and water vapor and / or drain filled in the high-pressure fluid circuit 30 is discharged from the steam exhaust drain port 22.

本実施例の場合には、270MPaの高圧処理における耐圧高圧シールと、その1.5倍想定の衝撃圧が加わった高圧流体をシールし、尚且つ装置に組み込むための極力の小型化を達成するために最適なピストン径とバネ力を選択した。図3はエア圧力が0.4MPaの時の内部ピストンの戻し力と押付けバネ力の関係を示す線図である。尚、実施例において エアによるピストン戻し力F3(=(πD/4−πd/4)×a(a:エア圧、D:大径ピストン部径、d:小径ピストン部径))、エアによるピストン押圧力F1(=πD/4×a)、瞬時衝撃想定反力(F5=耐圧設計圧力×1.5)、F2(=F5−F1)を各々定義する。 In the case of the present embodiment, a pressure-resistant high-pressure seal in a high-pressure process of 270 MPa and a high-pressure fluid to which an impact pressure assumed 1.5 times that is applied are sealed, and the miniaturization as much as possible is incorporated. Therefore, the optimum piston diameter and spring force were selected. FIG. 3 is a diagram showing the relationship between the return force of the internal piston and the pressing spring force when the air pressure is 0.4 MPa. Note that the piston returning force by the air in the Example F3 (= (πD 2/4 -πd 2/4) × a (a: air pressure, D: large-diameter piston section diameter, d: diameter piston portion diameter)), air the piston pressing force of F1 (= πD 2/4 × a), the instantaneous impact assumed reaction force (F5 = withstand design pressure × 1.5), defining respectively F2 (= F5-F1).

図3に示す通り、本実施例では耐圧設計圧力が270MPaとした。そのため、その1.5倍想定の瞬時衝撃想定反力を:F5=5,085(N)、エアによるピストン押圧力を:F1(N)とし、必要バネ補助力を:F2(N)=F5−F1とし、エアによるピストン戻し力を:F3(N)との関係を求めた。その結果、図3に示す通り、設計条件は、F2<F3であり、ピストン径Dの小型化最適領域を選択すると、ピストンの小型化を達成可能な領域として、ピストン径Dの領域94〜127mmが得られる。本実施例ではD=110mmとした高圧流体回路用蒸気滅菌自動オンオフバルブを用いた。尚、本実施例では、エア圧力を0.4MPa、耐圧設計圧力を270MPaとしたが、これらの設計圧力を変更すると、F1,F2,F3,F5の値を変化させることにより、ピストン径Dが変更されることは言うまでもない。   As shown in FIG. 3, in this embodiment, the withstand pressure design pressure was 270 MPa. Therefore, the assumed instantaneous impact reaction force of 1.5 times is: F5 = 5,085 (N), the piston pressing force by air is: F1 (N), and the necessary spring assist force is: F2 (N) = F5 -F1, and the relationship between the piston return force by air and F3 (N) was determined. As a result, as shown in FIG. 3, the design condition is F2 <F3, and when the optimum region for reducing the piston diameter D is selected, the region of the piston diameter D is 94 to 127 mm as the region where the piston can be reduced. Is obtained. In this example, a steam sterilization automatic on / off valve for high-pressure fluid circuit with D = 110 mm was used. In this embodiment, the air pressure is 0.4 MPa and the pressure resistance design pressure is 270 MPa. However, when these design pressures are changed, the values of F1, F2, F3, and F5 are changed to change the piston diameter D. Needless to say, it will change.

本実施例の高圧流体回路用蒸気滅菌自動オンオフバルブの具体的な動作は次の通りである。
(1) 高圧処理の際には、第1エア供給口18から0.4MPaのエアを供給する。
(2) エア押付け圧による力F1と押圧バネ17の押圧力F2によって段付きピストン11が小径ピストン部13方向に押し上げられる。
(3) 段付きピストン11の端部に装着されたピン状の閉塞片21が高圧流体回路30との連通孔31を塞ぎ、常用圧245MPa(耐用圧力270MPa)をシールする。
The specific operation of the steam sterilization automatic on / off valve for the high-pressure fluid circuit of the present embodiment is as follows.
(1) During the high-pressure treatment, 0.4 MPa air is supplied from the first air supply port 18.
(2) The stepped piston 11 is pushed up in the direction of the small diameter piston portion 13 by the force F1 caused by the air pressing pressure and the pressing force F2 of the pressing spring 17.
(3) The pin-shaped closing piece 21 attached to the end of the stepped piston 11 closes the communication hole 31 with the high-pressure fluid circuit 30 and seals the normal pressure 245 MPa (the service pressure 270 MPa).

即ち、閉塞片21は段付きピストン11と固定されており、閉塞片21の先端のテーパーシール部が高圧流体回路30の壁面に穿孔された分岐流路の開口テーパー部に合致するように形成されている。この場合、段付きピストン11の大径ピストン部12の面積が9499mmであるため、エア0.4MPaによって、ピストンの段付きピストン11は3800N(=0.4×9499)の力(F1)で小径ピストン部13方向に押し上げられる。また、この場合の押圧バネ17の押圧力(F2)は1285Nであるため、合計5085N(F5)の力でピストン先端側へ押される。一方、高圧処理の際には、270MPaの原料は連通孔の径が12.56mmであるため、3392N(=270×12.56)で押圧されるため、充分に対向できる押圧力である。 That is, the closing piece 21 is fixed to the stepped piston 11, and the tapered seal portion at the tip of the closing piece 21 is formed so as to match the opening tapered portion of the branch flow channel drilled in the wall surface of the high-pressure fluid circuit 30. ing. In this case, since the area of the large-diameter piston portion 12 of the stepped piston 11 is 9499 mm 2 , the stepped piston 11 of the piston has a force (F1) of 3800 N (= 0.4 × 9499) by air 0.4 MPa. It is pushed up in the direction of the small-diameter piston portion 13. Further, since the pressing force (F2) of the pressing spring 17 in this case is 1285N, it is pressed to the piston tip side with a total force of 5085N (F5). On the other hand, in the case of high-pressure treatment, since the diameter of the communication hole of the 270 MPa raw material is 12.56 mm 2, it is pressed with 3392N (= 270 × 12.56).

(4) 蒸気滅菌の際には、第2エア供給口19からエアを供給し、押圧バネ17の押圧力に打ち勝ち、段付きピストン11を大径ピストン部12方向に押圧する。閉塞片21が増圧機43から離れ、連通孔31が開く。この場合、エアが供給される段付きピストン11の段付き部の面積は大径ピストン部面積から小径ピストン部面積を除外した面積(9499−707mm)のであるため、エア0.4MPaによって、ピストンの段付きピストン11は3517N(=0.4×(9499−707))の力(F3)で大径ピストン部12方向に押し下げられる。また、この場合の押圧バネ17の押圧力(F2)は、1285Nであるため、段付きピストン11は大径ピストン部12方向に押圧され、連通孔31が開放される。 (4) At the time of steam sterilization, air is supplied from the second air supply port 19 to overcome the pressing force of the pressing spring 17 and press the stepped piston 11 toward the large-diameter piston portion 12. The blocking piece 21 is separated from the pressure booster 43, and the communication hole 31 is opened. In this case, the area of the stepped portion of the stepped piston 11 to which air is supplied is the area (9499-707 mm 2 ) excluding the area of the small diameter piston portion from the large diameter piston portion area. The stepped piston 11 is pushed down toward the large-diameter piston portion 12 with a force (F3) of 3517N (= 0.4 × (9499-707)). In this case, since the pressing force (F2) of the pressing spring 17 is 1285N, the stepped piston 11 is pressed in the direction of the large-diameter piston portion 12 and the communication hole 31 is opened.

(5) この状態を保持しながら、流路内に121℃の蒸気を流し、蒸気流出口を通って蒸気排気ドレン口22から蒸気が排出される。
(6) 121℃、15分間又は115℃、30分間の蒸気滅菌が終了した後に、蒸気供給を停止し、再度、第1エア供給口18からエアを供給して、高圧シールを行い、常用圧245MPaをシールする。これにより、高圧装置の定置滅菌(SIP)が可能となる。
(5) While maintaining this state, steam at 121 ° C. flows through the flow path, and the steam is discharged from the steam exhaust drain port 22 through the steam outlet.
(6) After the steam sterilization at 121 ° C. for 15 minutes or 115 ° C. for 30 minutes is finished, the steam supply is stopped, air is supplied again from the first air supply port 18, high pressure sealing is performed, Seal 245 MPa. Thereby, stationary sterilization (SIP) of a high-pressure apparatus is attained.

2.高圧噴射型微粒化装置の蒸気滅菌
図4は図1のバルブを蒸気滅菌経路に組み込んだ湿式微粒化装置の概略配管図である。図5は図4の湿式微粒化装置の蒸気滅菌時の概略配管図である。各図は高圧噴射型微粒化装置(商品名「スターバースト HJP−25008SIP」:株式会社スギノマシン製)の原料高圧処理時回路と、蒸気滅菌時回路を示している。図4に示す通り、原料高圧処理時回路は、回路中の三方弁42で流路を切り替え、図中の黒矢印の流れの通り原料を供給する。即ち、供給口40から原料を入れ第1流路41を通り、原料を増圧するための増圧機43内に原料が供給される。
2. Steam Sterilization of High Pressure Injection Atomizer FIG. 4 is a schematic piping diagram of a wet atomizer incorporating the valve of FIG. 1 in a steam sterilization route. FIG. 5 is a schematic piping diagram during steam sterilization of the wet atomization apparatus of FIG. Each figure shows a high-pressure injection type atomization apparatus (trade name “Starburst HJP-25008SIP”: manufactured by Sugino Machine Co., Ltd.) and a raw material high-pressure treatment circuit and a steam sterilization circuit. As shown in FIG. 4, the raw material high-pressure processing circuit switches the flow path with a three-way valve 42 in the circuit, and supplies the raw material as indicated by the black arrow in the figure. That is, the raw material is supplied from the supply port 40, passes through the first flow path 41, and is supplied into the pressure booster 43 for increasing the pressure of the raw material.

増圧機43により、原料は高圧で押し出され、高圧の第2流路44を通って粉砕室であるチャンバー45に高圧で供給され、チャンバー45内の噴射ノズル(穴径がφ0.1〜0.5mm)49から高圧噴射され、原料が微粒化・乳化される。粉砕された原料は第3流路46を介して貯留槽47に貯留される。尚、粉砕された原料は高圧噴射時原料温度が上昇するため、チャンバー通過後コイル状の熱交換器48で原料が冷却される。   The raw material is pushed out at a high pressure by the pressure intensifier 43 and supplied to the chamber 45 which is a crushing chamber through the high-pressure second flow path 44 at a high pressure, and the injection nozzle (hole diameter is φ0.1 to. 5 mm) 49, high pressure injection is performed, and the raw material is atomized and emulsified. The pulverized raw material is stored in the storage tank 47 through the third flow path 46. In addition, since the raw material temperature at the time of high-pressure injection rises in the pulverized raw material, the raw material is cooled by the coiled heat exchanger 48 after passing through the chamber.

この高圧噴射型微粒化装置の回路や構成装置等を分解せずに蒸気滅菌SIPを行う場合は図5のような流路の流れとする。具体的には、回路中の三方弁42で流路を切り替え、図中の白抜き矢印の流れとする。即ち、蒸気供給装置50が接続された供給口40から増圧機43内までの第1流路と、三方弁42の手前で第1流路から分岐され、第3流路46の一部を熱交換器48を経由してチャンバー45の低圧側に逆方向に供給される分岐路46bが形成される。尚、流路内の凝結水を排出(ドレン)するために、蒸気入口直後、増圧機、プランジャ滅菌流路出口、チャンバー高圧入口側、チャンバー低圧出口側に各々設置した圧力調整弁51、52、53、54、55を活用する。   When steam sterilization SIP is performed without disassembling the circuit or component of the high-pressure jet atomizer, the flow of the flow path is as shown in FIG. Specifically, the flow path is switched by the three-way valve 42 in the circuit, and the flow is indicated by the white arrow in the figure. That is, the first flow path from the supply port 40 to which the steam supply device 50 is connected to the inside of the pressure booster 43 is branched from the first flow path before the three-way valve 42, and a part of the third flow path 46 is heated. A branch path 46 b is formed that is supplied in the reverse direction to the low pressure side of the chamber 45 via the exchanger 48. In order to discharge (drain) the condensed water in the flow path, immediately after the steam inlet, the pressure regulating valves 51, 52 respectively installed on the pressure intensifier, the plunger sterilization flow path outlet, the chamber high pressure inlet side, and the chamber low pressure outlet side, 53, 54 and 55 are utilized.

また、第1流路、プランジャ滅菌流路出口、チャンバー高圧入口側、チャンバー低圧出口側に温度センサー61、62、63、64を備えた。これにより、各々の流路内が121℃を維持していることを確認することができる。尚、各所ドレン排出口(圧力調整弁)に熱電対温度計を取り付け、温度計測した。尚、SIPでは、流路の排出時における温度が121℃であれば、排出口に繋がっている流路内は排出口よりも温度が高いため、排出口の温度を基準とした測定を行った。そのため、粉砕室の直前及び直後の排出口が最も重要ではあるが、全ての流路内において、滅菌条件を確実にするために、その他の箇所においても、温度検知手段を配置することにした。   Further, temperature sensors 61, 62, 63, and 64 were provided on the first flow path, the plunger sterilization flow path outlet, the chamber high pressure inlet side, and the chamber low pressure outlet side. Thereby, it can confirm that the inside of each flow path is maintaining 121 degreeC. A thermocouple thermometer was attached to each drain discharge port (pressure regulating valve) to measure the temperature. In SIP, if the temperature at the time of discharge of the flow path is 121 ° C., the temperature in the flow path connected to the discharge port is higher than that of the discharge port, so measurement was performed based on the temperature of the discharge port. . Therefore, the discharge ports immediately before and immediately after the pulverization chamber are the most important, but in order to ensure the sterilization conditions in all the flow paths, temperature detection means are arranged at other locations.

さらに、供給口40に接続された蒸気供給装置50から蒸気を投入し、第1流路41を通り、増圧機43内に蒸気を送り込む。途中、プランジャ滅菌用の第1分岐流路41bにも蒸気を分岐させ、高圧シール部を抜け出た領域でプランジャを蒸気滅菌する。また、増圧機43内に完全に蒸気を行き渡らせるために、増圧機43のハウジング内から分岐した流路を介して蒸気が高圧流体回路用蒸気滅菌自動オンオフバルブ10aを通過し、圧力調整弁52を介して自動的に排出される。   Further, steam is supplied from the steam supply device 50 connected to the supply port 40, passes through the first flow path 41, and sends the steam into the pressure intensifier 43. On the way, steam is also branched into the first branch flow path 41b for plunger sterilization, and the plunger is steam sterilized in the region that has come out of the high-pressure seal portion. Further, in order to allow the steam to completely reach the inside of the pressure booster 43, the steam passes through the steam sterilization automatic on / off valve 10a for the high-pressure fluid circuit through the flow path branched from the housing of the pressure booster 43, and the pressure regulating valve 52 Will be automatically discharged through.

第1流路41の蒸気は高圧流路である第2流路44を通ってチャンバー45の高圧入口側の高圧流体回路用蒸気滅菌自動オンオフバルブ10bを通過し、圧力調整弁54を介して排出される。チャンバー45の低圧側にも自動オンオフバルブ10cが配されており、このオンオフバルブは図1,図2の高圧流体用であっても、低圧流体用であってもよい。一方、第1流路41の途中で三方弁42で分岐された蒸気は、第3流路46のコイル状の熱交換器48を通ってチャンバー45の低圧出口側に流入しすぐに圧力調整弁55方向へ排出されながら、他方噴射ノズル49を通過し、高圧流体回路用蒸気滅菌自動オンオフバルブ10bから排出される。   The steam in the first flow path 41 passes through the second flow path 44 which is a high pressure flow path, passes through the high pressure fluid circuit steam sterilization automatic on / off valve 10b on the high pressure inlet side of the chamber 45, and is discharged through the pressure adjustment valve 54. Is done. An automatic on / off valve 10c is also arranged on the low pressure side of the chamber 45, and this on / off valve may be used for the high pressure fluid shown in FIGS. On the other hand, the steam branched by the three-way valve 42 in the middle of the first flow path 41 flows into the low pressure outlet side of the chamber 45 through the coiled heat exchanger 48 of the third flow path 46 and is immediately pressure-regulated. While being discharged in the 55 direction, it passes through the other injection nozzle 49 and is discharged from the high pressure fluid circuit steam sterilization automatic on / off valve 10b.

尚、高圧発生機構である増圧機43の往復運動用の高圧シール部を直接的に蒸気滅菌することは、プランジャと高圧パッキンとの間に隙間がないため不可能である。そこで、往復稼動するプランジャの動きを利用して、稼動範囲の中でシール部から抜けた部分のプランジャを蒸気滅菌する。   It is impossible to directly sterilize the high pressure seal portion for reciprocating motion of the pressure booster 43, which is a high pressure generating mechanism, because there is no gap between the plunger and the high pressure packing. Therefore, by using the movement of the reciprocating plunger, the portion of the plunger that has come out of the seal portion within the operating range is steam sterilized.

また、本実施例では、高圧流体回路用蒸気滅菌自動オンオフバルブを蒸気及び/又はドレン抜きとして使用することを開示したが、高圧流体回路への蒸気の供給箇所に適用する場合もある。これは図5の2点鎖線で示した通り、蒸気供給装置50から分岐して、チャンバー45と熱交換器48との間の回路中に蒸気を供給するように配置してもよい。   Further, in the present embodiment, the use of the steam sterilization automatic on / off valve for a high pressure fluid circuit as steam and / or drain removal has been disclosed, but there are cases where it is applied to a steam supply point to the high pressure fluid circuit. As shown by a two-dot chain line in FIG. 5, this may be arranged so as to branch from the steam supply device 50 and supply steam into a circuit between the chamber 45 and the heat exchanger 48.

図4、図5に示す通り、第1流路41から閉塞弁58を介して分岐させた第1分岐流路41bからの蒸気を、抜けた部分のプランジャに接触させ滅菌を行う。100〜245MPaの範囲で用いることのできる高圧発生装置は通常、一次側発生圧力に低圧の油圧を用い、パスカルの原理を利用した増圧機で二次側原料を100〜245MPaに増圧している。その構造において一次側油圧と二次側原料との間に油と原料が接触しない縁切り空間を設けている。その空間内で高圧シール部から抜けた部分のプランジャに蒸気を接触させて滅菌可能とした。   As shown in FIGS. 4 and 5, sterilization is performed by bringing the vapor from the first branch flow path 41 b branched from the first flow path 41 through the closing valve 58 into contact with the plunger of the part that has been removed. A high-pressure generator that can be used in the range of 100 to 245 MPa usually uses a low-pressure hydraulic pressure as the primary-side generated pressure, and the pressure on the secondary side is increased to 100 to 245 MPa with a pressure booster that uses the Pascal principle. In this structure, an edge cutting space is provided between the primary side hydraulic pressure and the secondary side raw material so that the oil and the raw material do not contact each other. Sterilization was made possible by bringing steam into contact with the plunger in the space that was removed from the high-pressure seal.

また、100〜245MPaに耐えることのできる高圧シールに使用されているパッキン材質は、一般的にロングランを考慮して耐磨耗性を重視した超硬分子ポリエチレンが用いられる。しかし、その耐熱性は100℃以下と低く、蒸気滅菌には耐えられない。このため、従来の100〜245MPaの高圧シールに使用されているパッキン材質を耐熱性を持たせた材質に変更した。一般的に高圧シールにはロングラン(耐磨耗性)を考慮して超硬分子ポリエチレンが用いられるが、蒸気滅菌が必要な医薬品・食品等の使用ではパッキンを頻繁に交換するためロングランは重要ではなく、耐熱性を持たせたポリテトラフルオロエチレン(PTFE)を使用した。PTFEの耐熱は180℃である。尚、耐圧性と耐熱性とを満たす素材であればポリテトラフルオロエチレン(PTFE)以外のフッ素ゴム(耐熱140℃)等の材質であっても使用できることは言うまでもない。   In addition, as a packing material used for a high-pressure seal capable of withstanding 100 to 245 MPa, a cemented carbide polyethylene in which wear resistance is emphasized in consideration of a long run is generally used. However, its heat resistance is as low as 100 ° C. or less and cannot withstand steam sterilization. For this reason, the packing material used for the conventional high pressure seal of 100 to 245 MPa was changed to a material having heat resistance. In general, high molecular weight polyethylene seals are used for high-pressure seals in consideration of long run (wear resistance). However, long run is not important because the packing is frequently changed when using drugs and foods that require steam sterilization. However, polytetrafluoroethylene (PTFE) having heat resistance was used. The heat resistance of PTFE is 180 ° C. Needless to say, a material satisfying both pressure resistance and heat resistance can be used even with a material such as fluororubber (heat resistant 140 ° C.) other than polytetrafluoroethylene (PTFE).

更に、原料流路(即ち、蒸気滅菌流路)は上から下への流れとなるように、各々の流路に1/100以上の下がり勾配をつけた。更に、下がり勾配が配設できない箇所はドレン口を設けるようにした。尚、各所ドレン口(圧力調整弁)を開けたときに原料または蒸気凝結水が流れ出るようにして流路内での滞留を防ぐこととした。原料の供給圧力や高圧処理時の圧力を表示する圧力センサには、耐熱200℃の隔膜式圧力計を使用した。   Furthermore, each channel was provided with a descending gradient of 1/100 or more so that the raw material channels (that is, steam sterilization channels) flow from top to bottom. Further, a drain port is provided at a location where a downward gradient cannot be provided. In addition, it was decided to prevent stagnation in the flow path by allowing the raw material or steam condensed water to flow out when the drain port (pressure regulating valve) was opened at various places. A heat resistant 200 ° C. diaphragm type pressure gauge was used as a pressure sensor for displaying the supply pressure of the raw material and the pressure during high-pressure processing.

本実施例の高圧噴射型微粒化装置の通常操作としては、高圧流体回路用蒸気滅菌自動オンオフバルブ10a、10bを高圧シール状態にした上で、常用圧力245MPaで高圧運転する。この際に、バルブの高圧シール部から漏れがないことを確認する。図6は図4に示した高圧噴射型微粒化装置での高圧処理時における高圧噴射圧力波形を示す線図である。図に示す通り、本実施例の高圧噴射型微粒化装置の噴射圧力は245MPaを維持し、原料の微粒化を行うことが確認された。   As a normal operation of the high-pressure jet atomization apparatus of the present embodiment, the high-pressure fluid circuit steam sterilization automatic on / off valves 10a and 10b are placed in a high-pressure sealed state and then operated at a normal pressure of 245 MPa. At this time, confirm that there is no leakage from the high-pressure seal of the valve. FIG. 6 is a diagram showing a high-pressure spray pressure waveform during high-pressure processing in the high-pressure spray atomizer shown in FIG. As shown in the figure, it was confirmed that the injection pressure of the high-pressure injection type atomizer of the present example was maintained at 245 MPa, and the material was atomized.

また、蒸気滅菌操作としては、微粒化装置を停止し、高圧流体回路用蒸気滅菌自動オンオフバルブ10a、10bを蒸気通過状態に自動切換えする。121℃の蒸気を流路内に通して、高圧流体回路用蒸気滅菌自動オンオフバルブ10a、10bの蒸気排気ドレン口22から蒸気が排出される。蒸気滅菌の規定として、高圧流体回路内を121℃で30分間を保持する。その際、蒸気漏れがないことを確認する。図7は図4に示した高圧噴射型微粒化装置での蒸気滅菌時における増圧機43の入口温度と高圧シリンダ蒸気ドレン口の温度推移を示す線図である。図に示す通り、何れの箇所において、121℃で30分間を保持されたことが確認された。   As the steam sterilization operation, the atomization apparatus is stopped, and the steam sterilization automatic on / off valves 10a and 10b for the high-pressure fluid circuit are automatically switched to the steam passage state. Steam of 121 ° C. is passed through the flow path, and the steam is discharged from the steam exhaust drain port 22 of the steam sterilization automatic on / off valve for high pressure fluid circuit 10a, 10b. As a regulation of steam sterilization, the high-pressure fluid circuit is kept at 121 ° C. for 30 minutes. Confirm that there is no steam leakage. FIG. 7 is a diagram showing the temperature transition of the inlet temperature of the pressure booster 43 and the temperature of the high pressure cylinder steam drain port during steam sterilization in the high pressure injection atomizer shown in FIG. As shown in the figure, it was confirmed that the sample was held at 121 ° C. for 30 minutes at any location.

再度の高圧噴射型微粒化装置の通常操作としては、蒸気滅菌を停止し、再度、高圧流体回路用蒸気滅菌自動オンオフバルブ10a、10bを高圧シール状態にし、スターバーストを常用圧力245MPaで高圧運転する。その際、バルブの高圧シール部から漏れがないことを確認する。   As a normal operation of the high-pressure injection atomization apparatus again, the steam sterilization is stopped, the high-pressure fluid circuit steam sterilization automatic on / off valves 10a and 10b are again put into a high-pressure sealed state, and the starburst is operated at a high pressure at a normal pressure of 245 MPa. . At that time, confirm that there is no leakage from the high-pressure seal of the valve.

10、10a、10b …高圧流体回路用蒸気滅菌自動オンオフバルブ、
11 …段付きピストン、
12 …大径ピストン部、
13 …小径ピストン部、
14 …大径シリンダ部、
15 …小径シリンダ部、
16 …段付きシリンダ、
17 …押圧バネ、
18 …第1エア供給口、
19 …第2エア供給口、
20 …エア切換手段、
21 …閉塞片、
22 …蒸気排気ドレン口、
23 …シール材、
30 …高圧流体回路、
31 …連通孔、
40 …(原料又は蒸気)供給口、
41 …第1流路、
42 …三方弁、
43 …増圧機、
44 …第2流路、
45 …チャンバー、
46 …第3流路、
47 …貯留槽、
48 …熱交換器、
49 …噴射ノズル、
50 …蒸気供給装置、
51、52、53、54、55 …圧力調整弁、
58 …閉塞弁、
61、62、63、64 …温度センサー、
10, 10a, 10b ... steam sterilization automatic on / off valve for high pressure fluid circuit,
11: Stepped piston,
12 ... large diameter piston part,
13 ... small diameter piston part,
14: Large diameter cylinder,
15 ... small diameter cylinder,
16 ... cylinder with steps,
17… Pressing spring,
18 ... 1st air supply port,
19 ... second air supply port,
20 ... air switching means,
21 ... Occlusion piece,
22 ... steam exhaust drain port,
23 ... sealing material,
30 ... high pressure fluid circuit,
31 ... communication hole,
40 ... (raw material or steam) supply port,
41 ... 1st flow path,
42 ... three-way valve,
43 ... booster,
44 ... the second flow path,
45 ... chamber,
46 ... the third flow path,
47 ... storage tank,
48 ... heat exchanger,
49 ... injection nozzle,
50 ... steam supply device,
51, 52, 53, 54, 55 ... pressure regulating valve,
58 ... block valve,
61, 62, 63, 64 ... temperature sensor,

Claims (2)

大径ピストン部及びその上部に形成された小径ピストン部を有する段付きピストンと、
この段付ピストンの前記大径ピストン部が内部に摺動可能に挿入される大径シリンダ部及び前記小径ピストン部が内部に摺動可能に挿入される小径シリンダ部を有する段付きシリンダと、
前記段付きシリンダ内に挿入された段付きピストンを往復動させるピストン往復動手段とを備え、
前記小径シリンダ部の上端には100〜245MPaの高圧流体回路からの流路に連通する連通孔を有し、
前記段付きピストンが小径ピストン部方向に摺動した際に前記連通孔を閉塞し、前記段付きピストンが大径ピストン部方向に摺動した際に前記連通孔を開放する閉塞片が前記小径ピストン部上に形成されており、
前記ピストン往復動手段が、
前記段付きピストンを小径ピストン部方向に押圧する押圧バネと、
大径シリンダ部内の大径ピストン部の下側シリンダ空間に流体を供給して段付きピストンを小径ピストン部方向に押圧する第1流体供給手段と、
大径シリンダ部内の大径ピストン部の上側シリンダ空間に流体を供給して段付きピストンを大径ピストン部方向に押圧する第2流体供給手段と、
前記第1流体供給手段と第2流体供給手段とを切換える切換手段とを備え、
前記第1流体供給手段と押圧バネとによる押圧力が、高圧流体回路内の流体圧による押圧力以上であり、
前記第2流体供給手段による押圧力が、前記押圧バネによる押圧力よりも大きいことを特徴とする高圧流体回路用蒸気滅菌自動オンオフバルブ。
A stepped piston having a large-diameter piston portion and a small-diameter piston portion formed thereon;
A stepped cylinder having a large diameter cylinder portion into which the large diameter piston portion of the stepped piston is slidably inserted and a small diameter cylinder portion into which the small diameter piston portion is slidably inserted;
Piston reciprocating means for reciprocating a stepped piston inserted into the stepped cylinder,
At the upper end of the small diameter cylinder portion, there is a communication hole communicating with a flow path from a high pressure fluid circuit of 100 to 245 MPa ,
When the stepped piston slides in the direction of the small-diameter piston portion, the communication hole is closed, and when the stepped piston slides in the direction of the large-diameter piston portion, a closing piece that opens the communication hole is the small-diameter piston. Formed on the part ,
The piston reciprocating means is
A pressing spring that presses the stepped piston toward the small-diameter piston portion;
First fluid supply means for supplying fluid to the lower cylinder space of the large-diameter piston portion in the large-diameter cylinder portion and pressing the stepped piston toward the small-diameter piston portion;
A second fluid supply means for supplying fluid to the upper cylinder space of the large-diameter piston portion in the large-diameter cylinder portion and pressing the stepped piston toward the large-diameter piston portion;
Switching means for switching between the first fluid supply means and the second fluid supply means,
The pressing force by the first fluid supply means and the pressing spring is not less than the pressing force by the fluid pressure in the high-pressure fluid circuit;
A steam sterilization automatic on / off valve for a high-pressure fluid circuit , wherein the pressing force by the second fluid supply means is larger than the pressing force by the pressing spring .
請求項1に記載の高圧流体回路用蒸気滅菌自動オンオフバルブを用いた滅菌装置であって、
原料を100〜245MPaで加圧する増圧機と、
前記原料を投入するための供給口から前記増圧機のハウジング内部へ原料を供給する第1流路と、
前記増圧機のハウジング内部から加圧された原料が流通する第2流路と、
前記第1流路、第2流路又は前記ハウジング内部に蒸気を吹き込む蒸気供給装置と、
前記第2流路又は前記増圧機のハウジング内部に接続され、蒸気の排出量を調整する前記蒸気滅菌自動オンオフバルブ装置とを備えたことを特徴とする滅菌装置。
A sterilization apparatus using the steam sterilization automatic on / off valve for high-pressure fluid circuit according to claim 1 ,
A pressure intensifier that pressurizes the raw material at 100 to 245 MPa ;
A first flow path for supplying the raw material from the supply port for charging the raw material to the inside of the housing of the pressure intensifier;
A second flow path through which pressurized raw material flows from inside the housing of the pressure intensifier;
A steam supply device for blowing steam into the first flow path, the second flow path or the housing;
A sterilization apparatus comprising: the steam sterilization automatic on / off valve device which is connected to the second flow path or the inside of the pressure intensifier housing and adjusts a discharge amount of steam.
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