WO2013175834A1 - Procédé de stérilisation à la vapeur à haute pression et outil médical stérilisé - Google Patents

Procédé de stérilisation à la vapeur à haute pression et outil médical stérilisé Download PDF

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Publication number
WO2013175834A1
WO2013175834A1 PCT/JP2013/057137 JP2013057137W WO2013175834A1 WO 2013175834 A1 WO2013175834 A1 WO 2013175834A1 JP 2013057137 W JP2013057137 W JP 2013057137W WO 2013175834 A1 WO2013175834 A1 WO 2013175834A1
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pressure steam
sterilization
sterilized
packaging material
article
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PCT/JP2013/057137
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English (en)
Japanese (ja)
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伸夫 須藤
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株式会社大協精工
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/12—Sterilising contents prior to, or during, packaging
    • B65B55/14—Sterilising contents prior to, or during, packaging by heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics

Definitions

  • the present invention relates to a high-pressure steam sterilization method for sterilizing medical supplies such as rubber stoppers, syringe pistons, vials, syringe barrels (syringe barrels), and a sterilized medical product obtained by the high-pressure steam sterilization method. Is.
  • High-pressure steam sterilization is a method of sterilizing a subject to be sterilized by exposing it to a high-temperature, high-pressure steam atmosphere (for example, 121 ° C., 20 minutes).
  • a high-temperature, high-pressure steam atmosphere for example, 121 ° C., 20 minutes.
  • biopolymers constituting microorganisms are likely to be decomposed, which is mild compared to dry heat sterilization (for example, 180 ° C., 30 minutes or 160 ° C., 1 hour).
  • a high sterilization effect can be obtained. Therefore, it is suitable for sterilization of plastic and rubber medical products which are inferior in heat resistance compared to metal and glass.
  • there is an advantage that the process is simple as compared with other sterilization methods such as radiation sterilization (electron beam irradiation, etc.) and gas sterilization (EOG ⁇ ethylene oxide gas>, hydrogen peroxide gas, etc.).
  • a medical article to be sterilized is enclosed in a microbially impermeable packaging material (for example, a sterilization bag) having at least a part of a water vapor permeable portion to form a package.
  • a sterilization method has been performed in which high-temperature and high-pressure steam is introduced from the water-vapor-permeable portion of the packaging material into the package to sterilize the object to be sterilized. According to such a method, it is possible to obtain a package in which a sterilized article is enclosed in a microorganism-impermeable packaging material. Therefore, it can be delivered while maintaining the sterilized state, which is preferable from the viewpoint of quality assurance.
  • a pressure vessel that houses and holds an object to be sterilized
  • a heater that is disposed in the pressure vessel
  • an air supply mechanism that supplies a sterilized air flow to the heater to spray the air flow.
  • a far-infrared heater is provided to supply dry air, and the far-infrared heater is operated.
  • An autoclave device configured to dry a sterilized article is disclosed (see Patent Document 2).
  • the high-pressure steam sterilization apparatus described in Patent Document 1 is devised to improve drying efficiency by heating with a heater and feeding a heated air flow.
  • the autoclave device described in Patent Document 2 is devised to improve the drying efficiency by operating a far-infrared heater in addition to supplying dry air.
  • Patent Document 1 or 2 has a problem that it takes a considerable amount of time and energy to remove the moisture and dry the sterilized article because water having a large specific heat is converted into water vapor again. there were.
  • high-pressure steam sterilization is performed in the state of the package as described above, it is difficult to remove moisture condensed inside the package, and the above problem is remarkable.
  • the present invention has been made to solve the problems of the prior art. That is, the present invention provides a high-pressure steam sterilization method and a high-pressure steam sterilization method that can obtain a sterilized article effectively prevented from adhering moisture or solid foreign matter in a short time without requiring a large amount of energy. A sterilized medical product obtained by the method is provided.
  • the present inventor preliminarily heated the sterilization target before performing high-pressure steam sterilization, and by raising the temperature of the sterilization target in advance, high-temperature and high-pressure steam is sterilized.
  • the present invention has been completed by conceiving that it is difficult for water to condense even when in contact with the object, and that it is possible to effectively prevent moisture from adhering to the object to be sterilized.
  • a high-pressure steam sterilization method for obtaining a sterilized article by subjecting a medical article to be sterilized and exposing the sterilization target to a high-temperature / high-pressure steam atmosphere to perform high-pressure steam sterilization.
  • the sterilization target is enclosed in a microorganism-impermeable packaging material having a water vapor permeable part in the part to form a package, and before the sterilization target is exposed to high temperature and high pressure steam, the sterilization target is Pre-heated to 50 to 110 ° C., and then introduced high-temperature and high-pressure steam into the package from the steam-permeable portion of the packaging material, and sterilized the object to be sterilized by high-pressure steam sterilization.
  • a high-pressure steam sterilization method characterized by obtaining a package enclosed in a microorganism-impermeable packaging material.
  • the sterilization target in a water vapor atmosphere having a saturated water vapor amount or less at the preheating temperature.
  • the sterilization target it is preferable to preheat the sterilization target while repeatedly increasing and decreasing the atmospheric pressure in the pressurized atmosphere. Furthermore, in the present invention, it is preferable that the sterilization target is subjected to high-pressure steam sterilization to obtain the sterilized article, and then dried under reduced pressure while the sterilized article is sealed in the packaging material.
  • the packaging material it is preferable to use, as the packaging material, at least a part having a transparent part that allows the inside of the package to be visually recognized. Furthermore, in this invention, it is preferable to use what the said water-vapor-permeation part is comprised with the nonwoven fabric sheet as said packaging material.
  • a sterilized medical article obtained by the high-pressure steam sterilization method is provided.
  • the high-pressure steam sterilization method of the present invention it is possible to obtain a sterilized article in which adhesion of moisture and solid foreign matter is effectively prevented in a short time without requiring a great deal of energy.
  • High-pressure steam sterilization method is a sterilization method for sterilizing medical supplies.
  • the target of sterilization refers to an article to be sterilized and refers to a medical product before sterilization.
  • Medical supplies means machines, instruments, devices, containers and parts thereof used in medical applications. For example, syringes, cartridges, vials, prefillable syringes, screw vials, bulk containers, piston parts used in these, rubber parts such as nozzle caps, rubber stoppers, packings, and syringe barrels, plunger rods, vials, rubber stoppers Examples thereof include resin parts such as fixing caps, resin caps including rubber plugs, and the like.
  • the sterilization target is enclosed in a microorganism-impermeable packaging material having a water vapor permeable portion at least in part to form a package.
  • Packaging material means a packaging material for enclosing a sterilization target inside to form a package.
  • the packaging material is made of a heat-resistant material that can withstand the conditions of high-pressure steam sterilization (eg, 121 ° C., 20 minutes).
  • the packaging material needs to be made of a microorganism-impermeable material. Thereby, it becomes possible to maintain the sterilized state of the sterilized article.
  • the “microorganism impermeable” is sufficient if it is a level of the microorganism impermeability possessed by a commercially available sterile packaging material (such as a sterilization bag). Therefore, the level of microbial permeability may be appropriately selected from commercially available sterile packaging materials according to the purpose. More specifically, a material having a bacterial barrier property measured in accordance with ASTM 1608 of 3.0 to 5.5 is preferable, a material of 3.2 to 5.2 is more preferable, and a material of 5.2 is preferable. Is particularly preferred.
  • the packaging material needs to have a water vapor transmission part at least in part.
  • high-temperature and high-pressure steam can be introduced into the package, and the object to be sterilized can be sterilized with high-pressure steam in the state of the package.
  • the level of water vapor permeability can be appropriately selected according to the purpose.
  • the material is preferably moisture permeability measured is 1500 ⁇ 1640g / m 2/24 hours at 85% relative humidity conditions, the material is 1615g / m 2/24 hours Further preferred.
  • nonwoven fabric sheet a high density nonwoven fabric sheet, more specifically, a high density polyethylene nonwoven fabric sheet in which polyethylene ultrafine fibers having a fiber diameter of 0.5 to 10 ⁇ m are randomly laminated and bonded only by heat and pressure (for example, a trade name “Tyvek” (manufactured by DuPont) and the like can be suitably used.
  • the high-density polyethylene nonwoven fabric sheet has a bacterial barrier property measured in accordance with ASTM 1608 of 3.2 to 5.2, and has a microorganism impermeability. Moreover, the said high density polyethylene nonwoven fabric sheet shows 98% or more of protection with respect to the dust of 0.5 micrometer or more. Bacteria having a size of 1 to several ⁇ m are considered to be the smallest microorganism, and it can be said that the high-density polyethylene nonwoven fabric sheet has a microorganism impermeability.
  • the high-density polyethylene nonwoven sheet in compliance with the TAPPI T523, 23 ° C., the moisture permeability measured at 85% relative humidity conditions is not less 1500g / m 2/24 hours or more, excellent water vapor permeability.
  • the transparency level is sufficient if the transparency level of a commercially available transparent resin film is sufficient. Therefore, the level of transparency may be appropriately selected from commercially available transparent resin films and the like according to the purpose. For example, a material having a total light transmittance of 5 to 100% measured according to JIS K 7375 can be suitably used.
  • a transparent polyethylene film for example, trade name “ultra-high molecular weight polyethylene film No. 440” ⁇ manufactured by Nitto Denko Corporation>, etc.
  • a transparent polyethylene film for example, trade name “ultra-high molecular weight polyethylene film No. 440” ⁇ manufactured by Nitto Denko Corporation>, etc.
  • the polyethylene film is a polyethylene film having a thickness of 50 to 100 ⁇ m, a heat resistant temperature of 136 ° C., and a total light transmittance of 5 to 100% measured in accordance with JIS K 7375. Therefore, it has heat resistance, microbial impermeability and transparency.
  • the transparent resin film is preferably a multi-layer film, and more preferably a 2- to 5-layer multi-layer film, in order to ensure microbial permeability even if there is a pinhole.
  • “At least part of” the water vapor permeable portion and the transparent portion means that the entire packaging material may not have water vapor permeability or transparency.
  • the packaging material is partially formed with a water vapor permeable part and a transparent part within a range where high pressure steam sterilization can be performed on the sterilization target enclosed in the packaging material, and within a range where the inside of the package can be visually confirmed. do it.
  • a packaging material in which all of the packaging material is a water vapor transmission part is also included in the scope of the present invention.
  • the water vapor permeable portion and the transparent portion need to have microbial impermeability as a matter of course.
  • the water vapor permeable portion is constituted by a nonwoven fabric sheet.
  • a packaging material examples include a sterilization bag in which a nonwoven fabric sheet constituting a water vapor transmission part and a transparent resin film constituting a transparent part are combined.
  • a sterilization bag in which the high-density polyethylene non-woven sheet and the polyethylene film are combined for example, a trade name “Cleantex bag” ⁇ manufactured by AMCO> can be exemplified.
  • the vial tray etc. by which the nonwoven fabric sheet was stuck to the upper opening part can also be used.
  • the package is formed by enclosing a sterilization target inside the packaging material.
  • the seal at the time of sealing is not particularly limited as long as it is a seal having microbial impermeability.
  • a sealing method such as an adhesive seal or a welding seal can be employed.
  • Preheating In the present invention, as shown in the process diagram of FIG. 1, after a package is formed from a sterilization target and a packaging material, the sterilization target is preliminarily kept at 50 to 110 ° C. before being exposed to high-temperature and high-pressure steam. Heat.
  • the present invention is not based on the idea of removing once condensed water as water vapor, but intends to obtain the above effect by reducing the amount of condensed water as much as possible.
  • the sterilization target is preheated without high temperature and high pressure inside the package. Introduce steam.
  • the temperature of the steam rapidly decreases and a large amount of condensed water is generated. Therefore, even if the heated air stream is sent or the far infrared heater is operated to improve the drying efficiency, it takes a considerable amount of time and energy to remove the condensed water as steam again. .
  • it heat-drys for a long time in the state which water adhered a structural component tends to elute from the sterilization object, and adhesion of a solid foreign material tends to generate
  • the effect is obtained by preheating the object to be sterilized to 50 ° C. or higher. By preheating at 110 ° C. or lower, deterioration due to heat of the sterilization target can be prevented.
  • the preheating temperature is preferably 60 to 110 ° C., and more preferably 65 to 90 ° C.
  • the sterilization target in a water vapor atmosphere having a saturated water vapor amount or less at the preheating temperature.
  • a water vapor atmosphere having a saturated water vapor amount or less By performing preheating using water vapor having a large specific heat, it is possible to raise the temperature of the sterilization target in a short time, thereby shortening the preheating time and reducing the energy cost.
  • the package is heated in a water vapor atmosphere with a saturated water vapor amount or less, condensation of water on the surface to be sterilized can be prevented.
  • the temperature increase is divided into several steps, and the temperature of the preheating and the amount of water vapor are stepped so as to be equal to or less than the amount of water vapor saturated at the lowest temperature to be sterilized for each step.
  • a method of increasing the amount of water vapor in accordance with the temperature of the sterilization target assumed from the temperature rising process It is preferable to adopt.
  • the sterilization target it is preferable to preheat the sterilization target in a pressurized atmosphere.
  • This pressurization can be controlled by a mechanism different from the supply and heating of water vapor. For example, after supplying water vapor, the temperature can be controlled by a heater, and the air pressure can be controlled by a compressor or the like.
  • the present invention it is preferable to preheat the sterilization target while repeatedly increasing and decreasing the pressure in the pressurized atmosphere. According to such a method, the effect that water vapor enters and exits the inside of the package and the preheating of the sterilization target is promoted can be obtained.
  • the pattern of increase or decrease of the atmospheric pressure There is no particular limitation on the pattern of increase or decrease of the atmospheric pressure. For example, a method of preheating the sterilization target in a pattern in which the pressure is increased to 150 to 300 kPa and the operation of lowering the pressure (100 to 250 kPa) is repeated a plurality of times.
  • a sterilized article is obtained by exposing the object to be sterilized to a high-temperature and high-pressure steam atmosphere and performing high-pressure steam sterilization. Specifically, after the preliminary heating, high-temperature and high-pressure steam is introduced into the package from the steam-permeable portion of the packaging material, and the sterilization target is subjected to high-pressure steam sterilization. Thereby, the package in which the sterilized article is enclosed in the inside of the packaging material impermeable to microorganisms can be obtained.
  • High-pressure steam sterilization can be performed according to a conventionally known method, for example, by the following method.
  • a pressure vessel such as an autoclave with water and a package fixed to a special basket.
  • Heating is performed with the pressure vessel lid fixed and the upper exhaust port open.
  • Water vapor is ejected from the exhaust port, and the exhaust port is closed in a state where the pressure vessel is filled with water vapor, and heating is performed for a predetermined time while controlling the temperature and pressure.
  • the inside of the pressure vessel is cooled, and the sterilization target is taken out.
  • the conditions for high-pressure steam sterilization are not particularly limited. For example, it can be performed in a saturated steam atmosphere. More specifically, it can be performed in a saturated water vapor atmosphere at 121 ° C. for 20 minutes.
  • the sterilization target is subjected to high-pressure steam sterilization to obtain the sterilized article, and then dried under reduced pressure while the sterilized article is sealed in the packaging material.
  • high-pressure steam sterilization to obtain the sterilized article
  • reduced pressure to reduce the amount of condensed water, and drying under reduced pressure
  • moisture can be removed more reliably.
  • the drying is performed under reduced pressure
  • the sterilized article can be dried in a short time without setting the drying temperature to a high temperature. According to the vacuum drying, the sterilized article is not exposed to a high temperature for a long time in the presence of condensed water, and the components to be sterilized are not easily eluted. Accordingly, it is possible to effectively prevent the solid matter from adhering to the sterilization target.
  • the conditions for drying under reduced pressure are not particularly limited.
  • a method of drying under non-heating conditions under reduced pressure conditions of 10 to 50 kPa can be employed.
  • a method of drying without heating from the conditions of high-pressure steam sterilization or cooling to 40 to 50 ° C. can be mentioned.
  • atmospheric pressure about 100 kPa
  • water vapor inside the package can be efficiently discharged, and drying can be performed together with cooling of the sterilizer. Therefore, the work time of the whole sterilization process can be shortened.
  • the pressure reduction is preferably performed by repeating the atmospheric pressure and pressure reduction about 2 to 5 times, since the efficiency is further improved.
  • a drying method other than drying under reduced pressure can be employed. What is necessary is just to select suitably from the conventionally well-known drying methods according to the characteristic of sterilization object, such as heat drying, hot air drying, and drying with an infrared heater, for example.
  • the medical product of the present invention is a sterilized medical product obtained by the high-pressure steam sterilization method.
  • the medical article is a package enclosed in a microorganism-impermeable packaging material. Therefore, it is not necessary for a user (medical institution, pharmaceutical manufacturer, etc.) to perform cleaning, drying, and sterilization, and the user can unpack and use it immediately.
  • the effect of reducing condensed water by preheating was evaluated.
  • a package was formed.
  • the packaging uses a sterilization bag (trade name “Cleantex bag” ⁇ Amco>) as the packaging material, and a rubber plug (product name “20 mL Piston” ⁇ made by Daikyo Seiko>) as the sterilization target. It was.
  • the packaging material sterilization bag has a transparent portion on one side of the bag.
  • the transparent portion is made of a transparent resin film made of polyethylene (trade name “ultra high molecular weight polyethylene film No. 440” ⁇ manufactured by Nitto Denko Corporation>).
  • the thickness of this transparent resin film was 60 ⁇ m, the heat resistant temperature was 136 ° C., and the total light transmittance measured in accordance with JIS K 7375 was 40%.
  • the other surface of the bag body is a water vapor permeable portion.
  • the water vapor transmission part is made of a high-density polyethylene nonwoven fabric sheet (trade name “Tyvek 1073B” ⁇ DuPont>) in which polyethylene ultrafine fibers having a fiber diameter of 0.5 to 10 ⁇ m are randomly laminated and bonded only by heat and pressure. It is configured.
  • the bacterial barrier property of this high-density polyethylene non-woven sheet measured according to ASTM 1608 was 5.2. Further, in conformity with TAPPI T523, 23 ° C., the moisture permeability measured at 85% relative humidity conditions was 1615g / m 2/24 hours.
  • the opening of the packaging material was sealed by heat sealing, whereby the sterilization object was sealed inside the packaging material to form a package.
  • a temperature sensor was attached to the center position of many filled sterilization objects inside the packaging material. The total mass in this state was 4130 g.
  • the package 1 was preheated at a target temperature of 20 ° C. During the preheating, the temperature of the sterilization target was 23 ° C. Preheating was performed at the temperature for 120 minutes. More specifically, preheating was performed by a method of repeating the operation of pressurizing to 250 kPa (pressurized state) and reducing the pressure to 150 kPa three times under the above temperature condition. The maximum amount of water vapor was 16.5 g / m 3 or less so that no condensation occurred on the sterilized object.
  • Comparative Example 2 Preheating was performed at a target temperature of 40 ° C., and preheating and high-pressure steam sterilization were performed in the same manner as in Comparative Example 1 except that the maximum water vapor amount was 45.0 g / m 3 or less (no drying step) ). During the preheating, the temperature of the object to be sterilized was 46 ° C. In the case where there was no drying step, the amount of condensed water calculated by subtracting the total mass before sterilization was 116 g from the total mass after sterilization.
  • Example 1 Preheating was performed at a target temperature of 60 ° C., and preheating and high-pressure steam sterilization were performed in the same manner as in Comparative Example 1 except that the maximum water vapor amount was 125.0 g / m 3 or less (no drying step) ). During the preheating, the temperature of the sterilization target was 67 ° C. In the case of no drying step, the amount of condensed water calculated by subtracting the total mass before sterilization from the total mass after sterilization was 25 g.
  • Example 1 Furthermore, a method of performing the same drying process as in Comparative Example 1 was also attempted (there is a drying process).
  • the amount of condensed water with a drying step was 16 g.
  • Example 1 when the amount of condensed water was measured in the pattern without the drying process and with the drying process, the condensed water could not be visually observed on the surface of the sterilized article. However, it was completely dried by the same method as in Comparative Example 1. Thereafter, the number of sterilized articles having solid foreign substances attached to the surface was confirmed. As a result, when there was no drying process, there was no sterilized article to which solid foreign matter adhered even when there was a drying process. The results are shown in Table 1.
  • Example 2 Preheating was performed at a target temperature of 80 ° C., and preheating and high-pressure steam sterilization were performed in the same manner as in Comparative Example 1 except that the maximum water vapor amount was 280.0 g / m 3 or less (no drying step) ).
  • the temperature of the object to be sterilized was 86 ° C.
  • the amount of condensed water calculated by subtracting the total mass before sterilization from the total mass after sterilization was 23 g.
  • Example 2 Furthermore, a method of performing the same drying process as in Comparative Example 1 was also attempted (there is a drying process).
  • the amount of condensed water in the presence of the drying step was 15 g.
  • Example 2 when the amount of condensed water was measured in the pattern without the drying process and with the drying process, the condensed water could not be visually observed on the surface of the sterilized article. However, it was completely dried by the same method as in Comparative Example 1. Thereafter, the number of sterilized articles having solid foreign substances attached to the surface was confirmed. As a result, when there was no drying process, there was no sterilized article to which solid foreign matter adhered even when there was a drying process. The results are shown in Table 1.
  • Example 3 Preheating was performed at a target temperature of 100 ° C., and preheating and high-pressure steam sterilization were performed in the same manner as in Comparative Example 1 except that the maximum water vapor amount was 580.0 g / m 3 or less (no drying step) ). During the preheating, the temperature of the sterilization target was 105 ° C. In the case without the drying step, the amount of condensed water calculated by subtracting the total mass before sterilization from the total mass after sterilization was 21 g.
  • Example 3 when the amount of condensed water was measured in the pattern without drying process and with drying process, the condensed water could not be visually observed on the surface of the sterilized article. However, it was completely dried by the same method as in Comparative Example 1. Thereafter, the number of sterilized articles having solid foreign substances attached to the surface was confirmed. As a result, when there was no drying process, there was no sterilized article to which solid foreign matter adhered even when there was a drying process. The results are shown in Table 1.
  • Comparative Example 3 Preheating was performed at a target temperature of 115 ° C., and preheating and high-pressure steam sterilization were performed in the same manner as in Comparative Example 1 except that the maximum water vapor amount was 800.0 g / m 3 or less (no drying step) ). During the preheating, the temperature of the object to be sterilized was 118 ° C. In the case without the drying step, the amount of condensed water calculated by subtracting the total mass before sterilization from the total mass after sterilization was 20 g.
  • the high-pressure steam sterilization method of the present invention can obtain a sterilized article in which moisture adhesion and solid foreign matter adhesion are effectively prevented in a short time without requiring a great deal of energy. Therefore, it can be suitably used as a method for sterilizing medical supplies.

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  • Mechanical Engineering (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un procédé de stérilisation à la vapeur à haute pression qui permet d'obtenir un article stérilisé qui peut empêcher efficacement l'humidité ou un corps étranger solide d'adhérer à celui-ci dans un court délai sans nécessiter beaucoup d'énergie. L'invention concerne un procédé de stérilisation à la vapeur à haute pression pour obtenir un article stérilisé en exposant un article à stériliser à un environnement de vapeur ayant une température élevée et une pression élevée pour obtenir la stérilisation à la vapeur à haute pression de l'article, un outil médical étant utilisé en tant qu'article à stériliser. Un procédé de stérilisation à la vapeur à haute pression est caractérisé en ce qu'un article à stériliser est emballé à l'intérieur d'un matériau d'emballage imperméable aux microorganismes, ayant une partie perméable à la vapeur en tant qu'au moins une partie du matériau d'emballage pour former un corps emballé, l'article est préchauffé de 50 à 110°C avant l'exposition de l'article à la vapeur ayant une température élevée et une pression élevée, et la vapeur ayant une température élevée et une pression élevée est ensuite introduite à l'intérieur du corps emballé à travers la partie perméable à la vapeur du matériau d'emballage pour obtenir la stérilisation à la vapeur à haute pression de l'article, ce qui permet ainsi d'obtenir le corps emballé composé du matériau d'emballage imperméable aux microorganismes et l'article stérilisé emballé à l'intérieur du matériau d'emballage.
PCT/JP2013/057137 2012-05-22 2013-03-14 Procédé de stérilisation à la vapeur à haute pression et outil médical stérilisé WO2013175834A1 (fr)

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JP2017093861A (ja) * 2015-11-25 2017-06-01 株式会社細川洋行 滅菌済み医療用複室容器の製造方法
JP7291924B2 (ja) * 2017-11-21 2023-06-16 株式会社大協精工 医療用機器類の製造工場

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