WO2021044775A1 - Procédé de préparation d'agent injectable stérile contenant du teriparatide ou un sel de ce dernier - Google Patents

Procédé de préparation d'agent injectable stérile contenant du teriparatide ou un sel de ce dernier Download PDF

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Publication number
WO2021044775A1
WO2021044775A1 PCT/JP2020/029435 JP2020029435W WO2021044775A1 WO 2021044775 A1 WO2021044775 A1 WO 2021044775A1 JP 2020029435 W JP2020029435 W JP 2020029435W WO 2021044775 A1 WO2021044775 A1 WO 2021044775A1
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WO
WIPO (PCT)
Prior art keywords
injection
sterile
package
teriparatide
salt
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PCT/JP2020/029435
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English (en)
Japanese (ja)
Inventor
保宏 松縄
健次 成瀬
成実 岡
卓治 前島
Original Assignee
旭化成ファーマ株式会社
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Application filed by 旭化成ファーマ株式会社 filed Critical 旭化成ファーマ株式会社
Priority to JP2020544311A priority Critical patent/JP7240407B2/ja
Publication of WO2021044775A1 publication Critical patent/WO2021044775A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis

Definitions

  • the present invention relates to a method for producing a sterile injection containing teriparatide or a salt thereof.
  • Non-Patent Document 1 There are two methods for manufacturing sterile drugs, the final sterilization method and the aseptic technique.
  • the former is a method of filling the final container with the drug and then sterilizing it, and the latter is a technique used for drugs to which the final sterilization method is not applied. It has been reported that this method is used for producing a sterile drug after filtration sterilization or by a series of aseptic steps from the raw material stage (Non-Patent Document 1).
  • Non-Patent Document 2 As a device or system having an aseptic operation area in the production of aseptic medicine by an aseptic operation method, an isolator and an access restricted barrier system (RABS: Restricted Access Barrier System) are known (Non-Patent Document 3).
  • RABS Restricted Access Barrier System
  • Non-Patent Document 4 a system that physically isolates the worker, eliminates the risk of introducing contamination from the air, and prevents the introduction of non-sterile substances into the isolator. It has been reported that in order to maintain the sterility of the isolator, everything brought inside must be sterilized (Non-Patent Document 5).
  • An example is also disclosed in which the filling and winding steps are carried out in an isolator in a grade A environment, and the inspection and packaging steps are carried out in a grade D environment (Non-Patent Document 5).
  • Patent Document 1 erythropoietin, granular colony stimulating factor, insulin, monoclonal antibody, and other protein preparations are liquefied and contained in a container such as a syringe have been widely used.
  • VHP hydrogen peroxide vapor
  • Non-Patent Documents 7 to 8 a therapeutic agent for osteoporosis containing teriparatide or an acetate thereof as an active ingredient is on the market (Non-Patent Documents 7 to 8), and a method for producing a freeze-dried preparation containing PTH has also been reported (Patent Document 4).
  • An object of the present invention is to provide a method for producing a sterile injection containing teriparatide or a salt thereof by an aseptic technique, such as a method for producing a sterile injection having high quality and excellent storage stability.
  • the present invention relates to the following [1] to [7].
  • [1] A method for producing a sterile injection containing teriparatide or a salt thereof by an aseptic technique, which is a step of carrying a package containing an injection container containing no drug into an apparatus or system having a sterile operating area.
  • a method for producing a sterile injection which comprises a step of decontaminating the outer surface of the package with hydrogen peroxide or alcohol before the delivery.
  • a method for producing a sterile injection containing teriparatide or a salt thereof by an aseptic technique which is a step of decontaminating the outer surface of a package containing an injection container containing no drug with hydrogen peroxide or alcohol.
  • a method for producing a sterile injection which comprises a step of bringing the package obtained in the decontamination step into an apparatus or system having a sterile operating area.
  • a method for stabilizing a sterile injection containing teriparatide or a salt thereof as an active ingredient in which the outer surface of a package containing an injection container containing no chemical solution containing the active ingredient is removed with hydrogen peroxide or alcohol.
  • an aseptic operation method including a step of dyeing, a step of carrying the package obtained in the decontamination step into an apparatus or system having an aseptic operation area, and a step of aseptically filling the injection container with the drug solution.
  • a method for stabilizing a sterile injection which comprises producing a sterile injection.
  • a method for stabilizing the active ingredient during storage of a sterile injection containing teriparatide or a salt thereof as an active ingredient in which the outer surface of a package containing an injection container containing no chemical solution containing the active ingredient is peroxidized.
  • Sterility including a step of decontaminating with hydrogen or alcohol, a step of bringing the package obtained in the decontamination step into an apparatus or system having an aseptic operation area, and a step of aseptically filling the injection container with the drug solution.
  • a method for stabilizing an active ingredient during storage of a sterile injection which comprises producing a sterile injection by a manufacturing method according to an operation method.
  • a method for suppressing oxidation and / or cleavage of an active ingredient during storage of a sterile injection which comprises producing a sterile injection by a manufacturing method according to a sterile operation method including a filling step.
  • a method for producing a sterile injection containing teriparatide or a salt thereof by an aseptic technique such as a method for producing a sterile injection having high quality and excellent storage stability.
  • a method for stabilizing an aseptic injection containing teriparatide or a salt thereof as an active ingredient a method for stabilizing the active ingredient during storage of the sterile injection, and an active ingredient during storage of the sterile injection.
  • a method of suppressing the oxidation and / or cleavage of Teriparatide can also be provided.
  • the production method of the present invention is a method for producing a sterile injection containing teriparatide or a salt thereof by an aseptic technique, which is a package containing an injection container containing no drug, and the outer surface thereof is excessive.
  • the step of carrying the decontaminated product with hydrogen oxide or alcohol into an apparatus or system having a sterile operation area is included.
  • the aseptic technique is a technique used for drugs that do not apply the final sterilization method, which is a method of filling a drug into a final container (the container that the drug finally uses) and then sterilizing it. It means a method used for producing a sterile drug after sterilization or by a series of aseptic steps from the raw material stage (Non-Patent Documents 1 and 6). In general, it is preferable to apply the final sterilization method to a drug that has high heat resistance and is stable in a solution state, and for a drug solution with low heat resistance or a drug that is not stable in a solution state. It is preferably manufactured by applying an aseptic technique.
  • the teriparatide solution is not always sufficiently stable, it is preferably produced by applying an aseptic technique.
  • the sterile drug itself is generally known and can be easily understood (Non-Patent Documents 2 to 6).
  • injections sterile injections
  • eye drops eye ointments and the like, which are administered for the purpose of treating / preventing / diagnosing mammals including humans, can be exemplified.
  • the production method of the present invention relates to a method for producing a sterile injection among sterile pharmaceutical products obtained by an aseptic technique.
  • sterilization means killing or removing microorganisms of an object to the extent that the purpose of sterilization is achieved.
  • sterilization means "a state in which all kinds of microorganisms are killed or removed, and there are no viable microorganisms in the target substance".
  • the sterilization method can generally be carried out by considering the appropriate selection of the method and the optimization of the operation method and conditions according to the type of microorganism, the state of contamination, and the nature and condition of the sterilized substance.
  • teriparatide means a free human PTH (1-34).
  • Human PTH (1-34) is a partial amino acid sequence consisting of the first to 34th amino acid residues when viewed from the N-terminal side in the amino acid sequence of human PTH (1-84), which is a human parathyroid hormone. The peptide shown.
  • Teriparatide can also be in the form of salt.
  • the teriparatide salt include any salt formed by teriparatide and one or more volatile organic acids.
  • the ratio of teriparatide and the volatile organic acid to form a salt is not particularly limited as long as the salt is formed.
  • Acetic acid is preferable as the volatile organic acid. That is, as the salt of teriparatide in the production method of the present invention, teriparatide acetate can be preferably exemplified.
  • the amount of teriparatide or a salt thereof contained in the sterile injection is not particularly limited, but the following can be preferably exemplified. That is, the lower limit is preferably 20 ⁇ g or more, more preferably 25 ⁇ g or more, 27 ⁇ g or more, and further preferably 28 ⁇ g or more.
  • the upper limit is preferably 50 ⁇ g or less, more preferably 40 ⁇ g or less, 35 ⁇ g or less, 30 ⁇ g or less, and further preferably 29 ⁇ g or less. Above all, it is preferably 28.2 ⁇ g or 29.2 ⁇ g.
  • the amount of teriparatide salt is a teriparatide equivalent amount. For example, when the amount of teriparatide pentaacetate is 30.3 ⁇ g or 31.3 ⁇ g, the teriparatide equivalent amount is 28.2 ⁇ g or 29.2 ⁇ g.
  • the injection container is not particularly limited as long as it is a medical container for containing a drug for injection, and for example, an ampoule, a syringe (injection cylinder), a cartridge used for a pen-type injector, and the like. Examples include vials, bottles, and bags.
  • the material of the injection container is not particularly limited, and may be made of glass or plastic. However, since the glass injection container is heavy and easily damaged, a plastic injection container is preferable as the injection container in the production method of the present invention, and a plastic syringe is more preferable.
  • the plastic material is not particularly limited, and examples thereof include polypropylene, polyethylene, cyclic olefin-based polymers, polyvinyl chloride, polyester, polyamide, polycarbonate, and polymethacrate.
  • the injection container must be sterilized when manufactured by an aseptic technique.
  • the method for sterilizing the container is not particularly limited, and examples thereof include high-pressure steam sterilization, dry heat sterilization, and radiation sterilization using gamma rays or electron beams.
  • the package is not particularly limited as long as it is a package for storing an injection container containing no drug, and is, for example, a package mainly composed of a tank portion and a lid portion. Therefore, all or part of the lid can be a package that can be easily opened by a peel-away procedure (Patent Document 3).
  • the material of the package is not particularly limited, and for example, a plastic resin can be used.
  • the state of the injection container housed in the package is not limited, but it is preferably in a sterilized state.
  • the storage method of the injection container in the package is not particularly limited, but it is preferable that the structure method is such that a plurality of injection containers stored in the package do not come into contact with each other during the transportation or filling process of the package, and the package has a multi-layer structure.
  • the injection containers may be stored in a plurality of stages, or the injection containers may be stored in a state of being arranged in a grid pattern. Examples of such a package include "sterilized glass syringe D2F (registered trademark)" and "sterilized packaging solution-D2F (registered trademark)” (manufactured by Nipro).
  • the exterior surface of the package used in the manufacturing method of the present invention is decontaminated.
  • the exterior of a package containing an injection container containing no drug is often contaminated by outside air or the like in the process of being transported to a manufacturing site for sterile injections.
  • it may be put in a sterilization bag or an outer bag and brought to the manufacturing site, but when it is brought into the aseptic operation area, it is packaged from the sterilization bag or the outer bag immediately before that. It is necessary to take out the bag, and the risk of contamination at that time cannot be denied.
  • the package is pre-packaged before being delivered to a device or system having an aseptic technique area existing at the manufacturing site. It is extremely important to decontaminate the exterior surface of the product.
  • the outer surface of the package is decontaminated with hydrogen peroxide or alcohol.
  • the sterile injection containing teriparatide or a salt thereof it has been newly found that, surprisingly, a sterile injection having high quality and excellent storage stability can be obtained by producing the sterile injection using such a package.
  • the package When decontaminating the exterior surface of a package with hydrogen peroxide or alcohol, it is preferable to decontaminate all exterior surfaces that may be contaminated.
  • the package is a box-like package composed of six parts, a bottom part, four wall parts, and a lid part, it is preferable to decontaminate each exterior surface of the six parts.
  • the method of decontaminating hydrogen peroxide is not particularly limited, but for example, a method of fumigation sterilization with hydrogen peroxide gas can be preferably mentioned.
  • hydrogen peroxide can be vaporized to an appropriate concentration (eg, about 10 to 1000 ppm) around the package, and the exterior of the package can be decontaminated under hydrogen peroxide gas. It is generally understood that killing microorganisms by oxidative action is the main mechanism of action of hydrogen peroxide decontamination.
  • the method of alcohol decontamination is also not particularly limited, but for example, 50 to 90% concentration of isopropanol or ethanol can be sprayed or vaporized around the package to decontaminate the package exterior, and 50 to 90% concentration of isopropanol or the like can be used. You can also wipe all sides of the package exterior with a cloth moistened with ethanol. It is generally understood that killing microorganisms by denaturing proteins and nucleic acids is the main mechanism of action of alcohol decontamination.
  • decontamination means removing living microorganisms by a reproducible method or reducing them to a level specified in advance (Non-Patent Document 3). In practice, it may be possible to ensure a reduction of 4-6 logs of spores that are highly resistant to the applied decontamination agent.
  • the aseptic operation area means "highly advanced air, raw materials and materials, structural equipment and staff to be supplied in order to control microorganisms and fine particles below an allowable level. It means "managed environment”.
  • the aseptic technique area can be further divided into an important area and a direct support area (Non-Patent Document 3).
  • the important area is the area where the air cleaning level is grade A (ISO 5), and the manufacturing process such as aseptic work (sterile connection, addition of sterile raw materials), aseptic filling, container closure and tapping before filling with chemicals. Is preferably performed in important areas.
  • the direct support area is an area where the air cleanliness level is grade B (ISO7) and is the background area of the important area.
  • Non-Patent Document 3 As an apparatus or system having an aseptic operation area, for example, an isolator and an access restricted barrier system (RABS: Restricted Access Barrier System) are known (Non-Patent Document 3).
  • RABS Restricted Access Barrier System
  • the sterile injection according to the production method of the present invention may be filled with various components such as inorganic salts / organic salts, buffers, and additives.
  • Such components include, for example, disaccharides (eg, sucrose), inorganic salts such as hydrochlorides or sodium salts (eg, sodium chloride), neutral amino acids (eg, L-methionine), and sugar alcohols (eg, sugar alcohols). : D-mannitol) can be mentioned.
  • the pH of the sterile injection is also not particularly limited, and for example, the range of 3 to 6 can be exemplified.
  • the manufacturing method of the present invention is not particularly limited as long as it includes a step of bringing a package containing an injection container containing no drug into an apparatus or system having an aseptic operation area, and the outer surface of the package is covered. It may further include a step of decontaminating with hydrogen peroxide or alcohol. That is, the production method of the present invention is a step of decontaminating the outer surface of a package containing an injection container containing no drug with hydrogen peroxide or alcohol, and an aseptic operation of the package obtained in the decontamination step. It may include a step of bringing it into a device or system having an area.
  • the sterile injection according to the production method of the present invention is not particularly limited as long as it is a liquid pharmaceutical preparation for injection.
  • the sterile injection according to the production method of the present invention for example, ampoule preparations, vial preparations, prefilled syringe preparations and the like in which a drug containing teriparatide or a salt thereof is enclosed or filled can be preferably mentioned.
  • the route of administration when administering (injecting) the sterile injection according to the production method of the present invention is not particularly limited, and examples thereof include intravenous administration, intramuscular administration, intradermal administration, and subcutaneous administration. Can be done.
  • the sterile injection according to the production method of the present invention is a high quality sterile injection.
  • high quality means that the analogs of teriparatide or a salt thereof contained in the manufactured sterile injection are reduced.
  • the analog of teriparatide or a salt thereof is not particularly limited, but means an octaoxide, an 18 oxide, an 8-18 oxide, a truncated product, or all of them.
  • the octaoxidant is an oxidant in which the 8th methionine residue from the N-terminal of teriparatide or its salt is methoxy
  • the 18-oxidant is the 18th methionine from the N-terminal of teriparatide or its salt.
  • the cleaved product is a partial peptide of teriparatide or a salt thereof, and examples thereof include a 1-30 cleaved product.
  • the 1-30 cleaved product consists of the 1st to 30th amino acid residues from the N-terminal of teriparatide. It means a peptide or a salt thereof.
  • the total amount of analogs (total amount of analogs) contained in the sterile injection according to the production method of the present invention at the time of production is preferably 1.5% or less, more preferably 1.2% or less, still more preferably 1. It is 0.0% or less, more preferably 0.9% or less, and the lower limit is not particularly limited, but can be 0.1% or more.
  • the amount of the cut body contained in the sterile injection during production is preferably 0.3% or less, more preferably 0.2% or less, still more preferably 0.1% or less, and most preferably 0.0%. Is. These numerical values are the area percentage of HPLC, that is, the ratio (%) when the total amount (total peak area) of teriparatide or a salt thereof and their related substances is 100.
  • the sterile injection according to the production method of the present invention is a sterile injection that can be stably stored after its production.
  • stable storage means that specific analogs do not increase or decrease when a sterile injection is stored. More specifically, for example, under storage conditions of 25 ° C. and 60% RH, stable storage is possible when the amount of 18 oxidants contained in the sterile injection does not substantially increase for several months. Can be seen as.
  • the storage conditions are the conditions in the accelerated test, and the storage conditions for the sterile injection according to the production method of the present invention can be premised on refrigerated storage.
  • the injection container used for manufacturing was a sterilized plastic syringe, and these were arranged and stored in a grid pattern in the package in a state where the drug was not filled. Since the package was transported and brought into the pharmaceutical manufacturing factory, the exterior surface of the package was decontaminated with hydrogen peroxide (Example 1) or alcohol (Example 2) in advance, and then carried into the isolator. did.
  • the decontamination conditions are as follows.
  • Hydrogen peroxide decontamination conditions Hydrogen peroxide is vaporized by dropping hydrogen peroxide on a heated iron plate, and the package containing the drug-unfilled syringe is vaporized into hydrogen peroxide. The exterior was decontaminated by exposure.
  • the sterile injections produced in Examples 1 and 2 and Comparative Example 1 were each subjected to an accelerated test, sampled over time, the stability was measured by high performance liquid chromatography, and the generated impurities were analyzed.
  • the specific conditions for each test are as follows.
  • Mobile phase B Dissolve 28.4 g of anhydrous sodium sulfate in 900 mL of water, add phosphoric acid to adjust the pH to 2.3, and then add water to make 1000 mL. Add 500 mL of acetonitrile to 500 mL of this solution. 5.
  • Mobile phase feed The concentration gradient is controlled by changing the mixing ratio of mobile phase A and mobile phase B as shown in Table 1 below. 6. Flow rate: 1.0 mL / min 7. Detection time: 45 minutes after injection of sample solution. However, it starts from behind the solvent peak.
  • Test results (impurity analysis) The test results are shown in Table 2 below. The numerical values in the table indicate the ratio (%) when the total amount of teriparatide and its related substances contained in the prescription is 100. "0M” means immediately before the accelerated test (immediately after manufacturing), “1M” means one month after the start of the accelerated test, and “3M” means three months after the start of the accelerated test.
  • Hydrogen peroxide (%) means the content (%) of each analog in the sterile injection obtained by decontaminating the package with hydrogen peroxide.
  • Alcohol (%) means the content (%) of each analog in a sterile injection obtained after decontaminating the package with alcohol.
  • Ni (%) means the content (%) of each analog in the sterile injection obtained by manufacturing the package without decontamination.
  • the diagonal line (/) in the table indicates the fact that the impurity analysis has not been performed.
  • the method for producing an aseptic injection of the present invention is a sterile injection that enables the aseptic injection as a product to be of high quality and can be stably stored after production.
  • the present invention is extremely useful in the pharmaceutical industry, for example in the field of osteoporosis treatment.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Pharmacology & Pharmacy (AREA)
  • Physical Education & Sports Medicine (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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  • Engineering & Computer Science (AREA)
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  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Selon la présente invention, un procédé de préparation d'un agent injectable stérile contenant du teriparatide ou un sel de ce dernier par l'intermédiaire d'une technique d'opération aseptique, comprend une étape consistant à transporter un emballage, dans lequel un récipient d'injection ne contenant pas d'agent thérapeutique est stocké dans un appareil ou un système ayant une zone d'opération aseptique, la surface extérieure de l'emballage étant décontaminée par du peroxyde d'hydrogène ou de l'alcool. Selon la prévente invention, dans le procédé de préparation d'un agent injectable stérile, l'agent injectable stérile ainsi préparé présente une qualité élevée et peut être conservé de manière stable après la préparation. La présente invention est très utile dans les industries pharmaceutiques, par exemple, dans le domaine du traitement de l'ostéoporose.
PCT/JP2020/029435 2019-09-05 2020-07-31 Procédé de préparation d'agent injectable stérile contenant du teriparatide ou un sel de ce dernier WO2021044775A1 (fr)

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JP2020544311A JP7240407B2 (ja) 2019-09-05 2020-07-31 テリパラチド又はその塩を含有する無菌注射剤を製造する方法

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JP2016220747A (ja) * 2015-05-27 2016-12-28 株式会社エアレックス 電子線照射装置
JP2019065042A (ja) * 2017-09-22 2019-04-25 旭化成ファーマ株式会社 安定性に優れるテリパラチド含有液状医薬組成物
JP2018057396A (ja) * 2017-12-01 2018-04-12 澁谷工業株式会社 無菌作業システム
WO2019111938A1 (fr) * 2017-12-07 2019-06-13 藤森工業株式会社 Sac muni d'un orifice et sac muni d'un capuchon

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