WO2023181841A1 - 使い捨てピペット - Google Patents

使い捨てピペット Download PDF

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Publication number
WO2023181841A1
WO2023181841A1 PCT/JP2023/007974 JP2023007974W WO2023181841A1 WO 2023181841 A1 WO2023181841 A1 WO 2023181841A1 JP 2023007974 W JP2023007974 W JP 2023007974W WO 2023181841 A1 WO2023181841 A1 WO 2023181841A1
Authority
WO
WIPO (PCT)
Prior art keywords
resin
resin filter
pipette
filter
less
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2023/007974
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
幸太 五十嵐
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Bakelite Co Ltd
Original Assignee
Sumitomo Bakelite Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sumitomo Bakelite Co Ltd filed Critical Sumitomo Bakelite Co Ltd
Priority to CN202380028584.0A priority Critical patent/CN118900725A/zh
Priority to EP23774440.4A priority patent/EP4501458A1/en
Priority to JP2023546196A priority patent/JP7444340B2/ja
Priority to US18/847,282 priority patent/US20250196125A1/en
Publication of WO2023181841A1 publication Critical patent/WO2023181841A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/02—Burettes; Pipettes
    • B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/02—Burettes; Pipettes
    • B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
    • B01L3/0213—Accessories for glass pipettes; Gun-type pipettes, e.g. safety devices, pumps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/12—Specific details about manufacturing devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter

Definitions

  • the present invention relates to disposable pipettes.
  • Disposable resin pipettes are used.
  • An example of such a disposable pipette is disclosed in, for example, Japanese Utility Model Application Publication No. 63-90438 (Patent Document 1).
  • Patent Document 1 a cotton plug is inserted into a connection portion of the pipette body made of resin to a suction device in order to facilitate control of the amount of sample dropped.
  • the disposable pipette according to the present invention includes: A disposable pipette used in the pharmaceutical field or biochemical field, a resin pipette body having a connection part connected to a suction device; When inserted into the connection part and irradiated with radiation so that the absorbed dose is 20 kGy or more, the elution amount measured according to the eluate test of the Japanese Pharmacopoeia Plastic Pharmaceutical Container Test Method is at a wavelength of 220 nm to 241 nm. and a resin filter having a maximum absorbance of 0.08 or less in the wavelength range of 241 nm to 350 nm and a maximum absorbance of 0.05 or less in the wavelength range of 241 nm to 350 nm.
  • the resin filter is inserted into the connection part of the resin pipette body, unlike when a cotton plug is inserted, for example, fibers from the cotton plug can be mixed into the sample as foreign matter. There is no need to worry about doing so. Furthermore, when disposable pipettes are used in the pharmaceutical or biochemical fields, they are often subjected to radiation irradiation for sterilization, but even in such cases, elution from the resin filter can be kept to an extremely small amount. It will be done. Therefore, it is possible to realize a disposable pipette that can withstand use in the medical field or biochemical field and can avoid contamination of foreign substances into the sample.
  • the resin filter has a maximum absorbance of 0.08 or less in a wavelength range of 220 nm to 241 nm, and a maximum absorbance in a wavelength range of 241 nm to 350 nm when irradiated with radiation such that the absorbed dose is 70 kGy or more. It is preferable that the absorbance corresponds to 0.05 or less.
  • the resin filter is preferably a porous resin sintered filter.
  • the resin filter is made of polyethylene resin or polypropylene resin.
  • the pipette 1 of this embodiment is a disposable pipette that is scheduled to be discarded after each use.
  • the pipette 1 includes a pipette body 20.
  • the pipette main body 20 has a main body part 21 , a tip part 22 provided at one end of the main body part 21 , and a connecting part 23 provided at the other end of the main body part 21 .
  • the main body portion 21 is formed into a cylindrical shape.
  • the size of the main body portion 21 is not particularly limited.
  • the length of the main body portion 21 can be, for example, 100 to 500 mm, and the inner diameter can be, for example, 2 to 20 mm. Further, the capacity of the main body portion 21 can be, for example, 1 to 500 mL.
  • the outer surface of the main body portion 21 may be provided with a scale for indicating the amount of liquid sucked and held.
  • the tip portion 22 is formed into a truncated cone shape.
  • the distal end portion 22 has a proximal end located on the side of the main body portion 21 and is formed so as to gradually reduce in diameter toward the distal end portion on the opposite side to the main body portion 21 .
  • the size of the tip portion 22 is not particularly limited.
  • the length of the tip portion 22 can be, for example, 5 to 30 mm.
  • the inner diameter of the tip opening of the tip portion 22 can be, for example, 0.1 to 3 mm.
  • the connecting portion 23 is formed in a cylindrical shape.
  • the connecting portion 23 is formed into a cylindrical shape that is one size smaller than the main body portion 21 .
  • the size of the connecting portion 23 is not particularly limited.
  • the length of the connecting portion 23 can be, for example, 10 to 30 mm, and the inner diameter can be, for example, 2 to 10 mm.
  • the connecting portion 23 is connected to the suction device 9 at the end opposite to the main body portion 21 .
  • the suction device 9 is a device for sucking liquid into the pipette body 20 from the tip 22 side.
  • the suction device 9 may be an automatic suction device such as a pipettor, or a manual suction device such as a pipette cap (rubber bulb).
  • the pipette main body 20 is made of resin and is suitable for disposable use.
  • the resin material constituting the pipette main body 20 is not particularly limited, but it is preferable to use one that has high transparency and excellent moldability.
  • the pipette body 20 can be formed using, for example, polyethylene, polypropylene, cyclic polyolefin, polyester, polystyrene, polycarbonate, polymethylpentene, or the like.
  • the pipette main body 20 can be formed, for example, by extrusion molding, injection molding, or the like.
  • the main body part 21 and the tip part 22 may be formed integrally, the connecting part 23 may be formed separately from them, and these two parts may be joined.
  • the two parts can be joined by, for example, thermal welding, laser welding, ultrasonic welding, bonding with an adhesive or pressure-sensitive adhesive, or the like.
  • the pipette 1 of this embodiment includes a resin filter 30 in addition to a pipette main body 20.
  • the resin filter 30 is inserted into the connecting portion 23 of the pipette main body 20.
  • the resin filter 30 is press-fitted into the connection part 23 of the pipette main body 20.
  • a porous resin sintered filter is used as the resin filter 30.
  • the porous resin sintered filter is a filter made of a porous resin sintered body having continuous pores, and is obtained by placing resin particles in a mold and heating them under pressure. It is a filter made up of the body.
  • the resin material constituting the resin filter 30 is not particularly limited, but various thermoplastic resins can be preferably used.
  • the thermoplastic resin include low density polyethylene, high density polyethylene, ultra-high molecular weight polyethylene, polymethyl methacrylate, polypropylene, ethylene-vinyl acetate copolymer, polystyrene, polyamide, and polycarbonate.
  • polyethylene resins eg, low density polyethylene, ethylene-vinyl acetate copolymers, etc.
  • polypropylene resins can be preferably used.
  • the average pore diameter (size of continuous pores) of the resin filter 30 (porous resin sintered filter) is not particularly limited, but can be, for example, 1 to 10 ⁇ m. Further, the porosity (porosity) of the resin filter 30 (porous resin sintered filter) is not particularly limited, but can be set to, for example, 20 to 50%. Furthermore, the length and outer diameter of the resin filter 30 are not particularly limited, but may be, for example, 5 to 10 mm in length and 2 to 10 mm in outer diameter.
  • the elution amount when irradiated with radiation such that the absorbed dose is 20 kGy or more satisfies the following conditions.
  • the elution amount of the resin filter 30 means the elution amount measured according to the Japanese Pharmacopoeia Plastic Pharmaceutical Container Test Method Eluate Test (7.02.1.2).
  • the elution amount of the resin filter 30 is such that the maximum absorbance in the wavelength range of 220 to 241 nm is 0.08 or less, and the maximum absorbance in the wavelength range of 241 to 350 nm is 0.05.
  • the following is equivalent.
  • the elution amount of the resin filter 30 when irradiated with radiation under stronger conditions such that the absorbed dose is 70 kGy or more is the same equivalent amount as above.
  • the amount of elution from the resin filter 30 is such that even when radiation is irradiated so that the absorbed dose is 20 kGy or more, the maximum absorbance in the wavelength range of 220 to 241 nm is 0.08 or less, and the maximum absorbance in the wavelength range of 241 to 350 nm is It is preferable that the maximum absorbance in the section is equivalent to 0.05 or less.
  • the resin filter 30 has a maximum absorbance of 0.07 or less in the wavelength range of 220 to 241 nm, and a maximum absorbance of 0.07 or less in the wavelength range of 220 to 241 nm when radiation is irradiated so that the absorbed dose is 20 kGy or more. It is preferable that the maximum absorbance in the section is equivalent to 0.04 or less. Furthermore, the resin filter 30 has a maximum absorbance of 0.06 or less in the wavelength range of 220 to 241 nm, and a maximum absorbance of 0.06 or less in the wavelength range of 241 to 350 nm when irradiated with radiation under the same conditions. More preferably, it corresponds to 0.03 or less.
  • the resin filter 30 has a maximum absorbance of 0.07 or less in the wavelength range of 220 to 241 nm, and the amount of elution when radiation is irradiated under stronger conditions so that the absorbed dose is 70 kGy or more, and It is more preferable that the maximum absorbance in the wavelength range of 241 to 350 nm is equivalent to 0.04 or less. Further, the resin filter 30 has a maximum absorbance of 0.06 or less in the wavelength range of 220 to 241 nm, and a maximum absorbance of 0.06 or less in the wavelength range of 241 to 350 nm when irradiated with radiation under the same conditions. More preferably, it is equivalent to 0.03 or less. In this case, even when radiation irradiation is performed under stronger conditions, the amount eluted from the resin filter 30 can be further suppressed to a very small amount.
  • the pipette 1 of this embodiment can be used for weighing, dispensing, etc. of various solutions, for example, in experiments and inspections in the pharmaceutical field and biochemistry field. For this reason, the pipette 1 of this embodiment is sterilized by radiation irradiation after manufacturing. From the viewpoint of ensuring sterility, radiation irradiation for sterilization is preferably carried out so that the absorbed dose is 20 kGy or more, more preferably 25 kGy or more, and the absorbed dose is 70 kGy or more. It is more preferable to carry out the process as described above. By performing the sterilization treatment under stronger conditions, the sterility of the pipette 1 can be improved. Moreover, even if such sterilization is performed, contamination with eluates derived from the resin filter 30 can be avoided.
  • a resin filter 30 made of polyester was prepared.
  • the resin filter 30 was produced by sintering polyester fibers.
  • the obtained resin filter 30 had an outer diameter of 4.3 mm and a length of 10 mm.
  • This resin filter 30 was irradiated with an electron beam at an absorbed dose of 70 kGy.
  • Test Example 2 A resin filter 30 made of low density polyethylene was prepared.
  • the resin filter 30 was created by filling a mold with low-density polyethylene particles having an average particle diameter of 400 ⁇ m and pressing them together.
  • the obtained resin filter 30 had the same size as Test Example 1, and the average pore size was 30 ⁇ m.
  • This resin filter 30 was irradiated with an electron beam under the same conditions as Test Example 1. Using the resin filter 30 after electron beam irradiation as a specimen, foaming, pH, potassium permanganate reducing substance, ultraviolet absorption spectrum, and evaporation residue were measured in the same manner as in Test Example 1.
  • a resin filter 30 made of ethylene-vinyl acetate copolymer was prepared.
  • the resin filter 30 was produced by filling a mold with ethylene-vinyl acetate copolymer particles having an average particle diameter of 300 ⁇ m and compacting them.
  • the obtained resin filter 30 had the same size as Test Example 1, and the average pore size was 30 ⁇ m.
  • This resin filter 30 was irradiated with an electron beam under the same conditions as Test Example 1. Using the resin filter 30 after electron beam irradiation as a specimen, foaming, pH, potassium permanganate reducing substance, ultraviolet absorption spectrum, and evaporation residue were measured in the same manner as in Test Example 1.
  • the resin filters 30 of Test Examples 2 and 3 made of low-density polyethylene or ethylene-vinyl acetate copolymer showed that the amount of elution was extremely high enough to meet the standards for plastic aqueous injection containers. It was confirmed that the amount was suppressed to a very small amount.
  • these resin filters 30 were inserted into the connecting portion 23 of the pipette main body 20 and used for trial purposes, no foreign matter was found to be mixed into the test liquid being handled.
  • Disposable pipettes can be provided.

Landscapes

  • Health & Medical Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
PCT/JP2023/007974 2022-03-24 2023-03-03 使い捨てピペット Ceased WO2023181841A1 (ja)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN202380028584.0A CN118900725A (zh) 2022-03-24 2023-03-03 一次性移液管
EP23774440.4A EP4501458A1 (en) 2022-03-24 2023-03-03 Disposable pipette
JP2023546196A JP7444340B2 (ja) 2022-03-24 2023-03-03 使い捨てピペット
US18/847,282 US20250196125A1 (en) 2022-03-24 2023-03-03 Disposable pipette

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022-048741 2022-03-24
JP2022048741 2022-03-24

Publications (1)

Publication Number Publication Date
WO2023181841A1 true WO2023181841A1 (ja) 2023-09-28

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ID=88100589

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2023/007974 Ceased WO2023181841A1 (ja) 2022-03-24 2023-03-03 使い捨てピペット

Country Status (5)

Country Link
US (1) US20250196125A1 (https=)
EP (1) EP4501458A1 (https=)
JP (1) JP7444340B2 (https=)
CN (1) CN118900725A (https=)
WO (1) WO2023181841A1 (https=)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6390438U (https=) 1986-11-28 1988-06-11
JP2001121005A (ja) * 1999-10-26 2001-05-08 Nitto Denko Corp ピペット及びピペット用フィルタ−
JP2003245564A (ja) * 2002-02-21 2003-09-02 Nitto Denko Corp チップ用フィルター及びその製造方法
JP2004148158A (ja) * 2002-10-29 2004-05-27 Nitto Denko Corp チップ用フィルターおよびチップ
JP2007061751A (ja) * 2005-08-31 2007-03-15 Sumitomo Bakelite Co Ltd ピペットカートリッジ
WO2015033876A1 (ja) * 2013-09-06 2015-03-12 日本ゼオン株式会社 滅菌済み医療用成形体の製造方法
JP2015515364A (ja) * 2012-03-06 2015-05-28 ポレックス コーポレーション 血清学用ピペットのための焼結多孔質プラスチックプラグ
JP2016159274A (ja) * 2015-03-04 2016-09-05 住友ベークライト株式会社 ピペットカートリッジ及びそれを備えた止水フィルタ付きピペット
JP2018111789A (ja) * 2017-01-13 2018-07-19 日本ポリプロ株式会社 放射線滅菌対応医療キット製剤用プロピレン系樹脂組成物及びその医療キット製剤
JP2019031609A (ja) * 2017-08-07 2019-02-28 住友化学株式会社 ポリプロピレン樹脂組成物、及びこれを用いた医療用成形体

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9566579B1 (en) 2015-09-03 2017-02-14 Vistalab Technologies, Inc. Low insertion force, low wobble serological pipette

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6390438U (https=) 1986-11-28 1988-06-11
JP2001121005A (ja) * 1999-10-26 2001-05-08 Nitto Denko Corp ピペット及びピペット用フィルタ−
JP2003245564A (ja) * 2002-02-21 2003-09-02 Nitto Denko Corp チップ用フィルター及びその製造方法
JP2004148158A (ja) * 2002-10-29 2004-05-27 Nitto Denko Corp チップ用フィルターおよびチップ
JP2007061751A (ja) * 2005-08-31 2007-03-15 Sumitomo Bakelite Co Ltd ピペットカートリッジ
JP2015515364A (ja) * 2012-03-06 2015-05-28 ポレックス コーポレーション 血清学用ピペットのための焼結多孔質プラスチックプラグ
WO2015033876A1 (ja) * 2013-09-06 2015-03-12 日本ゼオン株式会社 滅菌済み医療用成形体の製造方法
JP2016159274A (ja) * 2015-03-04 2016-09-05 住友ベークライト株式会社 ピペットカートリッジ及びそれを備えた止水フィルタ付きピペット
JP2018111789A (ja) * 2017-01-13 2018-07-19 日本ポリプロ株式会社 放射線滅菌対応医療キット製剤用プロピレン系樹脂組成物及びその医療キット製剤
JP2019031609A (ja) * 2017-08-07 2019-02-28 住友化学株式会社 ポリプロピレン樹脂組成物、及びこれを用いた医療用成形体

Also Published As

Publication number Publication date
JP7444340B2 (ja) 2024-03-06
JPWO2023181841A1 (https=) 2023-09-28
EP4501458A1 (en) 2025-02-05
US20250196125A1 (en) 2025-06-19
CN118900725A (zh) 2024-11-05

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