JP7110360B2 - 凍結乾燥方法 - Google Patents
凍結乾燥方法 Download PDFInfo
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- JP7110360B2 JP7110360B2 JP2020540696A JP2020540696A JP7110360B2 JP 7110360 B2 JP7110360 B2 JP 7110360B2 JP 2020540696 A JP2020540696 A JP 2020540696A JP 2020540696 A JP2020540696 A JP 2020540696A JP 7110360 B2 JP7110360 B2 JP 7110360B2
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- JP
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- Prior art keywords
- freeze
- section
- breathable
- drying
- container
- 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.)
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D51/00—Closures not otherwise provided for
- B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
- B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying means
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0278—Physical preservation processes
- A01N1/0284—Temperature processes, i.e. using a designated change in temperature over time
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0278—Physical preservation processes
- A01N1/0289—Pressure processes, i.e. using a designated change in pressure over time
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1468—Containers characterised by specific material properties
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
- F26B25/06—Chambers, containers, or receptacles
- F26B25/063—Movable containers or receptacles, e.g. carts, trolleys, pallet-boxes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2093—Containers having several compartments for products to be mixed
Description
Claims (8)
- 前面部と、背面部と、ポート領域を有し、凍結乾燥される液体、固体、気体、又はそれらの組み合わせを収容した非通気性セクションと、通気性膜を有し、気体のみを収容する通気性セクションと、前記非通気性セクションと前記通気性セクションとの間に配置され、前記非通気性セクションと前記通気性セクションとの間で前記液体、前記固体又は前記気体の移動を阻止するために一時的又は永久的なシールを形成するように構成された閉塞ゾーンと、を有する、マルチパート凍結乾燥容器を用いた流体の凍結乾燥方法であって、該方法は、
前記閉塞ゾーンに前記非通気性セクションを前記通気性セクションから分離する一時的なシールを形成するステップと、
液体を前記非通気性セクションに投入するステップと、
前記液体を凍結するステップと、
前記一時的なシールを開放して、前記非通気性セクションと前記通気性セクションとの間の蒸気移動を可能にするステップと、
前記凍結させた液体に、真空下で熱エネルギーを加えるステップと、
を有し、
前記通気性セクションは、気体のみを収容するように構成された、
凍結乾燥方法。 - 請求項1記載の凍結乾燥方法において、さらに、気体を前記非通気性セクションに投入して、前記投入した液体の上側に蒸気空間を形成するステップを有する、
凍結乾燥方法。 - 請求項1又は2記載の凍結乾燥方法において、該方法はさらに、pH調整ガスを前記非通気性セクションに投入してpHを調節するステップを有する、
凍結乾燥方法。 - 請求項1~3のいずれか1項に記載の凍結乾燥方法において、さらに、凍結乾燥装置の前記マルチパート凍結乾燥容器を収容する凍結乾燥容器チャンバを大気圧の分圧までガス充填するステップを有する、
凍結乾燥方法。 - 請求項4記載の凍結乾燥方法において、前記凍結乾燥容器チャンバを大気圧の分圧までガス充填する前記ステップは、pH調整ガスを用いて行われる、
凍結乾燥方法。 - 請求項5記載の凍結乾燥方法において、さらに、前記閉塞ゾーンにおいて前記マルチパート凍結乾燥容器を閉塞するステップを有する、
凍結乾燥方法。 - 請求項6記載の凍結乾燥方法において、さらに、前記非通気性セクションの内部が大気圧の分圧の状態で前記マルチパート凍結乾燥容器の前記通気性セクションに恒久的なシームを形成するステップを有する、
凍結乾燥方法。 - 請求項7記載の凍結乾燥方法において、さらに、前記マルチパート凍結乾燥容器の前記通気性セクションを除去するステップを有する、
凍結乾燥方法。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2022077855A JP7227417B2 (ja) | 2017-10-09 | 2022-05-11 | マルチパート凍結乾燥容器 |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762569858P | 2017-10-09 | 2017-10-09 | |
US62/569,858 | 2017-10-09 | ||
US201762571087P | 2017-10-11 | 2017-10-11 | |
US62/571,087 | 2017-10-11 | ||
PCT/US2018/054943 WO2019074886A1 (en) | 2017-10-09 | 2018-10-09 | LYOPHILIZATION CONTAINER AND METHOD OF USE |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2022077855A Division JP7227417B2 (ja) | 2017-10-09 | 2022-05-11 | マルチパート凍結乾燥容器 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2021500919A JP2021500919A (ja) | 2021-01-14 |
JP7110360B2 true JP7110360B2 (ja) | 2022-08-01 |
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP2020540696A Active JP7110360B2 (ja) | 2017-10-09 | 2018-10-09 | 凍結乾燥方法 |
JP2022077855A Active JP7227417B2 (ja) | 2017-10-09 | 2022-05-11 | マルチパート凍結乾燥容器 |
Family Applications After (1)
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JP2022077855A Active JP7227417B2 (ja) | 2017-10-09 | 2022-05-11 | マルチパート凍結乾燥容器 |
Country Status (6)
Country | Link |
---|---|
US (2) | US10793327B2 (ja) |
EP (1) | EP3694322A1 (ja) |
JP (2) | JP7110360B2 (ja) |
CN (1) | CN111295094A (ja) |
CA (1) | CA3078625C (ja) |
WO (1) | WO2019074886A1 (ja) |
Families Citing this family (15)
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CN106461327B (zh) * | 2014-06-09 | 2019-12-13 | 泰尔茂比司特公司 | 冻干法 |
US9561184B2 (en) | 2014-09-19 | 2017-02-07 | Velico Medical, Inc. | Methods and systems for multi-stage drying of plasma |
EP3494349B1 (en) * | 2016-08-05 | 2020-10-07 | Bachem AG | Lid for drying container |
JP7110360B2 (ja) * | 2017-10-09 | 2022-08-01 | テルモ ビーシーティー バイオテクノロジーズ,エルエルシー | 凍結乾燥方法 |
FR3086739B1 (fr) * | 2018-09-27 | 2021-02-12 | Maat Pharma | Recipient de lyophilisation |
EP3886879A4 (en) | 2018-11-30 | 2022-12-07 | Cellphire Inc. | PLATES AS DELIVERY AGENTS |
WO2020185916A1 (en) * | 2019-03-14 | 2020-09-17 | Terumo Bct Biotechnologies, Llc | Lyophilization container fill fixture, system and method of use |
US11529587B2 (en) | 2019-05-03 | 2022-12-20 | Cellphire, Inc. | Materials and methods for producing blood products |
US20210308066A1 (en) | 2020-02-04 | 2021-10-07 | Cellphire, Inc. | Anti-fibrinolytic loaded platelets |
EP4013496A4 (en) | 2019-08-16 | 2023-10-18 | Cellphire Inc. | THROMBOSOMES AS AN ANTI-PLATELET DEACTIVATING AGENT |
CN112810954A (zh) * | 2020-12-30 | 2021-05-18 | 上海东富龙医用包装材料有限公司 | 一种运用在冻干工艺的一次性无菌容器 |
CN113101213B (zh) * | 2021-04-22 | 2022-09-16 | 上海乐纯生物技术有限公司 | 一种细胞治疗专用储液袋 |
US20220340961A1 (en) * | 2021-04-27 | 2022-10-27 | Enplas Corporation | Freeze-dried structure and producing method thereof |
US11841189B1 (en) | 2022-09-15 | 2023-12-12 | Velico Medical, Inc. | Disposable for a spray drying system |
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