JP5837670B2 - 噴霧凍結および撹拌乾燥を使用するバルク・フリーズドライ - Google Patents
噴霧凍結および撹拌乾燥を使用するバルク・フリーズドライ Download PDFInfo
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- JP5837670B2 JP5837670B2 JP2014216841A JP2014216841A JP5837670B2 JP 5837670 B2 JP5837670 B2 JP 5837670B2 JP 2014216841 A JP2014216841 A JP 2014216841A JP 2014216841 A JP2014216841 A JP 2014216841A JP 5837670 B2 JP5837670 B2 JP 5837670B2
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- 238000004108 freeze drying Methods 0.000 title claims description 62
- 238000003756 stirring Methods 0.000 title claims description 15
- 239000007921 spray Substances 0.000 title description 36
- 238000007710 freezing Methods 0.000 title description 16
- 230000008014 freezing Effects 0.000 title description 15
- 238000001035 drying Methods 0.000 title description 13
- 238000000034 method Methods 0.000 claims description 57
- 239000000843 powder Substances 0.000 claims description 51
- 239000003795 chemical substances by application Substances 0.000 claims description 30
- 239000007788 liquid Substances 0.000 claims description 23
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 19
- 239000002245 particle Substances 0.000 claims description 18
- 238000010438 heat treatment Methods 0.000 claims description 16
- 230000007246 mechanism Effects 0.000 claims description 14
- 239000007789 gas Substances 0.000 claims description 11
- 238000005507 spraying Methods 0.000 claims description 10
- 229910052757 nitrogen Inorganic materials 0.000 claims description 9
- 238000000859 sublimation Methods 0.000 claims description 7
- 230000008022 sublimation Effects 0.000 claims description 7
- 239000013529 heat transfer fluid Substances 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000010907 mechanical stirring Methods 0.000 claims 1
- 239000000047 product Substances 0.000 description 103
- 230000008569 process Effects 0.000 description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 23
- 239000002904 solvent Substances 0.000 description 13
- 239000012263 liquid product Substances 0.000 description 11
- 238000013019 agitation Methods 0.000 description 7
- 238000004891 communication Methods 0.000 description 7
- 238000009833 condensation Methods 0.000 description 7
- 230000005494 condensation Effects 0.000 description 7
- 238000012545 processing Methods 0.000 description 7
- 230000001954 sterilising effect Effects 0.000 description 7
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 6
- 238000004659 sterilization and disinfection Methods 0.000 description 6
- 239000003206 sterilizing agent Substances 0.000 description 5
- 238000012546 transfer Methods 0.000 description 5
- 239000012530 fluid Substances 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 238000005054 agglomeration Methods 0.000 description 3
- 230000002776 aggregation Effects 0.000 description 3
- 238000012865 aseptic processing Methods 0.000 description 3
- 238000001816 cooling Methods 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 238000011084 recovery Methods 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 238000010924 continuous production Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 238000003801 milling Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 238000010257 thawing Methods 0.000 description 2
- 238000000889 atomisation Methods 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 239000013590 bulk material Substances 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 239000002826 coolant Substances 0.000 description 1
- 238000007872 degassing Methods 0.000 description 1
- 239000000645 desinfectant Substances 0.000 description 1
- 229910001873 dinitrogen Inorganic materials 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
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- 239000010419 fine particle Substances 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000006193 liquid solution Substances 0.000 description 1
- 239000006194 liquid suspension Substances 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002105 nanoparticle Substances 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
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- 238000001291 vacuum drying Methods 0.000 description 1
- 238000002061 vacuum sublimation Methods 0.000 description 1
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- Drying Of Solid Materials (AREA)
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Description
Claims (8)
- 液体を含有するバルク製品をフリーズドライする方法であって、
バルク製品をフリーズ槽内へと噴霧することと、
フリーズ剤を前記フリーズ槽内へと噴霧することであって、前記フリーズ剤が、噴霧された前記バルク製品と混ぜ合わさり、前記バルク製品に含有される前記液体を凍結させて、前記製品が前記フリーズ槽の下部に落下する前に凍結粉末を生成することと、
前記フリーズ槽内で前記凍結粉末を移動しないで前記凍結粉末を真空に晒すことと、
機械式撹拌機構を用いて真空下で前記凍結粉末を撹拌し、前記凍結粉末の粒子を前記フリーズ槽の壁へと移動させることと、
前記フリーズ槽の壁へと熱を移動させて前記凍結粉末を加熱し、前記バルク製品中の凍結液体を昇華させて凍結乾燥製品を形成することと、
前記凍結乾燥製品を大気圧に戻すこととを含む方法。
- 真空下で前記凍結粉末を撹拌することおよび前記凍結粉末を加熱することが、前記フリーズ槽内で行われる、請求項1に記載の方法。
- 前記フリーズ剤が無菌液体窒素である、請求項1に記載の方法。
- 前記バルク製品および前記フリーズ剤が、別個のノズルから前記フリーズ槽内へと噴霧される、請求項1に記載の方法。
- 前記バルク製品の噴霧および前記フリーズ剤の噴霧が同時に行われる、請求項1に記載の方法。
- 前記凍結粉末を加熱することが、伝熱流体を使用して槽壁へと熱を移動させることを含む、請求項1に記載の方法。
- 前記フリーズ剤の生成による脱気ガスを使用して冷却した伝熱流体を使用して、噴霧中に前記フリーズドライ槽の前記壁から熱を除去することをさらに含む、請求項6に記載の方法。
- 凝縮槽内の前記凍結液体の昇華によって蒸気を凝縮することをさらに含む、請求項1に記載の方法。
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JP2014216841A JP5837670B2 (ja) | 2014-10-24 | 2014-10-24 | 噴霧凍結および撹拌乾燥を使用するバルク・フリーズドライ |
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JP2014216841A JP5837670B2 (ja) | 2014-10-24 | 2014-10-24 | 噴霧凍結および撹拌乾燥を使用するバルク・フリーズドライ |
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JP2013523125A Division JP5680199B2 (ja) | 2010-08-04 | 2010-08-04 | 噴霧凍結および撹拌乾燥を使用するバルク・フリーズドライ |
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JP2015025652A JP2015025652A (ja) | 2015-02-05 |
JP5837670B2 true JP5837670B2 (ja) | 2015-12-24 |
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Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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US9945611B2 (en) * | 2010-08-04 | 2018-04-17 | Ima Life North America Inc. | Bulk freeze drying using spray freezing and agitated drying |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
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CH408781A (de) * | 1964-04-24 | 1966-02-28 | Anderwert Fritz | Verfahren zur Trocknung von zerstäubbarem Gut durch Sublimation und Trockeneinrichtung zur Ausführung des Verfahrens |
DE2659546A1 (de) * | 1976-12-30 | 1978-07-13 | Boehringer Mannheim Gmbh | Verfahren zur herstellung von gefrorenen granulaten |
US6440336B1 (en) * | 1997-10-06 | 2002-08-27 | Adalbert-Raps-Stiftung | Method for producing a powder product from a liquid substance or mixture of substances |
MXPA04004726A (es) * | 2001-11-19 | 2004-07-30 | Becton Dickinson Co | Composiciones farmaceuticas en forma particulada. |
JP4421885B2 (ja) * | 2003-12-12 | 2010-02-24 | 株式会社アルバック | 噴霧式真空乾燥法による封入装置 |
WO2005061088A1 (en) * | 2003-12-22 | 2005-07-07 | Finlay Warren H | Powder formation by atmospheric spray-freeze drying |
DK1794524T3 (da) * | 2004-07-23 | 2012-04-16 | Bayer Technology Services Gmbh | Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler) |
JP2010144966A (ja) * | 2008-12-17 | 2010-07-01 | Kyowa Shinku Gijutsu Kk | 凍結乾燥装置 |
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