制药工艺与装备3：无菌制剂生产

ISSN1674-5922CN11-5669/T LIUCHENGGONGYE1998౎ظ਽/$਽/ጺڼ653೺ 06 2024౎ڼ06೺ PharmaTEC዆¿+¿ᇑጎԢ•࿮ਪ዆व)p №ܻ—$§hƒׯMۯ዆ᄱႜᄽຕጴࣅገ№ᆅଶኁă࿮ஃ๟ሞຕጴ ࣅ˛ᅅᄱ੔र˛ࠃᆌ૾࣏๟$ײरຍଶᇘ,№ܻۼሞfl༵ࠃ@ݛ࿋@׼,]ƒQࣩणཷၹ№ၳᆌ, flظሰ߸ٷॏኵă P12 №ᅁࡨƒ⻾ឭfiУ͇ߎፚ䨭ਜ਼Ⴥ ArnaudPortet ႜᄽ࠵ִ18 ƒⒸn);͇ӈᏁ$ $⤳䔉⼸M䃎⮱ᕊ$ ༬՚֧ࣄ42 "p㻱½⮱݈᫝㼐Q᫦ᵵ ิ]၄ׇ58 ധλc。x_T$VBµ$䊸߬ᷭ侹ツ∂⮱MVR㈨㐌]㏔ ࣹշ 1998౎ظ਽/$਽/௅$20Q؜Ӳ/2024౎ڼ06೺(õڼ653೺) .࠶ڇƒ:$ࡔऐႁ+ᄽ૴ęࣷ .Ӹڇƒ:ऐႁ+ᄽ႑တg৯ᇾ $ࡔऐႁ+ᄽणཷ$ࠅິ ؜Ӳڇƒ:3№+ᄽՊडևں኷:ԛ৙y$׭;$J:ٷন22ªᆰՊ:100037 ม׊:ିׯዒg?ޭม׊:ঁჱԐ ޭม׊:ቧލਚ4$ .Պ:ࢲৢ4$ ޭ.Պ:№ૢዱ№݀Պडև:٢ݚݤቧ฽লႸרץWඪՊड:ࢲৢ Պडևۉࣆ:+86-10-63326091 E-mail:pharmatec@vogel.com.cn 3ኁޜ?ۉࣆ:+86-10-63326083 ݀ႜڇƒ:3№+ᄽՊडև ݀ႜݔྷ:ࡔాྔࠅfl݀ႜ ؜Ӳዜ೺:$਽ ࡔƒƒ‰૶3؜Ӳ࿿ª:ISSN1674-5922 ࡔాཥ—૶3؜Ӳ࿿ª:CN11-5669/T ׶ᆇ:ԛ৙ձ࡛ƒ֒෥ᆇຘ$ࠅິ ;ॏ:10ᇮ/೺ jߢõپ૙:ԛ৙ऐ+ޡߦد௃jߢ$ࠅິں኷:ԛ৙y$׭;$J:ٷন22ªᇾ2ª୍3֫ᆰՊ:100037 Add.:3rdFloor,2ndBuilding,No22,BaiwanzhuangStreet,XichengDistrict,Beijing,100037 ۉࣆTel:+86-10-63326090 [࡛Tel:1391726425417755450823 ໋ዝTel:18662595387flހTel:13683598646ኣዝTel:18810368957ళཚTel:18510064198ƒTel:18545558115 ęྗں;૴ஏت:J&MMediaCorporation ۉࣆTel:+886-42296-5959 ഄ໱jߢپ૙: ڤࡔ:VogelCommunicationsGroupGmbH&Co.KG Tel:+499314182988 ெࡔ:GardnerBusinessMedia,Inc. Tel:+15135278800 ᅪٷ૧:FerdinandoSalarisTel:+393388285021 ෌๗:VogelCommunicationsGroupAG Tel:+41447227700 հW:RavenMediasp.zo.o.Tel:+48717823181A:MMpublishings.r.oTel:+420775245802ӎں૧:Technik&MedienVerlagsges.m.b.H. Tel:+43187683790 Ⴅ]૧:MüszakiMédiaKiadóKft.Tel:+36203967942 ໽ࡔ:GreenWorldMedida(Thailand)CompanyLimitedTel:+6627311191 ࡔ:MMMaschinenMarktKoreaCo.,Ltd.Tel:+821084065100 PharmaTEC№ᄱß hƒƒၛࡔాྔ዆ᄱႜᄽظƒ੔र˛$;˛]ⒸᅜतᆫႯํ№ӄ૩ ⵖ蚋䗎䊨⥌蒌Ⱆ♸⠍鄳〿㢊 1IBSN錠B5곸&$〿ⵖ蚋⚌ $ƒሗኾ൩ݡ࿚: https://pharm.jgvogel.cn/dzzz/ ྲ႑ၭײQ 2024-063ײ]ᄽ1 侹ツ∂⮱MVR㈨㐌]㏔ $⤳䔉⼸M䃎⮱ᕊ$㼐Q᫦ᵵ ƒⒸn);͇ӈᏁ$"p㻱½⮱݈᫝ധλc。x_T$VBµ$䊸߬ᷭ ิ]၄ׇ58 ༬՚֧ࣄ42 ႜᄽ࠵ִ18 №ܻ—$§hƒׯMۯ዆ᄱႜᄽຕጴࣅገ№ᆅଶኁă࿮ஃ๟ሞຕጴ ࣅ˛ᅅᄱ੔र˛ࠃᆌ૾࣏๟$ײरຍଶᇘ,№ܻۼሞfl༵ࠃ@ݛ࿋@׼,]ƒQࣩणཷၹ№ၳᆌ, flظሰ߸ٷॏኵă P12 №ᅁࡨƒ⻾ឭfiУ͇ߎፚ䨭ਜ਼Ⴥ ArnaudPortet ۯༀ۳߅ဣཥڦ ยऺ৯ PharmaTEC዆¿+¿ᇑጎԢ•࿮ਪ዆व)p LIUCHENGONGYE1998౎ظ਽$਽/ڼ೺ 06 2024౎ڼ06೺ SSN1674-5922CN-5669/T Ė3№+ᄽėڦ࡛ྔ႑တᆯऐႁ+ᄽ႑တg৯ᇾཚࡗӲ඄Ⴙ੗ݛ๕ՊᅳڤࡔޡߦدխणཷڦሗኾPROCESSăInternationalEditorialofLiuChengGongYeislicensedfromPROCESS.Ӳ඄ำ௽:$਽ߡॲӲ඄໯$,$ঢ়NႹ,փڥገሜăN๚]༬๺ຫ௽,ፕኁ№ߡ๫ྺཞ้๲඄࿢਽¾÷਽࿿तྪበ˛ྲ႑˛ྲձᅜ၎ᆌӲ඄ă jߢ໭ᆅAdvertiserIndex ݤ༬($ࡔ)዆¿੔र$ࠅິ ހ= CSEഽ៥णཷ 31 [࡛ᇺҾ3༹ยԢ੔र$ࠅິ 3 †۫‰ڤభऐႁ੔र$ࠅິ 33 Sieversӳဆᅏ(ྰ½ჯ) 4 g૞ëߐ༬([࡛)$ࠅິ 35 ڱఐ+ᄽยԢ([࡛)$ࠅິ 7 ԛ৙ABBۉഘدۯဣཥ$ࠅິ 39 ୾༬࣍ৣ੔रNဍ$ࠅິ 9 [࡛ᅪ݀ஒ዆¿ยԢ$ࠅິ 41 ƒॿಋ࿦ጲ੦ᅏ$$ࠅິ 11 [࡛ᗼଲ3༹ऐႁยԢ$ࠅິ 49 [࡛ྰુऐۉยԢ$ࠅິ 17 Ԡ๘຤रຍ([࡛)$ࠅິ 51 ౷ߦ([࡛)ஹᅟ$ࠅິ 19 jዝyૂgڥ಩ཱยԢ$ࠅິ 53 №௑ۉƒ([࡛)$ࠅິ 21 ॿ໋;໋ટิ࿿੔र$ࠅິ 57 ྰ½ჯ຤ت૙रຍ([࡛)$ ࠅິ 25 ᆈࡔFLYGERޡટߦ݅ோ$ࠅິ 67 ྰૂ($ࡔ)຤ԭဣཥ$ࠅິ29 2024-063ײ]ᄽ1 №ᄱ]¿ᇑጎԢ 2024౎ڼ6೺ ऊ౅ྴܻRìਸfiڦ)ం੔ბຕጴࣅ½ਦݛӄ P24 $7ሞטӱጎႂဣཥQ๑)7ЫഗT,-QKሞ੦዆$Q P41 ⚌歲餴雴MBSLFU/FXT ࡔాႎ‰DmoesticNews 6๖ธfifiࡻͧڞ$“᪝ᮧ$$”๔὎№ ࡔƒႎ‰WorldNews 8⹩Გ䔪ߍ53K㒻ٰ㜗$ጒJn)“ۼ㗒⺋ƒ” ႎरຍਸ%NewTechnology 11䊈:ݖ᫜fi䊈䄧㤟व҉,$͇ࡃ〜ݝ〜Ꭰęᑧࡃy⍥ጒ¿ ➃暟FJHVSF 12Ç∕݈᫝侞ffiݣƒ㵹͇᪝ႄࡃ䒙№/$ݚݤ Drivingdigitaltransformationinthepharmaceuticalindustrywithafocusoninnovation 遤⚌錜㻋*OEVTUSZ0CTFSWBUJPO 16᪝ᮧ䉸㘪䉕᩵:]/ר¼ Digitalempowermentfordualenhancementofqualityandefficiency 18ƒⒸn);͇ӈᏁ$$⤳䔉⼸M䃎⮱ᕊ$/ࢲݚ,:ᔛ,ࢲᕎڪ Reflectionsonremoteauditofsuppliermanagementinpharmaceuticalmanufacturingenterprises 22䰺ᅩ‡ᅁ䉸㘪nপ⻾႓᪝ᮧࡃ䒙№,ᐭg᫝䉕n)fi᫝㏗ٰ /$ݚݤHoneywellempowersdigitaltransformationinlifesciences,openinganeweraofproductivity 26ࡼ№݈᫝,ᑂ䶳ధҀݣݯ)͇$Გ᫝⾮ⵡ/¾ૢዱ Collaborativeinnovationleadingthefuturebreakthroughsinsoliddosageformulationindustry 28㏳ܳ;ݣ,倅᩵Ⅱ∢ߖfiݣƒ㵹͇䉕᩵:]/¾ૢዱ Segmentedcustomization,high-efficiencypumpsboostingthedual enhancementofqualityandefficiencyinthepharmaceuticalindustry 32—Ҁࡃ݈᫝᫦ᵵߖfinপ⻾႓;͇ក䕍ᮧ㘪ݣƒጒJ/¾ૢዱIntegratedinnovativesolutionshelpinglifescienceenterprisesbuildsmartpharmaceuticalfactories 3430Ꭱ⌞㕂n➖ݣƒ䉸㘪㵹͇倅䉕䛼ࣾᆂ/ר¼Empoweringindustry'shigh-qualitydevelopmentwith30yearsofdeepcultivationinbiopharmaceuticals 暵ⵆ瘻ⴢ/偽蝒ⵖ⵫欰❡ATFQUJDMBOVGBDUVSJOH 36ffiᔮƒ᎟㈨㐌⮱䃫䃎g⾣/ᄮᤷ Researchonthedesignofdynamicfreeze-dryingsystems 40]㣹ࡧ⮱⤳ᘠঅጒ/Steriline½a Theidealemployeeinasterileenvironment 42"p㻱½⮱݈᫝㼐Q᫦ᵵ/MartinJäger Innovativesolutionsforunconventionalprojects 欰❡梡㖞MBOVGBDUVSF1SBDUJDF ࡗײरຍᇑ߾¿ProcessTechnics 44Д᰺ధҀݣݯ䔋㐚ݣ䕍⮱ጒ¿ឭᱜg⾣䔈ᆂ /$ॆૂ,ିൣ଄,Ω૞Advancesinprocesstechnologyforcontinuousmanufacturingoforalsoliddosageforms 48≲䄵ƒJ∮ۭ㈨㐌⅁䬥⮱ᒏᐼ/:½Ԑ Abriefdiscussionontheformsofairlocksinpharmaceuticalcleanroomsystems 23ײ]ᄽ2024-06№ᄱ]¿ᇑጎԢ ࠽ߢ Contentsᄬ൓ ႓ڤ੔Ⓒ߲ဣཥ๟ྺਜ਼pøว¿዆ڦ,ٗरຍࢅ®ሰ)܈ઠੂK -3ܾP43 ࿿3ᇑԈጎLogistics&Packaging 50 GMP὎಄ࡃJᝬ⮱䓽䓀⶛䃑TransportconfirmationforGMPModularplantbuildings /yናᇔ 54 ]㣹ࡨ⫄கNф㷲䉕䛼ƒݣ㺮A(1) /֤Ⴝ Keypointsinqualitycontrolofsterilemedicaldevicepackaging(Part1) ጲۯࣅᇑᅏÇAutomationandInstrumentation 58ധλcox_stuart䊸߬ᷭ侹ツ∂⮱MVR㈨㐌]㏔ /க໋[,ି௽ॵ,Ԉᄏᇔڪ UpgradeofMVRsystembasedoncox-stuarttrendtestAlgorithm ํᄓ๪ᇑ%LaboratoryandR&D 63ᓛn➖nࡃ䞡;⮱ᒞD఍㉍ᣏ⾣/@Ⴙ݉,୥֍ᄝ,ঁ39ڪ Exploringfactorsinfluencingmicrobiologicalbiochemicalidentification ㉁⸉⥌䜂度BVZFST(VJEF 66)Ⓒᣕ㡽Products 1Aᱰ±Imprint 1Ꭼॷ㉏ᑂAdvertisementIndex SS1674-5922CN1-5669/T LUCHENGONGY1998౎ظ਽/$਽/63೺ 06 2024౎ڼ06೺ PharmaTEC዆¿+¿ᇑጎԢ•࿮ਪ዆व)p ۯༀ߅ဣڦย №ܻ—$§hƒׯMۯ዆ᄱႜᄽ ຕጴࣅገ№ᆅଶኁă࿮ஃ๟ሞຕጴ ࣅ˛ᅅᄱ੔र˛ࠃᆌ૾࣏๟$ײरຍଶᇘ,№ܻۼሞfl༵ࠃ@ݛ࿋@׼,]ƒQࣩणཷၹ№ၳᆌ, flظሰ߸ٷॏኵă P12 №ᅁࡨƒ⻾ឭfiУ͇ߎፚ䨭ਜ਼Ⴥ ArnaudPortet ႜᄽ࠵ִ18༬՚֧ࣄ42ิ]၄ׇ58 ƒⒸn);͇ӈᏁ$"p㻱½⮱݈᫝ധλc。x_T$VBµ$䊸߬ᷭ $⤳䔉⼸M䃎⮱ᕊ$㼐Q᫦ᵵ侹ツ∂⮱MVR㈨㐌]㏔ ހ௬ڞ3: ƒ߅रຍሞᅅ¿.๋r.ࣅΩڪ;߲ଶᇘڥ ڟ7)ݘڦᆌ)ăaए7ƒ߅ยׯ‡ߛ. ీࡼß.ƒ߅Ω;ዜ¾№