制药工艺与装备6：生物药商业化生产

122023ुᎨ12ಪ ዆ᄱ߾ᅝᇑጎԢĄิ࿿ᄱฆᄽࣅิׂPharmaceutical Process and Equipment ิ࿿዆ᄱरຍገᅎڦဆݴۅవ 20ु֚ႋᩙ14Ꮑᄦᬒ䊸็ٰ⮱㢜ᠾᝅݣ ႋ҆ᎻѺ54$*1 䓴⼸͚⮱፥㻮䬛䷅ ま ➏ ⩌ ➖ 㢜ࣾ ᆂ ⮱ᵦധ ໜጣิ࿿रຍڦփ৊օLjᅜतᅃဣଚ၎ࠞ࠲૤አڦ֧໼Lj࿢ࡔิ࿿ᅅᄱׂᄽৎ౎ઠᆓઠକຩ຤ຩޅĂߛ໏݀ቛڦ঩܎ă඗ܸLjኄዖ൧઄ሞৎଇ౎݀ิକՎࣅLjጨԨĐ۬ࡦđĂ๨ׇ৪ኛघଜܠڪዖᅺ໎۠ेLjߴኝ߲ิ࿿ᅅᄱႜᄽټઠକփၭٶڦऍăܸႜᄽሦ๴ُْٰችڦᇱᅺLjߵࡃ঳ڹLjईႹ৽๟ሞტ௓݀ቛڦཞ้ࢮ୼କዾ઺ߵएLj࿄ీኈኟፔڟඇ௬݀ڦቛă ፕྺ ߛरຍׂ ᄽLjิ ࿿ᅅᄱ૗փਸظႎჺ݀Lj໲੗࿍ኝ߲ ႜᄽڦए็ăߵ਍ࠅਸԒڢཥऺLjপ዁11ሆLj2023౎ඇ൰ჇքڛԿڦิ࿿रᆶࠌິࠅຍ26ॆLjഄዐᅃӷࠅິڛԿڦᇱᅺদྺ ଣض๬ᄓ฿Өă੗९༵ื Ꮈႃᚸ׋ኜԷʸ؏ˁӝᅱ̐ልപܡⅥᅱႆӫᚸ͈ˁૉᖚчāDŽࡢ᧞ᦽĀۈޘಗ ჺ݀ీ૰ᅈ඗๟ิ࿿ᅅᄱႜᄽຩ૧݀ቛڦᆘႴăᅃݛ௬Ljჺ݀ీ૰ڦ༵ืႴᄲٷଉߛڦዊଉට֍ओેLj࿢ࡔิ࿿዆ᄱഐօྟLjሞኄݛ௬࣏ᆶ໯വඍLj࿄Ǘ ፕࢇბჺׂڦܠ߸ځઠ࣏ᆶଷᅃݛ௬Lj༵ߛᄱ࿿ჺࠀׯڦ݀୲ᄺᆶડᇀႎरຍڦᆌᆩLjසට߾዇ీDŽAIDžरຍLjᅃၵཀྵևᄱഓᅙঢ়ሞ׈๬ॽAIᆌᆩᇀᄱ࿿݀၄ᇑଣض๬ᄓኮዐLjཚࡗAIઠ༵ߛჺ݀ၳ୲ă ჺ݀ኮࢫLjॽࡕׯገՎྺฆᄽࣅิܔׂᇀิ࿿዆ᄱഓᄽઠຫᄺ๟࠲॰ڦ࣍বăิ࿿ᄱิ߾ׂᅝްሗLjࡀٷఇิׂገࣅԨ৽٪ሞవ܈ Ǘཞ้Lj࿢ࡔิ࿿዆ิࡔྺ࿢ׯׂఇฆᄽิࡀٷڥ๑ۼঢ়ᄓăኄၵ݄௬ฉධඍݛLjሞኄ܌ቛ้क़݀ᄱ࿿዆ᄱഓᄽփඹࢮ๫܌ڦӱăኟᅺසُLjԨ೺ሗኾᅜĐิ࿿ᄱฆᄽࣅิׂ đྺዷ༶Ljᄥ൩କܠ࿋ጆॆLj৽ิ࿿ᄱڦरຍገᅎĂ࿮ਪ߾ᅝڦยऺᇑํแĂ৛ᅮURSڦॺ૬ڪඤۅࣆ༶৊ႜକ༑༪Ljထྭ঺ᆯدխํᆩኪ๎Ljӻዺႜᄽཞඦ்ٶ઺ኄᅃߵएă ዾ઺ߵएLjႜ࿘ዂᇺăړူLjሞܠዖᅺ໎ࠌཞፕᆩူLjิ࿿ᅅᄱႜᄽ৊෇କۙኝ೺Lj ᆛԑႜᄽՎࣅLjࡳํጲวएإLj ഓᄽ֍ీٗඹᆌܔ཈቟Lj૬ፁփӨኮںă Ջ᪦̺᩵ʵథঅᕉᐳ઩̾ ⅳ ˁᆉᦐᣎMarket News еతᱨڵDomestic NewsᲝతᱨڵWorld NewsతૣಲॻԷNew Technology 20ु֚ႋᩙ20th Anniversary Special Edition 14Ꮑᄦᬒ䊸็ٰ⮱ݣ㢜ᠾᝅ/ݧႹAddressing the increasingly diverse challenges of pharmaceuticals 16ߍ䕌ࣹ䒙ಸࡼहᲱᐧ⩌প⻾႓㵹͇जᠮ㐚᱗Გ /ตૢዱAccelerating the dual transformation and collaboratively building asustainable future for the life science industry 19倅ჳ䬚ឭᱜͧ㢜৮Ⴖڕ⩌ϔԊ侫៑㝗/ตૢዱHigh containment technology to ensure the safety of pharmaceuticalproduction 22ٵ㵹̭ₒ喑և⌞̭ᅯ/ݤݚ٢Take the lead and go deeper 25᝻ᵦ͚పݺा߈㖇/ݤݚ٢Rooted in China, moving forward 28Вឭᱜ䲖᫝হ᰺ࡴߎ㏔䉸㘪㵹͇倅䉕䛼ࣾᆂ/ตૢዱEmpowering the high-quality development of the industry with technolog-ical innovation and service upgrading 30ϧጒᮧ㘪侞ߕ⮱㢜৮▜ᷭឭᱜ/Ӥܻ੐$UWL¿FLDOLQWHOOLJHQFHGULYHQGUXJLQVSHFWLRQWHFKQRORJ\ 32㢜৮⩌ϔ䒓䬡ۭࡃ⾧䄰㈨㐌⅁䨮ბ䃫䃎ᣏ䃕/ିၠሊDiscussion on the design of airlock room for pharmaceutical productionZRUNVKRSSXUL¿FDWLRQDLUFRQGLWLRQLQJV\VWHP 36ࡃ႓࣌᫆㢜⩌ϔധౝᏌ⅁⇨⤳ᩦ઱ᣏ䃕/ۭڪᇮଢLjDiscussion on Improvement of waste gas treatment in chemical raw materialproduction baseࡦᠺˁᢙIndustry Observation 42݈ ᫝Ƞ䯳᜽ȠⰡ㻯Ƞᮧ㘪᫝̭Аࢸ❴ᱧ/༬ݤInnovative, integrated, intuitive, intelligent , new generation tablet press 44ᣏ㉏ᰡ㐬㞟ᮧ㘪⮱᱗Გ/ݧႹExplore a greener and smarter future 47㢜Ю᪝ႄࡃ䒙ಸ჋䌢̻ᠾᝅ/ตૢዱPractice and challenges of pharmaceutical enterprises' digital transformationႋ҆ᎻѺ/ᅱႆᚸ؏ˁӝᅱ̐Commercial manufacturing 51⩌➖ݣ㢜ឭᱜ䒙⼨⮱䯫◦ܳᲽ/ဲୣࣀ$QDO\VLVRIWKHGL൶FXOWLHVLQELRSKDUPDFHXWLFDOWHFKQRORJ\WUDQVIHU 54 CIP䓴⼸͚⮱፥㻮䬛䷅/ᆴॅૢLjڪCommon problems in CIP process ᄬ൓ᄬ൓Contents 1998ࣩѰѦ/జѦ/ൿజ20஽њྗ/2023ࣩቻ12ధᵧফቻ647ధᵨ˖እӤͦ ᵹˎڅల೑ࢱˁᐆՃ͏˖ҠӤͦ ᵹల೑ࢱˁήৃᆈሺᬊˎڅల೑ࢱˁᬮٻДԺˎڅల೑᝱ܣᤀњԧফДԺڅ᫼ᮆᪿ ᵹGerd KielburgerњྗӤͦ ᵹฮሥࢱˁ፻ᣛᦁᵹ ڞژӉ̒ࣁᜬۙӔჿʱࣲܯᛛ22Թᵧ100037ᵨᇢ᪹ ᵹѭਾॾ˖፻ ᵹᑂ᭙఻ࢁҕ˖፻ ᵹᥨ˗ባͬԞ੧ᛘ˖፻ ᵹᔁᖞࢍ፻ᣛᦁ ᵹᝬ᮲ดڐय᠁́፻ᣛ ᵹᑂ᭙፻ᣛᦁၺណ ᵹ+86-10-63326091E-mailᵹprocess@vogel.com.cnឫᏟఠңၺណ ᵹ+86-10-63326083ԞᛘӤͦ ᵹฮሥࢱˁ፻ᣛᦁԞᛘᔬځ ᵹڅЦܨДटԞᛘњྗվధ ᵹజѦڅ᫼಍хᤃፕњྗྤԹ ᵹISSN 1674-5922څЦፉʮᤃፕњྗྤԹ ᵹCN 11-5669/TࣰծԞࣂჽᝥԹ ᵹ̒ᜬࣁᄚࣰჽߑ20170180ԹੵӶ ᵹӉ̒ӧ้ӛैᓛӶѼఝᬄДԺ᝘̀ ᵹ̘ඖࣀ10Ђ/ధࣰծফ̴ဨ ᵹӉ̒లࢱफ਷͓ެࣰծఝᬄДԺᵹ ڞژӉ̒ࣁᜬۙӔჿʱࣲܯᛛ22Թᬊ2Թഅ3ᵧࡆ100037ᵨ3rdFloor, 2ndBuilding, No 22, Baiwanzhuang Street, Xicheng District,Beijing, 100037ၺណᵧTelᵨᵹ+86-10-63326090ʴ้Telᵹ13917264254 17755450823ᔑࢮTelᵹ18662595387ࠧटTelᵹ13683598646ࣰࢮTelᵹ13922411786᥷ࢮTelᵹ18810368957ӦᤧTelᵹ18510064198 ි᫱Telᵹ18545558115ԳຩژӔᐆፆܢ ᵹJ&M Media Corporationၺណ(Tel)ᵹ+886-4 2296-5959Мࣰ̬ծ̴ဨ ᵹᵹ څ५Vogel Communications Group Tel: +49-9314182988ਊܯѵ ᵹFerdinando Salaris Tel: +39-3388285021ᵹ ܚ၃Vogel Communications Group AG Tel: +41 44 722 77 00฀З ᵹRaven Media sp.zo.o. Tel: +48 71 7823184Ӄྜѵ ᵹMediaCity Magyarország Kft. Tel: +36 1 445302413૰Ј ᵹMM publishing s.r.o Tel: +42-0-267216405ᵹ ѵژݏTechnik & Medien Verlagsges.m.b.H. Tel: +43-1-876 8379 0ᕪЗ ᵹS.I.P.A.S Tel: +31-299671 - 303ංѵை ᵹS.I.P.A.S Tel: +31-299671 - 303ᵹ څᔥVogel Europublishing Inc. Tel: +44 800 3101 704ᵹ څᎶVogel Europublishing Inc. Tel: +1 925 803 1265Ңઽܯ ᵹVogel Europublishing Inc. Tel: +1 925 803 1265஽బ ᵹJapan Advertising Communications, Inc. Tel: 81-3-3261-4591ᵹ څ᭵Jes Media, Inc. Tel: 82-2-481-3411/3ljฮሥࢱˁNJᄁ้ܨήৃၷల೑ࢱˁήৃᆈሺᬊᤧ᣶ྗశᝬԲ஬ध፻គ५څफ਷͓୞ᬮٻᄁవॺPROCESSDŽInternational Editorial of LiuCheng GongYe islicensed fromPROCESS.ྗశܝ௑ ᵹబѦሴ̿ྗ శ੕ఝᵫపጺЁᝬᵫʷॡᢸᣉDŽݗ஻˺Іྩ ൫ឤ௑ᵫͲᏟ੽ሴӸ᜴˕Նை૶శਿѦጥ̥ѦྤԚᎡቚǃ३ήǃ३ӧ̶ᄨࣻྗశDŽ 56⩌➖㢜ᬍ㣹ጒ㞧჋䌢ᕨ㐀/ዜᨘPractice summary of sterile process for biological drugs 60व᜽⩌➖႓㏼ڥᵵҸ䬛䷅ܳᲽ/ڪዜᄝLjAnalysis of classical cases in synthetic biology 62㇫⯷⩕ᝤ䰭Ⅿ⮱ᣏ䃕/ࡔໄഔDiscussion on lean user requirements 65๔ಸDCS㈨㐌ౕव᜽⩌➖႓⩌ϔ͚⮱Ꮑ⩕/ቶ෌Application of large-scale DCS system in synthetic biological productionۋᅱ̐ჽManufacture Practice ᩵ፋૣಲʸइᘨProcess Technics 66⇥㚫ݣㆿᱧ⮱፥㻮䬛䷅ܳᲽࣷᄦゃ/ྦྷຩୄAnalysis and countermeasures of common problems in boiling granulators 70倅㇫Ꮣ๞䛺ᐼય᫆ᱧ 喟䔋㐚ݣ㢜ጒ㞧⮱ᵥᓰ /Sharon NowakHigh-precision weight-loss feeder: the core of continuous pharmaceuticalprocess 74᪝ႄࡃౕݣ㢜⩌ϔ㏬͚⮱Ꮑ⩕/ڪ᪮ഽLjApplication of digitalization in pharmaceutical production line 77ᮧ㘪∮ۭბᣔݣ㈨㐌Ꮑ⩕ᣏ䃕/Ԑࢤ૚Discussion on the application of intelligent clean room control system 80ݣ㢜䒓䬡͚Ꮑᄦࢸ߈俑ࡴ⮱࢘⩌㼐۠᫦ᵵ/௝߃ Health solutions for dealing with sudden pressure rise in pharmaceuticalworkshops ʸኜԷࡊ᷁ࡅLaboratory and R & D 82ധλₐϑ䄂侹х䔶䚸䚥䧆䷄ㆿݣิጒ㞧/ো૧૧Ljڪ Optimization of preparation process of calcium acetate granules based onorthogonal experiment ؏ҶεਦནBuyer's Guide 85ϔ