制药工艺与装备6：生物制药工艺与工程
122025ڼ12 ᄱ߾ᅝᇑጎԢ!!ิᄱ߾ᅝᇑײ߾ 生 物 制 药 工 厂 G M P培 训 改 进 ᅝ߾रຍᇑײࡗ56͚㢜ధҀݯݣ䔋㐚ݣ䕍➖᫆䓀䔮㈨㐌䔈ᆂ ִ࠵ႜᄽ12ᱽ࠲ڲ㢜⩕⣨⦰ݯ∕ᄱ⮱अᰡⵁ⾣≲Ჽ ײ߾ጎዃ߾53 ࡃ႓࣌᫆㢜䒓䬡䃫䃎ࣷࣾᆂ䊸߬ᣏ䃕 ǒืሮࢺˊǓ͘ނᎄ 1998ظ/ሆ/ሆ20නӲ/2025ڼ12ڼDŽጺ671Dž րނ˟͊ ິࠅᆶ၌ߢ࠽دߦޡ߾ǖԛऐپጺߢ࠽ںǖԛဇ൶ӥྤግٷন22ᇾࡽ2୍ࡽ3֫ᆰՊǖ100037Add.: 3rd Floor, 2nd Building, No 22, BaiwanzhuangStreet, Xicheng District, Beijing, 100037ࣆۉTelǖ+86-10-63326090࡛ฉTelǖ13917264254 17755450823໋ዝTelǖ18662595387ހਸTelǖ13683598646ኣዝTelǖ18810368957ళཚTelǖ18510064198ฬᄞTelǖ18545558115ྗں൶ஏتǖJ&M Media CorporationࣆۉTelǖ+886-4 2296-5959 ࣷࢇᄽ߾ऐႁࡔ࿋ǖዐڇ࠶ዷዷӸڇ࿋ǖऐႁ߾ᄽ႑တჺ৯ᇾዐࡔऐႁ߾ᄽणཷᆶ၌ࠅິӲڇ࿋ǖୁ߾ײᄽՊडևںǖԛဇ൶ӥྤግٷন22ࡽᆰՊǖ100037 ڎဍᣝ Ҟ˟͊ނր ڎဍಞऋࣹङᗘᄇᜦϤᩐቡ߸և߱ ᦌ۲Ϥ֙ᔵլ߷ڎᅵ๒ணᒬঽᦀ ࣻᔮᖱ มǖঁჱԐޭǖมᛉਚލቧዜბᆗዷՊǖࢲ ৢᛉޭዷՊǖตૢዱࢆ݀ ݤݚՊडևǖ٢ቧলႸ෴ࣜ᫇ቛᇸ 匔ⷶ⍒ⷶ⢆ ǖپߢ࠽ഄǖࡔڤVogel Communications Group GmbH & Co. KGTel: +49 9314182988ǖࡔெGardner Business Media, Inc.Tel: +1 5135278800૧ǖٷᅪFerdinando Salaris Tel: +39 3388285021๗ǖVogel Communications Group AGTel: +41 447227700հનǖRaven Media sp.zo.o. Tel: +48 717823181যਖ਼ǖMM publishing s.r.o Tel: +42 0775245802૧ǖںӎTechnik & Medien Verlagsges.m.b.H.Tel: +43 187683790Ⴅც૧ǖMüszaki Média Kiadó Kft.Tel: +36 203967942ǖࡔGreen World Medida (Thailand) CompanyLimited Tel: +66 27311191ǖࡔࡣMM MaschinenMarkt Korea Co., Ltd.Tel: +82 1084065100 DŽӀᅼಇႾDž ߵӊॐᘀᩤᬈᬈᮻᬈᩤᬈᤉᬈቡழᬈ߱ Քپᬈሮʸ໘ၷʸᗉЋ᭕ ̷сюᰴ ूࠂᰴභᔥੇрမڎ͵ ᳧ ࣼथॴކᗘһޏһᭇҽౄฉౄйౄᴝౄᇼڎౄౄູౄຎູ ್ᇖ໘ѶҧकѶຍ್ѶՔ̈ҪߦѶ ᯱᰏ ᯱ୳ ᯱᆰ ᯱ௴ˌˌ࠵ඐൗϤ߷༿˰ᓍ ͊उУՃ᳁ԾΫᔚᏤˌࠃංסᬝᨷ᭢ၿ༷᩸ᓨࠃဍဍΈᭋဍйဍРဍՔᣝဍ ̈᱐ΈᲞں᱐न᱐අᮊں៙ௌ१ழᓢ ᫆᫂ࡻᭇ˗ӨޅՁҽՁ ̆ห˿ ̆ˇঽ᧧ѸܙභεඅसНसቡूससழᡏဗ࣌ᡏᡏ၊ևևߺևᏕևᥴᤌᥴঃ̈ Պडևۉࣆǖ+86-10-63326091E-mailǖprocess@vogel.com.cnࣆǖۉခޜኁ܁+86-10-63326083 ݀݀ᄽՊडև߾ײ࿋ǖୁڇႜႜ݀ਸࠅాྔࡔྷǖݔႜӲዜǖሆࡔाՔጚჄӲࡽǖISSN 1674Ċ5922ࡔాཥᅃჄӲࡽǖCN 11Ċ5669/Tᆇǖԛձ࡛ื֒ᆇຘᆶ၌ࠅິ ۨॏǖ10ᇮNj ሗڦխणཷدߦޡࡔڤ๕ՊᅳݛӲႹࡗᄽ႑တჺ৯ᇾཚ߾ྔ႑တᆯऐႁ࡛ڦᄽė߾ײĖୁኾPROCESSăInternational Editorial of LiuCheng GongYe is licensed from PROCESS.Ӳำ ǖԨߡॲӲᆶLj࿄ঢ়ሎႹLjփڥገሜăස๚ံ༬ຫLjፕኁཨߡनྺཞ้ኽतྪበĂྲ႑Ăྲձᅜ၎ᆌӲă 1IBSNB5&$ ⵖ蚋⚌錠곸〿 ۉጱሗኾ൩ݡ࿚https://pharm.jgvogel.cn/dzzz/ ᆅߢ࠽Advertiser Index 357212335SieversݴဆᅏDŽྰ૬ჯDž39ኅॿಋጲ੦ᅏᆶ၌ࠅິ43౷ߦDŽฉ࡛Džஹᅟᆶ၌ࠅິ51۫ෘڤభऐႁरᆶ၌ࠅິ61ฉ࡛ഔ᮱ํᄽᆶ၌ࠅິ65ڱఐ߾ᄽยԢDŽฉ࡛Džᆶ၌ࠅິ79 ݤ༬DŽዐࡔDžᄱरᆶ၌ࠅິฉ࡛ᅪ݀ஒᄱยԢᆶ၌ࠅິິࠅᆶ၌ڢ࠶ᄽ༬ዖ߾໒۫࠽ટຯҾඇ݅ோDŽཀৄDžᆶ၌ࠅິฉ࡛ᇺҾୁ༹ยԢरᆶ၌ࠅິࡔᆈFLYGERິࠅோᆶ၌݅ߦટޡԠ๘रຍDŽฉ࡛Džᆶ၌ࠅິ ྲႾײ႑ၭ ᄱ߾ᅝᇑጎԢ 2025-12 ୁᄽ߾ײ12025-12 ୁᄽ߾ײ1 ܻӤڦඇኽԈጎऐ༵ࠃఇࣅકቛڦဣཥLjํ၄ሞ߀ሰืपP73 ᇀܔCDMOઠຫLjԈጎยԢࠃᆌฆᆌਏԢยऺฉऐኽీ૰ڦ࢈P72 遤⚌錜㻋*OEVTUSZ0CTFSWBUJPO 40⩌➖ݣ㢜ጒࢯGMPദ䃚ᩦ䔈/ᄮዐࣀImprovement of GMP training in a biopharmaceutical plant 08≲Ჽݣ㢜㵹͇䃎䔪䍗⮱ノ⤳/ྦྷਬA brief analysis of audit trail management in the pharmaceutical industry 44㵭⋟ݣ৮ܳ㷲கڤ⌲∮∂℁ᄦܳᲽ /࿊ዜ༢ᄘଳཚିཀႧ֍࣪க࿊ਭࣱ&RPSDUDWLYHDQDO\VLVRIFOHDQLQJPHWKRGVIRUEORRGSURGXFW¿OOLQJDFFHVVRULHV 12∕ᄱݯ㢜⩕⣨⦰࠲ڲᱽ⮱अᰡⵁ⾣≲Ჽ /ឌૢનኌᇱᅸ֔ᅉዜ႓ుᏕרA brief analysis of change studies for injectable medicinal glass primarypackaging materials 48⩌➖ݣ৮➖᫆䉕䛼ᴴ۳⮱ߕᔮᐧ⿸ゃ⪒ /ྦྷॅṫቧᇣᦿྣኆࢦStrategy for dynamic establishment of quality standards for biologics rawmaterials 19ᥧڞ䔈喑ក䕇ⵁϔ෮ಿÿÿ㤟➦͚ప≈䭠ⵁ䃕чߌͫߋ /ݤݚ٢Joining hands to break down R&D-production barriersĊsuccessful holding ofFette China Luoyang seminar 䊨⾊鄳縨䊨玐 'BDJMJUJFTBOE&OHJOFFSJOH 22㢜৮ڞ㏬⩌ϔ͚⮱⌲∮侹䃮̻䷻䮖ノᣔ/ྦٳCleaning validation and risk control in multi-product pharmaceutical manufacturing 53ࡃ႓࣌᫆㢜䒓䬡䃫䃎ࣷࣾᆂ䊸߬ᣏ䃕/٢૬ᄊӣ൭ሆ०ਬᚴDesign and development trends of chemical API production workshops 24ᒏ̸߬㢜৮⩌ϔЮ͇ദ䃚Ҁ㈨хࡃ⮱݈ⵁ⾣̻ᣏ㉏ /ձބቧ࿀މInnovative research and exploration on optimizing training systems inpharmaceutical manufacturers under the new landscape 鵂玐䪮助♸䊨蒌 1SPDFTT5FDIOJRVFT 282025࣌᫆㢜ٵ䔈ጒ㞧̻व㻱ᮧ䕍䌢ឭᱜϑ≮чߌͫߋ 56 ͚㢜ధҀݯݣ䔋㐚ݣ䕍➖᫆䓀䔮㈨㐌䔈ᆂ /ၢᄊႸਚᆖרಯ݀ၰূஆၭඵಌڭAdvances in material handling systems for continuous manufacturing of solidTraditional Chinese Medicine preparations /ตૢዱSuccessful holding of the 2025 API advanced process & compliant smartmanufacturing practical seminar 30㯴㗳ጊ䉊⋟Ⱑᣒᣒ㼓㢜৮࠲㷲ᱽ᫆अᰡ⮱㢜႓ⵁ⾣ 62䲋ᰭ㏵▚㣹ᬍ㣹ݯݣB㏔∮ۭࡧ➖᫆䓀ڒ⮱䬛䷅ܳᲽࣷᄦゃ /ඖ֒ቧ᥀ࣀቧၤᅿ࡛ࢲॺPharmaceutical research on changes in primary packaging materials for ShedanChuanbei oral liquid ᣏ䃕/ஆᢚߑ࿔ྦྷ՝ቧीಣẎظᄘAnalysis and countermeasures for material entry into grade B clean areas fornon-terminally sterilized aseptic preparations 暵ⵆ瘻ⴢ 欰暟ⵖ蚋䊨蒌♸䊨玐#JPQIBSNBDFVUJDBM1SPDFTTBOE&OHJOFFSJOH 66ݣ㢜⩕Ⅱ㏵〜䊲␑̻侹䃮/ൣᄙᄾვᅫ8OWUD¿OWUDWLRQDWSRLQWVRIXVHDQGYDOLGDWLRQLQSKDUPDFHXWLFDOZDWHUV\VWHPV 36㢜ݣ⩌➖300 L⠙⿸⌤व㑽▚㣹ጒ㞧侹䃮ⵁ⾣ 69Ⅱั⤳㈨㐌ࣺ⍄䔼㛉ൢܳᲽࣷ⌲≄∂≲Ჽ/ቧሂẎ๏ሊAnalysis of RO membrane fouling and cleaning methods in water treatmentsystems /ഔ༢ߛቶ๘ࢢቧߑרᄘᆨValidation study on sterilization process for a 300 L independent mixing vesselin biopharmaceutical manufacturing Contents ᄬ णׂׯ၍ᆫࣅ࠶ဣཥڪຕጴࣅ߾ਏ๑ْܾ Ԉጎऐၳ୲݊P73 暟崨♸⺫鄳 -PHJTUJDTBOE1BDLBHJOH 72ᴁᕔࡃ̻ႄࡃ 喟CDMOЮ͇ι⁎࠲㷲ឭᱜࡴ㏔䌜ᒱᣏᲽ/՝ࡓFlexibility and digitalization: exploring upgrade paths for secondary packagingtechnology in CDMO enterprises 㹊낉㹔♸灇〄 -BCPSBUPSZ3% 74䙿叱͚㢜些❴◛ݣጒ㞧ᩦ䔈ⵁ⾣䔈ᆂ/ॅᬋרResearch progress on processing technology improvement for wine-processedpolygonatum cyrtonema hua (Jiu Huangjing) Traditional Chinese Medicinedecoction pieces 77ϻ㢜ڥᢏ❵䄵➈俕㘣௷⩕ᬻ㘣⩌ϔЮ͇अᰡノ⤳ /๘ಶרਖ਼ᄝ๘ࣷרDiscussion on change management for gelatin manufacturers for bovine bonecapsules from the perspective of pharmacopoeia edition u
