BIOSTAT B-DCU BIOSTAT B-DCU 2

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1 BIOSTAT B-DCU

2 BIOSTAT B-DCU BIOSTAT B-DCU 2

3 BIOSTAT B-DCU BioPAT MFCS DeltaV BIOSTAT B-DCU UniVessel Glass UniVessel SU 3

先进工艺溶液可放大性和数据完整性 l 罐体设计几何结构相似 l 持续一致的混合和充气策略 l 相似的用户界面和控制器 DoE DoE

培养基和补料优化 Design of Experiments Multivariate Data Analysis 工艺开发工艺参数优化

提供多种模块以满足您的特定需求这款软件设计为即插即用工具非常适合记录储存和可视化您的 BIOSTAT B-DCU

网络的能力 4 先进 21 CFR 11 部分符合型 BioPAT MFCS 是一款功能丰富的 GAMP 4 类软件套件

4 先进工艺溶液可放大性和数据完整性 l 罐体设计几何结构相似 l 持续一致的混合和充气策略 l 相似的用户界面和控制器 DoE DoE Design of Experiments MVDA MVDA Multivariate Data Analysis 克隆筛选培养基和补料优化 Design of Experiments Multivariate Data Analysis 工艺开发工艺参数优化临床试验 BioPAT MFCS SCADA监测工艺开发和工艺传输加速需要工艺数据和控制的无缝可放大性和整合 BioPAT MFCS 提供多种模块以满足您的特定需求这款软件设计为即插即用工具非常适合记录储存和可视化您的 BIOSTAT B-DCU 和其他第三方装置的工艺设备的工艺数据这款软件可让您通过使用我们预先配置的生物工艺优化解决方案来增强您构建专属的 SCADA 网络的能力 4 先进 21 CFR 11 部分符合型 BioPAT MFCS 是一款功能丰富的 GAMP 4 类软件套件能够支持要求最为苛刻的研究或生产环境除了拥有完全成熟的 SCADA 系统的核心功能外 BioPAT MFCS 和 BioPAT DCU 的共同组合是最具成本效益和灵活的平台为生物工艺应用程序专门定制

5 DoE MVDA 制造 Design of Experiments MVDA Multivariate Data Analysis MVDA Multivariate Data Analysis 工艺鉴定稳健性测试 Online Multivariate Data Analysis 商业制造方案用于可靠的监管控制和数据采集 CO2 S88 模块网络连接性 Lac 21 CFR Part 11 5

6 BIOSTAT B-DCU 19 / Connect UniVessel Glass 1 L, 2 L, 5 L 10 L 6

7 1:200 Sartorius Cubis Quintix Secura Sartorius Connect UniVessel SU 2 L 7

8 1:200 BIOSTAT B-DCU Max 60.0% Cascade 1 Air Max 30.0% Cascade 2 O 2 Cascade 3 Stirrer Max 7.5% DO DO DO BIOSTAT B-DCU Min 5.0% Min 0.0% Min 0.5% Oxygen Demand DO Air lpm Air lpm Air lpm O 2 lpm O 2 lpm O 2 lpm Stirrer rpm Stirrer rpm Stirrer rpm Oxygen Demand Oxygen Demand Oxygen Demand - DO DO 8

9 Advanced Additive Flow Advanced Additive Flow Advanced Additive Flow O 2, N 2 CO 2 1:1200 BIOSTAT B-DCU 1 L 10 L Advanced Additive Flow Sartorius O 2 enrichment Additive Flow Additive Flow O 2 O 2 Enrichment 3 2 O 2 O 2 (DO) DO 9

10 BioPAT BIOSTAT B-DCU PAT BioPat ViaMass BioPAT ViaMass l l BioPAT Trace BioPAT Trace BioPAT Xgas BioPAT Xgas O 2 CO 2 l 10

11 BioPAT Fundalux BioPAT Fundalux l 1,5 10 mm l LED 10 Hamilton Arc (ph DO) ARC, l ph DO l ph l VisiFerm l ArcAir GMP 11

12 12

13 l BIOSTAT B-DCU l l DCU BioPAT MFCS l BioPAT ViaMass l DCU BioPAT MODDE MFCS QbD BioPAT MFCS l BioPAT MFCS DoE DoE 13

14 14

$l BIOSTAT B-DCU BioPAT MFCS l O 2 CO 2 l BIOSTAT B-DCU \ l l$

15 l BIOSTAT B-DCU BioPAT MFCS l O 2 CO 2 l BIOSTAT B-DCU \ l l l BioPAT MODDE MFCS QbD BioPAT MFCS l BioPAT MFCS DoE DoE 15

16 ambr 250 ml 250 UniVessel 2 L SU 2L STR 50 L50 L STR L L BIOSTAT B-DCU 8 ff. ICH Q

MVDA 模块 DoE MVDA Design of Experiments DoE

BioPAT MFCS win 内 l Multivariate Data Analysis

以减少数据管理相关的工作量并比较当前和历史批次释放工艺理解以最终改善您药品的质量

17 可使用 BIOSTAT B-DCU 和我们的 BioPAT 化学计量学工具箱来轻松实现工艺特性鉴定 SCADA BioPAT MFCS DoE 模块 MVDA 模块 DoE MVDA Design of Experiments DoE MVDA BioPAT MODDE BioPAT SIMCA 确定关键工艺参数及其最佳范围并预估设计空间比较批次与规模确定重要删除趋势相关性模式和关系充分利用 BioPAT 化学计量学工具箱并将先进的多变量分析方法整合进您的工艺控制软件 BioPAT MFCS win 内 l Multivariate Data Analysis 从您的 BIOSTAT B-DCU 将数据传输到 BioPAT MODDE 和 SIMCA 以减少数据管理相关的工作量并比较当前和历史批次释放工艺理解以最终改善您药品的质量安全性和效率务必要理解模型代表商业工艺的程度包括任何可能存在的差异因为这种差异会对从模型提取的信息相关性造成影响 FDA 工艺检验指南 17

18 SCADA BIOSTAT B-DCU BIOSTAT B-DCU BioPAT MFCS Turnkey SCADA BioPAT MFCS SCADA BIOSTAT ambr Sartorius DCU Modbus DCU OPC Siemens Simatic PCS 7 Rockwell DeltaV BIOSTAT B-DCU DeltaV, Modbus DeltaV 18

19 Windows BIOSTAT B-DCU Microsoft : BIOSTAT B-DCU BIOSTAT B-DCU IT Microsoft Windows Microsoft Corporation 19

20 l IQ OQ l 1 2 Sartorius l 3 l 4 SAT SCADA BioPAT MFCS 21 CRF Part 11 MFCS l Sartorius l ISO Microsoft Windows Microsoft Corporation 20

Sartorius l (IQ OQ) ISO 17025 GLP GMP FDA

21 Sartorius l (IQ OQ) ISO GLP GMP FDA l GMP Windows 3 BIOSTAT B-DCU SAT 10% 10% 21

30 kg ( 66 lbs) (W + H + D) 490 mm + 730 mm + 535 mm (19.3" + 28.7" + 21.

22 30 kg ( 66 lbs) (W + H + D) 490 mm mm mm (19.3" " ") V, Hz, 4 A AISI 304 EN IP 30 19" 85 dpi SCADA Modbus TCP USB 6 + CE OSHA NRTL 22

23 45 kg (99 lbs); (W + H + D) 360 mm mm mm (14.2" " ") 230 V ( 10 %) 50 Hz 10 A 120 V ( 10 %) 60 Hz 12 A ~ 190 kwh AISI 304 IP (22 psi) d = 3.2 mm (0.13") d = 6 mm (0.24") / = 4 d = 8 mm (0.31") 12 dh 1.5 (22 psi) V ma 24 V V CE OSHA NRTL 23

24 200 W (400 W ) 200 W (400 W ) 1L Glass 20 2,000 rpm 2L Glass 20 2,000 rpm 5L Glass 20 1,500 rpm 10L Glass rpm 2L rpm 1L Glass 20 2,000 rpm 2L Glass 20 2,000 rpm 5L Glass 20 1,500 rpm 10L Glass rpm UniVessel Glass UniVessel SU Pt C ( 0 80 C) 0.1 C % 0.1 % DO % 0.1 % ph 2 12 ph 0.01 ph ph ph ph 0.1 ph Level 1 NIR 0 6 AU 0.01 AU ph 1,000 1,000 mv 1 mv 7 kg (15.4 lbs) max. 1 g (0.035 oz) 60 kg (132.3 lbs) max. 10 g (0.35 oz) 60 kg (132.3 lbs) max. 10 g (0.35 oz) 75 g/h 6050 g/h mbarg ( mbarg) 1 mbar 0 40 g/l 0.01 g/l 0 10 g/l 0.01 g/l pf/cm or E 6 cells/ml 0.1 pf/cm or 0.01 E 6 cells/ml O vol % 0.1 vol % CO vol % 0.1 vol % d = 3.2 mm (0.13") d = 6 mm (0.24") 24

25 UniVessel Glass MO O 2 Enrichment Additive Flow 2 8 ff lpm 2 1 : % % 2 1 :10 5 % 2 UniVessel Glass CC () UniVessel SU Additive Flow 4 O 2, N 2, CO ff. 2 (/ 20 lpm : % % 6 1 :10 5 % 6 25

26 5 / 44 / rpm rpm Watson Marlow ID: 0.5 mm (0.2"): ml/min ID: 0.8 mm (0.31"): ml/min ID: 1.6 mm (0.63"): ml/min ID: 2.4 mm (0.94"): ml/min ID: 3.2 mm (1.26"): ml/min ID: 4.8 mm (1.89"): ml/min ID: 0.5 mm (0.2"): ml/min ID: 0.8 mm (0.31"): ml/min ID: 1.6 mm (0.63"): ml/min ID: 2.4 mm (0.94"): ml/min ID: 3.2 mm (1.26"): ml/min ID: 4.8 mm (1.89"): ml/min ID: 0.5 mm (0.2"): ml/min ID: 0.8 mm (0.31"): ml/min ID: 1.6 mm (0.63"): ml/min ID: 2.4 mm (0.94"): ml/min ID: 3.2 mm (1.26"): ml/min ID: 4.8 mm (1.89"): ml/min ID: 0.5 mm (0.2"): ml/min ID: 0.8 mm (0.31"): ml/min ID: 1.6 mm (0.63"): ml/min ID: 2.4 mm (0.94"): ml/min ID: 3.2 mm (1.26"): ml/min ID: 4.8 mm (1.89"): ml/min Watson Marlow WM rpm DCU =

27 UniVessel Glass 8 C 60 C 1 L 2 L 5 L 10 L: W UniVessel Glass 8 C 80 C 1000 W UniVessel SU 50 C 2 L 200 W UniVessel SU 50 C 1000 W 27

Sales and Service Contacts For further contacts, visit www.sartorius-stedim.com Europe Americas Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen Phone +49.551.308.

28 Sales and Service Contacts For further contacts, visit Europe Americas Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse Goettingen Phone Fax Sartorius Stedim Systems GmbH Robert-Bosch-Strasse Guxhagen Phone Fax France Sartorius Stedim FMT S.A.S. ZI des Paluds Avenue de Jouques CS Aubagne Cedex Phone Fax Sartorius Stedim France SAS ZI des Paluds Avenue de Jouques CS Aubagne Cedex Phone Fax Austria Sartorius Stedim Austria GmbH Modecenterstrasse Vienna Phone Fax Belgium Sartorius Stedim Belgium N.V. Rue Colonel Bourg Bruxelles Phone Fax Hungary Sartorius Stedim Hungária Kft. Kagyló u Budakeszi Phone Fax Italy Sartorius Stedim Italy S.r.l. Via dell Antella, 76/A Antella-Bagno a Ripoli (FI) Phone Fax Netherlands Sartorius Stedim Netherlands B.V. Phone Fax filtratie.nederland@sartorius-stedim.com Poland Sartorius Stedim Poland Sp. z o.o. ul. Wrzesinska Kostrzyn Phone Fax Russian Federation LLC Sartorius Stedim RUS Uralskaya str. 4, Lit. B St. Petersburg Phone Fax Spain Sartorius Stedim Spain, S.A.U. Avda. de la Industria, 32 Edificio PAYMA Alcobendas (Madrid) Phone Fax Switzerland Sartorius Stedim Switzerland AG Ringstrasse 24 a 8317 Tagelswangen Phone Fax U.K. Sartorius Stedim UK Ltd. Longmead Business Centre Blenheim Road, Epsom Surrey KT19 9 QQ Phone Fax Ukraine LLS Sartorius RUS Post Box 440 B Kiev, Ukraine Phone Fax USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 200 Bohemia, NY Toll-Free Fax Argentina Sartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires Phone Fax Brazil Sartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP SP- Brasil Phone Fax Mexico Sartorius de México, S.A. de C.V. Libramiento Norte de Tepotzotlan s/n, Colonia Barrio Tlacateco, Municipio de Tepotzotlan, Estado de México, C.P Phone Fax leadsmex@sartorius.com Peru Sartorius Peru S.A.C. Av. Emilio Cavenecia 264 San Isidro Lima, Perú Phone Fax Asia Pacific Australia Sartorius Stedim Australia Pty. Ltd. Unit 5, 7-11 Rodeo Drive Dandenong South Vic 3175 Phone Fax China Sartorius Stedim Biotech (Beijing) Co. Ltd. No. 33 Yu an Road Airport Industrial Park Zone B Shunyi District, Beijing Phone Fax Sartorius Stedim (Shanghai) Trading Co., Ltd. 3rd Floor, North Wing, Tower 1 No Jinke Road Zhangjiang Hi-Tech Park Pudong District Shanghai , P.R. China Phone Fax Sartorius Stedim Biotech (Beijing) Co. Ltd. Guangzhou Representative Office Unit K, Building 23 Huihua Commerce & Trade Building No. 80 Xianlie Middle Road Guangzhou Phone Fax India Sartorius Stedim India Pvt. Ltd. #69/2-69/3, NH 48, Jakkasandra Nelamangala Tq Bangalore, India Phone Fax Japan Sartorius Stedim Japan K.K. 4th Fl., Daiwa Shinagawa North Bldg. 8-11, Kita-Shinagawa 1-chome Shinagawa-ku, Tokyo, Japan Phone Fax Malaysia Sartorius Stedim Malaysia Sdn. Bhd. Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil Kuala Lumpur, Malaysia Phone Fax Singapore Sartorius Stedim Singapore Pte. Ltd. 1 Science Park Road, The Capricorn, #05-08A, Singapore Science Park II Singapore Phone Fax South Korea Sartorius Korea Biotech Co., Ltd. 8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu SeongNam-Si, GyeongGi-Do, Phone Fax Specifications subject to change without notice. Copyright Sartorius Stedim Biotech GmbH. Printed in the EU on paper bleached without chlorine. Publication No.: SBI1555av Order No.: Ver

BIOSTAT A BIOSTAT A BIOSTAT A BIOSTAT A

BIOSTAT A BIOSTAT A BIOSTAT A BIOSTAT A BIOSTAT A 简单的自动化充气控制直观的 BIOSTAT A 操作甚至可在实验室以外实现操作 BIOSTAT A 采用全新充气系统可针对使用的各种气体提供持续的自动流量控制所以 BIOSTAT A 不要求手动调整流量计故而不存在脉冲曝气的问题生物反应器的使用设置非常简单只需连接充气管道配置充气属性