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1、制药业不同类型的灭菌设备不同类型的灭菌设备 饱和蒸汽 饱和蒸汽 过热水喷淋 过热水喷淋 蒸汽-空气混合 蒸汽-空气混合 高危高致病原灭活灭菌 高危高致病原灭活灭菌 胶塞处理 胶塞处理 旋转灭菌 旋转灭菌 百级层流干热灭菌除热原 百级层流干热灭菌除热原 低温灭菌柜 低温灭菌柜 物料消毒传递窗 物料消毒传递窗 Fedegari Autoclavi SpA Proprietary 制药业湿热消毒灭菌柜湿热消毒灭菌柜 FOA FOA 蒸汽蒸汽- -空气混合灭菌柜 空气混合灭菌柜 Fedegari Autoclavi SpA Proprietary 制药业动态灭菌动态灭菌 Fedegari Autocl
2、avi SpA Proprietary 制药业空气空气+ +蒸汽混合式湿热消毒灭菌柜蒸汽混合式湿热消毒灭菌柜 FOA和FOAF系列 FOA和FOAF系列 Fedegari Autoclavi SpA Proprietary 制药业空气空气+ +蒸汽混合式湿蒸汽混合式湿热消毒消毒灭菌柜菌柜 FOA和FOAF系列 FOA和FOAF系列 Fedegari Autoclavi SpA Proprietary 反压控制反压控制，防止容器变形或破裂 防止容器变形或破裂 制药业Moist-heat sterilizersMoist-heat sterilizers FOW 系列 FOW 系列 过热水水喷淋式
3、湿淋式湿热灭菌柜菌柜 Fedegari Autoclavi SpA Proprietary 制药业空气空气+ +蒸汽混合式湿蒸汽混合式湿热消毒消毒灭菌柜菌柜 FOA和FOAF系列 FOA和FOAF系列 反压控制反压控制，防止容器变形或破裂 防止容器变形或破裂 制药业Fedegari Autoclavi S.p.A. Proprietary 空气-蒸汽混合反压灭菌 无密封磁驱风机 无密封磁驱风机 无穿透箱体转轴无穿透箱体转轴，无 泄漏 无 泄漏 无机械密封无机械密封，无污染 无污染 无需润滑 无需润滑 高抗热磁驱系统 高抗热磁驱系统 高效高效，低能耗 低能耗 低转速风叶低转速风叶 无因泄漏而无法
4、保压 问题 无因泄漏而无法保压 问题 制药业预充注射器灭菌-参考布局 制药业预充注射器灭菌-托盘转移 制药业预充注射器灭菌-托盘设计 制药业预充注射器灭菌-机内车 制药业预充注射器灭菌-托盘设计 制药业预充注射器灭菌-装车就绪 制药业多室软袋过热水灭菌-摇摆式 制药业灭菌器设计关键因素灭菌器设计关键因素 压力容器压力容器pressure vessel pressure vessel 门门door/s door/s 管道和配件管道和配件piping & components piping & components 过程控制器过程控制器process controller process cont
5、roller 过程性能过程性能process performances process performances Fedegari Autoclavi SpA Proprietary 制药业制造加工技术和装备制造加工技术和装备 Fedegari Autoclavi SpA Proprietary 制药业PRESSURE VESSELS PRESSURE VESSELS 箱体 箱体 Fedegari Autoclavi SpA Proprietary 制药业滑动 滑动 铰链 铰链 门 门 Fedegari Autoclavi SpA Proprietary 压力容器 压力容器 制药业其它设计 其
6、它设计 门密封 门密封 Fedegari Autoclavi SpA Proprietary 制药业门密封 门密封 其它设计 其它设计 Fedegari Autoclavi SpA Proprietary 制药业门密封门密封 Fedegari 设计 Fedegari 设计 Fedegari Autoclavi SpA Proprietary 制药业门密封 门密封 Fedegari Autoclavi SpA Proprietary 无接点 无接点 特殊形状 特殊形状 无润滑 无润滑 非常长久的使用寿命非常长久的使用寿命 制药业管件和阀门管件和阀门 Fedegari Autoclavi SpA
7、Proprietary 所有接口为卫生型所有接口为卫生型 制药业THEMA4 THEMA4 灭菌柜过程自控系统灭菌柜过程自控系统 Fedegari Autoclavi SpA Proprietary 1.1. 开放式硬件结构开放式硬件结构，基于基于PC/PLC (Siemens和Allen-Bradley) 2.2. 基于实时操作系统的过程控制基于实时操作系统的过程控制 (Wind River VxWorks) 3. Windows-like视窗类软件操作界面 4.视窗类软件操作界面 4. 设计符合设计符合GAMP5规范 5.规范 5. 系统符合美国系统符合美国FDA 21 CFR, part
8、 11准 则 准 则 6. Ethernet LAN企业网络功能 企业网络功能 制药业THEMA4 HARDWARE ARCHITECTURE Fedegari Autoclavi SpA Proprietary THEMA4 STERILIZERS PROCESS CONTROLLER THEMA4 STERILIZERS PROCESS CONTROLLER BRANDS COMPONENTS Panel PC (L1, L2 ,L3) Remote I/O Thermal Printer UPS HUB Remote GUI (PC-Win) A4 Printer SW LANGUAGE
9、S ANSI C Java 1 ARCHIVE DATA AND FILES STORAGE 8 REMOTE STATION Panel PC L1 PCS Nucleus PGL FECP SRVR GUI + JWORKS Panel PC L2 Panel PC L3 FIELD BUS Log Data STERILIZER thermal printer HUB BUS board Conf. Data 2 BUS D IN D OUT AN IN AN OUT PW Converter 4-20mA/Pt100 3 RTOS + bootrom File config.I/O B
10、US board File config. Coverter 4-20/Pt100 PC WINDOWS RS232 PDF Data UPS local/ central Printer OS Windows Net-integration Leader in RTOS Archive management (BIN and ASCII filesI) with integrity check (FDA CFR21p11 compliance) REAL-TIME OPERATING SYSTEM RTOS RTOS is intended for real-time application
11、s as embedded systems (programmable thermostats, household appliance controllers, mobile telephones,.), industrial robots, spacecraft, defence systems industrial controllers (PLC, DCS, SCADA), and scientific research equipment. An RTOS allows the creation of a real-time systems, for mission critical
12、 applications, by an appropriate life cycle of software development. RTOS VxWorks VxWorks VxWorks is a Unix-like real-time operating system made and sold by Wind River Systems of Alameda, California, USA. Like most real-time operating systems, VxWorks includes a multitasking kernel with pre-emptive
13、scheduling and fast interrupt response, extensive inter-process communication and synchronization facilities, and a file system. Major distinguishing features of VxWorks include efficient POSIX-compliant memory management, multiprocessor facilities, a shell for user interface, symbolic and source le
14、vel debugging capabilities, and performance monitoring. VxWorks development is done on a “host“ machine running (Unix or Windows), by Tornado (VxWorks integrated development environment IDE for software cross- development). cross-compiling target software to run on various “target“ CPU architectures
15、 as well as on the “host“ by means of VxSim. VxWorks has been ported to a number of platforms and now runs on practically any modern CPU that is used in the embedded market (x86 family, MIPS, PowerPC, SH-4 and the closely related family of ARM, StrongARM and xScale) RTOS VxWorks: market leader Notable products using VxWorks The Spirit and Opportunity Mars Exploration Rovers The Mars Reconnaissance Orbiter The Deep Impact space probe Stardust (spacecraft) The Boeing 787 airliner (in development) The Boeing 747-8 airliner (in de
