不同类型的灭菌设备 饱和蒸汽 过热水喷淋 蒸汽 - 空气混合 高危高致病原灭活灭菌 胶塞处理 旋转灭菌 百级层流干热灭菌除热原 低温灭菌柜 物料消毒传递窗
FOA 蒸汽 - 空气混合灭菌柜 湿热消毒灭菌柜
动态灭菌
FOA 和 FOAF 系列 空气 + 蒸汽混合式湿热消毒灭菌柜
FOA 和 FOAF 系列 空气 + 蒸汽混合式湿热消毒灭菌柜 反压控制, 防止容器变形或破裂
Moist-heat sterilizers FOW 系列 过热水喷淋式湿热灭菌柜
FOA 和 FOAF 系列 空气 + 蒸汽混合式湿热消毒灭菌柜 反压控制, 防止容器变形或破裂
空气 - 蒸汽混合反压灭菌 无密封磁驱风机 无穿透箱体转轴, 无泄漏 无机械密封, 无污染 无需润滑 高抗热磁驱系统 高效, 低能耗 低转速风叶 无因泄漏而无法保压问题 Fedegari Autoclavi S.p.A. Proprietary
预充注射器灭菌-参考布局 制 业 药
预充注射器灭菌 - 托盘转移
预充注射器灭菌 - 托盘设计
预充注射器灭菌 - 机内车
预充注射器灭菌 - 托盘设计
预充注射器灭菌 - 装车就绪
多室软袋过热水灭菌 - 摇摆式
灭菌器设计关键因素 压力容器 pressure vessel 门 door/s 管道和配件 piping & components 过程控制器 process controller 过程性能 process performances
制造加工技术和装备
PRESSURE VESSELS 箱体
压力容器 门 滑动 铰链
门密封 其它设计
门密封 其它设计
门密封 Fedegari 设计
门密封 无接点 特殊形状 无润滑 非常长久的使用寿命
管件和阀门 所有接口为卫生型
THEMA4 灭菌柜过程自控系统 1. 开放式硬件结构, 基于 PC/PLC (Siemens 和 Allen-Bradley) 2. 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. 设计符合 GAMP5 规范 5. 系统符合美国 FDA 21 CFR, part 11 准则 6. Ethernet LAN 企业网络功能
THEMA4 STERILIZERS PROCESS CONTROLLER COMPONENTS STERILIZER 3 PW File config. Coverter 4-20/Pt100 BUS D IN FIELD BUS D OUT File config.i/o BUS board AN IN AN OUT 1 BUS board thermal printer Panel PC L1 RTOS + bootrom UPS local/ central HUB 2 Leader in RTOS Panel PC L2 Panel PC L3 Panel PC (L1, L2,L3) Remote I/O Thermal Printer UPS HUB Remote GUI (PC-Win) A4 Printer BRANDS Converter 4-20mA/Pt100 RS232 Net-integration Log Data 8 PC Conf. Data PCS Nucleus PGL FECP SRVR GUI THEMA4 HARDWARE ARCHITECTURE + JWORKS Archive management (BIN and ASCII filesi) with integrity check (FDA CFR21p11 compliance) WINDOWS Printer OS Windows PDF Data S LANGUAGES ANSI C W Java
REAL-TIME OPERATING SYSTEM RTOS RTOS is intended for real-time applications 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 applications, by an appropriate life cycle of software development.
VxWorks RTOS 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 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 level 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 crossdevelopment). cross-compiling target software to run on various "target" CPU architectures 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 development) The BMW idrive system Linksys WRT54G wireless routers (versions 5.0 and later) Xerox Phaser and other Adobe PostScript-based computer printers The Experimental Physics and Industrial Control System (EPICS) DIGIC II and some early DIGIC III image-processors by Canon Thuraya SO-2510 Satellite phone and ThurayaModule The Apache Longbow attack helicopter The ALR-67(V)3 Radar Warning Receiver used in the F/A-18E/F Super Hornet The James Webb Space Telescope (in development) Many products from National Instruments (CompactRIO) Many products from Nortel Huawei Serving GPRS Support Node (SGSN) and other products Ferrari racing telemetry system Thema4 Fedegari sterilizer control system
THEMA4 STERILIZERS PROCESS CONTROLLER REAL TIME OPERATING SYSTEM PCS FECP SRVR GUI P/G LIB. NUCLEUS THEMA4 SOFTWARE ARCHITECTURE PCS: Process Control System FECP SRVR: Fedegari External Communication Protocol Server GUI: Graphic User Interface
Instrumentation Highest specification, careful selection of suppliers High precision, low drift, temperature calibrated, chamber pressure transducer AISI 316L separation membrane Temperature sensors: High Precision 4-wire Pt100, Class 1/3 DIN, silicone sheath
所有焊接由自动机器人或自动焊机完成 内腔光洁度优于 Ra 0.40 µm 特殊箱体和夹套加固 冷热换夹套为标准配置 无缝无接点门密封条 特殊构造承压密封门 温度分布优于 ±0.5ºC 独有动态灭菌技术 F 0 值和温度 + 时间双模式自动控制 无轴风机 无轴滚筒驱动 专用于生物安全 P3/P4 级灭菌灭活技术 符合 cgmp 和 21 CFR PART 11 规范 符合 GAMP 5 指引 制造加工技术和装备