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对生命科学的热情.pdf

上传人: 淡然 编号:732536 2025-07-19 17页 2.28MB

1、Passion for life scienceRTU formats for small scale fill&finishManufacturing facilities and agentsPassion for life science2Company profileProjects around the worldPassion for life science3Company profileOfficesPassion for life science4Company profilePassion for life science5Manufacturing facilitiesC

2、ompany profileIsolators&RABSPassion for life scienceProducts Other solutions6Isolator for aseptic filling linesCell&Gene Therapies isolatorContainment isolatorSterility Test IsolatorRABSSmall-scale Fill&Finish isolatorCompany profileTable of contentsPassion for life science7Fill and Finish of small

3、batch of sterile medicines.Fill&Finish Isolator-OPTION 1:100%Manual-Table-Top Equipment-Non Integrated equipment-Statistical IPC-OPTION 2:100%Manual-Integrated PUMP,weight-cells,stoppering.-Integrated equipment in Isolator Control System:recipes,reports,audit trail.-100%IPC.-OPTION 3:Semiautomatic-T

4、able-top machine-Pump+load cells integrated-Integrated equipment in Isolator Control System:recipes,reports,audit trail-Statistical IPC.-OPTION 4:Automatic Multiformat:vials,syringes,cartridges.-Small-scale-Medium scale-100%IPC-No glass to glass contact,-Integrated equipment in Isolator Control Syst

5、em:recipes,reports,audit trailPassion for life scienceCappingFillingProducts-IsolatorsCompany profileOption 1:Manual F&FNest o TraysIsolator LITEK+Filling Machine GroningerPassion for life scienceProducts-IsolatorsCompany profileOption 2:Manual Process with integrated componentsRTU TrayOption 3:Semi

6、automatic F&F integrated componentsPassion for life science10Fill and Finish of small batch of sterile medicines.RTU TrayPassion for life scienceProducts-IsolatorsCompany profileOption 3:Semiautomatic F&F integrated components and LyoPassion for life scienceProducts-IsolatorsComp

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本文主要介绍了一家名为Litek的公司,专注于为小规模无菌药物填充和完成提供隔离器解决方案。关键点如下: 1. 提供四种不同配置的隔离器系统,包括手动、半自动和全自动多格式选项。 2. 隔离器可集成如泵、重量传感器等组件,并配备有控制系统,支持配方、报告和审计跟踪。 3. 产能估计:手动选项1和2分别为300-500和400-600瓶/小时;半自动选项3为800-1000瓶/小时;全自动选项4从2500瓶/小时起。 4. Litek的隔离器可以定制,与市场上任何填充机集成,并符合21CFR Part 11的电子记录和数字报告要求。 联系信息:Gonzalo Ojea – gonzalo.ojea@litek-pharma.com,网站:www.litek-pharma.com。
哪种选项最适合你?" "如何实现高效的小规模药品封装?" 提升药品生产安全?"
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