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我们的能力
概念研发及可制造性设计（DFM）
成功蓝图
西氏团队产品研发,可帮助优化设计, 显著的短期和长期效益。这些效益包括改善周期时间、降低废品率、资本成本以及长期维护成本。此外，西氏团队拥有材料专家，可根据具体应用确定正确的用材。
我们的设计服务包括：
- 设计概念开发
- 设计探索
- 机械设计完善
- 机械设计发布
- 设计验证
- 模流分析
- 有限元分析
冷链解决方案
让低温冷藏不再复杂
温度敏感类药品需要的储存解决方案不仅要满足药品产品本身的需求，还须确保适当监测的稳定持续环境符合监管准则。任何偏离理想环境的情况都可能会影响患者的安全并危及药品的质量，导致药效、疗效的丧失，甚至需要完全丢弃产品。
西氏队可为寻求全套器械制造和装配综合方法的制药商提供药品处理运营和冷链解决方案。这有助于确保药品在整个冷链中储存在所需的温度范围内，从而降低风险并提高生产效率。
临床支持
- 规模可调节的商业化解决方案
药品重新包装
- 适应中小批量应用的基础设施
- 药品稳定性的冷链服务
- 针对大批量应用的经验和能力
序列化/跟踪和追溯
- UDI、sNDC、自定义序列化
- 聚合
- MES基础设施
- 工作单元历史和分析
产品设计
让概念成为现实
通过战略伙伴关系，西氏团队提供广泛的产品设计服务，包括一次性产品应用和机电装配。
- 用户研究
- 界面设计
- 工业设计
- 机械设计
- 原型设计
原型和试验生产
经验和专业知识的重要作用
在西氏合同制造工厂, 工程师们采取创新科学的方法开发品。制造和设计产品的能力取决于模制和组件组装等方面的专业知识。
产品开发服务包括：
- 协作的跨职能工程团队
- 全球开发和制造部署
- 原型开发和采购
- 可制造性设计
工艺开发
可靠可重复的工艺
西氏合同制造团队通过科学、数据驱动的方法以发掘和记录每个项目的最佳工艺参数。现代注塑机以此根据项目规格量身定制并进行监控，以最大限度地提高质量和效率，形成了一套可靠、可重复的工艺。
工艺开发服务包括：
- 分离的2&3工艺开发
- 广泛使用实验设计（DOE）来帮助定义工艺
- 安装确认/运行确认/性能确认（IQ/OQ/PQ）方案，确保稳健的生产工艺
- 纳入“先进工艺监测”。
- 归档数据用于持续改进和根本原因分析
装配解决方案
产品组装成型环节
对于寻求增值装配的客户，西氏合同制造工厂在装配产品方面具有显著而广泛的经验。我们了解多组件、复杂装配件的手动组装方案，也拥有高精尖的高速装配系统。目前已有50多个装配单元投入运营，每年集成超过20亿个装配件。
我们的装配服务包括：
- 注塑成型与完全集成的下游装配
- 专用的ISO 7级和8级洁净室装配
- 初级和次级包装
- 药品重新包装和贴标签
- 针头处理、紫外线粘合、激光蚀刻、印刷、焊接、泄漏测试
注塑成型
细节决定成败
西氏是世界财富500强客户首选的注塑件合作伙伴从洁净室制造环境到最新的过程监测技术，我们的合同制造团队不断扩大能力，以满足全球市场不断变化的需求。
我们的成型能力包括：
- 全球七家ISO认证的生产工厂
- 超过300台成型机
- ISO 7级和8级洁净室（成型和装配）
- 实时过程监测
- 专业成型 - 多射成型、嵌入成型、液态硅胶成型、光学成型
专题博客
五月 29, 2020
Contract Manufacturing: An Integrated Solutions Approach
In today’s increasingly complex drug delivery and device development landscape, a reliable contract manufacturing partner can become a distinct competitive advantage for pharmaceutical and device companies. West brings together the right combination of insights and infrastructure to help our customers reduce costs, mitigate risk and accelerate path to market.
五月 15, 2020
Speed to Market with a Platform Approach
Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. West, through the Integrated Solutions platform, is ideally positioned to provide this data.
十二月 31, 2019
Combination Products: The Top Three Device Challenges
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
五月 29, 2020
Contract Manufacturing: An Integrated Solutions Approach
In today’s increasingly complex drug delivery and device development landscape, a reliable contract manufacturing partner can become a distinct competitive advantage for pharmaceutical and device companies. West brings together the right combination of insights and infrastructure to help our customers reduce costs, mitigate risk and accelerate path to market.
五月 15, 2020
Speed to Market with a Platform Approach
Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. West, through the Integrated Solutions platform, is ideally positioned to provide this data.
十二月 31, 2019
Combination Products: The Top Three Device Challenges
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
