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预灌封卡式瓶和针式注射系统测试服务（ISO 11608 系列）
适用产品
现有测试服务
待灌装和预灌封玻璃和高级聚合物注射器测试服务（ISO 11040 系列）
适用产品
现有测试服务
西林瓶适配器和其他转移装置测试服务
适用产品
现有测试服务
用于早期相容性评估的小型容器灌装加工
适用产品
现有服务
西氏的分析服务实验室可帮助客户满足USP <382>测试需求。这一新章节“注射剂产品包装/给药系统中的弹性体组件功能适用性”于2020年12月发布，客户将有5年的限期以实现合规性。
西氏支持以下引用的所有USP <382>章节：
USP <1207>规定的包装和给药系统完整性测试
针头和穿刺器穿刺功能适用性测试
活塞功能适用性测试
锥头护帽和针头护帽功能适用性测试
我们将根据应用和预期用途评估选定的西氏组件以证明符合USP <382>的要求，帮助客户选择合适的组件。
欲了解USP <382>的更多信息
监管和定制测试结合
充分了解公认标准相关的产品性能，可降低产品监管申报的复杂性，这一点至关重要。将公认标准与定制测试相结合，辅以适当的执行方式，极大地降低了客户延迟上市的风险，并最终降低患者的风险。
以监管测试标准为基准
组合产品问题解决和定制方法开发
在组合产品开发的各个阶段，经常会发现新的技术挑战和风险。西氏的分析服务实验室拥有扎实的专业知识，可有效为客户排除故障问题，为各种组合产品开发定制先进测试方法，包括以下示例：
* 需要知识中心帐户才能访问。
携手西氏，分析服务解决方案 – 组合产品的性能及功能测试
Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
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