无菌测试耗材、培养基和仪器
无菌性检测是根据 GMP 生产的无菌产品验证的重要组成部分。假阴性结果可能导致受污染产品的释放，而假阳性结果则可能导致冗长而昂贵的调查。我们拥有广泛的质量控制解决方案组合，您可以信赖我们的无菌测试结果，以符合美国药典、欧洲药典和日本药典等法规的要求。
产品
Products
用于无菌测试的 Steritest® 系统
配置您的 Steritest® 系统，以满足您对样品、包装和受控测试环境的需求。
我们的产品组合提供完全符合法规要求的测试工作流程（USP <71>、EU Pharmacopoeia < 2.6.1> 和日本药典 < 4.06>）包括：
- 稳定性测试泵和配件
- 膜过滤装置
- 培养基、冲洗液和溶剂
- 直接接种法
用于无菌测试的 M-Trace® 电子测试记录软件和移动应用程序
通过提供逐步指导和实时自动记录数据，M-Trace® 系统为符合有关可追溯性和数据完整性的法规要求提供了方便可靠的途径。b>® 系统提供了一种方便、可靠的方法，以符合有关可追溯性和数据完整性的监管要求。在每次无菌测试过程中，M-Trace® 软件都会在泵的显示屏上或通过语音给出逐步处理说明，同时实时捕获所有相关测试数据。
MILLIFLEX® Rapid 系统用于快速惰性测试
Milliflex® Rapid System 2.0 是一种自动化解决方案，可在整个生产过程中对可过滤样品中的微生物污染物进行快速检测、成像和定量。Milliflex® Rapid System 2.0 采用最先进的 ATP 技术和高灵敏度检测相机，可在 5 天内提供无菌结果，而不是传统的 14 天，从而在发生污染时更快地采取纠正措施。
相关资源
- Article: Sterility Testing Devices
Minimizing the risk of false positive and false negative results, the Steritest® NEO unit has been proven to be the most reliable filtration device available on the market.
- Article: Sterility Testing Culture Media and Fluids
Our sterility testing culture media and rinse fluids are formulated and tested to meet international standards. They provide the highest level of quality and testing confidence.
- Article: Sterility Testing Pumps
Our Steritest® Symbio pumps are designed to integrate perfectly into all testing environments. They will speed up and streamline your workflow, maximizing safety, confidence and convenience.
- Article: Sterility Testing Accessories
The Steritest® Symbio accessories are designed to facilitate your daily sterility testing work routine. To address your special requirements, accessories are available for a variety of different drug packaging configurations.
- Article: Direct Inoculation Method
Sterility testing of non-filterable samples, complying with your different direct inoculation method requirements.
- Article: Rapid Sterility Testing Method
The Milliflex® Rapid System 2.0 has been proven to be used for rapid sterility testing by the FDA’s Center for Biologics Evaluation and Research as a faster sterility test to identify microbial contamination in biologicals.
- M-Trace® Software for Sterility Testing
Article: Our M-Trace® digital solution enables full traceability and regulatory compliance of your Sterility Test data.
- Poster: Complete Solutions for Complete Confidence with the Steritest® System
Complete solution for the most secure and reliable sterility testing.
- Brochure: Sterility Testing Complete Portfolio
Our large variety of devices and pumps help you stay compliant with membrane filtration or direct inoculation methods.
- Brochure: M-Trace® Electronic Test Record Software & Mobile App
Your Digital QC companion for trusted and efficient data traceability.
- Data Sheet: Steritest® Symbio Pump and Accessories
Speed up your workflow with our Steritest™ Symbio Pumps and accessories, maximizing safety, confidence, and convenience, making reliable sterility testing even easier.
- Data Sheet: Milliflex® Rapid System
Our automated solution rapidly and accurately detects and enumerates microorganisms.
- Data Sheet: Steritest® Culture Media and Fluids
Our easy-to-use, reliable, and sterile products come in multiple configurations and volumes, ensuring accurate sterility testing.
- Article: Sterility Testing of Products with Antimicrobial Properties
Sterility testing of products with antimicrobial properties and how to prevent false negative results.
- Article: Sterility Testing of Products to be Diluted in Isopropyl Myristate
Complete solution for the most secure and reliable sterility testing.
- Data Sheet: Our Services portfolio supporting the Steritest® family
Discover our full range of professional and best-in-class Services related to our Steritest™ family.
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