無菌測試耗材、介質與儀器
穩定性測試是根據 GMP 製造的聲稱無菌產品驗證的重要部分。假陰性結果可能會導致受污染產品的釋放，而假陽性結果則可能導致冗長且昂貴的調查。我們提供廣泛的品質控制解決方案組合，讓您對無菌測試結果有信心，您可以信賴這些解決方案，以符合美國藥典、歐洲藥典和日本藥典等法規。
產品
Steritest® System for Sterility Testing
配置您的 Steritest® system 以符合您的樣品、包裝和受控測試環境需求。
我們的產品組合提供完全符合法規的測試工作流程（USP <71>、EU Pharmacopoeia < 2.6.1> 和 JP Pharmacopoeia <4.06>）包括：
- 藥品穩定性測試泵及配件
- 膜過濾裝置
- 培養基、沖洗液及溶劑
- 直接接種法
M-Trace® 電子測試記錄軟體及手機應用程式用於無菌測試
透過提供逐步指導和即時自動記錄資料，M-Trace® 系統提供方便可靠的方式，以符合有關可追蹤性和資料完整性的法規要求。b>® 系統提供方便可靠的方式，以符合有關可追蹤性和資料完整性的法規要求。在每次無菌測試期間，M-Trace® 軟體會在幫浦的顯示器上或透過語音提供逐步的處理指示，同時即時擷取所有相關的測試資料。
MILLIFLEX® RAPID SYSTEM FOR RAPID STERILITY TESTING
The Milliflex® Rapid System 2.0 是一種自動化解決方案，可在整個製造過程中快速檢測、成像和定量可過濾樣品中的存活微生物污染物。Milliflex® Rapid System 2.0 採用最先進的 ATP 技術和高靈敏度檢測相機，可在 5 天內提供無菌結果，而不是傳統的 14 天，從而在發生污染時更快地採取糾正措施。
相關資源
- 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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