無菌試験の消耗品（フィルター、培地）および装置
無菌試験は、無菌医薬品の製品の出荷判定に不可欠な試験です。偽陰性の場合、微生物汚染された製品が市場に出回る可能性があります。一方で擬陽性の場合、長期にわたり多くの調査費用がかかる可能性があります。米国薬局方（USP）、ヨーロッパ薬局方（EP）、日本薬局方（JP）などの規制に準拠した私たちの幅広い品質管理ソリューションのポートフォリオなら、信頼できる無菌試験結果が得られます。
製品
Products
無菌試験用 Steritest® システム
Steritest® システムを、試料、パッケージ、制御された試験環境のニーズに合わせて設定しましょう。
規制を完全に遵守した試験作業工程（USP<71>、EP<2.6.1>、日本薬局方<4.06>）を提供する私たちのポートフォリオは以下を含みます。
- 無菌試験用ポンプ・アクセサリー
- メンブレンろ過装置
- 培地、洗浄液、溶剤
- 直接法
M-Trace® 電子試験記録ソフトウェアおよび無菌試験用モバイルアプリ
M-Trace® システムは、段階的なガイダンスとリアルタイムの自動データ記録により、トレーサビリティおよびデータ整合性の規制要件を順守する、便利で信頼性の高い方法を提供します。無菌試験中は、M-Trace® ソフトウェアが、ポンプのディスプレイまたは音声で段階的な操作手順を表示し、関連するすべての試験データをリアルタイムで記録します。
迅速無菌試験用Milliflex® Rapidシステム
Milliflex® Rapidシステム2.0は、製造工程を通してろ過可能なサンプル中に生存している微生物を迅速に検出、イメージング、定量するための自動化ソリューションです。Milliflex® Rapidシステム2.0は、最新技術のATPベース技術と高感度検出カメラにより、従来の14日間ではなく5日間で無菌試験の結果を判定し、汚染が発生した場合には、より迅速な是正措置を実施できます。
関連資料
- 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.
