Sterility Testing Consumables, Media & Instruments
Sterility testing is an essential part of validation for products manufactured according to GMP purporting to be sterile. False negative results could lead to the release of contaminated products, whereas false positives could give rise to lengthy and costly investigations. Have confidence in your sterility test results with our extensive portfolio of Quality control solutions that you can rely on for regulatory compliance e.g. with USP, the European Pharmacopoeia and the Japanese Pharmacopoeia.
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Tryptic Soy Broth Ready-to-use Bottles
bottle capacity 125 mL, bottle filling volume 100 mL, closure type, green screw cap with septum, pack of 12 bottles
Fluid Thioglycollate Medium
bottle capacity 125 mL, bottle filling volume 100 mL, closure type, Red screw cap with septum and protector, pack of 12 bottles
Fluid D - Ready-to-use Rinse Fluid
bottle capacity 500 mL, bottle filling volume 300 mL, closure type, Black screw cap with septum and protector, pack of 4 bottles
Fluid K - Ready-to-use Rinse Fluid
bottle capacity 500 mL, bottle filling volume 300 mL, closure type, Black screw cap with septum and protector, pack of 4 bottles
Fluid A - Ready-to-use Rinse Fluid
bottle capacity 500 mL, bottle filling volume 300 mL, closure type, Black screw cap with septum and protector, pack of 4 bottles
Clear Thioglycollate Medium
bottle capacity 125 mL, bottle filling volume 100 mL, closure type, Red screw cap with septum and protector, pack of 12 bottles
Fluid A - Ready-to-use Rinse Fluid
bottle capacity 125 mL, bottle filling volume 100 mL, Black screw cap with septum and protector, pack of 12 bottles
Steritest® vent needles
suitable for sterility testing, for glass vials with rubber septa and rigid plastic vials., PTFE (hydrophobic membrane filter)
Fluid A - Ready-to-use Rinse Fluid
bottle capacity 1000 mL, bottle filling volume 600 mL, closure type, Black screw cap with septum and protector, pack of 4 bottles
Fluid Thioglycollate Medium
bottle capacity 125 mL, bottle filling volume 100 mL, closure type, Red screw cap with septum and protector, double packed of 12 bottles
Steridilutor® NEO Device
For liquid transfer from ampoules or vials to a diluent vial with septum pooling., pkg of 10 blisters per box, Single packed
Tryptic Soy Broth- Ready-to-use Bags, Tubes & Ampoules
tube capacity 17 mL, tube filling volume 9 mL, closure type, blue screw cap with 2 loci, box of 100 tubes
Tryptone Glucose Extract Broth
ampoule capacity 2 mL, ampoule filling volume 2 mL, ready-to-use, pack of 50 tests, for heterotrophic bacteria
Tryptic Soy Broth Ready-to-use Bottles
bottle capacity 125 mL, bottle filling volume 100 mL, closure type, green screw cap with septum, double packed of 12 bottles
Fluid A - Ready-to-use Rinse Fluid
bottle capacity 125 mL, bottle filling volume 100 mL, closure type, Black screw cap with septum and protector, double packed of 12 bottles
Tryptic Soy Broth Ready-to-use Bottles
bottle capacity 125 mL, bottle filling volume 100 mL, closure type, blue crimp cap with septum, pack of 10 or 70 bottles
Fluid A - Ready-to-use Rinse Fluid
bottle capacity 500 mL, bottle filling volume 300 mL, closure type, Red flip cap with septum, pack of 6 bottles
Silicone drain tubing
Accessory for Steritest® Symbio pumps, 1.5 meters
Clear Thioglycollate Medium
bottle capacity 125 mL, bottle filling volume 100 mL, closure type, Red screw cap with septum and protector, double packed of 12 bottles
Fluid A - Ready-to-use Rinse Fluid
bottle capacity 1000 mL, bottle filling volume 900 mL, closure type, Black screw cap with septum and protector, pack of 4 bottles
Steritest® System for Sterility Testing
Configure your Steritest® system to fit your sample, packaging, and controlled testing environment needs.
Our portfolio, which offers a fully regulatory compliant testing workflow (USP <71>, EU Pharmacopoeia < 2.6.1> and JP Pharmacopoeia <4.06>) includes:
- Sterility testing pumps and accessories
- Membrane filtration devices
- Culture media, rinse fluids and solvent
- Direct inoculation method
M-Trace® Electronic Test Record Software & Mobile App for Sterility Testing
By giving step-by-step guidance and recording data automatically in real time, the M-Trace® system offers a convenient and reliable way to comply with regulatory requirements regarding traceability and data integrity. During each sterility test, the M-Trace® software gives step-by-step handling instructions, either on the pump’s display or by voice, while capturing all relevant test data in real time.
MILLIFLEX® RAPID SYSTEM FOR RAPID STERILITY TESTING
The Milliflex® Rapid System 2.0 is an automated solution for the rapid detection, imaging, and quantification of viable microbial contaminants in filterable samples throughout the manufacturing process. Its state-of-the-art ATP-based technology and highly sensitive detection camera, allow the Milliflex® Rapid System 2.0 to deliver sterility results in 5 days instead of the traditional 14 days resulting in faster corrective actions in case of contamination.
Related Resources
- 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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