Description
General description
Device Configuration: 2 canisters
Steritest® NEO Device is a membrane filtration device for sterility testing of filterable pharmaceutical products. The device simplifies every aspect of testing, from handling to traceability. The closed system minimizes false positives and offers the highest levels of quality and reliability. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. This test system offers an optimized and fully regulatory compliant testing process, when used with the Steritest® Symbio pump, specific accessories and high-quality culture media and rinsing fluids. The device is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest® NEO devices. The blue based canisters indicate mixed cellulose esters (MCE) membrane, which provides an optimal filtration flow rate for standard products.
Application
The Steritest® NEO Device is used for sterility testing of liquids in large vials (double packed), which includes large volume parenterals and synthetic drugs, without antimicrobial agent.
Features and Benefits
One-stop-shop for sterility testing with our devices, pumps, media, fluids, and services
Steritest® devices are manufactured in our Center of Excellence in Molsheim, France, with high-quality control standards maintaining the Certificate of Quality for each lot.
New needle design
The design of this new needle has been optimized with short needle length, grips, and ridges to offer dexterity and security to the operator while piercing the small container
Smarter workflow
The new Steritest® NEO cartridge device benefits fromall the improvements such as colored clamps, graduations for accurate volume measurement, optimized identification, and traceability with the new peel-off label
Completely closed set up
Pharmaceutical products are never exposed to the environment during the testing process with Steritest® NEO devices. Filtration, rinsing, media addition and incubation are conducted within a closed system.
Consistent performance
100% integrity testing, strict physical and microbiological tests performed at every step of the assembly of the Steritest® NEO device before release from manufacturing.
New tubing disconnection tool
The Velax® cutting clamps are mounted on all Steritest® NEO devices and allow safe and easy cutting of the tubes.
Packaging
Pack of 10 double packed blisters in 2 bags of 5 blisters per box
Legal Information
MF-Millipore is a trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
VELAX is a registered trademark of Merck KGaA, Darmstadt, Germany
