STERITEST EZ FOR MEDICAL DEVICE 10/PK

Code: tzhamd210 D2-231

Non disponible en dehors du Royaume-Uni et de l'Irlande

Application

Steritest® NEO Device for medical device and collapsible bags is used for sterility testing of medical devices, collapsible bags and products with...


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Votre prix
$681.86 EACH

Non disponible en dehors du Royaume-Uni et de l'Irlande

Application

Steritest® NEO Device for medical device and collapsible bags is used for sterility testing of medical devices, collapsible bags and products without antimicrobial agents.

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 designThe 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 workflowThe 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 upPharmaceutical 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 performance100% integrity testing, strict physical and microbiological tests performed at every step of the assembly of the Steritest® NEO device before release from manufacturing

General description

Device Configuration: 2 canistersSteritest® 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 ensures that pharmaceutical products are never exposed to the environment during the testing process. This minimizes false positives and offers the highest levels of quality and reliability. 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 Steritest® NEO Device for medical devices provides three adapters: male Luer, female Luer or single needle allow connection to a variety of test devices. A separate vent needle is used for the transfer of culture media or rinse buffer. The Steritest® NEO Device for medical devices can be used with Novaseptum® for sterile sampling devices. The blue canister base indicates mixed cellulose esters (MCE) membrane. This membrane provides an optimal filtration flow rate for standard products.

Legal Information

NOVASEPTUM is a registered trademark of Millipore AB - Sweden

MF-Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany

STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

Packaging

Pack of 10 single packed blisters per box

agencyJP 4.06, EP 2.6.1, USP 71
application(s)pharmaceutical, sterility testing
colorblue Canister Base
inputsample type pharmaceutical(s)
manufacturer/tradenameSteritest®
materialmixed cellulose esters (MCE) membrane, PVC tubing (double lumen), styrene-acrylonitrile (SAN) ( for Canister), stainless steel ( for needle), plain filter, Nylon 66 adapter (for needle)
matrixMF-Millipore®
packagingpkg of 10 blisters per box, Single packed
parameter120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL), 45 °C max. temp., 3.1 bar max. inlet pressure (45 psi) at 25 °C
pore size0.45 µm pore size
Quality Level400
shipped inambient
sterilitysterile; γ-irradiated
tubing L850 mm
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