STERITEST EZ HV FOR MEDICAL DEVICES AND

Code: tzhvmd210 D2-231

Not available outside of the UK & Ireland.

Application

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


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Your Price
£575.00 EACH

Not available outside of the UK & Ireland.

Application

Steritest® NEO Device for medical devices and collapsible bags is used for sterility testing of medical devices, collapsible bags and products with 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 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, 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. 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 included for the transfer of the test product, culture media or rinse buffer. The Steritest® NEO Device for medical devices can be used with Novaseptum® for sterile sampling devices. The red canister base indicates low absorption. Durapore® hydrophilic Poly vinylidene fluoride (PVDF) membrane and specific drain design. This optimizes the rinsing of products that inhibit microbial growth.

Legal Information

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

NOVASEPTUM is a registered trademark of Millipore AB - Sweden

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

Packaging

Pack of 10 single packed blisters per box

agencyUSP 71, JP (4.06), EP (2.6.1)
application(s)pharmaceutical, sterility testing
colorred Canister Base
inputsample type pharmaceutical(s)
manufacturer/tradenameSteritest®
materialPVC tubing (double lumen), plain filter, PVDF membrane, stainless steel (for needle), styrene-acrylonitrile (SAN) (for canister), Nylon 66 adapter (for needle)
matrixDurapore®
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
This product has met the following criteria: