STERITEST EZ FOR SOLVENTS 10/PK

Code: tzhvsl210 D2-231

Not available outside of the UK & Ireland.

Application

The Steritest® NEO Device is used for sterility testing of products dissolved in solvents (such as creams, ointments and veterinary injectables), ...


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Your Price
$734.31 EACH

Not available outside of the UK & Ireland.

Application

The Steritest® NEO Device is used for sterility testing of products dissolved in solvents (such as creams, ointments and veterinary injectables), requiring increased chemical compatibility.

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 minimizes false positives and offers the highest levels of quality and reliability, ensuring 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 canister connections and reinforced base structure provide better resistance to pressure. The single needle adapter is used for products in vials or ampoules. A separate vent needle is included for the transfer of the test product, culture media or rinsing buffer. The canisters come with green canister base indicating increased chemical compatibility with solvents due to Durapore® Poly vinylidene fluoride (PVDF) membrane and specific canister polymer (nylon). This optimizes the chemical compatibility of products dissolved in solvents.

Legal Information

Durapore 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

agencyUSP 71, JP (4.06), EP (2.6.1)
application(s)pharmaceutical, sterility testing
colorgreen Canister Base
inputsample type pharmaceutical(s) solvent(s)
manufacturer/tradenameSteritest®
materialPVC tubing (double lumen), plain filter, Nylon (for canister), PVDF membrane, stainless steel (for needle), 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
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