MilliporeSigma
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TZHVSL210

Millipore

Steritest® NEO Device

suitable for sterility testing, with single needle adaptor for products in vials or ampoules, pkg of 10 blisters per box, Single packed

eCl@ss:
32014001
NACRES:
NB.24

Quality Level

material

Nylon (for canister)
Nylon 66 adapter (for needle)
PVC tubing (double lumen)
PVDF membrane
plain filter
stainless steel (for needle)

Agency

EP (2.6.1)
JP (4.06)
USP 71

sterility

sterile; γ-irradiated

manufacturer/tradename

Steritest®

packaging

pkg of 10 blisters per box, Single packed

parameter

120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL)
3.1 bar max. inlet pressure (45 psi) at 25 °C
45 °C max. temp.

tubing L

850 mm

color

green Canister Base

matrix

Durapore®

pore size

0.45 μm pore size

input

sample type pharmaceutical(s)
solvent(s)

application(s)

pharmaceutical
sterility testing

shipped in

ambient

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, 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.

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.

Legal Information

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

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Quality

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Articles

Application Note - Sterility Testing of Products to be Diluted in Isopropyl Myristate

Application Note - Steritest™ NEO System – Sterility testing of products to be diluted in Isopropyl Myristate

Related Content

Steritest® NEO Membrane Filtration Sterility Test

Regulatory compliant membrane filtration sterility testing devices to ensure the safety of your pharmaceutical products.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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