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TZHVAB210

Millipore

Steritest® NEO Device

suitable for sterility testing, with separate vented needle for antibiotics in ampoules and collapsible bags., pkg of 10 blisters per box, Single packed

eCl@ss:
32014001
NACRES:
NB.24

Quality Level

material

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

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

3.1 bar max. inlet pressure (45 psi) at 25 °C
45 °C max. temp.

tubing L

850 mm

color

red Canister Base

matrix

Durapore®

pore size

0.45 μm pore size

input

sample type pharmaceutical(s)

test parameters

sample volume: 120 mL (graduation marks at 25, 50, 75 and 100 mL)

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, offers the highest levels of quality & reliability, and ensures that pharmaceutical products are not exposed to the environment. 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. A separate vent needle is included for the transfer of the test product, culture media or rinsing buffer. The red canister base indicates low absorption Durapore® polyvinylidene fluoride (PVDF) membrane and specific drain design, to optimize the rising of products that inhibit microbial growth.

Application

The Steritest® NEO Device for Liquids Antibiotics is used for sterility testing of antibiotics and products containing antimicrobial agents. The red canister base indicates low absorption Durapore 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
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

Articles

Application Note - Sterility Testing of Products with Antimicrobial Properties

Steritest™ NEO System – Specific Steritest™ NEO closed systems allow aseptic dissolution/dilution of product samples. The Steridilutor® NEO system is specifically designed to dissolve and dilute drugs in vials. The Steridilutor® NEO device for liquid transfer kit enables to dilute liquids from open ampoules into a diluent container with septum.

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