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TZHALA205

Millipore

Steritest® NEO Device

For liquids in ampoules or collapsible bags. Blue base canister with a single-needle adapter. Double packed.

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Synonym(s):
Blue Base Steritest® NEO device for sterility testing
eCl@ss:
32014001
NACRES:
NB.24

material

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

Quality Level

Agency

EP (2.6.1)
JP (4.06)
USP 71

sterility

sterile; γ-irradiated

manufacturer/tradename

Steritest®

packaging

pkg of 10 blisters in 2 bags of 5 blisters per box, double 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

blue Canister Base

matrix

MF-Millipore

pore size

0.45 μm pore size

input

liquid
sample type pharmaceutical(s)

application(s)

pharmaceutical
sterility testing

shipped in

ambient

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Steritest® NEO Device

packaging

pkg of 10 blisters in 2 bags of 5 blisters per box, double packed

packaging

pkg of 1 kit

packaging

pkg of 10 blisters per box, Single packed

packaging

pkg of 10 blisters in 2 bags of 5 blisters per box, Double packed

pore size

0.45 μm pore size

pore size

0.45 μm pore size

pore size

0.45 μm pore size

pore size

0.45 μm pore size

application(s)

pharmaceutical
sterility testing

application(s)

pharmaceutical
sterility testing

application(s)

pharmaceutical
sterility testing

application(s)

pharmaceutical
sterility testing

shipped in

ambient

shipped in

ambient

shipped in

ambient

shipped in

ambient

agency

EP (2.6.1)

agency

EP (2.6.1), JP (4.06), USP 71

agency

EP (2.6.1), JP (4.06), USP 71

agency

EP (2.6.1), JP (4.06), USP 71

General description

Device Configuration: 2 canisters

Steritest® 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. The device is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. A single needle adapter enables an easy access to ampoules or collapsible bags. A separate vent needle is included for the transfer of the test product, culture media or rinsing buffer. The blue based canisters indicate mixed cellulose ester (MCE) membrane, which provides an optimal filtration flow rate for standard products. The new Velax® cutting clamp allows a safe and clean disconnection of the tubing and is readily mounted on all Steritest® NEO devices.

Application

The Steritest® NEO Device for liquids in ampoules or collapsible bags is used for sterility testing of large volume parenterals and synthetic drugs without antimicrobial activity.

Legal Information

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

related product

Product No.
Description
Pricing

Storage Class Code

11 - Combustible Solids

WGK

WGK 2


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Articles

Sterility testing is one of the most crucial steps in pharmaceutical product release. Regulatory-compliant membrane filtration sterility testing devices ensure the safety of 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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