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TZHALA205

Millipore

Steritest® NEO Device

For liquids in ampoules or collapsible bags., Blue base canister with a single-needle adapter., pkg of 10 blisters in 2 bags of 5 blisters per box, double packed

Synonim(y):

Blue Base Steritest® NEO device for sterility testing

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About This Item

Kod UNSPSC:
23151818
eCl@ss:
32014001
NACRES:
NB.24

Materiały

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)

Poziom jakości

400

agency

EP (2.6.1)
JP (4.06)
USP 71

sterylność

sterile; γ-irradiated

Właściwości

Blue base canister with a single-needle adapter.

producent / nazwa handlowa

Steritest®

opakowanie

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

Parametry

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.

dł. rurki

850 mm

kolor

blue Canister Base

Matryca

MF-Millipore™

wielkość porów

0.45 μm pore size

moc wejściowa

liquid
sample type pharmaceutical(s)

Zastosowanie

pharmaceutical
sterility testing

kompatybilność

For liquids in ampoules or collapsible bags.

Warunki transportu

ambient

Opis ogólny

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.

Zastosowanie

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.

Informacje prawne

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
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Kod klasy składowania

11 - Combustible Solids

Klasa zagrożenia wodnego (WGK)

WGK 2

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Produkty

Steritest® Test sterylności filtracji membranowej NEO

Testowanie sterylności jest jednym z najważniejszych etapów uwalniania produktów farmaceutycznych. Zgodne z przepisami urządzenia do testowania sterylności metodą filtracji membranowej zapewniają bezpieczeństwo produktów farmaceutycznych.

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