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Key Documents

TZHADA210

Millipore

Steritest® NEO Device

For soluble powders in ampoules. Blue base canister with a single needle for transfer into and out of ampoules.

Sinônimo(s):

Blue Base Steritest® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration

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About This Item

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

Materiais

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)

Nível de qualidade

Agency

EP (2.6.1)
JP (4.06)
USP 71

esterilidade

sterile; γ-irradiated

fabricante/nome comercial

Steritest®

embalagem

pkg of 10 blisters per box, Single packed

Parâmetros

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.

C tubulação

850 mm

cor

blue Canister Base

matriz

MF-Millipore

tamanho de poro

0.45 μm pore size

entrada

sample type pharmaceutical(s)

aplicação(ões)

pharmaceutical
sterility testing

Condições de expedição

ambient

Descrição geral

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 and reliability, and ensures 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 device has vented double needle and simultaneously dissolves/dilutes the sample in sterile diluent and transfers the resulting solution to canisters for further filtration. The blue based canisters indicate mixed cellulose esters (MCE) membrane, which provides an optimal filtration flow rate for standard products.

Aplicação

The Steritest® NEO Device is used for sterility testing of soluble powders in ampoules, without antimicrobial agent. The device simultaneously dilutes and transfers the test products to the canister set.

Características e benefícios

  • 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 design
The 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 workflow
The 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 up
Pharmaceutical 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 performance
100% integrity testing, strict physical and microbiological tests performed at every step of the assembly of the Steritest® NEO device before release from manufacturing.

  • New tubing disconnection tool
The Velax® cutting clamps are mounted on all Steritest® NEO devices and allow safe and easy cutting of the tubes.

Embalagem

Pack of 10 single packed blisters per box

Informações legais

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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Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 2


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