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Merck
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Documentos Principais

TZHVDV205

Millipore

Steritest® NEO Device

For soluble powders in vials with septa., Red base canister with vented double needle for small vials with septa., pkg of 10 blisters in 2 bags of 5 blisters per box, Double packed

Sinônimo(s):

Red 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
Preço e disponibilidade não estão disponíveis no momento.

Materiais

Nylon 66 adapter (for needle)
PVC tubing (double lumen)
PVDF 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

Características

Red base canister with vented double needle for small vials with septa.

fabricante/nome comercial

Steritest®

embalagem

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

red Canister Base

Matriz

Durapore®

tamanho de poro

0.45 μm pore size

entrada

sample type pharmaceutical(s)

aplicação(ões)

pharmaceutical
sterility testing

compatibilidade

For soluble powders in vials with septa.

Condições de expedição

ambient

Categorias relacionadas

Descrição geral

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 & 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. The device simultaneously dissolves/dilutes the sample in sterile diluent and transfers the resulting solution to canisters. A small diameter double needle adapter is used for small vials with septum. The red canister base indicates low absorption. Durapore® hydrophilic Poly vinylidene fluoride (PVDF) membrane and specific drain design. This optimizes the rinsing of products that inhibit microbial growth.

Aplicação

Steritest® NEO Device is used for sterility testing of antibiotics and products with antimicrobial activity that require dilution or dissolution.

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 double packed blisters in 2 bags of 5 blisters per box

Informações legais

Durapore is a registered 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

Certificados de análise (COA)

Busque Certificados de análise (COA) digitando o Número do Lote do produto. Os números de lote e remessa podem ser encontrados no rótulo de um produto após a palavra “Lot” ou “Batch”.

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