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Merck
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Documentos Principais

TZHVSV205

Millipore

Steritest® NEO Device

For liquids in small vials with septa. Red base canister with a vented double needle for small vials with septa. 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
NACRES:
NB.24

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

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)

cor

red Canister Base

tamanho de poro

0.45 μm pore size

entrada

liquid
pharmaceutical(s)

aplicação(ões)

pharmaceutical
sterility testing

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 minimizes false positives and offers the highest levels of quality and reliability. This device 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 Steritest® NEO Double Packed Device for liquids in small vials is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. The device contains a small diameter double needle adapter 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 for liquids in small vials is used for sterility testing of small volume parenterals of products with antimicrobial activity.

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 from all 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)

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