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Merck

TZHADV210

Steritest® NEO Device

For soluble powders in vials., Blue base canister with a vented double needle for small vials with septa.

동의어(들):

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

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제품정보 (DICE 배송 시 비용 별도)

UNSPSC Code:
23151818
NACRES:
NB.24
eCl@ss:
32014001
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Quality Level

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)

agency

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

sterility

sterile; γ-irradiated

feature

Blue base canister with a vented double needle for small vials with septa.

manufacturer/tradename

Steritest®

packaging

pkg of 10 blisters per box, Single 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

compatibility

For soluble powders in vials., for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01)

shipped in

ambient

General description

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 ensures that pharmaceutical products are never exposed to the environment during the testing process. This 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. A small diameter double needle adapter is used for small vials with septa. The blue based canisters indicate mixed cellulose esters (MCE) membrane, which provides an optimal filtration flow rate for standard products.

Application

The Steritest® NEO Device is used for sterility testing of soluble powders in vials, without antimicrobial agents. The device simultaneously dissolves/dilutes the sample in sterile diluent and transfers the resulting solution to canisters for further filtration.

Features and Benefits

  • 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.

Packaging

Pack of 10 single packed blisters per box

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


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저장 등급

11 - Combustible Solids

wgk

WGK 2



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관련 콘텐츠

The new Velax® cutting clamp to sever the tubing of a Steritest® NEO device makes sterility testing by membrane filtration safer and more convenient than ever before.

관련 콘텐츠 모두 보기




국제 무역 품목 번호

SKUGTIN
TZHADV21004053252604331