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TZHADV210

Millipore

Steritest® NEO Device

suitable for sterility testing, with small diameter double needle adaptor for soluble powders in vials with septa, pkg of 10 blisters per box, Single packed

eCl@ss:
32014001
NACRES:
NB.24

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

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

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.

Legal Information

MF-Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Certificate of Analysis

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Certificate of Quality

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