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TZHALV210

Millipore

Steritest® NEO Device

suitable for sterility testing, with vented needle adapter for liquids in large vials, 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

The STERITEST® NEO Device for liquids in vials is used for sterility testing of large Volume Parenterals and synthetic drugs without antimicrobial activity. A vented needle adapter vents and transfers the test product from large volume containers with a septa to the STERITEST® NEO devices. The blue canister base indicates mixed esters of cellulose membrane. This membrane provides an optimal filtration flow rate for standard products.
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. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest® NEO devices. The canisters with blue base indicate mixed cellulose ester (MCE) membrane, which provides an optimal filtration flow rate for standard products.

Application

The Steritest® NEO Device is used for sterility testing of large volume parenterals and synthetic drugs without antimicrobial activity.

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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Steritest® NEO Membrane Filtration Sterility Test

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