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TZHASY210

Millipore

Steritest® NEO Device

suitable for sterility testing, The Steritest® NEO Device for pre-filled syringes is used for sterility testing of pre-filled syringes., 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
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. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. The closed system 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. The device comes with vented double needle. The adapter allows for sequential testing of syringe contents and needle surfaces. The system has two blue based canisters with mixed cellulose esters (MCE) membrane, providing an optimal filtration flow rate for standard products.

Application

The Steritest® NEO Device for liquids in syringes is used for sterility testing of pre-filled syringes, for products without antimicrobial agents.

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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