TZHADA210
Steritest® NEO Device
For soluble powders in ampoules. Blue base canister with a single needle for transfer into and out of ampoules.
Recommended Products
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)
Quality Level
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
sample type pharmaceutical(s)
application(s)
pharmaceutical
sterility testing
shipped in
ambient
Related Categories
General description
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 minimizes false positives, offers the highest levels of quality and reliability, and 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 device has vented double needle and simultaneously dissolves/dilutes the sample in sterile diluent and transfers the resulting solution to canisters for further filtration. The blue based canisters indicate mixed cellulose esters (MCE) membrane, which provides an optimal filtration flow rate for standard products.
Application
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
- Smarter workflow
- Completely closed set up
- Consistent performance
- New tubing disconnection tool
Packaging
Legal Information
Configured for
related product
required but not provided
wgk_germany
WGK 2
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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