TZHALV205
Steritest® NEO Device
For liquids in large vials., Blue base canister with a vented double needle for large glass containers with septa., pkg of 10 blisters in 2 bags of 5 blisters per box, Double packed
Synonym(s):
Blue Base Steritest® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration
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About This Item
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 large glass containers with septa.
manufacturer/tradename
Steritest®
packaging
pkg of 10 blisters in 2 bags of 5 blisters per box, Double 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 liquids in large vials.
shipped in
ambient
Quality Level
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 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. The device is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest® NEO devices. 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
Storage Class
11 - Combustible Solids
wgk
WGK 2
Regulatory Listings
Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.
TZHALV205:
jan
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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Articles
Sterility testing is one of the most crucial steps in pharmaceutical product release. Regulatory-compliant membrane filtration sterility testing devices ensure the safety of pharmaceutical products.
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Global Trade Item Number
| SKU | GTIN |
|---|---|
| TZHALV205 | 04053252385827 |
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