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Quality Segment
material
blue base (canister), mixed cellulose esters (MCE) (for membrane filter), 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 vented needle adapter
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)
color
blue Canister Base
matrix
MF-Millipore™
pore size
0.45 μm pore size
input
pharmaceutical(s)
application(s)
pharmaceutical
sterility testing
compatibility
For liquids in large vials with septa.
shipped in
ambient
General description
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 blue canister base indicates mixed esters of cellulose membrane. This membrane 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
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| description For liquids in large vials with septa., Blue base canister with vented needle adapter, pkg of 10 blisters per box, Single packed | description For liquids in small vials., Blue base canister with a vented double needle for small vials with septa., pkg of 10 blisters per box, Single packed | description For liquids in small vials., Blue base canister with a vented double needle for small vials with septa. | description For liquids in large vials., Blue base canister with a vented double needle for large glass containers with septa., pkg of 10 blisters per box, Single packed |
| compatibility For liquids in large vials with septa. | compatibility for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), For liquids in small vials., for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) | compatibility For liquids in small vials. | compatibility For liquids in large vials., for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01), for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01) |
| shipped in ambient | shipped in ambient | shipped in ambient | shipped in ambient |
| material styrene-acrylonitrile (SAN) (for canister), plain filter, blue base (canister), mixed cellulose esters (MCE) (for membrane filter), stainless steel (for needle) | material mixed cellulose esters (MCE) membrane, PVC tubing (double lumen), plain filter, Nylon 66 adapter (for needle), styrene-acrylonitrile (SAN) (for canister), stainless steel (for needle) | material mixed cellulose esters (MCE) membrane, PVC tubing (double lumen), Nylon 66 adapter (for needle), plain filter, styrene-acrylonitrile (SAN) (for canister), stainless steel (for needle) | material Nylon 66 adapter (for needle), stainless steel (for needle), plain filter, styrene-acrylonitrile (SAN) (for canister), PVC tubing (double lumen), mixed cellulose esters (MCE) membrane |
| parameter 120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL) | 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. | parameter 120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL), 45 °C max. temp., 3.1 bar max. inlet pressure (45 psi) at 25 °C | parameter 3.1 bar max. inlet pressure (45 psi) at 25 °C, 45 °C max. temp., 120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL) |
| input pharmaceutical(s) | input liquid | input sample type pharmaceutical(s) | input sample type pharmaceutical(s) |
| feature Blue base canister with vented needle adapter | feature Blue base canister with a vented double needle for small vials with septa. | feature Blue base canister with a vented double needle for small vials with septa. | feature Blue base canister with a vented double needle for large glass containers with septa. |
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Lagerklasse
11 - Combustible Solids
Was ist los?
WGK 2
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