TZHAMD210
Steritest® NEO Device
For medical devices and collapsible bags., Blue base canister provided with 3 adaptors for connecting various test devices.
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
Quality Segment
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 provided with 3 adaptors for connecting various test devices.
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
compatibility
For medical devices and collapsible bags., for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01)
shipped in
ambient
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 ensures that pharmaceutical products are never exposed to the environment during the testing process. This 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 Steritest® NEO Device for medical devices provides three adapters: male Luer, female Luer or single needle allow connection to a variety of test devices. A separate vent needle is used for the transfer of culture media or rinse buffer. The Steritest® NEO Device for medical devices can be used with Novaseptum® for sterile sampling devices. The blue canister base indicates mixed cellulose esters (MCE) 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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This Item | |||
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| description For medical devices and collapsible bags., Blue base canister provided with 3 adaptors for connecting various test devices. | description Green base canister with a single needle is ideal for testing solvents, creams, ointments, and veterinary injectables., pkg of 10 blisters per box, Single packed | 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 syringes., Blue base canister with vented double needle adapter for sequential testing of syringe contents and needle surfaces. |
| compatibility for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), For medical devices and collapsible bags., for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) | compatibility Green base canister with a single needle is ideal for testing solvents, creams, ointments, and veterinary injectables. | compatibility For liquids in large vials with septa. | compatibility For liquids in syringes. |
| material PVC tubing (double lumen), Nylon 66 adapter (for needle), stainless steel ( for needle), plain filter, mixed cellulose esters (MCE) membrane, styrene-acrylonitrile (SAN) ( for Canister) | material PVDF membrane, plain filter, Nylon (for canister), PVC tubing (double lumen), stainless steel (for needle), Nylon 66 adapter (for needle) | material styrene-acrylonitrile (SAN) (for canister), plain filter, blue base (canister), stainless steel (for needle), mixed cellulose esters (MCE) (for membrane filter) | material stainless steel (for needle), mixed cellulose esters (MCE) membrane, Nylon 66 adapter (for needle), PVC tubing (double lumen), styrene-acrylonitrile (SAN) (For Canister) |
| shipped in ambient | shipped in ambient | shipped in ambient | shipped in ambient |
| packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed |
| Quality Level 400 | Quality Level 400 | Quality Level 400 | Quality Level 400 |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical |
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Storage Class
11 - Combustible Solids
WGK
WGK 2
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