| UNSPSC Code | 23151818 |
|---|---|
| NACRES | NB.24 |
| eCl@ss | 32014001 |
| material | Nylon 66 adapter (for needle) |
| agency | EP (2.6.1) |
| sterility | sterile; γ-irradiated |
| feature | Blue base canister with a vented double needle for small vials with septa. |
| 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) |
| tubing L | 850 mm |
| color | blue Canister Base |
| matrix | MF-Millipore™ |
| pore size | 0.45 μm pore size |
| input | liquidsample type pharmaceutical(s) |
| application(s) | pharmaceuticalsterility testing |
| compatibility | For liquids in small vials. |
| shipped in | ambient |
| Quality Level | 400 |
Answer:It is designed for pharmaceutical liquids in small vials with septa.
Answer:It uses a vented double needle.
Answer:The mixed cellulose ester membrane has a 0.45 µm pore size.
Steritest® NEO Device is designed for membrane-filtration sterility testing of pharmaceutical liquids in small vials. This version uses a blue-base two-canister system with a vented double needle for small vials fitted with septa. The canisters use plain 0.45 µm mixed cellulose ester membranes and provide a 120 mL sample volume with graduation marks at 25, 50, 75, and 100 mL. Materials include styrene-acrylonitrile for the canister, PVC for the 850 mm double-lumen tubing, Nylon 66 for the needle adapter, and stainless steel for the needle. The device is sterile by gamma irradiation and is packed as 10 individually sealed blisters per box. Maximum inlet pressure is 3.1 bar at 25 °C, and maximum operating temperature is 45 °C. The device is intended for pharmaceutical sterility testing under USP , EP 2.6.1, and JP 4.06. Its vial-specific vented double-needle connection supports closed transfer from septum-sealed small vials while retaining the same MCE membrane filtration format used by the blue-base Steritest NEO configuration. Compatibility information for this version includes the Steritest Symbio FLEX, ISL, and LFH pump-kit workflows. This allows the vial-specific device to be integrated into the corresponding Steritest NEO pumping configuration while retaining the defined membrane and tubing set. The device is shipped at ambient conditions and is intended specifically for liquid pharmaceutical samples.
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