| 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 | Red base canister with 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 | red Canister Base |
| matrix | Durapore® |
| pore size | 0.45 μm pore size |
| input | sample type pharmaceutical(s) |
| application(s) | pharmaceuticalsterility testing |
| compatibility | For soluble powders in vials with septa. |
| shipped in | ambient |
| Quality Level | 400 |
Answer:It is intended for soluble powders in small septum-sealed vials.
Answer:It uses a 0.45 µm Durapore® PVDF membrane.
Answer:It is gamma-irradiated and supplied in a box of ten individually packed sterile blisters.
Steritest® NEO Device is designed for closed-system membrane-filtration sterility testing of soluble pharmaceutical powders supplied in small vials with septa. This specific red-base configuration uses a vented double-needle adapter to connect to the vial and two canisters containing plain 0.45 µm Durapore® polyvinylidene fluoride membranes. The PVDF chemistry distinguishes it from otherwise similar blue-base configurations that contain mixed-cellulose-ester membranes. Each canister provides a 120 mL sample volume with graduation marks at 25, 50, 75, and 100 mL. Construction includes styrene-acrylonitrile canisters, 850 mm double-lumen PVC tubing, a Nylon 66 adapter, and stainless-steel needle components. The closed sample path helps minimize environmental exposure during sample transfer and filtration. The device is gamma-irradiated and supplied sterile as ten individually packed blisters per box. Maximum inlet pressure is 3.1 bar at 25 °C and maximum operating temperature is 45 °C. It supports sterility-testing workflows aligned with USP , EP 2.6.1, and JP 4.06, using compatible Steritest Symbio pump systems.
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