| 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 soluble powders in vials. |
| shipped in | ambient |
| Quality Level | 400 |
Answer:It is intended for soluble powders in small vials with septa.
Answer:It uses a plain mixed cellulose ester membrane with a 0.45 µm pore size.
Answer:Yes. It is gamma-irradiated and packed as 10 single blisters per box.
Steritest® NEO Device is designed for membrane-filtration sterility testing of soluble powders in vials. The blue-base device uses a vented double-needle adapter sized for small vials with septa, allowing the vial presentation to be connected to a closed two-canister filtration system. Each canister uses a plain 0.45 µm mixed cellulose ester membrane and provides a 120 mL sample volume with graduation marks at 25, 50, 75, and 100 mL. The device includes 850 mm PVC double-lumen tubing, styrene-acrylonitrile canisters, a Nylon 66 needle adapter, and stainless-steel needle components. It is sterile by gamma irradiation and is supplied as 10 individually packed blisters per box. The operating limits include a maximum inlet pressure of 3.1 bar at 25 °C and a maximum temperature of 45 °C. The device is intended for pharmaceutical sterility testing aligned with USP , EP 2.6.1, and JP 4.06. Its vial-specific vented double-needle configuration makes it suitable for transferring and filtering reconstituted soluble-powder products without substituting a different container adapter or membrane format. The two-canister closed configuration keeps the transferred product inside the Steritest filtration path during processing. The blue canister base corresponds to the MCE membrane version, distinguishing it from Steritest NEO configurations that use other membrane chemistries.
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