| 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 single-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) |
| tubing L | 850 mm |
| color | blue Canister Base |
| matrix | MF-Millipore™ |
| pore size | 0.45 μm pore size |
| input | sample type pharmaceutical(s) liquid |
| application(s) | pharmaceuticalsterility testing |
| compatibility | For liquids in ampoules or collapsible bags. |
| shipped in | ambient |
| Quality Level | 400 |
Answer:It is designed for liquids in ampoules or collapsible bags.
Answer:It uses a plain 0.45 µm mixed cellulose ester membrane with a 47 mm filter diameter.
Answer:It is supplied sterile by gamma irradiation in 10 individually packed blisters per box.
Steritest® NEO Device is designed for membrane-filtration sterility testing of pharmaceutical liquids in ampoules or collapsible bags. This blue-base version uses a single-needle adapter and a closed two-canister configuration. The filtration medium is a plain 0.45 µm mixed cellulose ester membrane with a 47 mm filter diameter, and each canister provides 120 mL of volume. Graduation marks at 25, 50, 75, and 100 mL support visual volume control during the test workflow. Construction includes styrene-acrylonitrile canisters, 850 mm PVC double-lumen tubing, a Nylon 66 needle adapter, and stainless-steel needle components. The device is sterile by gamma irradiation and is supplied as 10 individually packed blisters per box. Maximum inlet pressure is 3.1 bar at 25 °C, and the maximum temperature is 45 °C. It is intended for sterility testing under USP , EP 2.6.1, and JP 4.06. The single-needle adapter provides a dedicated connection format for ampoules and collapsible bags while keeping the sample inside a closed membrane-filtration path. The two-canister closed configuration keeps the test liquid contained during transfer and membrane filtration. The blue canister base corresponds to the mixed-cellulose-ester membrane version, while the single-needle adapter differentiates this format from syringe and vial configurations. The device is shipped at ambient conditions and is intended specifically for liquid pharmaceutical samples.
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