| 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 vented double needle adapter for sequential testing of syringe contents and needle surfaces. |
| 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 syringes. |
| shipped in | ambient |
| Quality Level | 400 |
Answer:It is designed for pharmaceutical liquids in syringes and supports sequential testing of syringe contents and needle surfaces.
Answer:The device uses a plain 0.45 µm mixed cellulose ester membrane with a 47 mm filter diameter.
Answer:It is gamma-irradiated and supplied as 10 individually packed blisters per box.
Steritest® NEO Device is designed for membrane-filtration sterility testing of pharmaceutical liquids supplied in syringes, including sequential testing of syringe contents and needle surfaces. The closed device uses two canisters with plain 0.45 µm mixed cellulose ester membranes, each with a 47 mm filter diameter and a 120 mL volume. A vented double-needle adapter provides the syringe-specific sampling interface. Construction includes styrene-acrylonitrile canisters, 850 mm PVC double-lumen tubing, and a stainless-steel/polyamide needle adapter. The device is sterile by gamma irradiation and is supplied as 10 individually packed blisters per box. It is designed for sterility testing under USP , EP 2.6.1, and JP 4.06 requirements. The canisters include graduation marks at 25, 50, 75, and 100 mL, with a maximum inlet pressure of 3.1 bar at 25 °C and a maximum temperature of 45 °C. The closed membrane-filtration format keeps the pharmaceutical sample contained during transfer and filtration while providing a dedicated adapter geometry for syringe presentations. The two-canister arrangement supports the membrane-filtration sterility-test workflow without opening the sample path to the surrounding environment. The blue canister base identifies the MCE membrane configuration used for this version of the device. The canister volume is 120 mL and the filter diameter is 47 mm.
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