| UNSPSC Code | 23151818 |
|---|---|
| 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 |
| pore size | 0.45 μm pore size |
| input | pharmaceutical(s) liquid |
| application(s) | pharmaceuticalsterility testing |
| compatibility | For liquids in cartridges and small soft plastic containers. |
| material | Nylon 66 adapter (for needle) |
| agency | EP 2.6.1 |
| sterility | sterile; γ-irradiated |
| feature | Blue base canister with single short (20 mm) needle. |
Answer:It is designed for liquids in cartridges and small soft-plastic containers.
Answer:The device uses a single short 20 mm needle.
Answer:It uses a 0.45 µm mixed cellulose ester membrane and is supplied sterile after gamma irradiation.
Steritest® NEO Device is designed for membrane-filtration sterility testing of pharmaceutical liquids in cartridges and small soft-plastic containers. This version uses a blue-base two-canister configuration with a single short 20 mm needle, matching the access requirements of these container formats. The filtration membrane is plain mixed cellulose ester with a 0.45 µm pore size. Each canister has a 120 mL sample volume with graduation marks at 25, 50, 75, and 100 mL. Construction includes styrene-acrylonitrile canisters, 850 mm PVC double-lumen tubing, a Nylon 66 needle adapter, and a stainless-steel needle. The device is sterile by gamma irradiation and supplied as 10 individually packed blisters per box. Maximum inlet pressure is 3.1 bar at 25 °C, and maximum operating temperature is 45 °C. It is intended for pharmaceutical sterility testing under USP , EP 2.6.1, and JP 4.06. The short-needle configuration lets the same closed membrane-filtration workflow be applied specifically to cartridge and small soft-container presentations without using an adapter intended for vials, syringes, or ampoules. The device uses two canisters in a closed filtration path, reducing the need to expose the test article during transfer and filtration. Its blue-base configuration corresponds to the mixed-cellulose-ester membrane version intended for standard filterable pharmaceutical products.
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