The Steridilutor device is equipped with two needles:
- an LVP-type needle that is inserted in the diluting fluid container with an external diameter of 1.20 +/- 0.03 mm,
- a product needle that is inserted in the sample vials which consists of two cannulas, one for the flow with an external diameter of 1.50 +/- 0.03 mm and a length of 16.5 0/- 0.80 mm, one for the venting with an external diameter of 1.30 +/- 0.03 mm and a length of 21.7 +0,80 / 0 mm.
TZV000010
Steridilutor® NEO Device
For liquids and soluble powders in vials., Devices without an expansion chamber for sample preparation and dilution., pkg of 10 blisters per box, Single packed
Synonym(s):
Steridilutor® NEO device for sterility testing
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About This Item
UNSPSC Code:
23151818
eCl@ss:
32014001
NACRES:
NB.24
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material
Nylon 66 adapter (for needle)
PVC tubing
stainless steel (for needle)
Quality Level
agency
EP (2.6.1)
JP (4.06)
USP 71
sterility
sterile; γ-irradiated
feature
Devices without an expansion chamber for sample preparation and dilution.
manufacturer/tradename
Steridilutor®
packaging
pkg of 10 blisters per box, Single packed
input
sample type pharmaceutical(s)
application(s)
pharmaceutical
sterility testing
compatibility
For liquids and soluble powders in vials.
for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01)
for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01)
for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01)
shipped in
ambient
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This Item | TZVC00010 | TZA000010 | TZHALA210 |
|---|---|---|---|
| compatibility For liquids and soluble powders in vials., for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) | compatibility For liquids and soluble powders in vials., for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) | compatibility For liquid transfer from ampoules or vials to a diluent vial with septum pooling., for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) | compatibility For liquids in ampoules or collapsible bags., for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical |
| packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed |
| material Nylon 66 adapter (for needle), stainless steel (for needle), PVC tubing | material Nylon 66 adapter (for needle), PVC tubing, stainless steel (for needle) | material Nylon 66 adapter (for needle), PVC tubing, stainless steel (for needle) | material Nylon 66 adapter (for needle), PVC tubing (double lumen), mixed cellulose esters (MCE) membrane, plain filter, stainless steel (for needle), styrene-acrylonitrile (SAN) (for canister) |
| shipped in ambient | shipped in ambient | shipped in ambient | shipped in ambient |
| agency EP (2.6.1) | agency EP (2.6.1), JP (4.06), USP 71 | agency EP (2.6.1), JP (4.06), USP 71 | agency EP (2.6.1), JP (4.06), USP 71 |
General description
The Steridilutor® NEO Device without expansion chamber is a tubing and needle assembly for difficult to dissolve powders, for dilution of super-potent antibiotics and pool products in vials. Pure products (solid or liquid) are difficult to rinse and residuals from products might be a major inhibitory factor in sterility testing. In the case of powders, a good dissolution is required to avoid any possible aggregate. A dilution step is strongly recommended for super potent antibiotics to reduce the concentration of the antimicrobial agent. This will reduce the possibility of binding of the agent to the filter. The small diameter double needle connects test products to the diluent. The diluted product is subsequently filtered with suitable Steritest® NEO devices.
Application
The Steridilutor® NEO Device without expansion chamber is used for difficult to dissolve powders, dilution of viscous products and pool products in vials. It helps for faster, easier and safer sterility testing.
Legal Information
STERIDILUTOR is a registered trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
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Sterility testing is one of the most crucial steps in pharmaceutical product release. Regulatory-compliant membrane filtration sterility testing devices ensure the safety of pharmaceutical products.
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What size is the needle for the Steridiluter? I know it is 20mm in length - but what about the gauge? Thanks in advance.
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