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TZVC00010

Millipore

Steridilutor® NEO Device

Devices with an expansion chamber for sample preparation and dilution. For liquids and soluble powders in vials.

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Synonym(s):
Steridilutor® NEO device for sterility testing
UNSPSC Code:
23151818
eCl@ss:
32014001
NACRES:
NB.24

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

manufacturer/tradename

Steridilutor®

packaging

pkg of 10 blisters per box, Single packed

input

sample type pharmaceutical(s)

application(s)

pharmaceutical
sterility testing

compatibility

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

General description

The Steridilutor® NEO device with 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 liquid antibiotics to reduce the concentration of the antimicrobial agent. This will reduce the possibility of binding of the agent to the filter. The expansion chamber vents residual vacuum or pressure from the vials without after-drip or contamination risk. The small diameter double needle connects test products with the diluent. The diluted product is subsequently filtered with suitable Steritest® NEO devices.

Application

The Steridilutor® NEO Device with expansion chamber is used for the dilution of powders and super-potent antibiotics and to pool products in vials. The expansion chamber enables the venting of diluent container.

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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Articles

Steritest® NEO device is ideal for sterility testing of antibiotics. The Steridilutor® NEO system is designed to dissolve and dilute drugs in vials whereas the Steridilutor® NEO device for the liquid transfer kit allows diluting liquids from open ampoules into a septum-equipped diluent container.

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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