Steritest^® NEO Device

32014001

NB.24

Device Configuration: 2 canisters

Steritest^® NEO is a membrane filtration device for sterility testing of filterable pharmaceutical products. The device simplifies every aspect of testing, from handling to traceability. The closed system minimizes false positives and offers the highest levels of quality and reliability. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. This test system offers an optimized and fully regulatory compliant testing process when used with the Steritest^® Symbio pump, specific accessories and high-quality culture media and rinsing fluids. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest^® NEO device. The red canister base indicates low absorption Durapore^® hydrophilic Poly vinylidene fluoride (PVDF) membrane and specific drain design. This optimizes the rising of products that inhibit microbial growth. The canister capacity of 120 mL allows to test larger volumes.

The Steritest^® NEO Device for liquids in large vials is used for sterility testing of large volume of products with antimicrobial activity.

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

400

Nylon 66 adapter (for needle)
PVC tubing (double lumen)
PVDF membrane
plain filter
stainless steel (for needle)
styrene-acrylonitrile (SAN) (for canister)

EP (2.6.1)
JP (4.06)
USP 71

sterile; γ-irradiated

Steritest^®

pkg of 10 blisters per box, Single packed

3.1 bar max. inlet pressure (45 psi) at 25 ℃
45 ℃ max. temp.

850 mm

red Canister Base

Durapore^®

0.45 μm pore size

liquid
sample type pharmaceutical(s)

sample volume: 120 mL (graduation marks at 25, 50, 75 and 100 mL)

pharmaceutical
sterility testing

ambient