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TZHVSL210

Millipore

Steritest® NEO Device

This green base canister with a single needle is ideal for testing solvents, creams, ointments, and veterinary injectables.

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Synonym(s):
Green Base Steritest® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration
eCl@ss:
32014001
NACRES:
NB.24

material

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

Quality Level

Agency

EP (2.6.1)
JP (4.06)
USP 71

sterility

sterile; γ-irradiated

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

tubing L

850 mm

color

green Canister Base

matrix

Durapore®

pore size

0.45 μm pore size

input

solvent(s)
sample type pharmaceutical(s)

application(s)

pharmaceutical
sterility testing

shipped in

ambient

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Steritest® NEO Device This green base canister with a single needle is ideal for testing solvents, creams, ointments, and veterinary injectables.

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Steritest® NEO Device For liquids in ampoules and collapsible bags. Red base canister with single needle for easy access. Single packed.

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TZHVAB210

Steritest® NEO Device

Steritest® NEO Device For liquids in ampoules or collapsible bags. Blue base canister with a single-needle adapter. Single packed.

Millipore

TZHALA210

Steritest® NEO Device

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

pore size

0.45 μm pore size

pore size

0.45 μm pore size

pore size

0.45 μm pore size

pore size

0.45 μm pore size

application(s)

pharmaceutical
sterility testing

application(s)

pharmaceutical
sterility testing

application(s)

pharmaceutical
sterility testing

application(s)

pharmaceutical
sterility testing

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

Device Configuration: 2 canisters

Steritest® NEO Device 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, ensuring 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. The canister connections and reinforced base structure provide better resistance to pressure. The single needle adapter is used for products in vials or ampoules. A separate vent needle is included for the transfer of the test product, culture media or rinsing buffer. The canisters come with green canister base indicating increased chemical compatibility with solvents due to Durapore® Poly vinylidene fluoride (PVDF) membrane and specific canister polymer (nylon). This optimizes the chemical compatibility of products dissolved in solvents.

Application

The Steritest® NEO Device is used for sterility testing of products dissolved in solvents (such as creams, ointments and veterinary injectables), requiring increased chemical compatibility.

Features and Benefits

  • One-stop-shop for sterility testing with our devices, pumps, media, fluids, and services
  • Steritest® devices are manufactured in our Center of Excellence in Molsheim, France, with high-quality control standards maintaining the Certificate of Quality for each lot.
  • New needle design
The design of this new needle has been optimized with short needle length, grips, and ridges to offer dexterity and security to the operator while piercing the small container
  • Smarter workflow
  • The new Steritest® NEO cartridge device benefits from all the improvements such as colored clamps, graduations for accurate volume measurement, optimized identification, and traceability with the new peel-off label
  • Completely closed set up
Pharmaceutical products are never exposed to the environment during the testing process with Steritest® NEO devices. Filtration, rinsing, media addition and incubation are conducted within a closed system.
  • Consistent performance
100% integrity testing, strict physical and microbiological tests performed at every step of the assembly of the Steritest® NEO device before release from manufacturing.
  • New tubing disconnection tool
The Velax® cutting clamps are mounted on all Steritest® NEO devices and allow safe and easy cutting of the tubes.

Packaging

Pack of 10 single packed blisters per box

Legal Information

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

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Sterility Testing of Products to be Diluted in Isopropyl Myristate

The combination of Sterile Isopropyl Myristate (IPM) and the Steritest® NEO device is an effective solution for sterility testing of viscous products like creams and ointments. IPM enhances sample filterability by diluting these products.

Steritest® NEO Membrane Filtration Sterility Test

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.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service