material
Nylon 66 adapter (for needle), PVC tubing (double lumen), PVDF membrane, plain filter, stainless steel (for needle), styrene-acrylonitrile (SAN) (for canister)
agency
EP (2.6.1), JP (4.06), USP (71)
sterility
sterile; γ-irradiated
feature
Red base canister with a vented double needle for small vials with septa.
manufacturer/tradename
Steritest®
packaging
pkg of 10 blisters in 2 bags of 5 blisters per box, Double packed
parameter
120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL)
color
red Canister Base
pore size
0.45 μm pore size
input
liquid
pharmaceutical(s)
application(s)
pharmaceutical
sterility testing
compatibility
For liquids in small vials with septa.
shipped in
ambient
Quality Level
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General description
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. The Steritest® NEO Double Packed Device for liquids in small vials is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. The device contains a small diameter double needle adapter for small vials with septum. The red canister base indicates low absorption. Durapore® hydrophilic Poly vinylidene fluoride (PVDF) membrane and specific drain design. This optimizes the rinsing of products that inhibit microbial growth.
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. The Steritest® NEO Double Packed Device for liquids in small vials is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. The device contains a small diameter double needle adapter for small vials with septum. The red canister base indicates low absorption. Durapore® hydrophilic Poly vinylidene fluoride (PVDF) membrane and specific drain design. This optimizes the rinsing of products that inhibit microbial growth.
Application
Steritest® NEO Device for liquids in small vials is used for sterility testing of small volume parenterals of products with antimicrobial activity.
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
- Smarter workflow
- Completely closed set up
- Consistent performance
- New tubing disconnection tool
Packaging
Pack of 10 double packed blisters in 2 bags of 5 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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