产品名称
Steritest® NEO Device, For liquids in large vials with septa., Blue base canister with vented needle adapter, pkg of 10 blisters per box, Single packed
material
blue base (canister)
mixed cellulose esters (MCE) (for membrane filter)
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
Blue base canister with vented needle adapter
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)
color
blue Canister Base
matrix
MF-Millipore™
pore size
0.45 μm pore size
input
pharmaceutical(s)
application(s)
pharmaceutical
sterility testing
compatibility
For liquids in large vials with septa.
shipped in
ambient
Quality Level
Application
The Steritest® NEO Device for liquids in vials is used for sterility testing of large volume parenterals and synthetic drugs without 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
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. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest® NEO devices. The blue canister base indicates mixed esters of cellulose membrane. This membrane provides an optimal filtration flow rate for standard products.
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 devices. The blue canister base indicates mixed esters of cellulose membrane. This membrane provides an optimal filtration flow rate for standard products.
Packaging
Pack of 10 single packed blisters per box
Legal Information
MF-Millipore is a 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
存储类别
11 - Combustible Solids
wgk
WGK 2
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