material
PVC tubing, mixed cellulose esters (HA) membrane, stainless steel needle, styrene-acrylonitrile (SAN) (canister)
agency
ChP
sterility
sterile; γ-irradiated
manufacturer/tradename
SteriSecure™
parameter
max. pressure at 3.15 bar and 25 °C, 45 °C max. temp.
L
850 mm
pore size
0.45 μm (Canister membrane)
input
liquid
application(s)
pharmaceutical
sterility testing
compatibility
for use with Steritest® systems
Quality Level
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General description
The SteriSecure™ Device for large vials is used to pump test solutions from large vials during sterility testing. A vented needle adapter vents and transfers the test solution from large volume containers with a septum to the SteriSecure™ Device
The closed system minimizes false positives and offers the highest level of quality and reliability. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. This membrane provides an optimal filtration flow rate for standard products. This test system offers an optimized and fully regulatory compliant testing process when used with the Steritest® Symbio pump, specific accessories, high-quality culture media and rinsing fluids.
The closed system minimizes false positives and offers the highest level of quality and reliability. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. This membrane provides an optimal filtration flow rate for standard products. This test system offers an optimized and fully regulatory compliant testing process when used with the Steritest® Symbio pump, specific accessories, high-quality culture media and rinsing fluids.
Application
The SteriSecure™ Device for large vials is used during testing of pharmaceutical products in large vials for streamlining the workflow and increasing safety during sterility testing.
Legal Information
STERISECURE is a trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
signalword
Danger
hcodes
Hazard Classifications
Flam. Sol. 1
存储类别
4.1B - Flammable solid hazardous materials
wgk
WGK 3
法规信息
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