製品名
NovaSeptum® High Purity Unit, 100mL
Quality Segment
material
316L stainless steel cannula (ASTM), polyester body, polyethylene bag (drainage), polyethylene bag (sampling), polyethylene tubing, silicone septum (medical grade platinum-cured)
needle size
1.0 mm
sterility
sterile
manufacturer/tradename
NovaSeptum®
parameter
-20-50 °C max. temp., 0.5 bar max. sampling pressure (7.25 psi), 100 mL sample volume
impurities
≤2.15 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
fitting
inlet septum unit (with a 1 mm needle), Luer outlet fitting (3-piece)
storage temp.
10-30°C
General description
Single sampling your product is critical throughout the manufacturing process. An imprecise or false positive result can lead to quarantine, as well may also require a repeat of the analysis.
With the NovaSeptum® High Purity Unit, contamination is no longer a threat. Ideal for aseptic and sterile processes, the closed design ensures your sample will be isolated from point of sample to analysis. NovaSeptum® also allows for savings of precious materials with its compact, no dead leg, design.
The wide range of standard and custom connectors guarantees the ability to collect sample everywhere needed. The high purity sampling units are ideally suited for sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, ph analysis, and fermentation applications, and applications requiring very low affinity for proteins, complex carbohydrates or small molecules. It is available as a flat bag for easy storage and hanging.
With the NovaSeptum® High Purity Unit, contamination is no longer a threat. Ideal for aseptic and sterile processes, the closed design ensures your sample will be isolated from point of sample to analysis. NovaSeptum® also allows for savings of precious materials with its compact, no dead leg, design.
The wide range of standard and custom connectors guarantees the ability to collect sample everywhere needed. The high purity sampling units are ideally suited for sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, ph analysis, and fermentation applications, and applications requiring very low affinity for proteins, complex carbohydrates or small molecules. It is available as a flat bag for easy storage and hanging.
Application
無菌試験、 パイロジェン試験、 エンドトキシン試験、 化学分析、 pH分析、 および醗酵用途
Preparation Note
Sterilization Method
ベータ線 (e-ビーム) 最小 25 kGy ISO 11137に従う
ベータ線 (e-ビーム) 最小 25 kGy ISO 11137に従う
Other Notes
Please refer to the Animal Origin Statement
Legal Information
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
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試験成績書(COA)
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