Sterile unit. Delivered hermetically sealed, with its Certificate of Quality
Product Information
Configuration
Gamma Gold Capsule
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.
Stacked Discs
40
Applications
Application
Sterile 0.22 µm membrane filter for particulate-free and bacteria-free water at the point of dispense
Biological Information
Media
Durapore®
Sterility
Sterile
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Wettability
Hydrophilic
Physicochemical Information
Pore Size (µm)
0.22
Gravimetric Extractables (%)
The extractables level was equal to or less than 1.5 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature.
Inlet Connection
NPTM
Non-Fiber Releasing
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
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