These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Gravimetric Extractables
The extractables level was equal to or less than 70 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 25 °C, Intermittent
Media
Multimedia Durapore®
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).
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
Pore Size
1.2 / 0.5 / 0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
6 autoclave or SIP cycles of 30 min @ 123 °C
Support Material
Polypropylene
Trade Name
Durapore®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
+852-3069 6950
css@gugent.com.hk
