These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Inlet Connection
Female Luer Lok
Length
3.9 cm (1.52 in.)
Material Size
6
Maximum Inlet Pressure, bar (psi)
4.0 bar (60 psi) @ 25 °C
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).
Outlet Connection
Male Luer Lok
Pore Size
1.2 / 0.22 µm
Sterility
Other
Sterilization
1 autoclave cycle of 60 min @ 123 °C
Support Material
Polypropylene
Trade Name
OptiScale®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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