material
polypropylene device, silicone seal
description
sanitization 30 min with hot water @ 80 °C
sterility
(10 autoclave cycles or SIP @ 126 °C for 30 min)
product line
Polygard
feature
hydrophilic
parameter
4.8 bar max. differential pressure (70 psid) at 25 °C, 4.8 bar max. inlet pressure (70 psi) at 25 °C
cartridge nominal length
20 in. (50 cm)
diam.
7.0 cm (2.75 in.)
impurities
≤0.5 EU/mL Aqueous extraction (LAL test)
pore size
25.0 μm nominal pore size, 25.0 μm pore size
input
sample type liquid
cartridge code
Code 5 (2-222 O-rings and spear)
General description
Device Configuration: Cartridge
Analysis Note
Gravimetric extractables:<=50 mg after 24-h soak in water
Will meet the USP Oxidizable Substances Test requirements after a water flush of >=10 L
Will meet the USP Oxidizable Substances Test requirements after a water flush of >=10 L
Legal Information
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
試験成績書（COA）
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