Optiscale^® Capsule Filter Polygard^® CN

32031610

Device Configuration: 取样皿滤膜

Format: Single Layer

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use:

• Organism Retention: Bacterial
• Mode of Action: Filtration (size exclusion)
• Appliication: Protein Purification
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer to the installation and wetting sections of OptiScale^® 47 Capsulle Filter with Polygard^® CN Media user guide
• Storage Statement: Store in original packaging at room temperature
• Disposal Statement: Dispose of in accordance with applicable federal, state, and local regulations

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥100 mL

OPTISCALE is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany

400

PVDF vent cap
fluoroelastomer FKM seal
polycarbonate
polypropylene
polypropylene support

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

OptiScale^®

25 ℃ max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 ℃
80 psig max. inlet pressure

6.9 cm (2.7 in.)

17.7 cm²

3/4 in.

1/4 in.

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)

Polygard^®-CN

0.6 μm nominal pore size
0.6 μm pore size

sample type liquid

inlet sanitary flange
19 mm (3/4 in.) inlet sanitary flange
outlet hose barb
6 mm (1/4 in.) outlet hose barb