Optiscale^®囊式过滤器(Durapore)^®

32031610

NB.24

Device Configuration: 取样皿滤膜

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)
• Application: Protein purification
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation and wetting sections of OPTISCALE^®-25 user guide
• Storage Statement: Please refer OPTISCALE^®-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C

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

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

PVDF membrane
PVDF vent cap
fluoroelastomer FKM seal
polycarbonate
polypropylene support

400

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

sterile

hydrophilic

OptiScale^®

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

7.4 cm (2.91 in.)

6.9 cm (2.7 in.)

17.7 cm²

3/4  in.

3/4 in.

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

Durapore^®

0.22 μm nominal pore size
0.22 μm pore size

sample type liquid

≥3450 mbar (50 psig), air with water at 23 ℃

inlet sanitary flange
19 mm (3/4 in.) inlet/outlet sanitary flange
outlet sanitary flange

ambient