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
1 autoclave cycle of 60 min @ 123 °C
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).

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
This product was tested and passes the USP <78> test for particulates in injectables.

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
OPTISCALE is a registered trademark of Merck KGaA, Darmstadt, Germany

PVDF membrane
polypropylene
polypropylene support
polypropylene vent cap

400

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

sterile

hydrophilic

OptiScale^®

4.1 bar max. inlet pressure (60 psi) at 25 ℃
60 psi max. differential pressure (4.1 bar) at 25 ℃ (forward)

3.9 cm (1.52 in.)

3.1 cm (1.2 in.)

3.5 cm²

≤0.25 EU/mL (LAL test, Aqueous extraction)
<0.25  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

Durapore^®

0.22 μm nominal pore size
0.22 μm pore size

sample type liquid

female Luer-Lok^® inlet connection
male Luer-Lok^® outlet connection

ambient