Opticap^® XL4 Durapore^®

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: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable
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, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 ºC.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

400

PVDF
polyester support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
silicone outer O-ring
silicone-coated EPDM rubber lead O-ring

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

EMPROVE^® Filter

gamma compatible
hydrophilic

Opticap^®

≤4.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 ℃ (in water)
1.0 bar max. differential pressure (15 psid) at 80 ℃ (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 ℃
2.8 bar max. differential pressure (40 psid) at 25 ℃ (Reverse; intermittent)
2.8 bar max. inlet pressure (40 psi) at 60 ℃
25 ℃ max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 ℃ (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 ℃
80 psig max. inlet pressure

17.0 cm (6.7 in.)

4 in. (10 cm)

6.1 cm (2.4 in.)

0.18 m²

1.5 in.

9/16 in.

4 in.

≤0.5 EU/mL bacterial endotoxins (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

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

1/4 in. drain/vent hose barb (with double O-ring Seal)
inlet sanitary flange
38 mm (1 1/2 in.) inlet sanitary flange
outlet hose barb
14 mm (9/16 in.) outlet hose barb

Double Easy-Open bag

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.