Opticap^® XL2 Durapore^®

400

PVDF
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

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

sterile

EMPROVE^® Filter

hydrophilic

Opticap^®

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. inlet pressure (40 psi) at 60 ℃
25 ℃ max. inlet temp.
3.4 bar max. differential pressure (50 psid) at 25 ℃ (Reverse; intermittent)
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

14.2 cm (5.6 in.)

2 in. (5 cm)

12.5 cm (4.9 in.)

0.09 m²

1.5 in.

14.2 cm (5.6 in.)

9/16 in.

2 in.

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

≤10 mg/capsule

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

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; 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).

Gravimetric Extractables: after 24 hours in water at controlled room temperature
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

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.