Opticap^® XL300 Millipore Express^® PHF

400

polyethersulfone
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
polysulfone
silicone seal

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

sterile

hydrophilic

Millipore Express^®

≤2.8 mL/min air diffusion at 2.8 bar (40 psig) and 23 ℃ (in water)
1.0 bar max. inlet pressure (15 psi) at 80 ℃
1000 bar max. differential pressure (15 psi) at 80 ℃
2.75 bar max. inlet pressure (40 psi) at 60 ℃
25 ℃ max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 ℃
5500 mbar max. differential pressure (80 psi) at 25 ℃
80 psig max. inlet pressure

11.9 cm (4.7 in.)

4.7 in. (11.9 cm)

5.6 cm (2.2 in.)

480 cm²

9/16 in.

11.9 cm (4.7 in.)

9/16 in.

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

Millipore Express^® PHF

0.2 μm nominal pore size
0.2 μm pore size

1/4 in. drain/vent hose barb (with double O-ring seal)
inlet hose barb
14 mm (9/16 in.) inlet/outlet hose barb
outlet hose barb

Double Easy-Open bag

Device Configuration: 取样皿滤膜
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

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 of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

This product was manufactured with a Millipore Express^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Sterilization Method
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable

TOC/Conductivity
After sterilization and a controlled water flush of 2.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Bacterial Retention
Samples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

ASTM is a registered trademark of American Society for Testing and Materials
MILLIPORE EXPRESS 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.