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KGEPG003FF3

Millipore

Millipore Express® SHF, Opticap® XL Capsule

Opticap® XL 3, inlet connection diam. 3/4 in., pore size 0.2 μm, cartridge nominal length 4.7 in. (11.9 cm)

Synonym(s):

Opticap XL 300 Millipore Express SHF Gamma Compatible 0.2 m 3/4 in. TC/TC

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About This Item

UNSPSC Code:
23151806

material

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

Quality Level

400

reg. compliance

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

sterility

non-sterile

sterilization compatibility

gamma compatible

product line

Opticap® XL 3

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤2.8 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water)
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
100 psi max. differential pressure (6.9 bar) (intermittent)
2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

L

11.9 cm (4.7 in.)

W

2.2 in.

cartridge nominal length

4.7 in. (11.9 cm)

diam.

5.6 cm (2.2 in.)

filtration area

480 cm2

inlet connection diam.

3/4 in.

inlet to outlet W

11.9 cm (4.7 in.)

outlet connection diam.

3/4 in.

impurities

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

matrix

Millipore Express® SHF

pore size

0.2 μm pore size

bubble point

≥4000 mbar (58 psig), air with water at 23 °C

fitting

1/4 in. drain/vent hose barb (with double O-ring seal)
 inlet sanitary flange
 outlet sanitary flange
 (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

General description

Device Configuration: Capsule
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

Packaging

Double Easy-Open bag

Other Notes

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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
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).

Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
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.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

Legal Information

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

Disclaimer

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.

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