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Merck

KVEPS003FB3

Millipore

Millipore Express® SHR, Opticap® XL Capsule

sterile, Opticap® XL 3, cartridge nominal length 4.7 in. (11.9 cm), filter diam. 5.6 cm (2.2 in.)

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About This Item

UNSPSC Code:
23151806

Pricing and availability is not currently available.

material

polyethylene support
polypropylene device
polypropylene housing
polypropylene vent cap
silicone seal

Quality Level

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

sterility

irradiated
sterile

product line

Opticap® XL 3

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤2.8 mL/min air diffusion at 3.45 bar (50 psig) (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

cartridge nominal length

4.7 in. (11.9 cm)

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This Item
TMO150067TMO374500-BRTMO374510-BR
packaging

case of 500 ea

packaging

case of 500 ea

packaging

case of 10 × 24 ea

packaging

case of 10 × 24 ea

sterility

sterile

sterility

sterile

sterility

-

sterility

-

diam.

25 mm

diam.

-

diam.

-

diam.

-

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 60 min at 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 &#x3C 500 ppb TOC per USP &#x3C 643 &#x3C and &#x3C 1.3 μS/cm per USP &#x3C 645 &#x3C at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 L

Other Notes

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

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

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