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KGEPS3THH1

Millipore Express® SHF 0.2µm, Opticap® XLT 30 Capsule

Fittings 5/8 in. HB, Sterile

Synonym(s):

Opticap XLT 30 Millipore Express SHF Sterile 0.2 μm 5/8 in. HB, Millipore Express® SHF, Opticap® XLT Capsule

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About This Item

UNSPSC Code:
23151806
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Product Name

Opticap® XLT 30 CapsuleMedia: Sterile Millipore Express® SHF 0.2 µm, Chemistry: Hydrophilic Polyethersulfone (PES)Inlet: 5/8 in. Hose BarbOutlet: 5/8 in. Hose BarbT-lineMax Operating Pressure: 80 psi @ 25 °C

Quality Segment

400

material

polyester support, polyethersulfone membrane, polypropylene housing, silicone O-ring

reg. compliance

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

sterility

sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XLT

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

1.0 bar max. differential pressure (15 psi) at 80 °C, 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.8 bar max. inlet pressure (40 psi) at 60 °C, 5.5 bar max. differential pressure (80 psi) at 25 °C, 5.5 bar max. inlet pressure (80 psi) at 25 °C, 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; intermittent), 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)

L

87.1 cm (34.3 in.)

diam.

10.7 cm (4.2 in.)

filtration area

1.71 m2 (18.4 ft2)

impurities

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

matrix

Millipore Express® SHF

pore size

0.2 μm

bubble point

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

fitting

16 mm (5/8 in.) inlet hose barb, 16 mm (5/8 in.) outlet hose barb

General description

Device Configuration: Capsule
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
T-line/Gauge Port: T-line

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
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 33 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 ≥4.5 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.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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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