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Merck
CN

KGEPS3THH1

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

Fittings 5/8 in. HB, Sterile

别名:

Millipore Express® SHF，Opticap® XLT囊式

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UNSPSC Code:
23151806

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产品名称

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

material

polyester support
polyethersulfone membrane
polypropylene housing
silicone O-ring

Quality Level

400

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

相关类别

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

General description

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

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.

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).

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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