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Millipore Express® SHC 0.5/0.2µm, Opticap® XLT 30 Capsule

Fittings 1-1/2 in. TC, Autoclavable

别名:

Millipore Express® SHC，Opticap® XLT囊式

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UNSPSC Code:
23151806
eCl@ss:
32031690
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产品名称

Opticap 可高压蒸汽灭菌 XLT 30 Millipore Express SHC 0.5/0.2 µm 1-1/2 in. TC, Chemistry: Hydrophilic Polyethersulfone (PES)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-lineMax Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

polyethersulfone membrane, polypropylene housing, polypropylene support, polypropylene vent cap, silicone O-ring, silicone seal

reg. compliance

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

sterility

non-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, 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent), 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)

technique(s)

sterile filtration: suitable

cartridge nominal length

30 in. (75 cm)

device L

87.1 cm (34.3 in.)

filter diam.

10.7 cm (4.2 in.)

filtration area

1.47 m2

inlet connection diam.

1-1/2 in.

inlet to outlet W

15.2 cm (6.0 in.)

outlet connection diam.

1-1/2 in.

impurities

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

matrix

Millipore Express® SHC

pore size

0.5/0.2 μm pore size

bubble point

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

fitting

38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange

General description

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °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 60 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 ≥6 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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