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Merck
CN

KGEPG006FH3

Millipore Express® SHF 0.2µm, Opticap® XL 600 Capsule

Fittings 3/4 in. TC- 9/16 in. HB, Gamma Compatible

别名:

Millipore Express® SHF, Opticap® XL 囊式

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UNSPSC Code:
23151806
NACRES:
NB.24

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产品名称

Opticap XL 600 Millipore Express SHF 可γ辐照 0.2 µm 3/4 in.TC-9/16 in.HB, Chemistry: Hydrophilic Polyethersulfone (PES) Inlet: 3/4 in. Sanitary Flange Outlet: 9/16 in. Hose Barb Max Operating Pressure: 80 psi @ 25 °C

material

polyester support, polyethersulfone membrane, polypropylene housing, 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)

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

1 bar max. differential pressure (15 psi) at 80 °C, 1 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

L

16.5 cm (6.5 in.)

W

2.2 in.

cartridge nominal length

6.5 in. (16.5 cm)

diam.

5.6 cm (2.2 in.)

filtration area

0.097 m2 (1.046 ft2)

inlet connection diam.

3/4 in.

inlet to outlet W

16.5 cm (6.5 in.)

outlet connection diam.

9/16 in.

Quality Level

400

sterility

non-sterile

sterilization compatibility

autoclavable compatible
gamma compatible
x-ray compatible

product line

Opticap® XL

impurities

<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

19 mm (3/4 in.) inlet sanitary flange, 14 mm (9/16 in.) outlet hose barb

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General description

Device Configuration: 取样皿滤膜
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

Packaging

Double Easy-Open bag

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 3.0 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

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

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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