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Merck
CN

KVEPA10TH1

Millipore Express® SHR 0.1µm, Opticap® XL 10 Capsule

Fittings 1-1/2 in. TC- 9/16 in. HB, Autoclavable

别名:

Millipore Express®SHR, Opticap® XL 囊式

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UNSPSC Code:
23151806

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产品名称

可高压蒸汽灭菌 Opticap XL 10 Millipore Express SHR 单层 0.1 µm 1-1/2 in.TC-9/16 in.HB, inlet connection diam. 1.5 in., Opticap® XL 10, cartridge nominal length 10 in. (25 cm)

material

polyethersulfone
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
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® XL 10

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

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

L

33.5 cm (13.2 in.)

cartridge nominal length

10 in. (25 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.6 m2

inlet connection diam.

1.5 in.

inlet to outlet W

33.5 cm (13.2 in.)

outlet connection diam.

9/16 in.

impurities

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

matrix

Millipore Express® SHR

pore size

0.1 μm

bubble point

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C

fitting

1/4 in. drain/vent hose barb (with double O-ring Seal)
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Quality Level

400

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 10 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

General description

Device Configuration: 取样皿滤膜

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.

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 @ 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).

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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