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KHGEG2TTT1H

Millipore Express® SHC High Area 0.5/0.2µm, Opticap® XLT 20 Capsule

Fittings 1-1/2 in. TC, Gamma Compatible

Synonym(s):

Gamma Compatible High Area Opticap® XLT 20 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC, Millipore Express® SHC High Area, Opticap® XLT Capsule

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About This Item

UNSPSC Code:
23151806
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Product Name

Opticap® XLT 20 CapsuleMedia: Millipore Express® SHC High Area 0.5 / 0.2 µm, 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 Segment

400

material

polyester support, polyethersulfone membrane, polypropylene housing, 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
gamma compatible
x-ray compatible

product line

Opticap® XLT

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

1 bar max. inlet pressure (15 psi) at 80 °C, 1.0 bar max. differential 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 23 °C (Intermittent)

technique(s)

sterile filtration: suitable

W

7.8 in.

cartridge nominal length

20 in. (50 cm)

device L

62.5 cm (24.6 in.)

filter diam.

10.7 in. (4.2 cm)

filtration area

2.0 m2

inlet to outlet W

15.2 cm (6.0 in.)

outlet connection diam.

1.5 in.

impurities

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

matrix

Millipore Express® SHC High Area

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

application(s)

sample preparation

General description

T-line/Gauge Port: T-line

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 42 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 L

Other Notes

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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