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Merck

KHGEG015HH3

Millipore Express® SHC 0.5/0.2µm, Opticap® XL 150 Capsule

Fittings 9/16 in. HB/HB, Gamma Compatible

別名:

Opticap® Gamma Compatible XL 150 Millipore Express® SHC 0.5/0.2 µm 9/16 in. HB/HB, Millipore Express® SHC, Opticap® XL Capsule

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UNSPSC Code:
23151806
NACRES:
NB.24
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製品名

オプティキャップ(Opticap)® XL10ミリポアエクスプレス(Millipore Express)® SHC, Chemistry: Hydrophilic Polyethersulfone (PES)Inlet: 9/16 in. Hose BarbOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80 psi @ 25 °C

Quality Segment

material

polyethersulfone , polyethylene support, polypropylene (gamma-stable), polypropylene housing, polypropylene vent cap, polysulfone , silicone seal

reg. compliance

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

sterility

non-sterile

sterilization compatibility

gamma compatible

product line

Opticap® XL 150

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤1.0 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 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

9.7 cm (3.8 in.)

W

2.2 in.

cartridge nominal length

3.8 in. (9.7 cm)

diam.

5.6 cm (2.2 in.)

filtration area

140 cm2

inlet connection diam.

9/16 in.

inlet to outlet W

9.7 cm (3.8 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® SHC

pore size

0.5/0.2 μm pore size

bubble point

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

fitting

1/4 in. drain/vent hose barb (with double O-ring seal), inlet hose barb, 14 mm (9/16 in.) inlet/outlet hose barb, outlet hose barb

General description

Device Configuration: Capsule

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 1.0 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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