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Merck
CN

KGW3A2THH1

Polysep™ II 1.0/0.2 µm nominal, Opticap® XLT Capsule

inlet connection diam. 5/8 in., Opticap® XLT 20, pore size 1.0/0.2 μm, cartridge nominal length 20 in. (50 cm)

别名:

Opticap XLT20 Polysep II 1.0/0.2 μm 5/8 in. HB

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eCl@ss:
32031610
UNSPSC Code:
23151806

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产品名称

Polysep™ II 1.0/0.2 µm nominal, Opticap® XLT Capsule, inlet connection diam. 5/8 in., Opticap® XLT 20, pore size 1.0/0.2 μm, cartridge nominal length 20 in. (50 cm)

material

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
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® XLT 20

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

1.0 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

technique(s)

prefiltration: suitable

L

62.5 cm (24.6 in.)

W

7.8 in.

cartridge nominal length

20 in. (50 cm)

filtration area

0.93 m2

inlet connection diam.

5/8 in.

inlet to outlet W

19.8 cm (7.8 in.)

outlet connection diam.

5/8 in.

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤290 mg/capsule

matrix

Polysep™ II

pore size

1.0/0.2 μm nominal pore size
1.0/0.2 μm pore size

input

sample type liquid

fitting

inlet hose barb
 outlet hose barb
 (16 mm (5?8 in.) Hose Barb Inlet and Outlet)

Quality Level

400

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Analysis Note

Gravimetric Extractables: after a 10 L flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥10 L

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.

Features and Benefits

Format: Double Layer

General description

Device Configuration: Capsule
T-line/Gauge Port: T-line

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
  • 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 30 min @ 121 °C; not in-line steam sterilizable
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Legal Information

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC

存储类别

11 - Combustible Solids

wgk

WGK 2

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