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Merck

KWLCA05FF1

Milligard® LPB 1.2/0.5 µm nominal, Opticap® XL Capsule

inlet connection diam. 3/4 in., Opticap® XL 5, pore size 1.2/0.5 μm, cartridge nominal length 5 in. (12.5 cm)

Synonym(s):

Opticap XL5 Milligard Low Protein Binding 1.2/0.5 μm 3/4 in. TC/TC

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About This Item

eCl@ss:
32031610
UNSPSC Code:
23151806

Key Documents

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Product Name

Milligard® LPB 1.2/0.5 µm nominal, Opticap® XL Capsule, inlet connection diam. 3/4 in., Opticap® XL 5, pore size 1.2/0.5 μm, cartridge nominal length 5 in. (12.5 cm)

material

mixed cellulose esters (MCE) (low protein-binding)
polyester support
polypropylene
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

product line

Opticap® XL 5

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

21.6 cm (8.5 in.)

W

4.2 in.

cartridge nominal length

5 in. (12.5 cm)

diam.

14.5 cm (5.7 in.)

filtration area

0.26 m2

inlet connection diam.

3/4 in.

inlet to outlet W

21.6 cm (8.5 in.)

outlet connection diam.

3/4 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

≤145 mg/capsule

matrix

Milligard® LPB

pore size

1.2/0.5 μm nominal pore size
1.2/0.5 μm pore size

input

sample type liquid

fitting

inlet sanitary flange
 outlet sanitary flange
 (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Quality Level

400

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Analysis Note

Gravimetric Extractables: after a 2 L flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 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

Filter Grade: Low Protein Binding Milligard® Media
Format: Double Layer

General description

Device Configuration: Capsule

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 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

MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class

4.1B - Flammable solid hazardous materials

wgk

WGK 3

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Global Trade Item Number

SKUGTIN
KWLCA05FF104053252450679

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