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KN25A05TT1

Millipore

Opticap® XL5 Polygard® CN

inlet connection diam. 1.5 in., pore size 2.5 μm, cartridge nominal length 5 in. (12.5 cm)

Synonym(s):
Opticap XL5 Polygard CN 2.5 μm 1-1/2 in. TC/TC
eCl@ss:
32031690

material

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

Quality Level

reg. compliance

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

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.
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure

L

21.6 cm (8.5 in.)

cartridge nominal length

5 in. (12.5 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.18 m2

inlet connection diam.

1.5 in.

inlet to outlet W

21.6 cm (8.5 in.)

outlet connection diam.

1.5 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

≤25 mg/capsule

matrix

Polygard®-CN

pore size

2.5 μm nominal pore size
2.5 μm pore size

input

sample type liquid

fitting

inlet sanitary flange
38 mm (1 1/2 in.) inlet/outlet sanitary flange
outlet sanitary flange

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This Item
KN25A05FF1KN12A05TT1KN50A05TT1
filtration area

0.18 m2

filtration area

0.18 m2

filtration area

0.18 m2

filtration area

0.18 m2

matrix

Polygard®-CN

matrix

Polygard®-CN

matrix

Polygard®-CN

matrix

Polygard®-CN

pore size

2.5 μm nominal pore size, 2.5 μm pore size

pore size

2.5 μm nominal pore size, 2.5 μm pore size

pore size

1.2 μm nominal pore size, 1.2 μm pore size

pore size

5.0 μm nominal pore size, 5.0 μm pore size

fitting

inlet sanitary flange, 38 mm (1 1/2 in.) inlet/outlet sanitary flange, outlet sanitary flange

fitting

inlet sanitary flange, 19 mm (3/4 in.) inlet/outlet sanitary flange, outlet sanitary flange

fitting

inlet sanitary flange, 38 mm (1 1/2 in.) inlet/outlet sanitary flange, outlet sanitary flange

fitting

inlet sanitary flange, 38 mm (1 1/2 in.) inlet/outlet sanitary flange, outlet sanitary flange

reg. compliance

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

reg. compliance

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

reg. compliance

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

reg. compliance

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

General description

Device Configuration: Capsule

Features and Benefits

Format: Single Layer

Packaging

Double Easy-Open bag

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use

  • Organism Retention: Microorganism reduction
  • 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.

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

Analysis Note

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

Legal Information

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