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5A05FF1

Millipore

Opticap® XL5 Polygard® CR

inlet connection diam. 3/4 in., pore size 25.0 μm, cartridge nominal length 5 in. (12.5 cm)

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Synonym(s):
Opticap® XL5 Polygard®-CR 25 µm 3/4 in. TC/TC

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.)

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

≤30 mg/capsule

matrix

Polygard®-CR

pore size

25.0 μm nominal pore size
25.0 μm pore size

input

sample type liquid

fitting

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

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This Item
5A05TT15A05HH1KR10A05FF1
matrix

Polygard®-CR

matrix

Polygard®-CR

matrix

Polygard®-CR

matrix

Polygard®-CR

pore size

25.0 μm nominal pore size, 25.0 μm pore size

pore size

25.0 μm nominal pore size, 25.0 μm pore size

pore size

25.0 μm nominal pore size, 25.0 μm pore size

pore size

10.0 μm nominal pore size, 10.0 μm pore size

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 hose barb, 14 mm (9/16 in.) inlet/outlet hose barb, outlet hose barb

fitting

inlet sanitary flange, 19 mm (3/4 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)

manufacturer/tradename

Opticap®

manufacturer/tradename

Opticap®

manufacturer/tradename

Opticap®

manufacturer/tradename

Opticap®

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.

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 ≥2.5 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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