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Merck
CN

KR75A10HH1

Millipore

Opticap® XL10 Polygard®-CR 75 µm 9/16 in. HB/HB

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690

Key Documents

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Quality Level

400

material

polypropylene
polypropylene housing (PP)
polypropylene support
polypropylene vent cap
silicone seal

sterility

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

Sterilization Compatibility

autoclavable compatible

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

33.5 cm (13.2 in.)

cartridge nominal length

10 in. (25 cm)

device size

10 in.

diam.

10.7 cm (4.2 in.)
4.2 in. (10.7 cm)

inlet connection diam.

9/16 in.

outlet W

33.5 cm (13.2 in.)

outlet connection diam.

9/16 in.

impurities

≤0.5 EU/mL Aqueous extraction (LAL test)

matrix

Polygard®-CR

pore size

75.0 μm nominal pore size
75.0 μm

fitting

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

suitability

suitable for endotoxin

General description

A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.

Packaging

Double Easy-Open bag

Analysis Note

The extractables level was equal to or less than 55 mg per capsule after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

Other Notes

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.

Legal Information

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

Disclaimer

All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Storage Class Code

10-13 - German Storage Class 10 to 13

Regulatory Information

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Certificates of Analysis (COA)

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