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Bacterial Endotoxins
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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Cartridge Nominal Length
5 in. (12.5 cm)
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Catalogue Number
KRK1A05HH1
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Chemistry
Polypropylene (PP)
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Device Configuration
Capsule
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Device Material
Polypropylene
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Device Size
5 in.
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Diameter
10.7 cm (4.2 in.)
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European Pressure Equipment Directive
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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Format
Single Layer
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Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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Gravimetric Extractables
The extractables level was equal to or less than 30 mg per capsule after 24 hours in water at controlled room temperature.
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Housing Material
Polypropylene (PP)
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Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
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Inlet Connection
Hose Barb
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Inlet Connection Diameter
9/16 in.
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Inlet to Outlet Width
21.6 cm (8.5 in.)
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Length
5 in. (12.5 cm)
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Material Package
Double Easy-Open bag
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Material Size
1
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Maximum Differential Pressure, bar (psid)
4.8 bar (70 psid) @ 20 °C
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Maximum Inlet Pressure (psig)
80 psig
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Maximum Inlet Pressure, bar (psi)
5.5 bar (80 psi) @ 25 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
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Maximum Inlet Temperature
25 °C
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Media
Polygard®-CR
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Nominal Pore Size
0.1 µm
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Outlet Connection
Hose Barb
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Outlet Connection Diameter
9/16 in.
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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2.5 L
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Pore Size
0.1 µm
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Seal Material
Silicone (SI)
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Sterilization
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
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Support Material
Polypropylene
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Trade Name
Opticap®
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USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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Vent Cap Material
Polypropylene (PP)
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Width
21.6 cm (8.5 in.)