Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Nominal Length
1 in. (2.5 cm)
Catalogue Number
KR75A51HH1
Chemistry
Polypropylene (PP)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
1 in.
Diameter
10.7 cm (4.2 in.)
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.
Format
Single Layer
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Gravimetric Extractables
The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature.
Housing Material
Polypropylene (PP)
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Inlet Connection
Hose Barb
Inlet Connection Diameter
9/16 in.
Inlet to Outlet Width
21.6 cm (8.5 in.)
Length
1 in. (2.5 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
4.8 bar (70 psid) @ 20 °C
Maximum Inlet Pressure (psig)
80 psig
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
Maximum Inlet Temperature
25 °C
Media
Polygard®-CR
Nominal Pore Size
75.0 µm
Outlet Connection
Hose Barb
Outlet Connection Diameter
9/16 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Pore Size
75.0 µm
Seal Material
Silicone (SI)
Sterilization
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
Support Material
Polypropylene
Trade Name
Opticap®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.