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Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Code 0 (2-222) O-rings
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVDR01TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.69 m²
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 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 1.7 bar (25 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 121 °C; Reverse - 1.7 bar (25 psi) @ 25 °C
Media
Durapore® w/Prefilter
Non-Fiber Releasing
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Pore Size
0.65 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
8 SIP cycles of 30 min or 8 autoclave cycles of 60 min @ 121 °C
Support Material
Polypropylene
Trade Name
Durapore®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Code 5 (2-222) O-rings and spear
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVDR51TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.69 m²
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 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 1.7 bar (25 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 121 °C; Reverse - 1.7 bar (25 psi) @ 25 °C
Media
Durapore® w/Prefilter
Non-Fiber Releasing
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Pore Size
0.65 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
8 SIP cycles of 30 min or 8 autoclave cycles of 60 min @ 121 °C
Support Material
Polypropylene
Trade Name
Durapore®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Code 7 (2-226) O-rings w/locking-tabs
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVDR71TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.69 m²
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 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 1.7 bar (25 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 121 °C; Reverse - 1.7 bar (25 psi) @ 25 °C
Media
Durapore® w/Prefilter
Non-Fiber Releasing
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Pore Size
0.65 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
8 SIP cycles of 30 min or 8 autoclave cycles of 60 min @ 121 °C
Support Material
Polypropylene
Trade Name
Durapore®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Cartridge Code
Not Applicable
Catalogue Number
MCGBL4S03
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polysulfone
Filtration Area
2000 cm²
Flow Rate
7.6 L/min @ 1 bar ΔP
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
Forward - 4.1 bar (60 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 123 °C; Reverse - 0.7 bar (10 psi) @ 25 °C
Media
Durapore®
Non-Fiber Releasing
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
4 SIP cycles of 60 min @ 135 °C; 4 autoclave cycles of 60 min @ 126 °C
Support Material
Polysulfone
Trade Name
Millidisk®
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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