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Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Code 7 (2-226) O-ring and spear
Cartridge Nominal Length
40 in. (100 cm)
Catalogue Number
CW0674S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
40 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
3.2 m²
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 50 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
40 in. (100 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
Media
Maximum Differential Pressure, bar (psid)
Nominal Pore Size
0.5 µm
Non-Fiber Releasing
This product was manufactured with a media combination 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 ≥9 L
Pore Size
0.5 µm
Seal Material
Silicone (SI)
Sterilization
10 autoclave cycles or SIP @ 121 °C for 30 min
Support Material
Polyester
Trade Name
Milligard®
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 0 (2-222) O-rings
Cartridge Nominal Length
40 in. (100 cm)
Catalogue Number
CW1904S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
40 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
3.2 m²
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 50 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
40 in. (100 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
Media
Maximum Differential Pressure, bar (psid)
Nominal Pore Size
1.2 µm
Non-Fiber Releasing
This product was manufactured with a media combination 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 ≥9 L
Pore Size
1.2 µm
Seal Material
Silicone (SI)
Sterilization
10 autoclave cycles or SIP @ 121 °C for 30 min
Support Material
Polyester
Trade Name
Milligard®
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 0 (2-222) O-rings
Cartridge Nominal Length
40 in. (100 cm)
Catalogue Number
CW1904S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
40 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
3.2 m²
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 50 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
40 in. (100 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
Media
Maximum Differential Pressure, bar (psid)
Nominal Pore Size
1.2 µm
Non-Fiber Releasing
This product was manufactured with a media combination 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 ≥9 L
Pore Size
1.2 µm
Seal Material
Silicone (SI)
Sterilization
10 autoclave cycles or SIP @ 121 °C for 30 min
Support Material
Polyester
Trade Name
Milligard®
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-ring and spear
Cartridge Nominal Length
40 in. (100 cm)
Catalogue Number
CW1974S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
40 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
3.2 m²
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 50 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
40 in. (100 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
Media
Maximum Differential Pressure, bar (psid)
Nominal Pore Size
1.2 µm
Non-Fiber Releasing
This product was manufactured with a media combination 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 ≥6 L
Pore Size
1.2 µm
Seal Material
Silicone (SI)
Sterilization
10 autoclave cycles or SIP @ 121 °C for 30 min
Support Material
Polyester
Trade Name
Milligard®
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-ring and spear
Cartridge Nominal Length
40 in. (100 cm)
Catalogue Number
CW1974S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
40 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
3.2 m²
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 50 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
40 in. (100 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
Media
Maximum Differential Pressure, bar (psid)
Nominal Pore Size
1.2 µm
Non-Fiber Releasing
This product was manufactured with a media combination 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 ≥6 L
Pore Size
1.2 µm
Seal Material
Silicone (SI)
Sterilization
10 autoclave cycles or SIP @ 121 °C for 30 min
Support Material
Polyester
Trade Name
Milligard®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
A sample aqueous extraction contains less than 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
Code 7 (2-226) O-rings w/locking-tabs
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVML71TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Size
10 in.
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 24 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.
Length
10 in. (25 cm)
Material Size
3
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).
Sterility
Other
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.
Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure (psig)
80 psig
Maximum Inlet Pressure, bar (psi)
6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
Media
Millipore Express® SHR w/Prefilter
Non-Fiber Releasing
This product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Outlet Connection
Sanitary Flange
Outlet Connection Diameter
1-1/2 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L
Pore Size
0.5 / 0.1 µm
Seal Material
Silicone (SI)
Sterilization
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Support Material
Polypropylene
Trade Name
Millipore Express®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure (psig)
80 psig
Maximum Inlet Pressure, bar (psi)
6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
Media
Millipore Express® SHR w/Prefilter
Non-Fiber Releasing
This product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Outlet Connection
Sanitary Flange
Outlet Connection Diameter
1-1/2 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L
Pore Size
0.5 / 0.1 µm
Seal Material
Silicone (SI)
Sterilization
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Support Material
Polypropylene
Trade Name
Millipore Express®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 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 Nominal Length
30 in. (75 cm)
Catalogue Number
KVGLG3THH1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Device Material
Gamma-stable polypropylene
Device Size
30 in.
Diameter
10.7 cm (4.2 in.)
Filtration Area
2.17 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 75 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
5/8 in.
Inlet to Outlet Width
19.8 cm (7.8 in.)
Length
30 in. (75 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
Maximum Inlet Pressure (psig)
80 psig
Maximum Inlet Pressure, bar (psi)
5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
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).
Outlet Connection
Hose Barb
Outlet Connection Diameter
5/8 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L
Pore Size
0.22 µm
Seal Material
Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Sterility
Gamma
Sterilization
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable
Support Material
Polyester
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.
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