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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 @ 25 °C; 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
Millipore Express® SHF
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.
Overview
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L
Pore Size
0.2 µm
Seal Material
Silicone (SI)
Sterility
Sterile
Sterilization
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyester
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 Code
Code 0 (2-222) O-rings
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVGB01TP3
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 20 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
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) @ 135 °C. Reverse: 3.5 bar (50 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) @ 135 °C; Reverse - 3.5 bar (50 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)
Sterilization
30 SIP cycles of 30 min @ 126 °C; 30 autoclave cycles of 60 min @ 126 °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
Code 0 (2-222) O-rings
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVGB01TP3
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 20 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
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) @ 135 °C. Reverse: 3.5 bar (50 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) @ 135 °C; Reverse - 3.5 bar (50 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)
Sterilization
30 SIP cycles of 30 min @ 126 °C; 30 autoclave cycles of 60 min @ 126 °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
Code 7
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVGB71TP3
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 20 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
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) @ 135 °C. Reverse: 3.5 bar (50 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) @ 135 °C; Reverse - 3.5 bar (50 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)
Sterilization
30 SIP cycles of 30 min @ 126 °C; 30 autoclave cycles of 60 min @ 126 °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
Code 7
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVGB71TP3
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 20 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
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) @ 135 °C. Reverse: 3.5 bar (50 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) @ 135 °C; Reverse - 3.5 bar (50 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)
Sterilization
30 SIP cycles of 30 min @ 126 °C; 30 autoclave cycles of 60 min @ 126 °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 0 (2-222) O-rings
Cartridge Nominal Length
30 in. (75 cm)
Catalogue Number
CWSC03S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
2.07 m²
Format
Double 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
30 in. (75 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 / 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 ≥6 L
Pore Size
1.2 / 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
30 in. (75 cm)
Catalogue Number
CWSC03S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
2.07 m²
Format
Double 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
30 in. (75 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 / 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 ≥6 L
Pore Size
1.2 / 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 5 (2-222) O-rings and spear
Cartridge Nominal Length
30 in. (75 cm)
Catalogue Number
CWSC53S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
2.07 m²
Format
Double 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
30 in. (75 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 / 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
1.2 / 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 5 (2-222) O-rings and spear
Cartridge Nominal Length
30 in. (75 cm)
Catalogue Number
CWSC53S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
2.07 m²
Format
Double 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
30 in. (75 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 / 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
1.2 / 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 7 (2-226) O-ring and spear
Cartridge Nominal Length
30 in.
Catalogue Number
CWSC73S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
2.07 m²
Format
Double 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
30 in.
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 / 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 ≥3 L
Pore Size
1.2 / 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.
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