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Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) clot test technique
Cartridge Code
Code 7
Cartridge Nominal Length
30 in.
Catalogue Number
CSGB73E06
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
2.8 in.
Filtration Area
1.95 (21.0) per 30 in. cartridge
Gravimetric Extractables
The extractables level was equal to or less than 35 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Housing Material
Stainless Steel
Length
30 in.
Material Package
Double Easy-Open bag
Material Size
6
Maximum Differential Pressure, bar (psid)
5.5 bar (80 psig) @ ambient temperature, 1.8 bar (25 psid) @80 °C
Media
Solvex™
Nominal Pore Size
0.2 µm
Non-Fiber Releasing
PTFE membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.2 µm
Sterilization
Steam sterilized 50 times forward and 50 times reverse for 30 minutes at 135 °C
Support Material
Polypropylene
Trade Name
Solvex™
USP Bacterial Endotoxins
Aqueous extraction contains <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
Cartridge Code
Code 7
Cartridge Nominal Length
40 in. (100 cm)
Catalogue Number
CTGB74TP3
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
40 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
2.6 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 35 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Length
40 in. (100 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 6.9 bar (100 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 145 °C. Reverse: 5.2 bar (75 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)
Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 145 °C; Reverse - 5.2 bar (75 psi) @ 25 °C
Media
Aerex®
Non-Fiber Releasing
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.2 µm
Seal Material
Silicone (SI)
Sterilization
200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 145 °C
Support Material
Polypropylene
Trade Name
Aerex®
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
Cartridge Nominal Length
40 in. (100 cm)
Catalogue Number
CTGB74TP3
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
40 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
2.6 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 35 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Length
40 in. (100 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 6.9 bar (100 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 145 °C. Reverse: 5.2 bar (75 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)
Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 145 °C; Reverse - 5.2 bar (75 psi) @ 25 °C
Media
Aerex®
Non-Fiber Releasing
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.2 µm
Seal Material
Silicone (SI)
Sterilization
200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 145 °C
Support Material
Polypropylene
Trade Name
Aerex®
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 0 (2-222) O-rings
Cartridge Nominal Length
30 in. (75 cm)
Catalogue Number
CLGL03TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Size
30 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 30 mg per 10-inch cartridge after a 1.5 L flush and 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
30 in. (75 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).
Pore Size
0.22 µm
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.
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 (2-226) O-rings w/locking-tabs
Cartridge Nominal Length
30 in. (75 cm)
Catalogue Number
CLGL73TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
3.21 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 30 mg per 10-inch cartridge after a 1.5 L flush and 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
30 in. (75 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).
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL
Pore Size
0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
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.
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 0 (2-222) O-rings
Cartridge Nominal Length
30 in. (75 cm)
Catalogue Number
CLVL03TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Size
30 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 30 mg per 10-inch cartridge after a 1.5 L flush and 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
30 in. (75 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).
Pore Size
0.1 µm
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.
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
30 in. (75 cm)
Catalogue Number
CLVL73TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Size
30 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 30 mg per 10-inch cartridge after a 1.5 L flush and 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
30 in. (75 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).
Pore Size
0.1 µm
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.
Trust Merck membrane filtration devices for the collection and preparation of samples, mobile phases, and buffers to obtain the highest quality results from downstream analysis.
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