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Aqueous extraction contains <0.25 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
30 in. (76 cm)
Catalogue Number
CTGR73TP1
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
1.95 m²
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
30 in. (76 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.8 bar (25 psid) @ 80 °C. Reverse: 4.1 bar (60 psid), intermittent
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; Reverse - 4.1 bar (60 psi), Intermittent
Media
Aervent®
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
150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °C
Support Material
Polypropylene
Trade Name
Aervent®
USP Bacterial Endotoxins
Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Aqueous extraction contains ≤0.25 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
CHGL01TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
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, intermittent
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, Intermittent
Media
Multilayer 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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
30 SIP cycles of 30 min @ 135 °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 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains ≤0.25 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
CHGL01TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
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, intermittent
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, Intermittent
Media
Multilayer 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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
30 SIP cycles of 30 min @ 135 °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 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains ≤0.25 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
CHGL71TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
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, intermittent
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, Intermittent
Media
Multilayer 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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
30 SIP cycles of 30 min @ 135 °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 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains ≤0.25 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
CHGL71TP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
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, intermittent
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, Intermittent
Media
Multilayer 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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
30 SIP cycles of 30 min @ 135 °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 0.25 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 @ 25 °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® SHC
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
Hose Barb
Outlet Connection Diameter
1 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L
Pore Size
0.5 / 0.2 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.
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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