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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
CWSS01S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
0.69 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
10 in. (25 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 / 0.2 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
0.5 / 0.2 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
10 in. (25 cm)
Catalogue Number
CWSS01S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
0.69 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
10 in. (25 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 / 0.2 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
0.5 / 0.2 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 5 (2-222) O-rings and spear
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CWSS51S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
0.69 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
10 in. (25 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 / 0.2 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
0.5 / 0.2 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 5 (2-222) O-rings and spear
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CWSS51S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
0.69 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
10 in. (25 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 / 0.2 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
0.5 / 0.2 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
10 in. (25 cm)
Catalogue Number
CWSS71S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
0.69 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
10 in. (25 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 / 0.2 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).
Pore Size
0.5 / 0.2 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
10 in. (25 cm)
Catalogue Number
CWSS71S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
0.69 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
10 in. (25 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 / 0.2 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).
Pore Size
0.5 / 0.2 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
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Catalogue Number
MPGL2GCA3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Gamma Gold Capsule
Device Material
Polycarbonate
Diameter
9/16 in.
Filtration Area
1000 cm²
Flow Rate
19 L/min @ 2.8 bar ΔP
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 5 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature.
Inlet Connection
Hose Barb
Inlet Connection Diameter
9/16 in.
Material Package
Blister
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)
5.2 bar (75 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).
Outlet Connection
Hose Barb
Outlet Connection Diameter
9/16 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Pore Size
0.22 µm
Process Volume
100 L
Sterility
Sterile
Sterilization
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
Support Material
Polycarbonate
Trade Name
Millipak®
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 Nominal Length
4 in. (10 cm)
Catalogue Number
KTGRA04NN3
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
4 in.
Diameter
8.4 cm (3.3 in.)
European Pressure Equipment Directive
EMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
Filtration Area
0.21 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 15 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Housing Material
Polypropylene (PP)
Inlet Connection
NPT
Inlet Connection Diameter
1/4 in.
Length
4 in. (10 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 4.1 bar (60 psid) @ 25 °C, intermittent
Maximum Inlet Pressure (psig)
80 psig
Maximum Inlet Pressure, bar (psi)
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
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).
Outlet Connection
NPT
Outlet Connection Diameter
1/4 in.
Pore Size
0.2 µm
Seal Material
Silicone (SI)
Sterilization
30 autoclave cycles of 30 min @ 135 °C; not in-line steam sterilizable
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.
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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