We have developed a unique portfolio of consumables, each adapted to the different feed water quality requirements and to your various applications. To maintain your water system’s performance, it’s critical to replace your purification cartridges on time and with genuine ISO 9001-certified parts.
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 Nominal Length
10 in. (25 cm)
Catalogue Number
KHVEG1THH1
Chemistry
Polyethersulfone (PES)
Device Configuration
Capsule
Device Material
Gamma stable polypropylene/Polysulfone
Device Size
10 in.
Diameter
19.8 cm (7.8 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
0.54 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Housing Material
Polypropylene (PP)
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
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® 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
Hose Barb
Outlet Connection Diameter
5/8 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
Pore Size
0.5 / 0.1 µm
Seal Material
Silicone (SI)
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 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 ≤0.25 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 Nominal Length
10 in. (25 cm)
Catalogue Number
KHGLG10TH1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
10 in.
Diameter
10.7 cm (4.2 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
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
Sanitary Flange
Inlet Connection Diameter
1-1/2 in.
Inlet to Outlet Width
33.5 cm (13.2 in.)
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 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; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
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).
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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyester/Polyethylene
Trade Name
Opticap®
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 Nominal Length
10 in. (25 cm)
Catalogue Number
KHGLG10TH1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
10 in.
Diameter
10.7 cm (4.2 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
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
Sanitary Flange
Inlet Connection Diameter
1-1/2 in.
Inlet to Outlet Width
33.5 cm (13.2 in.)
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 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; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
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).
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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyester/Polyethylene
Trade Name
Opticap®
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 Nominal Length
10 in. (25 cm)
Catalogue Number
KHGLG10TT1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
10 in.
Diameter
10.7 cm (4.2 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
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
Sanitary Flange
Inlet Connection Diameter
1-1/2 in.
Inlet to Outlet Width
33.5 cm (13.2 in.)
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 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; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
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).
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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyester/Polyethylene
Trade Name
Opticap®
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 Nominal Length
10 in. (25 cm)
Catalogue Number
KHGLG10TT1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
10 in.
Diameter
10.7 cm (4.2 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
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
Sanitary Flange
Inlet Connection Diameter
1-1/2 in.
Inlet to Outlet Width
33.5 cm (13.2 in.)
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 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; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
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).
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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyester/Polyethylene
Trade Name
Opticap®
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 Nominal Length
10 in. (25 cm)
Catalogue Number
KHGLG1TTT1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
10 in.
Diameter
10.7 cm (4.2 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
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
Sanitary Flange
Inlet Connection Diameter
1-1/2 in.
Inlet to Outlet Width
15.2 cm (6.0 in.)
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 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; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
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).
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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyester/Polyethylene
Trade Name
Opticap®
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 Nominal Length
10 in. (25 cm)
Catalogue Number
KHGLG1TTT1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
10 in.
Diameter
10.7 cm (4.2 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
0.55 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
Sanitary Flange
Inlet Connection Diameter
1-1/2 in.
Inlet to Outlet Width
15.2 cm (6.0 in.)
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 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; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
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).
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 ≥1.5 L
Pore Size
0.45 / 0.22 µm
Seal Material
Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyester/Polyethylene
Trade Name
Opticap®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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 24 hours in a 70/30% IPA/water mixture 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.
Key Applications
Food and BeverageBeerBottled WaterWine
Length
30 in. (75 cm)
Material Size
1
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) @ 121 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent; 0.35 bar (5 psid) @ 121 °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) @ 121 °C. Reverse - 3.5 bar (50 psi) @ 25 °C, Intermittent; 0.35 bar (5 psi) @ 121 °C
Media
Brewpore®
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
0.55 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
100 SIP cycles of 30 min @ 109 °C; hot water sanitized 50 times for 30 min @ 80 °C maximum
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 24 hours in a 70/30% IPA/water mixture 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.
Key Applications
Food and BeverageBeerBottled WaterWine
Length
30 in. (75 cm)
Material Size
1
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) @ 121 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent; 0.35 bar (5 psid) @ 121 °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) @ 121 °C. Reverse - 3.5 bar (50 psi) @ 25 °C, Intermittent; 0.35 bar (5 psi) @ 121 °C
Media
Brewpore®
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
0.55 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
100 SIP cycles of 30 min @ 109 °C; hot water sanitized 50 times for 30 min @ 80 °C maximum
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Not Applicable
Catalogue Number
MCSL20S02
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polysulfone
Filtration Area
1000 cm²
Flow Rate
75 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 24 hours in water at controlled room temperature.
Material Package
Double Easy-Open bag
Material Size
2
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)
Forward - 4.1 bar (60 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 123 °C; Reverse - 0.7 bar (10 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).
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Pore Size
5.0 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
Support Material
Polysulfone
Trade Name
Millidisk®
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.
Whether you need to collect, separate, or remove contaminants from air or fluid samples prior to downstream analysis, our broad selection of syringe filters, membranes, filter holders and related filtration devices ensures that we have the right solution for your application.
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