Millipore Express SHF Hydrophilic Cartridge Filters

Description

Millipore Express SHF (Sterile High-Flux) cartridge filters are the choice for optimal buffer filtration. A sterilizing grade, 0.2 µm hydrophilic polyethersulfone (PES) membrane, Millipore Express SHF filters provide sterility assurance, broad chemical compatibility, and exceptionally high flow rates for buffers at the high and low range of pH, 1–14.

The high flow rate of the Millipore Express SHF membrane cuts your filtration time in half, dramatically improving filtration economics and extending production capacity. The membrane is caustic compatible and offers high-flux performance with a full range of buffer chemistries. Its low extractables and non-fiber releasing properties contribute to clean processes. With Millipore Express SHF filters, you increase productivity, shorten cycle-time and reduce costs.

Superior Performance, Speed and Value

For biotech and pharmaceutical customers seeking fast, efficient and economical sterile buffer filtration, no PES membrane delivers more than Millipore Express SHF.

Fast filtration with sterility assurance
Broad chemical compatibility—even at high pH
Low filtration costs—reduced up-front filter and overall filtration costs

Developed to Enhance Your Buffer Filtration

Millipore Express SHF filters use a fast flowing process membrane specifically developed for the filtration of buffers, pH adjusters and other aqueous intermediate pharmaceutical and biotech process solutions. Designed to offer high-flux performance and improved economics, Millipore Express SHF membrane is compatible with a wide range of buffer chemistries, including acids and sodium hydroxide.

Reliable Performance

Millipore Express SHF membrane delivers all the benefits you’d expect from a quality Millipore membrane. Reliable sterilizing performance. Multiple steam-in-place or autoclave sterilization cycles. Broad chemical compatibility. Easy integrity testing. And fast flow to help you fill your buffer filtration tank quickly—now with the added benefits of improving filtration efficiency and economics.

Regulatory Compliance

Millipore Express SHF filters are designed, developed and manufactured in accordance with a Quality Management System approved by an accredited registering body of an ISO® 9000 Quality Systems Standard. Each cartridge is shipped with a Certificate of Quality. All cartridge filters are 100% integrity tested during manufacture and supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each filter is identified with product name and other characteristics.

Multiple Formats Available

Code 0 and code 7 O-ring adaptors are available to suit your application and housing needs.

Specifications

OptiScale Disposable Capsules and Cartridge Filters
	OptiScale 25 Capsules	OptiScale 47 Capsules	Cartridge Filters 5-inch	Per 10-inch Filter
Nominal Dimensions
Diameter:	31 mm (1.21 in)	69 mm (2.75 in.)	6.9 cm (2.7 in.)
Length:	39 mm (1.52 in.)	82 mm (3.24 in.) with flange inlet/hose barb outlet 74 mm (2.91 in.) with flange inlet/flange outlet 94 mm (3.70 in.) with hose barb inlet/hose barb outlet	12.5 cm (5 in.)	25.4 cm (10 in.)
Weight:	5.5 g (0.19 oz)	67 g (2.3 oz)	—	—
Filtration Area	3.5 cm²	17.7 cm²	0.29 m² (3.1 ft²) 0.29 m² (2.5 ft²)	0.54 m² (5.8 ft²) 0.54 m² (5.3 ft²)
Materials of Construction
Filter membrane:	Hydrophilic polyethersulfone
Film edge:	—	—	Polypropylene
Supports:	—	Polypropylene
Cage and end caps:	—	Polycarbonate	Polypropylene
Core:	—	Polycarbonate	Polysulfone
Structural components:	Polypropylene	Polycarbonate	—
Vent cap:	Polypropylene	Polyvinylidene fluoride (PVDF)	—
O-rings:	Fluorocarbon rubber		Silicone, EPDM or fluorocarbon rubber
Housing Vent	Capped vent with female Luer connections on inlet side of device.	Adjustable vent with male Luer and female Luer-Lok connections on inlet side of the device
Maximum Inlet Pressure	4136 mbar (60 psi) at 25 °C	5516 mbar (80 psi) at 25 °C	—
Maximum Differential Pressure
Forward:	4136 mbar (60 psi) at 25 °C	5516 mbar (80 psi) at 25 °C	6895 mbar (100 psi) at 25 °C 1700 mbar (25 psi) at 80 °C 340 mbar (5 psi) at 135 ° C
Reverse:	0 mbar (0 psi)	700 mbar (10 psi) at 25 °C	2068 mbar (30 psi) at 25 °C 69 mbar (1 psi) at 135 °C
Bubble Point at 23 °C	—		≥ 4000 mbar (58 psi) air with water
Air Diffusion at 23 °C	—	—	Through a water wet membrane at 2758 mbar (40 psi):
			≤16.4 cc/min.	≤30 cc/min.
Bacterial Retention	—	—	Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology
Bacterial Endotoxin	Aqueous extraction contains	—	Aqueous extraction contains
TOC/Conductivity	This product exhibited less than 500 ppb TOC per USP <643> and less than 1.3 um per USP <645> after autoclave and WFI water flush of 15 mL.	—	Autoclaved cartridges meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of:
			5.5 L at 25 °C	10 L at 25 °C
Oxidizable Substances	—	Effluent meets the USP Oxidizable Substance Test requirements for sterile purified water after a water flush of ≤100 mL.	Effluent meets the USP Oxidizable Substance Test requirements for sterile purified water after a water flush of: 1000 mL.
Sterilization	May be autoclaved for 1 cycle at 123 °C for 60 min.	May be autoclaved for 3 cycles of 60 min at 126 °C.	Autoclave: May be autoclaved 25x, 60 min. cycles at 126 °C In-line Steam: 25x (forward) or, 22x (forward) and 3x (reverse), 30 min cycles at 135 °C
USP Toxicity	—	—	Non-toxic per MEM elution ISO 10993-5.
Particle Shedding	Passes USP test for particulates in injectables.	—	Passes USP test for particulates in injectables.
Non-fiber Releasing	Millipore Express SHF membrane meet the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b)(6).
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express SHF filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182.
Good Manufacturing Practice	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Opticap XL and XLT Disposable Capsules (Autoclavable)
Opticap (Model)	XL 3	XL 5	XL 10	XLT 10	XLT 20	Opticap XLT 30
Nominal Dimensions
Maximum length:	17.3 cm (6.8 in.)	21.6 cm (8.5 in.)	33.5 cm (13.2 in.)	37.6 cm (14.8 in.)	62.5 cm (24.6 in.)	87.1 cm (34.3 in.)
Body diameter:	10.7 cm (4.2 in.)			—
Fitting to Fitting
Sanitary flange to sanitary flange:	—			15.2 cm (6.0 in.)
Sanitary flange to hose barb:	—			17.5 cm (6.9 in.)
Hose barb to hose barb:	—			19.8 cm (7.8 in.)
Filtration Area	0.16 m² (1.7 ft²)	0.29 m² (3.1 ft²)	0.54 m² (5.8 ft²)		1.08 m² (11.6 ft²)	1.62 m² (17.4 ft²)
Materials of Construction
Filter membrane:	Hydrophilic polyethersulfone
Film edge:	Polypropylene
Supports:	Polypropylene
Structural components: *	Polypropylene
Core:	Polysulfone
Vent O-rings:	Silicone
Vent/Drain	¼ in. hose barb with double O-ring seal
Maximum Differential Pressure
Forward:	5516 mbar (80 psi) at 25 °C 6895 mbar (100 psi) intermittent at 25 °C
Reverse:	2068 mbar (30 psi) intermittent at 25 °C
Bubble Point at 23 °C	≥ 4000 mbar (58 psi) air with water
Air Diffusion at 23 °C	Through a water wet membrane at 2758 mbar (40 psi):
	≤ 9.1 cc/min.	≤ 16.4 cc/min.	≤ 30 cc/min.		≤ 60 cc/min.	≤ 90 cc/min.
Bacterial Retention	Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology.
Bacterial Endotoxin	Aqueous extraction contains
TOC/Conductivity	Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of 10L at 25 °C (per 10-inch filter).
Oxidizable Substances	Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of:
	≤ 1000 mL				≤ 2000 mL	≤ 3000 mL
Sterilization	May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line).
Non-Fiber Releasing	Component materials meet criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b)(6).
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express SHF filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
USP Toxicity	Non-toxic per MEM Elution ISO 10993-5.
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.
* Cage, end caps and capsule housing

Opticap XL 150, 300 and 600 Disposable Capsules (Sterile and Gamma Compatible)*
Opticap (Model)	XL 150	XL 300	XL 600
Nominal Dimensions
Maximum length:	9.7 cm (3.8 in.)	11.9 cm (4.7 in.)	16.5 cm (6.5 in.)
Body diameter:	5.6 cm (2.2 in.)
Fitting to Fitting
Sanitary flange to Sanitary flange:	—
Sanitary flange to hose barb:	—
Hose barb to hose barb:	—
Filtration Area	0.022 m² (0.240 ft²)	0.048 m² (0.514 ft²)	0.097 m² (1.046 ft²)
Materials of Construction
Filter membrane:	Hydrophilic polyethersulfone
Film edge:	—
Supports:	Polyethylene
Structural components**:	Gamma stable polypropylene
Core:	Polysulfone
Vent O-rings***:	Silicone
Vent/Drain	¼ in. hose barb with double O-ring seal
Maximum Inlet Pressure	6895 mbar (100 psi) intermittent at 25 °C 5515 mbar (80 psi) at 25 °C 1035 mbar (15 psi) at 80 °C
Maximum Differential Pressure
Forward:	6895 mbar (100 psi) intermittent at 25 °C 5515 mbar (80 psi) at 25 °C 1035 mbar (15 psi) at 80 °C
Reverse:	2068 mbar (30 psi) intermittent at 25 °C
Bubble Point at 23 °C	≥4000 mbar (58 psi) air with water
Air Diffusion at 23 °C	Through a water wet membrane at 2758 mbar (40 psi):
	≤ 1.4 cc/min.	≤ 2.8 cc/min.	≤ 5.8 cc/min.
Bacterial Retention	Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology.
Bacterial Endotoxin	Aqueous extraction contains
TOC/Conductivity at 25 °C	Gamma Sterilized filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of:
	2 L	2.5 L	3 L
Oxidizable Substances	Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of ≤1000 mL.
Sterilization
Gamma compatible:	Gamma compatible to 45 kGy. May be autoclaved for 3 cycles of 60 minutes at 123 °C (cannot be steam sterilized in-line).
Sterile capsules:	May be autoclaved for 3 cycles of 60 minutes at 123 °C (cannot be steam sterilized in-line).
Sterility
Sterile capsules:	Meets current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
USP Toxicity	Non-toxic per MEM elution ISO 10993-5.
Particle Shedding	Passes USP test for particulates in injectables.
Non-Fiber Releasing	Millipore Express SHF membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3(b)(6).
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express SHF filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182.
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
* Cage, end caps and capsule housing.
** EPDM and fluorocarbon O-rings available by custom order.
Note: Filters were tested post gamma radiation at 25 – 65 kGy."

Opticap XL and XLT Disposable Capsules (Sterile and Gamma Compatible)*
Opticap (Model)	XL 3	XL 5	XL 10	XLT 10	XLT 20	XLT 30
Nominal Dimensions
Maximum length:	17.3 cm (6.8 in.)	21.6 cm (8.5 in.)	33.5 cm (13.2 in.)	37.6 cm (14.8 in.)	62.5 cm (24.6 in.)	87.1 cm (34.3 in.)
Body diameter:	10.7 cm (4.2 in.)			—
Fitting to Fitting
Sanitary flange to sanitary flange:	—			15.2 cm (6.0 in.)
Sanitary flange to hose barb:	—			17.5 cm (6.9 in.)
Hose barb to hose barb:	—			19.8 cm (7.8 in.)
Filtration Area	0.17 m² (1.8 ft²)	0.31 m² (3.3 ft²)	0.57 m² (6.1 ft²)		1.14 m² (12.3 ft²)	1.71 m² (18.4 ft²)
Materials of Construction
Filter membrane:	Hydrophilic polyethersulfone
Film edge:	Polyethylene
Supports:	Polyester
Structural components**:	Gamma stable polypropylene
Core:	Polysulfone
Vent O-rings:	Silicone
Vent/Drain	¼ in. hose barb with double O-ring seal
Maximum Differential Pressure
Forward:	5.5 bar (80 psi) at 25 °C 6.9 bar (100 psi) intermittent at 25 °C 1.0 bar (15 psi) at 80 °C
Reverse:	2.1 bar (30 psi) intermittent at 25 °C
Bubble Point at 23 °C	≥4000 mbar (58 psi) air with water
Air Diffusion at 23 °C	Through a water wet membrane at 2758 mbar (40 psi):
	≤ 9.5 cc/min.	≤ 17.4 cc/min.	≤ 32.7 cc/min.		≤ 65.5 cc/min.	≤ 98.2 cc/min.
Bacterial Retention	Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology.
Bacterial Endotoxin	Aqueous extraction contains
TOC/Conductivity	Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of 11 L at 25 °C (per 10-inch filter).
Oxidizable Substances	Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of:
	>1000 mL		≤1500 mL		≤ 3000 mL	≤ 4500 mL
Sterilization
Gamma compatible:	Gamma compatible to 45 kGy. May be autoclaved for 3 cycles of 60 minutes at 123 °C (cannot be steam sterilized in-line).
Sterile capsules:	May be autoclaved for 3 cycles of 60 minutes at 123 °C (cannot be steam sterilized in-line).
Sterility
Sterile capsules:	Meets current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
Non-Fiber Releasing	Component materials meet criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b)(6).
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express SHF filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
USP Toxicity	Non-toxic per MEM Elution ISO 10993-5.
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.
* Cage, end caps and capsule housing.
Note: Filters were tested post gamma radiation at 25 – 45 kGy.

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CGEP01TP3	0.2	10 (25)
	CGEP02TP3	0.2	20 (50)
	CGEP03TP3	0.2	30 (75)

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CGEP75TP3	0.2	5 (12.5)
	CGEP71TP3	0.2	10 (25)
	CGEP72TP3	0.2	20 (50)
	CGEP73TP3	0.2	30 (75)

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CGEP01TE3	0.2	10 (25)
	CGEP02TE3	0.2	20 (50)
	CGEP03TE3	0.2	30 (75)

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CGEP75TE3	0.2	5 (12.5)
	CGEP71TE3	0.2	10 (25)
	CGEP72TE3	0.2	20 (50)
	CGEP73TE3	0.2	30 (75)

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CGEP01TF3	0.2	10 (25)
	CGEP02TF3	0.2	20 (50)
	CGEP03TF3	0.2	30 (75)

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CGEP75TF3	0.2	5 (12.5)
	CGEP71TF3	0.2	10 (25)
	CGEP72TF3	0.2	20 (50)
	CGEP73TF3	0.2	30 (75)

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