C10099Millipore Express^® SHR (Sterile High-retention) devices provide sterilizing-grade performance and mycoplasma removal across a range of bioprocess solutions.

Description

High-flux hydrophilic sterilizing-grade 0.1 µm rated PES membrane for improved process economy
Designed for sterilizing grade performance and mycoplasma removal
On-board PES membrane prefilter for extended throughput in high fouling media
Robust construction which will withstand multiple sterilization cycles
Easy wetting and integrity testing
Broad chemical compatibility across a wide pH range (pH 1–14)

Millipore Express^® SHR (Sterile High-Retention) Opticap^® capsules provide sterilizing-grade performance and mycoplasma removal across a range of bioprocess solutions including: cell culture media, media additives, process intermediates, and other biological fluids. Millipore Express^® SHR Opticap capsules provide high sterility assurance, broad chemical compatibility, high flow rates and extended throughput for superior process efficiency and economy.

Sterilizing-grade Millipore Express^®SHR capsule filters are available with an on-board polyethersulfone membrane prefilter which protects the sterilizing grade 0.1 µm rated membrane from premature plugging for enhanced throughput in high fouling streams. These high-retention filters are recommended for the removal of mycoplasma and other small microorganisms that can pass through a 0.2 µm rated sterilizing-grade filter.

Filter Applications

Cell culture media
Media additives
Serum
Concentrated protein
Process intermediates
Biologicals

Sterilizing-grade Millipore Express^® SHR for Bacterial Retention and Mycoplasma Removal

Sterilizing-grade Millipore Express SHR for Bacterial Retention and Mycoplasma Removal

Enhanced Sterility Assurance

Millipore Express^® SHR sterilizing-grade devices are designed for the removal of mycoplasma and small microorganisms that can pass through a 0.2 µm rated sterilizing grade filter. Millipore Express^® SHR filters have demonstrated high mycoplasma removal – typical Log Reduction Value (LRV) ≥ 7 using Acholeplasma laidlawii ATCC® 23206 and Millipore's standardized test method.

Permeability/10-inch* and Typical LRV

*Tested in duplicate at 10 psi on 47 mm disc and scaled to 10-inch

Superior Process Efficiency/Economy

Millipore Express^® SHR filters provide high flow rates, broad chemical compatibility (pH 1–14) and extended capacity for lower filtration costs. You get fast flowing, caustic stable filters which provide enhanced sterility assurance and high performance with cell culture media, sera and other high fouling biological process solutions.

Reduce Surface Area and Lower Your Costs

The on-board polyethersulfone membrane prefilter protects the sterilizing grade membrane from premature plugging and extends filter capacity in highly fouling streams, so you can maintain batch volume while reducing filtration surface area requirements.

NS0 Serum-free, Protein-free, Cell Culture Media

CHO Serum-free Cell Culture Media

Reliable Performance

Millipore Express^® SHR filters deliver:

Enhanced sterility assurance: Validated sterilizing-grade filtration and reliable mycoplasma removal
High flow rates for improved process efficiency
Superior process economy: On-board PES membrane prefilter extends filter capacity and reduces filtration area requirements

Superior Filter Robustness

Multiple steam-in-place or autoclave sterilization cycles
Broad chemical compatibility
Easy filter wetting and integrity testing

Multiple Formats Available

Opticap^®XL 150, 300, and 600 capsule filters with Millipore Express^® membranes are ideal for small volume sterile filling applications and process development work. An optional filling bell can be used to reduce contamination risk when transferring sterile media from large containers to media bottles or culture vessels.

Opticap^® XL 3, 5, and 10 capsule filters have a unique design to minimize hold-up volume and reduce production losses.

Opticap^® XLT 10, 20, and 30 T-line capsule filters design accomodates series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration of the Opticap^® XLT filter into your existing process.

All of these formats are available as gamma-compatible or sterile devices. Opticap^® XL 3 and larger capsules are also available as autoclavable devices.

Autoclavable Capsules

Opticap^® XL and XLT Disposable Capsules ( Autoclavable Only) Millipore Express^® SHR 0.1 µm Membrane
	Opticap^® XL 3 Capsules	Opticap^® XL 5 Capsules	Opticap^® XL 10 Capsules
Nominal Dimensions
Maximum Length	17.3 cm (6.8 in.)	21.6 cm (8.5 in.)	33.5 cm (13.2 in.)
Body Diameter	10.7 cm (4.2 in.)	10.7 cm (4.2 in.)	10.7 cm (4.2 in.)
Filtration Area	0.16 m² (1.7 ft²)	0.29 m² (3.1 ft²)	0.60 m² (6.5 ft²)
Materials of Construction
Filter Membrane	Hydrophilic polyethersulfone
Film edge	Polypropylene
Supports	Polypropylene
Core	Polysulfone
Structural components*	Polypropylene
Vent O-rings	Silicone
Vent Drain	6 mm ( 1/4 in.) hose barb with double O-ring seal
Maximum Inlet Pressure	6900 mbar (100 psi) intermittent at 23° C 5500 mbar (80 psi) at 23° C 2800 mbar (40 psi) at 60° C 1000 mbar (15 psi) at 80° C
Maximum Differential Pressure
Forward	6900 mbar (100 psi) intermittent at 25° C 5500 mbar (80 psi) at 25° C 1000 mbar (15 psi) at 80° C
Reverse	2100 mbar (30 psi) intermittent at 25° C
70/30 IPA Bubble Point at 23° C	≥2590 mbar (37.5 psi) with nitrogen
Air Diffusion at 23° C	Through a water wet membrane at 3.4 bar (50 psi):
	≤8.7 cc/min.	≤15.9 cc/min.	≤33.3 cc/min.
Bacterial Retention	Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC° 19146 per ASTM° methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) >7 using A. laidlawii ATCC® 23206 and our validated test method.
Bacterial Endotoxin	Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
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:
	3 L	5.5 L	10 L
Oxidizable Substances	Meets the USP Oxidizable Substances Test requirements for sterile purified water after a WFI flush of:
	1000 mL	1000 mL	1000 mL
Sterilization	May be autoclaved for 3 cycles of 60 minutes at 123° C. ( Cannot be steam sterilized in-line.)
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express^®SHR filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Cytotoxicity	Non-toxic per MEM elution ISO® 10993-5.
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-fiber Releasing	Millipore Express^® SHR membranes meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6).
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.

Opticap^® XL and XLT Disposable Capsules ( Autoclavable Only) Millipore Express^®SHR 0.1 µm Membrane
	Opticap^® XLT 10 Capsules	Opticap^® XLT 20 Capsules	Opticap^® XLT 30 Capsules
Nominal Dimensions
Maximum Length	38.1 cm (15.0 in.)	62.5 cm (24.6 in.)	87.1 cm (34.3 in.)
Body Diameter	10.7 cm (4.2 in.)	10.7 cm (4.2 in.)	10.7 cm (4.2 in.)
Filtration Area	0.60 m² (6.5 ft²)	1.21 m² (13.0 ft²)	1.81 m² (19.5 ft²)
Materials of Construction
Filter Membrane	Hydrophilic polyethersulfone
Film edge	Polypropylene
Supports	Polypropylene
Core	Polysulfone
Structural components*	Polypropylene
Vent O-rings	Silicone
Vent Drain	6 mm ( 1/4 in.) hose barb with double O-ring seal
Maximum Inlet Pressure	6900 mbar (100 psi) intermittent at 23° C 5500 mbar (80 psi) at 23° C 2800 mbar (40 psi) at 60° C 1000 mbar (15 psi) at 80° C
Maximum Differential Pressure
Forward	6900 mbar (100 psi) intermittent at 25° C 5500 mbar (80 psi) at 25° C 1000 mbar (15 psi) at 80° C
Reverse	2100 mbar (30 psi) intermittent at 25° C
70/30 IPA Bubble Point at 23° C	≥2590 mbar (37.5 psi) with nitrogen
Air Diffusion at 23° C	Through a water wet membrane at 3.4 bar (50 psi):
	≤33.3 cc/min.	≤66.6 cc/min.	≤99.9 cc/min.
Bacterial Retention	Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC° 19146 per ASTM° methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) >7 using A. laidlawii ATCC^® 23206 and our validated test method.
Bacterial Endotoxin	Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
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:
	10 L	20 L	30 L
Oxidizable Substances	Meets the USP Oxidizable Substances Test requirements for sterile purified water after a WFI flush of:
	1000 mL	2000 mL	3000 mL
Sterilization	May be autoclaved for 3 cycles of 60 minutes at 123° C. ( Cannot be steam sterilized in-line.)
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express^®SHR filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Cytotoxicity	Non-toxic per MEM elution ISO^® 10993-5.
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-fiber Releasing	Millipore Express^® SHR membranes meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6).
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.

	Opticap^® XL and XLT Disposable Capsules (Autoclavable Only) Millipore Express^® SHR 0.5/0.1 µm Membrane with Prefilter
	Opticap^® XL 3	Opticap^® XL 5	Opticap^® XL 10
Filtration Area	0.13 m²	0.23 m²	0.49 m²
Materials of Construction
Filter Membrane	Polyethersulfone (PES)	Polyethersulfone (PES)	Polyethersulfone (PES)
Film Edge	Polypropylene	Polypropylene	Polypropylene
Supports	Polypropylene	Polypropylene	Polypropylene
Structural Components/Core	Polypropylene/Polysulfone	Polypropylene/Polysulfone	Polypropylene/Polysulfone
Vent O-rings	Silicone (SI)	Silicone (SI)	Silicone (SI)
Vent/Drain	1/4 in. hose barb with double silicone O-ring seal
Maximum Inlet Pressure, bar (psid)	6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Differential Pressure, bar (psid)
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
Bubble Point at 23 °C	≥ 2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water
Air Diffusion at 23 °C	≤7.2 mL/min @ 3.45 bar (50 psig) in water	≤12.8 mL/min @ 3.45 bar (50 psig) in water	≤27.1 mL/min @ 3.45 bar (50 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) > 7 using A. laidlawii ATCC 23206 and Millipore's standard test method
Bacterial Endotoxins	Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
TOC/Conductivity at 25◦ C	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:
TOC/Conductivity at 25◦ C	5.5 liters	9.5 liters	20 liters
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
Sterilization	3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products 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
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
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.

	Opticap^® XLT 10	Opticap^® XLT 20	Opticap^® XLT 30
Filtration Area	0.49 m²	0.98 m²	1.48 m²
Materials of Construction
Filter Membrane	Polyethersulfone (PES)	Polyethersulfone (PES)	Polyethersulfone (PES)
Film Edge	Polypropylene	Polypropylene	Polypropylene
Supports	Polypropylene	Polypropylene	Polypropylene
Structural Components/Core	Polypropylene/Polysulfone	Polypropylene/Polysulfone	Polypropylene/Polysulfone
Vent O-rings	Silicone (SI)	Silicone (SI)	Silicone (SI)
Vent/Drain	1/4 in. hose barb with double silicone O-ring seal
Maximum Inlet Pressure, bar (psid)	6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Differential Pressure, bar (psid)	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
Bubble Point at 23 °C	≥2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water
Air Diffusion at 23 °C	≤27.1 mL/min @ 3.45 bar (50 psig) in water	≤54.2 mL/min @ 3.45 bar (50 psig) in water	≤81.3 mL/min @ 3.45 bar (50 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) > 7 using A. laidlawii ATCC 23206 and Millipore's standard test method
Bacterial Endotoxins	Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
TOC/Conductivity at 25◦C	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:
TOC/Conductivity at 25◦C	20 liters	40 liters	60 liters
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L
Sterilization	3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Cytotoxicity	Non-toxic per MEM elution ISO^® 10993-5
Particle Shedding	Effluent meets the criteria set forth in USP <788> for large volume parenterals.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
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.

Typical Clean Water Flow Rate vs Pressure Drop (Autoclavable Capsules)

Opticap<sup>®</sup> XL 3 Capsule Filters with 0.5/0.1 µm Millipore Express<sup>®</sup> SHR Membrane

Opticap^® XL 3 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap<sup>®</sup> XL 5 Capsule Filters with 0.5/0.1 µm Millipore Express<sup>®</sup> SHR Membrane

Opticap^® XL 5 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap<sup>®</sup> XL 10 Capsule Filters with 0.5/0.1 µm Millipore Express<sup>®</sup> SHR Membrane

Opticap^® XL 10 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap<sup>®</sup> XLT 10 Capsule Filters with 0.5/0.1 µm Millipore Express<sup>®</sup> SHR Membrane

Opticap^® XLT 10 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap<sup>®</sup> XLT 20 Capsule Filters with 0.5/0.1 µm Millipore Express<sup>®</sup> SHR Membrane

Opticap^® XLT 20 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap<sup>®</sup> XLT 30 Capsule Filters with 0.5/0.1 µm Millipore Express<sup>®</sup> SHR Membrane

Opticap^® XLT 30 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Sterile and Gamma Compatible Capsules

Millipore Express^®SHR 0.1 μm Membrane

	Opticap^® XL 150	Opticap^® XL 300	Opticap^® XL 600
Filtration Area	0.025m²	0.048m²	0.101m²
Materials of Construction
Filter Membrane	Polyethylene
Supports	Polyester	Polyester	Polyester
Structural Components/Core	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone
Vent O-rings	Silicone	Silicone	Silicone
Maximum Inlet Pressure, bar (psid)	6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Differential Pressure, bar (psid)	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
Bubble Point at 23 °C	≥2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water
Air Diffusion at 23 °C	≤ 1.4 cc/min @3.45 bar (50 psig) in water	≤ 1.4 cc/min @3.45 bar (50 psig) in water	≤ 5.8 cc/min @ 3.45 bar (50 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) ≥ 7 using A. laidlawii ATCC 23206 and Millipore's standard test method
Bacterial Endotoxins	Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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:
	2 liters	2.5 liters	3 liters
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Sterilization
Gamma compatible capsules	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	These capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Cytotoxicity	Non-toxic per MEM elution ISO^® 10993-5
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
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.

	Opticap^®XL3	Opticap^®XL5	Opticap^®XL10
Filtration Area	0.17 m²	0.31 m²	0.69 m²
Materials of Construction
Filter Membrane	Polyethersulfone (PES)	Polyethersulfone (PES)	Polyethersulfone (PES)
Film Edge	Polypropylene	Polypropylene	Polypropylene
Supports	Polyester	Polyester	Polyester
Structural Components/Core	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone
Vent O-rings	Silicone (SI)	Silicone (SI)	Silicone (SI)
Vent/Drain	1/4 in. hose barb with double silicone O-ring seal
Maximum Inlet Pressure, bar (psid)	6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Differential Pressure, bar (psid)	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
Bubble Point at 23 °C	≥2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water
Air Diffusion at 23 °C	≤ 9.4 cc/min @3.45 bar ( 50 psig) in water	≤ 17.3 cc/min @3.45 bar ( 50 psig) in water	≤ 38.8 cc/min @3.45 bar ( 50 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) > 7 using A. laidlawii ATCC 23206 and Millipore's standard test method
Bacterial Endotoxins	Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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:
	3.5 liters	6.0 liters	11 liters
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 liter	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 liter	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 liter
Sterilization
Gamma compatible	Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Sterile capsules	3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Cytotoxicity	Non-toxic per MEM elution ISO^® 10993-5
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
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.

	Opticap^®XLT 10	Opticap^® XLT 20	Opticap^® XLT 30
Filtration Area	0.69 m²	1.38 m²	2.06 m²
Materials of Construction
Filter Membrane	Polyethersulfone (PES)	Polyethersulfone (PES)	Polyethersulfone (PES)
Film Edge	Polypropylene	Polypropylene	Polypropylene
Supports	Polyester	Polyester	Polyester
Structural Components/Core	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone
Vent O-rings	Silicone (SI)	Silicone (SI)	Silicone (SI)
Vent/Drain	1/4 in. hose barb with double silicone O-ring seal
Maximum Inlet Pressure, bar (psid)	6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Differential Pressure, bar (psid)	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
Bubble Point at 23 °C	≥2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water
Air Diffusion at 23 °C	≤ 38.8 cc/min @ 3.45 bar (50 psig) in water	≤ 77.6 cc/min @ 3.45 bar (50 psig) in water	≤ 116.4 cc/min @ 3.45 bar (50 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) > 7 using A. laidlawii ATCC 23206 and Millipore's standard test method
Bacterial Endotoxins	Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
TOC/Conductivity at 25◦ C	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 liters	22 liters	33 liters
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1.5 liters	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 3 liters	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 4.5 liters
Sterilization
Gamma compatible	Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Sterile capsules	3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Cytotoxicity	Non-toxic per MEM elution ISO^® 10993-5
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
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.

Opticap^® XL 150 / 300/ 600 Disposable Capsules ( Sterile and Gamma Compatible) Millipore Express^® SHR 0.5/0.1 µm Membrane with Prefilter
	Opticap^® XL 150 Capsules	Opticap^® XL 300 Capsules	Opticap^® XL 600 Capsules
Nominal Dimensions
Maximum length	9.7 cm (3.8 in.)	11.9 cm (4.7 in.)	16.5 cm (6.5 in.)
Maximum length with bell	11.4 cm (4.5 in.)	13.7 cm (5.4 in.)	18.3 cm (7.2 in.)
Body diameter	5.6 cm (2.2 in.)	5.6 cm (2.2 in.)	5.6 cm (2.2 in.)
Filtration Area	0.015 m² (0.163 ft²)	0.028 m² (0.308 ft²)	0.062 m² (0.664 ft²)
Materials of Construction
Filter Membrane	Hydrophilic polyethersulfone
Supports	Polyethylene
Core	Polysulfone
Structural components*	Gamma stable polypropylene
Vent O-rings	Silicone
Bell	Polycarbonate
Vent Drain	6 mm ( 1/4 in.) hose barb with double O-ring seal
Maximum Inlet Pressure	6900 mbar (100 psi) intermittent at 23° C 5500 mbar (80 psi) at 23° C 2800 mbar (40 psi) at 60° C 1000 mbar (15 psi) at 80° C
Maximum Differential Pressure
Forward	6900 mbar (100 psi) intermittent at 25° C 5500 mbar (80 psi) at 25° C 1000 mbar (15 psi) at 80° C
Reverse	2100 mbar (30 psi) intermittent at 25° C
70/30 IPA Bubble Point at 23° C	≥2590 mbar (37.5 psi) with nitrogen
Air Diffusion at 23° C	Through a water wet membrane at 3.4 bar (50 psi):
	≤1.0 cc/min.	≤1.9 cc/min.	≤3.7 cc/min.
Bacterial Retention	Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC° 19146 per ASTM° methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) >7 using A. laidlawii ATCC^® 23206 and our validated test method.
Bacterial Endotoxin	Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
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:
	1 L	2 L	3 L
Oxidizable Substances	Meets the USP Oxidizable Substances Test requirements for sterile purified water after a WFI flush of 1 L.
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	These capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express^®SHR filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Cytotoxicity	Non-toxic per MEM elution ISO^® 10993-5.
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-fiber Releasing	Millipore Express^® SHR membranes meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6).
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.

Millipore Express^®SHR with Prefilter 0.5/0.1 μm Membrane

	Opticap^® XL 3 Capsules	Opticap^® XL 5 Capsules	Opticap^® XL 10 Capsules	Per Standard Area Opticap^®XLT 10 Capsules	Per High Area Opticap^® XLT 10 Capsules**
Nominal Dimensions
Maximum length	17.3 com (6.8 in.)	21.6 cm (8.5 in.)	33.5 cm (13.2 in.)	38.1 cm (15.0 in.)	38.1 cm (15.0 in.)
Body diameter	10.7 cm (4.2 in.)	10.7 cm (4.2 in.)	10.7 cm (4.2 in.)	10.7 cm (4.2 in.)	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	0.13 m²(1.4 ft2)	0.24 m² (2.6 ft2)	0.54 m² (5.8 ft2)	0.54 m² (5.8 ft2)	1.0 m² (10.8 ft2)
Materials of Construction
Filter membrane	Hydrophilic polyethersulfone
Film edge	Polypropylene
Supports	Polypropylene
Core	Polysulfone			Polyethersulfone
Structural components*	Polypropylene
Vent O-rings	Silicone
Vent/Drain	6 mm (¼ in.) hose barb with double O-ring seal
Maximum Inlet Pressure
6900 mbar (100 psi) intermittent at 23 °C
5500 mbar (80 psi) at 23 °C
2800 mbar (40 psi) at 60 °C
1000 mbar (15 psi) at 80 °C
Maximum Differential Pressure
Forward	6900 mbar (100 psi) intermittent at 25 °C 5500 mbar (80 psi) at 25 °C 1000 mbar (15 psi) at 80 °C
Reverse	2100 mbar (30 psi) intermittent at 25 °C
70/30 IPA Bubble Point at 23 °C	≥2590 mbar (37.5 psi) with nitrogen
Air Diffusion at 23 °C	Through a water wet membrane at 3.4 bar (50 psi):
	≤7.3 cc/min.	≤13.6 cc/min.	≤30.4 cc/min.	≤30.4 cc/min.	≤54.2 cc/min.
Bacterial Retention	Quantitative retention of 10⁷ CFU /cm² Brevundimonas diminuta ATCC^® 19146 per ASTM® methodology
Mycoplasma Removal	Typical Log Reduction Value (LRV) >7 using A. laidlawii ATCC^® 23206 and our validated test method
Bacterial Endotoxin	Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL)
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 flush of:
	5.5 L	9.5 L	21 L	21 L	21 L
Oxidizable Subtances	Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of 2 L.
Sterilization
Gamma-compatible capsules	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	These capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
Cytotoxicity	Non-toxic per MEM elution ISO® 10993-5
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-fiber Releasing	Millipore Express^®SHR membranes 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^® SHC 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
**Only available in gamma-compatible formats

Typical Clean Water Flow Rate vs Pressure Drop (Sterile and Gamma Compatible Capsules)

Opticap^® XL 3 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap^® XL 5 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap^® XL 10 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap^® XLT 10 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap^® XLT 20 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

Opticap^® XLT 30 Capsule Filters with 0.5/0.1 µm Millipore Express^® SHR Membrane

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Millipore Express^® SHR Opticap^® Capsule Filters

Millipore Express^® SHR (Sterile High-retention) devices provide sterilizing-grade performance and mycoplasma removal across a range of bioprocess solutions. More

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