C9127Opticap^® XL and XLT capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.

Description

Millipore Express^® SHF (Sterile High-Flux) filters are an unparalleled combination of quality and process performance. A sterilizing-grade, hydrophilic polyethersulfone (PES) membrane, these filters provide sterility assurance, broad chemical compatibility, and exceptionally high flow rates for your validated process steps. Developed and designed for your validated sterile filtration processes, manufactured in a highly controlled process and supported by extensive documentation to fulfill your regulatory requirements.

Benefits

Highly efficient sterilizing-grade membrane
Designed for validated filtration steps which require sterility assurance
Drug Master File available
Retention testing on each lot of membrane and filter device
Each filter subject to the highest sensitivity integrity test in the industry
Validation kits available

Sterilization Capability

Autoclavable
Sterile
Gamma Compatible

Filter Formats

OptiScale^® small-scale disposable capsule filters
Opticap^® XL and XLT disposable capsule filters– autoclavable, sterile and gamma compatible
Cartridge filters

Regulatory Compliance

Filters are designed, developed and manufactured in accordance with a Quality Management System approved by an accredited registering body to the ISOR 9001 Quality Systems Standard.
Each filter and membrane lot is subjected to bacterial retention testing.
Every filter is subjected to the highest sensitivity integrity test in the industry.
All filters are shipped with a Certificate of Quality.
A Validation Guide, which is a summary of the product qualification, is available upon request.
For traceability and easy identification, each filter is identified with product name, lot number, and serial number.
Drug Master File is 16877DMF.

Reduced Surface Area and Lower Costs

Millipore Express^® SHF filters feature faster flow rates, allowing you to process equivalent volumes with reduced filtration area. This high-flux benefit has been shown to deliver greater than 50% savings in filtration costs.

The Emprove^® Program

The Emprove^® Program complements the product portfolio through

Comprehensive documentation to support qualification, risk assessment and process optimization needs.
Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
Convenient 24/7 access to up-to-date product information.

Specifications (Autoclavable Capsules)

	Opticap^® XL3	Opticap^® XL5	Opticap^® XL10
Filtration Area	0.16 m²	0.29 m²	0.54 m²
Materials of Construction
Filter	Polyethersulfone (PES)	Polyethersulfone (PES)	Polyethersulfone (PES)
Film Edge	Polypropylene	Polypropylene	Polypropylene
Supports	Polypropylene	Polypropylene	Polypropylene
Structural Components	Polypropylene/Polysulfone	Polypropylene/Polysulfone	Polypropylene/Polysulfone
Vent O-ring	Silicone (SI)	Silicone (SI)	Silicone (SI)
Vent/Drain	1/4 in. hose barb with double silicone O-ring seal
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	≥4000 mbar (58 psig) air with water
Air Diffusion	≤9.1 mL/min @ 2.8 bar (40 psig) in water	≤16.4 mL/min @ 2.8 bar (40 psig) in water	≤30 mL/min @ 2.8 bar (40 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
Bacterial Endotoxins	Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
TOC/Conductivity at 25 °C	Autoclaved filters meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 3 L	Autoclaved filters 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	Autoclaved filters meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 10 L
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	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
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.

	Opticap^® XLT10	Opticap^® XLT20	Opticap^® XLT30
Filtration Area	0.54 m²	1.08 m²	1.62 m²
Materials of Construction
Filter	Polyethersulfone (PES)	Polyethersulfone (PES)	Polyethersulfone (PES)
Film Edge	Polypropylene	Polypropylene	Polypropylene
Supports	Polypropylene	Polypropylene	Polypropylene
Structural Components	Polypropylene/Polysulfone	Polypropylene/Polysulfone	Polypropylene/Polysulfone
Vent O-ring	Silicone (SI)	Silicone (SI)	Silicone (SI)
Vent/Drain	1/4 in. hose barb with double silicone O-ring seal
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	≥4000 mbar (58 psig) air with water
Air Diffusion	≤30 mL/min @ 2.8 bar (40 psig) in water	≤60 mL/min @ 2.8 bar (40 psig) in water	≤90 mL/min @ 2.8 bar (40 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
Bacterial Endotoxins	Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
TOC/Conductivity	Autoclaved filters meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 10 liters at 25 °C	Autoclaved filters meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 20 liters at 25 °C	Autoclaved filters meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 30 liters at 25 °C
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 ≥2 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 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
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.

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

Opticap<sup>®</sup> XL 3 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XL 3 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap<sup>®</sup> XL 5 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XL 5 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap<sup>®</sup> XL 10 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XL 10 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap<sup>®</sup> XLT 10 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XLT 10 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap<sup>®</sup> XLT 20 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XLT 20 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap<sup>®</sup> XLT 30 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XLT 30 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Specifications (Sterile and Gamma Compatible Capsules)

	Opticap XL 150	Opticap XL 300	Opticap XL 600
Filtration Area	220 cm²	480 cm²	970 cm²
Materials of Construction
Filter	Polyethersulfone (PES)	Polyethersulfone (PES)	Polyethersulfone (PES)
Supports	Polyethylene	Polyethylene	Polyethylene
Structural Components	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone
Vent O-ring	Silicone (SI)	Silicone (SI)	Silicone (SI)
Vent/Drain	1/4 in. Hose Barb with double O-ring seal	1/4 in. Hose Barb with double O-ring seal	1/4 in. Hose Barb with double O-ring seal
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	≥4000 mbar (58 psig) air with water
Air Diffusion	≤1.4 mL/min @ 2.8 bar (40 psig) in water	≤2.8 mL/min @ 2.8 bar (40 psig) in water	≤5.8 mL/min @ 2.8 bar (40 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
Bacterial Endotoxins	Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
TOC/Conductivity at 25 °C	Gamma sterilized filters meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI flush of: 2 liter	Gamma sterilized filters meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI flush of: 2.5 liters	Gamma sterilized filters meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 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; 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
Sterility	Sterile 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.
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.
Non-Particle Releasing	Passes USP test for particulates in injectables.
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.

	Opticap XLT10	Opticap XLT20	Opticap XLT30
Filtration Area	0.57 m²	1.14 m²	1.71 m²
Materials of Construction
Filter	Polyethersulfone (PES)	Polyethersulfone (PES)	Polyethersulfone (PES)
Film Edge	Polyethylene	Polyethylene	Polyethylene
Supports	Polyester	Polyester	Polyester
Structural Components	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone	Gamma stable polypropylene/Polysulfone
Vent O-ring	Silicone (SI)	Silicone (SI)	Silicone (SI)
Vent/Drain	1/4 in. Hose Barb with double O-ring seal
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	≥4000 mbar (58 psig) air with water
Air Diffusion	≤32.7 mL/min @ 2.8 bar (40 psig) in water	≤65.5 mL/min @ 2.8 bar (40 psig) in water	≤98.2 mL/min @ 2.8 bar (40 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM^® F838-83 methodology
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: 11 liters 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: 22 liters 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: 33 liters at 25 °C
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1.5 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L
Sterilization
Gamma compatible capsules	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
Sterility	Sterile
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
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.

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

Opticap<sup>®</sup> XL 150 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XL 150 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap<sup>®</sup> XL 300 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XL 300 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap<sup>®</sup> XL 600 Capsule Filters with 0.2 µm Millipore Express<sup>®</sup> SHF Membrane

Opticap^® XL 600 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap^® XL 3 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap^® XL 5 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap^® XL 10 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap^® XLT 10 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap^® XLT 20 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

Opticap^® XLT 30 Capsule Filters with 0.2 µm Millipore Express^® SHF Membrane

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Millipore Express^® SHF 0.2 μm Capsule Filters

Opticap^® XL and XLT capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. More

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Specifications

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