Opticap XL and XLT Disposable Capsule Filters with Millipore Express^® SHF Hydrophilic Membrane

Opticap XL and XLT Disposable Capsule Filters with Millipore Express® SHF Hydrophilic Membrane

Description
Millipore Express SHF (Sterile High-Flux) devices are the ultimate 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, cleaning agents and sanitizing solutions 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.

Opticap XL and XLT capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsules patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness.


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 capsule is shipped with a Certificate of Quality. All devices 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
Opticap XL3, 5 and 10 Capsule Filters have a unique design to minimize hold-up volume and reduce production losses.

The Opticap XLT 10, 20 and 30 T-line Capsule Filters T-line design accommodates series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration of the Opticap XLT into your existing process.

They all exist as autoclavable, gamma-compatible or sterile devices.


Specifications (Autoclavable Capsules)    (return to top)

Opticap XL3 Opticap XL5 Opticap XL10 Filtration Area, m2 0.16 0.29 0.54 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polypropylene Polypropylene Polypropylene Supports Polypropylene Polypropylene Polypropylene Structural Components Polypropylene/Polysulfone Polypropylene/Polysulfone Polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Vent/Drain 1/4 in. hose barb with double silicone O-ring seal Maximum Differential Pressure, bar (psid) Forward - 5.5 (80) @ 25 °C; 6.9 (100) intermittent @ 25 °C; 1.0 (15) @ 80 °C; Reverse - 2.1 (30) @ 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 methodology. Bacterial Endotoxins <0.25 EU/mL as determined by the LAL test TOC/Conductivity 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 10 liters at 25 °C per 10-inch element 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 Device 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, m2 0.54 1.08 1.62 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polypropylene Polypropylene Polypropylene Supports Polypropylene Polypropylene Polypropylene Structural Components Polypropylene/Polysulfone Polypropylene/Polysulfone Polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Vent/Drain 1/4 in. hose barb with double silicone O-ring seal Maximum Differential Pressure, bar (psid) Forward - 5.5 (80) @ 25 °C; 6.9 (100) intermittent @ 25 °C; 1.0 (15) @ 80 °C; Reverse - 2.1 (30) @ 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 methodology. Bacterial Endotoxins <0.25 EU/mL as determined by the LAL test TOC/Conductivity 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 10 liters at 25 °C 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 20 liters at 25 °C 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 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 Device 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 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

Specifications (Sterile and Gamma Compatible Capsules)    (return to top)

Opticap XL3 Opticap XL5 Opticap XL10 Filtration Area, m2 0.17 0.31 0.57 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polyethylene Polyethylene Polyethylene Supports Polypropylene Polypropylene Polypropylene Structural Components Polypropylene/Polysulfone Polypropylene/Polysulfone Polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Vent/Drain 1/4 in. hose barb with double O-ring seal Maximum Differential Pressure, bar (psid) Forward - 5.5 (80) @ 25 °C; 6.9 (100) intermittent @ 25 °C; 1.0 (15) @ 80 °C; Reverse - 2.1 (30) @ 25 °C, intermittent Bubble Point ≥4000 mbar (58 psig) air with water Air Diffusion ≤9.5 mL/min @ 2.8 bar (40 psig) in water ≤17.4 mL/min @ 2.8 bar (40 psig) in water ≤32.7 mL/min @ 2.8 bar (40 psig) in water Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. Bacterial Endotoxins <0.25 EU/mL as determined by the LAL test TOC/Conductivity 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 11 liters at 25 °C per 10-inch element 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 ≤1.5 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 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 Device 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, m2 0.57 1.14 1.71 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polyethylene Polyethylene Polyethylene Supports Polypropylene Polypropylene Polypropylene Structural Components Polypropylene/Polysulfone Polypropylene/Polysulfone Polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Vent/Drain 1/4 in. hose barb with double O-ring seal Maximum Differential Pressure, bar (psid) Forward - 5.5 (80) @ 25 °C; 6.9 (100) intermittent @ 25 °C; 1.0 (15) @ 80 °C; Reverse - 2.1 (30) @ 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 methodology. Bacterial Endotoxins <0.25 EU/mL as determined by the LAL test TOC/Conductivity 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 11 liters at 25 °C 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 22 liters at 25 °C 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 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 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 Device 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 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