Multilayer Durapore® 0.45/0.22 µm Capsule Filters
Opticap XL and XLT capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.
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Opticap XL and XLT capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. Less
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Overview
Specifications
Ordering Information
Documentation
Operational Excellence Dossier
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Technical Info
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| Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters |
FAQ
| Question | Answer |
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| What is the compatibility of Durapore with high pH solutions? | The upper recommended pH limit for Durapore membranes is 10. At pH >10, the hydrophilization layer of the membrane may become subject to hydrolysis. The extent of hydrolysis is a function of time, temperature , concentration and time of exposure. Upon exposure to high pH, the hydrophylization layer can swell which could result in a loss of permeability or flux. The hydrolysis of the hydrophilic layer will also lead to increased extractables from the membrane. |
| What are Millipore's general recommendations for filtering high pH solutions? | For applications involving pH > 10, Millipore recommends the use or our PES membranes Express SHF or Express SHC. For information on these filters : Express SHF: http://www.millipore.com/catalogue.nsf/docs/C8873 Express SHC: http://www.millipore.com/catalogue.nsf/docs/C9146 |
| How can I differentiate filter plugging due to air bubbles, particulates, surface tension, inappropriate filter size, etc.? | Air locking will occur when filtration is initiated without adequate venting or when air bubbles become trapped in fluid lines. Air will pass easily through a dry hydrophillic or hydrophobic filter. However, when a filter is wet and air is applied to a surface, the air will remain until it is manually moved upstream by venting or until the bubble point of the filter is reached. Bubble point is defined as the pressure at which gas displaces liquid for the largest set of filter pores and is able to flow through the pores. Air locking reduces the effective filtration area of the filter and thus reduces the flow rate. Surface tension refers to the strong cohesive forces present between molecules at the surface of a liquid. The higher the surface tension, the more force is required to force fluid through the membrane.. Innapropriate filter size will can cause a filter to plug prematurely. Filter pore size is chosen based on the application. If the application requires a sterile fluid, than a 0.22 micron membrane would be used for standard solutions that have bacterial bioburden. A 0.1 micron filter would be used for applications where mycoplasma is a concern. Where virus contamination is a concern, ultrafiltration would be required. The selection of a filter pore size that is smaller than that required for the application will cause a decrease in filter capacity and an increase in cost. |
User Guides
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| Opticap® XL Capsules and Opticap® XLT Capsules |
Related Products & Applications
Product Families
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Multilayer Durapore® 0.45/0.22 µm Cartridge FiltersSterilizing grade, hydrophilic Multilayer Durapore 0.45/0.22 µm filters maximize process efficiency by providing high product recovery and extended throughput with low pressure drops.Learn More >> |
OptiScale® Capsule Filters for Aseptic Processing ApplicationsOptiScale® capsules, with a large variety of filtration media options, are a family of convenient, disposable filters ideal for media selection, process screening and scaling.Learn More >> |
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Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore |
Description
The combination of hydrophilic low protein binding 0.45 µm Durapore polyvinylidene fluoride (PVDF) membrane and sterilizing-grade 0.22 µm Durapore membrane in a single capsule is the superior choice for clean and sterile processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties. Sterilizing-grade, hydrophilic Multilayer Durapore 0.45/0.22 µm filters maximize process efficiency by providing high product recovery and extended throughput with low pressure drops.
Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness. The unique capsule design with pleated Durapore membranes minimizes hold-up volume and reduces production losses.
Regulatory Compliance
Filters with hydrophilic Durapore membrane are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each Opticap capsule filter is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each device is labeled with the product name and identifying characteristics.
Multiple Formats Available
Opticap XL 10 Capsule Filters are supplied with a choice of inlet and outlet connections to optimize your filtration process, including sanitary flanges which provide a high flow rate, fractional sanitary flanges and hose barbs.
Opticap XLT 10, 20 and 30 T-line Capsule Filters accommodate 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.
Typical Applications
Hydrophilic Multilayer Durapore 0.45/0.22 µm filters are recommended for a wide range of pharmaceutical and biological liquid applications including: the filtration of therapeutics, vaccines, antibiotics, blood fractionations, bulk pharmaceutical and other downstream biotechnology processing solutions where protein binding must be minimized. Hydrophilic Multilayer Durapore filters are ideally suited to applications requiring high sterility assurance, high product purity and high product yield.
| Specifications (Autoclavable Capsules) | ||||
| Opticap XL10 | Opticap XLT10 | Opticap XLT20 | Opticap XLT30 | |
| Filtration Area | 0.55 m² | 0.55 m² | 1.2 m² | 1.75 m² |
| Materials of Construction | ||||
| Filter | Polyvinylidene Fluoride (PVDF) | Polyvinylidene Fluoride (PVDF) | Polyvinylidene Fluoride (PVDF) | Polyvinylidene Fluoride (PVDF) |
| Supports | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| Structural Components | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| O-ring | Silicone (SI) | 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: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent | |||
| Bubble Point | ≥3450 mbar (50 psig) air with water | |||
| Air Diffusion | ≤10.8 mL/min @ 2.75 bar (40 psig) in water | ≤10.8 mL/min @ 2.75 bar (40 psig) in water | ≤21.6 mL/min @ 2.75 bar (40 psig) in water | ≤32.4 mL/min @ 2.75 bar (40 psig) in water |
| 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: 16 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: 16 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: 32 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: 48 liters at 25 °C |
| 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 | |||
| 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 ≥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 | 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable | |||
| 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. | |||
| 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. | |||
| Specifications (Sterile and Gamma Compatible Capsules) | ||||
| Opticap XL10 | Opticap XLT10 | Opticap XLT20 | Opticap XLT30 | |
| Filtration Area | 0.6 m² | 0.55 m² | 1.2 m² | 1.81 m² |
| Materials of Construction | ||||
| Filter | Polyvinylidene Fluoride (PVDF) | |||
| Supports | Polypropylene | |||
| Structural Components | Polypropylene | |||
| O-ring | Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone | |||
| Vent/Drain | 1/4 in. hose barb with double silicone O-ring seal | |||
| 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 | |||
| Bubble Point | ≥3450 mbar (50 psig) air with water | |||
| Air Diffusion | ≤15.0 mL/min @ 2.75 bar (40 psig) in water | ≤15.0 mL/min @ 2.75 bar (40 psig) in water | ≤30.0 mL/min @ 2.75 bar (40 psig) in water | ≤45.0 mL/min @ 2.75 bar (40 psig) in water |
| 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: 16 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: 16 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: 32 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: 48 liters at 25 °C |
| 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 | |||
| 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 ≥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 Format | Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable | |||
| 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. | |||
| 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
Opticap® XL 10 Capsule Filters 0.45/0.22 µm Hydrophilic Durapore®
Opticap® XLT 10 Capsule Filters 0.45/0.22 µm Hydrophilic Durapore®
Opticap® XLT 20 Capsule Filters 0.45/0.22 µm Hydrophilic Durapore®
Opticap® XLT 30 Capsule Filters 0.45/0.22 µm Hydrophilic Durapore®