Durapore® 0.1 µm and 0.22 µm Gamma Compatible Capsule Filters
Recommended Products
Overview
Specifications
Ordering Information
Related Products & Applications
Product Families
Durapore® 0.1 µm and 0.22 µm Capsule FiltersSterile Opticap capsule filters are fully contained capsule filters with Durapore 0.22 µm or 0.1 µm hydrophilic PVDF membrane.Learn More >> |
Durapore® 0.1 µm and 0.22 µm Cartridge FiltersA trusted name in the industry for over 25 years, The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.Learn More >> |
Durapore® 0.1 µm and 0.22 µm Capsule FiltersSterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs.Learn More >> |
Related Products By: Application Facete
| Antibody Purification |
| Dialysis and Filtration |
Related Products By: Brand Facete
| Millipak® |
Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration |
Superior Filters for the Sterile Filtration of Biopharmaceutical Liquids
Millipore gamma compatible capsule filters combine easy to use disposable technology with proven 0.1µm and 0.22 µm Durapore membrane.
Opticap™ XL and XLT capsules are designed to meet the growing demand for filtration into large sterile biocontainers. Up to 2000 liters of buffer, media and chromatographic eluents can be processed with these capsules. Millipak® disposable filter units are ideal for small volume processing and sterile fill and finish applications.
These disposable capsule filters are convenient, safe and supported by Millipore Validation Guides. Overall process efficiency and cost effectiveness are enhanced due to the elimination of cleaning and subsequent validation issues. The hydrophilic Durapore membrane provides high flow rates and throughput, low extractables and particle shedding, and broad chemical compatibility.
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 Millipak, Opticap XL and Opticap XLT capsule 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 marked with the product name and identifying characteristics.
Multiple Formats Available
Sterilizing-grade hydrophilic Durapore membranes are available in four formats, two pore sizes, and multiple configurations that vary by filtration area and type of inlet/outlet connection. We have a format to meet your application needs.
Millipak Low-Volume Capsule Filters
Millipak filters with hydrophilic Durapore membranes are uniquely designed for the removal of particles and micro-organisms. The stacked disc design allows minimal hold-up volume and no particle shedding, making Millipak units ideally suited for high value-added applications. Each Millipak filter is integrity tested during the manufacturing process.
Millipak filters are available in two different stack sizes. Adjustable, easy-to-turn, upstream vents and drain valves with O-ring seals and hose barb connections allow for easy process control.
Opticap XL and XLT Disposable Capsule Filters
Opticap XL and XLT 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 membrane minimizes hold-up volume and reduces production losses.
Opticap XL 4, 5 and 10 capsule filters with hydrophilic Durapore membrane are available in multiple filtration areas, providing an optimal choice for every application.
Opticap XLT 10, 20 and 30 T-line Capsule Filters with hydrophilic Durapore membrane accommodate series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration into your existing process.
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.
| Millipak-100 | Millipak-200 | |
| Filtration Area | 500 cm² | 1000 cm² |
| Materials of Construction | ||
| Filter membrane | Polyvinylidene Fluoride (PVDF) | Polyvinylidene Fluoride (PVDF) |
| Structural components | Polycarbonate | Polycarbonate |
| Vent caps | Polyvinylidene fluoride (PVDF) | Polyvinylidene fluoride (PVDF) |
| Housing Vent | Adjustable vent with male luer and female Luer-Lok™ connections on inlet side of device | |
| Maximum Inlet Pressure, bar (psi) | 5.2 bar (75 psi) @ 25 °C | 5.2 bar (75 psi) @ 25 °C |
| Maximum Differential Pressure, bar (psid) | Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C | |
| Integrity Test | ||
| Bubble Point, 0.1 µm | ≥4830 mbar (70 psig) air with water | |
| Bubble Point, 0.22 µm | ≥3450 mbar (50 psig) air with water | |
| Gravimetric Extractables, mg | Maximum value after 200 mL flush and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature: | |
| The extractables level was equal to or less than 2.5 mg per device after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 5 mg per device after 24 hours in water at controlled room temperature. | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL | |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | |
| Sterilization | 3 autoclave cycles of 90 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. | |
| Opticap XL 4 | Opticap XL 10 | Opticap XLT 10 | Opticap XLT 20 | Opticap XLT 30 | |
| Filtration Area, m2 | 0.18 m² | 0.73 m² | 0.73 m² | 1.45 m² | 2.17 m² |
| Materials of Construction | |||||
| Filter media | Polyvinylidene Fluoride (PVDF) | ||||
| Film edge | Polyethylene | ||||
| Supports | Polyester | ||||
| Structural components | Gamma-stable polypropylene | ||||
| Vent O-ring | Silicone | ||||
| Vent/Drain | 1/4 in. hose barb with double O-ring seal | ||||
| Integrity Test, Bubble Point | |||||
| 0.1 µm | ≥4830 mbar (70 psig) air with water | ||||
| 0.22 µm | ≥3450 mbar (50 psig) air with water | ||||
| Integrity Test, Air Diffusion | |||||
| 0.1 µm | ≤5.7 mL/min @ 3.9 bar (56 psig) in water | ≤5.7 mL/min @ 3.9 bar (56 psig) in water | ≤5.7 mL/min @ 3.9 bar (56 psig) in water | ≤5.7 mL/min @ 3.9 bar (56 psig) in water | ≤5.7 mL/min @ 3.9 bar (56 psig) in water |
| 0.22 µm | ≤4.6 mL/min @ 2.75 bar (40 psig) in water | ≤4.6 mL/min @ 2.75 bar (40 psig) in water | ≤4.6 mL/min @ 2.75 bar (40 psig) in water | ≤4.6 mL/min @ 2.75 bar (40 psig) in water | ≤4.6 mL/min @ 2.75 bar (40 psig) in water |
| Maximum Inlet Pressure, bar (psid) | 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: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.8 bar (40 psid) @ 25 °C, intermittent | ||||
| NVR Gravimetric Extractables | The extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 50 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 75 mg per capsule after 24 hours in water at controlled room temperature. | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL | 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 ≥2 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | ||||
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | ||||
| Sterilization | 3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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
Millipak 100//200 Capsule Filter with 0.1 µm Hydrophilic Durapore Membrane
Millipak 100//200 Capsule Filter with 0.22 µm Hydrophilic Durapore Membrane
Opticap® XL 10 Capsule Filters with 0.1 µm Hydrophilic Durapore® Membrane
Opticap® XL 10 Capsule Filters with 0.22 µm Hydrophilic Durapore® Membrane
Opticap® XLT 10 Capsule Filters with 0.1 µm Hydrophilic Durapore® Membrane
Opticap® XLT 10 Capsule Filters with 0.22 µm Hydrophilic Durapore® Membrane
Opticap® XLT 20 Capsule Filters with 0.1 µm Hydrophilic Durapore® Membrane
Opticap® XLT 20 Capsule Filters with 0.22 µm Hydrophilic Durapore® Membrane
Opticap® XLT 30 Capsule Filters with 0.1 µm Hydrophilic Durapore® Membrane
Opticap® XLT 30 Capsule Filters with 0.22 µm Hydrophilic Durapore® Membrane