Polysep™ II 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
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Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Polysep II |
Description
Polysep™ II filters are ideal for a broad range of aqueous-based applications. The Polysep II media consists of a borosilicate glass layer and a layer of mixed esters of cellulose membrane. The depth of the microfiber filter layer provides high particle loading capacity, and retention of large particulates while maintaining high flow rates. The mixed cellulose ester membrane layer provides the high retention needed during critical prefiltration steps while protecting more expensive downstream filtration devices and equipment.
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 Polysep II media minimizes hold-up volume and reduces production losses.
Regulatory Compliance
Polysep II filters 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™ XL and XLT capsule is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is marked with identifying characteristics.
Multiple Format
Opticap XL 2, 4, 5 and 10 capsule filters with Polysep II media are available in multiple filtration areas, providing an optimal choice for every application.
Opticap XLT 10, 20 and 30 T-line Capsule Filters with Polysep II media are available with or without a pressure gauge port for ease in monitoring process conditions. The 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.
Typical Applications
Buffer Preparation
Reduce particulate contamination and bioburden before final sterilizing filtration and provide excellent protection for sterilizing grade membrane filters in applications requiring more extensive buffer prefiltration.
Cell Culture Media
Polysep II prefilters effectively remove particles including lipids, and colloidal contaminants without obstructing the flow of vital media constituents.
Large Volume Parenterals (LVP)
Extend the service life of downstream sterilizing filters by removing colloidal and partiulate contaminants. The robust design withstands high differential and operating pressures, high flow rates and multiple steam-in-place or hot water sanitization cycles.
Ophthalmics
Polysep II prefilters reduce particle and bioburden before sterilizing filtration and will withstand process variability.
Serum
Polysep II prefilters remove lipids, colloids, and particles from serum before final sterilizing filtration without obstructing the passage of serum proteins.
| Opticap XL 2 | Opticap XL 4 | Opticap XL 5 | Opticap XL 10 | Opticap XLT 10 | Opticap XLT 20 | Opticap XLT 30 | |
| Filtration Area | |||||||
| Double Layer | 0.06 m² | 0.11 m² | 0.19 m² | 0.46 m² | 0.46 m² | 0.92 m² | 1.38 m² |
| Triple Layer | 0.17 m² | 0.42 m² | 0.42 m² | 0.84 m² | 1.26 m² | ||
| Materials of Construction | |||||||
| Filter media | Mixed Cellulose Esters (MCE) | ||||||
| Prefilter media | Borosilicate Glass Fiber (BGF) | ||||||
| Supports | Polypropylene | ||||||
| Structural components | Polypropylene | ||||||
| Vent O-ring | Silicone (SI) | ||||||
| Vent/Drain | 1/4 in. hose barb with double O-ring seal | ||||||
| Maximum Inlet Pressure, bar (psi) | 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) | 3.5 bar (50 psid) @ 25 °C | ||||||
| Gravimetric Extractables | The extractables level was equal to or less than 45 mg per capsule after a 600 mL flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 85 mg per capsule after a 1200 mL flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 61 mg per capsule after a 5 L flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 145 mg per capsule after a 5 L flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 145 mg per capsule after a 5 L flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 290 mg per capsule after a 10 L flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 435 mg per capsule after a 15 L flush and 24 hours in water at controlled room temperature. |
| 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 ≥2 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥10 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥15 L |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | ||||||
| Sterilization | 3 autoclave cycles of 30 min @ 121 °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. | ||||||
| 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 Capsule Legends Refer to Connection Type:
T T = 38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet
FF = 19 mm (3/4 in.) Sanitary Flange Inlet and Outlet
HH = 14 mm (9/16 in.) Hose Barb Inlet and Outlet
Opticap XLT Capsule Legends Refer to Connection Type:
T T = 38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet
TH = 38 mm (1 1/2 in.) Sanitary Flange Inlet and 16 mm (5/8 in.) Hose Barb Outlet
HH = 16 mm (5/8 in.) Hose Barb Inlet and Outlet
Opticap® XL 2 Capsule with Polysep II® Media - 1.0/0.2 µm Nominal (KGW3)
Opticap® XL 2 Capsule with Polysep II® Media - 1.0/0.5 µm Nominal (KGW6)
Opticap® XL 2 Capsule with Polysep II® Media - 1.0/1.2 µm Nominal (KGW2)
Opticap® XL 2 Capsule with Polysep II® Media - 2.0/1.2 µm Nominal (KGW9)
Opticap® XL 4 Capsule with Polysep II® Media - 1.0/0.2 µm Nominal (KGW3)
Opticap® XL 4 Capsule with Polysep II® Media - 1.0/0.5 µm Nominal (KGW6)
Opticap® XL 4 Capsule with Polysep II® Media - 1.0/1.2 µm Nominal (KGW2)
Opticap® XL 4 Capsule with Polysep II® Media - 2.0/1.2 µm Nominal (KGW9)
Opticap® XL 5 Capsule with Polysep II® Media - 1.0/0.2/0.1 µm Nominal (KGW1)
Opticap® XL 5 Capsule with Polysep II® Media - 1.0/0.2 µm Nominal (KGW3)
Opticap® XL 5 Capsule with Polysep II® Media - 1.0/0.5 µm Nominal (KGW6)
Opticap® XL 5 Capsule with Polysep II® Media - 1.0/1.2 µm Nominal (KGW2)
Opticap® XL 5 Capsule with Polysep II® Media - 2.0/1.2 µm Nominal (KGW9)
Opticap® XL 10 Capsule with Polysep II® Media - 1.0/0.2/0.1 µm Nominal (KGW1)
Opticap® XL 10 Capsule with Polysep II® Media - 1.0/0.2 µm Nominal (KGW3)
Opticap® XL 10 Capsule with Polysep II® Media - 1.0/0.5 µm Nominal (KGW6)
Opticap® XL 10 Capsule with Polysep II® Media - 1.0/1.2 µm Nominal (KGW2)
Opticap® XL 10 Capsule with Polysep II® Media - 2.0/1.2 µm Nominal (KGW9)
Opticap® XLT 10 Capsule with Polysep II® Media - 1.0/0.2/0.1 µm Nominal (KGW1)
Opticap® XLT 10 Capsule with Polysep II® Media - 1.0/0.2 µm Nominal (KGW3)
Opticap® XLT 10 Capsule with Polysep II® Media - 1.0/0.5 µm Nominal (KGW6)
Opticap® XLT 10 Capsule with Polysep II® Media - 1.0/1.2 µm Nominal (KGW2)
Opticap® XLT 10 Capsule with Polysep II® Media - 2.0/1.2 µm Nominal (KGW9)
Opticap® XLT 20 Capsule with Polysep II® Media - 1.0/0.2/0.1 µm Nominal (KGW1)
Opticap® XLT 20 Capsule with Polysep II® Media - 1.0/0.2 µm Nominal (KGW3)
Opticap® XLT 20 Capsule with Polysep II® Media - 1.0/0.5 µm Nominal (KGW6)
Opticap® XLT 20 Capsule with Polysep II® Media - 1.0/1.2 µm Nominal (KGW2)
Opticap® XLT 20 Capsule with Polysep II® Media - 2.0/1.2 µm Nominal (KGW9)
Opticap® XLT 30 Capsule with Polysep II® Media - 1.0/0.2/0.1 µm Nominal (KGW1)
Opticap® XLT 30 Capsule with Polysep II® Media - 1.0/0.2 µm Nominal (KGW3)
Opticap® XLT 30 Capsule with Polysep II® Media - 1.0/0.5 µm Nominal (KGW6)
Opticap® XLT 30 Capsule with Polysep II® Media - 1.0/1.2 µm Nominal (KGW2)
Opticap® XLT 30 Capsule with Polysep II® Media - 2.0/1.2 µm Nominal (KGW9)