Opticap XL and XLT Disposable Capsule Filters with Milligard Media
Description
Milligard® filters provide the finest prefiltration available. Milligard filters are constructed of homogeneous polymers of cellulose esters on a polyester web resulting in a versatile filter with high reproducibility and efficacy due to the highly retentive, non-fiber releasing membrane. The homogenous cellulose ester membrane provides the high retention needed during critical prefiltration steps while protecting more expensive downstream filtration devices from premature plugging.
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 Milligard membrane minimizes hold-up volume and reduces production losses.
Regulatory Compliance
Milligard 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 Milligard 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 Milligard 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
Cell Culture Media
Effectively remove particles and colloidal contaminants without obstructing the flow of vital media constituents. Milligard prefilters provide the high flow rates and consistently high throughput required to accomplish the separation in a timely and cost-effective manner.
Final Aseptic Fill of Small Volume Parenterals (SVP)
Extend the service life of downstream sterilizing filters by removing colloidal and particulate contaminants.
Large Volume Parenterals (LVP)
Extend the service life of downstream sterilizing filters by removing colloidal and particulate contaminants. Extremely robust and able to withstand high operating pressures, Milligard filters offer dependable retention and high flow rates needed for high volume manufacturing.
Plasma Proteins—Human Albumin
Remove colloids, aggregated and non-product proteins, lipids and particles prior to downstream purification without retaining the fractions of interest. Milligard filters provide superior protection of downstream sterile filters and/or chromatography columns.
Serum
Effectively remove lipids, colloids, and particles from serum before the final sterilizing filtration without obstructing the passage of serum proteins. Milligard filters provide high flow rates and consistently high throughput.
| Opticap XL 10 with Prefilter Layer | 4-inch Opticap | Opticap XL 5 | Opticap XL 5 | Opticap XLT 10 | Opticap XLT 20 | Opticap XLT 30 |
| Filtration Area, m2 | 0.1 | 0.2 | 0.34 | 0.8 | 0.8 | 1.6 | 2.4 |
| Single Layer | 0.1 | 0.2 | 0.34 | 0.8 | 0.8 | 1.6 | 2.4 |
| Double Layer | 0.07 | 0.16 | 0.28 | 0.69 | 0.69 | 1.38 | 2.07 |
| Materials of Construction |
| Filter Material | Mixed Cellulose Esters |
| Support Material | Polyester |
| Device Material | Polypropylene |
| Vent/Drain | 1/4 in. hose barb with double O-ring seal |
| Max Inlet Pressure, bar (psi) | 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 °C |
| Max Differential Pressure, bar (psid) | 3.5 (50) @ 25 °C |
| Gravimetric Extractables |
| Standard Milligard Media | ≤15 mg after 24-h soak in water and 1 L flush | ≤25 mg after 24-h soak in water and 2 L flush | ≤25 mg after 24-h soak in water and 2 L flush | ≤55 mg after 24-h soak in water and 5 L flush | ≤55 mg after 24-h soak in water | ≤110 mg after 24-h soak in water | ≤165 mg after 24-h soak in water |
| Low Protein Binding Milligard Media, 0.2 µm | ≤25 mg after 24-h soak in water and 1 L flush | ≤45 mg after 24-h soak in water and 2 L flush | ≤45 mg after 24-h soak in water and 2 L flush | ≤105 mg after 24-h soak in water and 5 L flush | | | |
| Low Protein Binding Milligard Media, 0.5 µm | ≤25 mg after 24-h soak in water and 1 L flush | ≤45 mg after 24-h soak in water and 2 L flush | ≤45 mg after 24-h soak in water and 2 L flush | ≤105 mg after 24-h soak in water and 5 L flush | | | |
| Low Protein Binding Milligard Media, 1.2 µm | ≤55 mg after 24-h soak in water and 1 L flush | ≤105 mg after 24-h soak in water and 2 L flush | ≤105 mg after 24-h soak in water and 2 L flush | ≤255 mg after 24-h soak in water and 5 L flush | | | |
| Low Protein Binding Milligard Media, 0.5/0.2 µm | ≤60 mg after 24-h soak in water and 1 L flush | ≤110 mg after 24-h soak in water and 2 L flush | ≤145 mg after 24-h soak in water and 2 L flush | ≤355 mg after 24-h soak in water and 5 L flush | | | |
| Low Protein Binding Milligard Media, 1.2/0.5 µm | ≤50 mg after 24-h soak in water and 1 L flush | ≤90 mg after 24-h soak in water and 2 L flush | ≤85 mg after 24-h soak in water and 2 L flush | ≤205 mg after 24-h soak in water and 5 L flush | | | |
| 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 ≤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 | <0.5 EU/mL as determined by the 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 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
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
BB = 25 mm (1 in.) Hose Barb Inlet and Outlet
Opticap XLT 10 Capsule with Milligard Media - 0.2 µm Nominal (KW03)
Opticap XLT 10 Capsule with Milligard Media - 0.5 µm Nominal (KW06)
Opticap XLT 10 Capsule with Milligard Media - 1.2 µm Nominal (KW19)
Opticap XLT 10 Capsule with Milligard Media - 1.2/0.5 µm Nominal (KWSC)
Opticap XLT 10 Capsule with Milligard Media - 0.5/0.2 µm Nominal (KWSS)
Opticap XLT 20 Capsule with Milligard Media - 0.2 µm Nominal (KW03)
Opticap XLT 20 Capsule with Milligard Media - 0.5 µm Nominal (KW06)
Opticap XLT 20 Capsule with Milligard Media - 1.2 µm Nominal (KW19)
Opticap XLT 20 Capsule with Milligard Media - 1.2/0.5 µm Nominal (KWSC)
Opticap XLT 20 Capsule with Milligard Media - 0.5/0.2 µm Nominal (KWSS)
Opticap XLT 30 Capsule with Milligard Media - 0.2 µm Nominal (KW03)
Opticap XLT 30 Capsule with Milligard Media - 0.5 µm Nominal (KW06)
Opticap XLT 30 Capsule with Milligard Media - 1.2 µm Nominal (KW19)
Opticap XLT 30 Capsule with Milligard Media - 1.2/0.5 µm Nominal (KWSC)
Opticap XLT 30 Capsule with Milligard Media - 0.5/0.2 µm Nominal (KWSS)
Opticap XL 10 Capsule with Milligard and Milligard LPB Media - 0.2 µm Nominal (KW03, KWL3)
Opticap XL 10 Capsule with Milligard and Milligard LPB Media - 0.5 µm Nominal (KW06, KWL6)
Opticap XL 10 Capsule with Milligard and Milligard LPB Media - 1.2 µm Nominal (KW19, KWL9)
Opticap XL 10 Capsule with Milligard and Milligard LPB Media - 1.2/0.5 µm Nominal (KWSC, KWLC)
Opticap XL 10 Capsule with Milligard and Milligard LPB Media - 0.5/0.2 µm Nominal (KWSS, KWLS)
Opticap XL 2 Capsule with Milligard and Milligard LPB Media - 0.2 µm Nominal (KW03, KWL3)
Opticap XL 2 Capsule with Milligard and Milligard LPB Media - 0.5 µm Nominal (KW06, KWL6)
Opticap XL 2 Capsule with Milligard and Milligard LPB Media - 1.2 µm Nominal (KW19, KWL9)
Opticap XL 2 Capsule with Milligard and Milligard LPB Media - 1.2/0.5 µm Nominal (KWSC, KWLC)
Opticap XL 2 Capsule with Milligard and Milligard LPB Media - 0.5/0.2 µm Nominal (KWSS, KWLS)
Opticap XL 4 Capsule with Milligard and Milligard LPB Media - 0.2 µm Nominal (KW03, KWL3)
Opticap XL 4 Capsule with Milligard and Milligard LPB Media - 0.5 µm Nominal (KW06, KWL6)
Opticap XL 4 Capsule with Milligard and Milligard LPB Media - 1.2 µm Nominal (KW19, KWL9)
Opticap XL 4 Capsule with Milligard and Milligard LPB Media - 1.2/0.5 µm Nominal (KWSC, KWLC)
Opticap XL 4 Capsule with Milligard and Milligard LPB Media - 0.5/0.2 µm Nominal (KWSS, KWLS)
Opticap XL 5 Capsule with Milligard and Milligard LPB Media - 0.2 µm Nominal (KW03, KWL3)
Opticap XL 5 Capsule with Milligard and Milligard LPB Media - 0.5 µm Nominal (KW06, KWL6)
Opticap XL 5 Capsule with Milligard and Milligard LPB Media - 1.2 µm Nominal (KW19, KWL9)
Opticap XL 5 Capsule with Milligard and Milligard LPB Media - 1.2/0.5 µm Nominal (KWSC, KWLC)
Opticap XL 5 Capsule with Milligard and Milligard LPB Media - 0.5/0.2 µm Nominal (KWSS, KWLS)
