Milligard® 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. Menos
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FAQ
| Pergunta | Resposta |
|---|---|
| Do Opticaps come pre-sterilized? | Opticaps are available in three formats:
|
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Categorias
| Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Milligard |
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 2 | Opticap XL 4 | Opticap XL 5 | Opticap XL 10 | Opticap XLT 10 | Opticap XLT 20 | Opticap XLT 30 | |
| Filtration Area | |||||||
| Single Layer | 0.1 m² | 0.2 m² | 0.34 m² | 0.8 m² | 0.8 m² | 1.6 m² | 2.4 m² |
| Double Layer | 0.07 m² | 0.16 m² | 0.28 m² | 0.69 m² | 0.69 m² | 1.38 m² | 2.07 m² |
| Materials of Construction | |||||||
| Filter media | Mixed Cellulose Esters (MCE) | ||||||
| Supports | Polyester | ||||||
| Structural components | Polypropylene | ||||||
| Vent O-ring | Silicone | ||||||
| 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 | |||||||
| Standard Milligard® Media | The extractables level was equal to or less than 15 mg per capsule after 24 hours in water at controlled room temperature. | ||||||
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 25 mg per capsule after a 1 L flush and 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 25 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 55 mg per capsule after 24 hours in water at controlled room temperature. | ≤55 mg after 24-h soak in water | The extractables level was equal to or less than 110 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 165 mg per capsule after 24 hours in water at controlled room temperature. |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 25 mg per capsule after a 1 L flush and 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 25 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 55 mg per capsule after 24 hours in water at controlled room temperature. | ≤55 mg after 24-h soak in water | The extractables level was equal to or less than 110 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 165 mg per capsule after 24 hours in water at controlled room temperature. |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 55 mg per capsule after a 1 L flush and 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 25 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 55 mg per capsule after 24 hours in water at controlled room temperature. | ≤55 mg after 24-h soak in water | The extractables level was equal to or less than 110 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 165 mg per capsule after 24 hours in water at controlled room temperature. |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 50 mg per capsule after a 1 L flush and 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 25 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 55 mg per capsule after 24 hours in water at controlled room temperature. | ≤55 mg after 24-h soak in water | The extractables level was equal to or less than 110 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 165 mg per capsule after 24 hours in water at controlled room temperature. |
| Low Protein Binding Milligard® Media | The extractables level was equal to or less than 60 mg per capsule after a 1 L flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 110 mg per capsule after a 2 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 2 L flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 355 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 355 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 355 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 355 mg per capsule after a 5 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 ≥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 | 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:
TT = 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:
TT = 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® 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 - 0.5/0.2 µm Nominal (KWSS, KWLS)
Opticap® XL 2 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 - 0.2 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 - 0.5/0.2 µm Nominal (KWSS, KWLS)
Opticap® XL 4 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 - 0.2 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 - 0.5/0.2 µm Nominal (KWSS, KWLS)
Opticap® XL 5 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 - 0.2 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 - 0.5/0.2 µm Nominal (KWSS, KWLS)
Opticap® XL 10 Capsule with Milligard® and Milligard LPB® Media - 1.2/0.5 µm Nominal (KWSC, KWLC)
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 - 0.5/0.2 µm Nominal (KWSS)
Opticap® XLT 10 Capsule with Milligard® Media - 1.2/0.5 µm Nominal (KWSC)
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 - 0.5/0.2 µm Nominal (KWSS)
Opticap® XLT 20 Capsule with Milligard® Media - 1.2/0.5 µm Nominal (KWSC)
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 - 0.5/0.2 µm Nominal (KWSS)
Opticap® XLT 30 Capsule with Milligard® Media - 1.2/0.5 µm Nominal (KWSC)