Opticap XL Disposable Capsule Filters with Polygard-CN Media
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Categorias
| Biopharmaceutical Manufacturing > Downstream Processing > Clarification > Clarisolve Depth Filters > Polygard Filters |
Description
Polygard®-CN products are nominally rated filters designed for particle removal applications in liquids and gases. The pleated structure of Polygard-CN filter media minimizes pressure differentials during the filtration process, and the all-polypropylene construction of these filters conveys low levels of extractables and broad chemical compatibility. Downstream filter performance is enhanced due to efficient particle and microorganism reduction.
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 Polygard-CN media minimizes hold-up volume and reduces production losses.
Regulatory Compliance
Polygard-CN 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 capsule filter is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is marked with identifying characteristics.
Multiple Formats Available
A range of filter sizes is available to fit all of your application needs, and to allow easy scale-up of your small volume filtration steps to larger, full-scale filtration processes.
Opticap XL capsule filters are supplied with a choice of inlet and outlet connections to optimize your filtration process.
| Opticap XL 5 | Opticap XL 10 | |
| Filtration Area | 0.18 m² | 0.42 m² |
| Materials of Construction | ||
| Filter media | Polypropylene (PP) | Polypropylene (PP) |
| Structural components | Polypropylene | Polypropylene |
| O-ring | Silicone (SI) | Silicone (SI) |
| Maximum Inlet Pressure, bar (psi) | 5.5 bar (80 psi) @ 25 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C | |
| Maximum Differential Pressure, bar (psid) | 4.8 bar (70 psid) @ 20 °C | 4.8 bar (70 psid) @ 20 °C |
| 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 55 mg per capsule after 24 hours in water at controlled room temperature. |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 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 ≥2 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L |
| Sterilization | 3 autoclave cycles of 30 min @ 126 °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. | |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | |
| European Pressure Equipment Directive | EMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark. | |
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® XL 5 Capsule with Polygard-CN® Media 5.0 µm Nominal (KN50)
Opticap® XL 10 Capsule with Polygard-CN® Media 5.0 µm Nominal (KN50)
Opticap® XL 5 Capsule with Polygard-CN® Media 0.3 µm Nominal (KN03)
Opticap® XL 10 Capsule with Polygard-CN® Media 0.3 µm Nominal (KN03)