Opticap XL Disposable Capsule Filters with Polygard-CR Media
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Overview
Specifications
Ordering Information
Documentation
Související produkty a aplikace
Product Families
|
Polygard-CR Cartridge FiltersNominally rated filters designed for particle removal applications in liquids and gases.Další informace >> |
Související produkty: Application Facete
| Sterility Testing |
| Fermentation Solutions |
| Dialysis and Filtration |
Související produkty: Brand Facete
| Opticap® |
Kategorie
| Biopharmaceutical Manufacturing > Downstream Processing > Clarification > Clarisolve Depth Filters > Polygard Filters > Polygard CR |
Description
Polygard®-CR products are nominally rated filters designed for particle removal applications in liquids and gases. The graded-density depth structure of Polygard-CR filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.
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 Polygard-CR media minimizes hold-up volume and reduces production losses.
Regulatory Compliance
Polygard-CR 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
Opticap XL disposable capsule filters with Polygard-CR media are available in multiple filtration sizes, providing an optimal choice for every application.
| Opticap XL 1 | Opticap XL 5 | Opticap XL 10 | |
| Materials of Construction | |||
| Filter medium | Polypropylene (PP) | Polypropylene (PP) | Polypropylene (PP) |
| Structural components | Polypropylene | Polypropylene | Polypropylene |
| O-rings | Silicone (SI) | 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 | 4.8 bar (70 psid) @ 20 °C |
| Gravimetric Extractables | The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 30 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. |
| 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 ≥2.5 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 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 @ 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 1 Capsule with Polygard-CR® Media 5.0 µm Nominal (KR05)
Opticap® XL 5 Capsule with Polygard-CR® Media 5.0 µm Nominal (KR05)
Opticap® XL 10 Capsule with Polygard-CR® Media 5.0 µm Nominal (KR05)
Opticap® XL 1 Capsule with Polygard-CR® Media 0.1 µm Nominal (KRK1)
Opticap® XL 5 Capsule with Polygard-CR® Media 0.1 µm Nominal (KRK1)
Opticap® XL 10 Capsule with Polygard-CR® Media 0.1 µm Nominal (KRK1)