|Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest|
|Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters|
|Filter Integrity Test Methods|
Ficha de dados
|Sterilizing-grade Durapore® Multimedia Filters|
Manuais do usuário
|Opticap® XL Capsules and Opticap® XLT Capsules|
|Wetting Instructions for Filter Units with Durapore Membrane|
Famílias de produtos
Multimedia Durapore® Cartridge FiltersProviding sterility assurance, high flow rates and extended throughputs, low extractables, and broad chemical compatibility.
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OptiScale® Capsule Filters for Aseptic Processing ApplicationsOptiScale<sup>®</sup> capsules, with a large variety of filtration media options, are a family of convenient, disposable filters ideal for media selection, process screening and scaling.
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|Biopharmaceutical Manufacturing > Downstream Processing > Single-use Capsules > Opticap > Opticap XL|
Durapore® Multimedia filters combine a 0.22 µm hydrophilic Durapore membrane with an upstream Milligard® prefilter media, providing sterility assurance, high flow rates and extended throughputs, low extractables, and broad chemical compatibility. The combination of prefiltration media and final sterilizing membrane in one filter results in process compression and improved economics.
Multimedia 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 multimedia minimizes hold-up volume and reduces production losses.
Multimedia 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 filter is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each device is marked with the product name and identifying characteristics.
Multiple Formats Available
Multimedia Opticap XL disposable capsule filters are available in multiple filtration areas, providing an optimal choice for every application. Each Opticap XL capsule is integrity tested during the manufacturing process.
|Opticap XL 10|
|Filtration Area, m2|
|Single Layer Prefilter||0.69 m²|
|Double Layer Prefilter||0.56 m²|
|Materials of Construction|
|Filter||Mixed Cellulose Esters (MCE)
Polyvinylidene Fluoride (PVDF)
|Prefilter||Mixed Cellulose Esters (MCE)|
|Vent/Drain||1/4 in. hose barb with double O-ring seal|
|Maximum Inlet Pressure, bar (psid)||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)||Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent|
|Integrity Test, Bubble Point||≥3450 mbar (50 psig) air with water|
|Integrity Test, Air Diffusion|
|Single Layer Prefilter||≤13.3 mL/min @ 2.75 bar (40 psig) in water|
|Double Layer Prefilter||≤10.8 mL/min @ 2.75 bar (40 psig) in water|
|Bacterial Retention||Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|NVR Gravimetric Extractables|
|Single Layer Prefilter||The extractables level was equal to or less than 50 mg per capsule after 24 hours in water at controlled room temperature.|
|Double Layer Prefilter||The extractables level was equal to or less than 75 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 ≥5 L|
|Sterilization||3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable|
|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.|
|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