|Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters|
|Opticap® XL Capsules and Opticap® XLT Capsules|
OptiScale® Capsule Filters for Clarification and Prefiltration ApplicationsThese “drop-in” filter devices, with a variety of media options, create an effective platform for rapidly evaluating biopharmaceuticals.
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Lifegard™ Cartridge FiltersSuperior filters for the clarification and prefiltration of viscous biological fluids when high contaminant holding capacity is required
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|Biopharmaceutical Manufacturing > Upstream Processing > Bioburden Reduction / Particulate Control > Membrane based > Lifegard|
Lifegard glass microfiber medium was designed for removal of deformable and non-deformable particles and microorganisms from liquids. Versatile depth-type products retain contaminants within the matrix of glass microfiber medium. The Lifegard media is used to achieve exceptional retention efficiency. Because of its high holding capacity, adsorptive removal properties and excellent wet strength, it is very well-suited for the clarification and prefiltration of serum, plasma proteins, gene therapy and other viscous biologicals.
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 minimizes hold-up volume and reduces production losses.
Filters with Lifegard media 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 for documentation accuracy. Each Opticap XL 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 Formats Available
A wide range of filtration areas is available to fit all of your application needs for 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.
The Filter of Choice in Plasma and Protein Serum Applications
Lifegard filters protect downstream sterile filters and chromatography columns while effectively removing contaminants and retaining valuable fractions of interest. These filters will remove colloids, aggregated and non-product proteins, lipids and other particles before downstream purification.
|Opticap XL5||Opticap XL10|
|Materials of Construction|
|Filter Media||Borosilicate Glass Fiber (BGF)||Borosilicate Glass Fiber (BGF)|
|O-rings (vent for capsules)||Silicone (SI)||Silicone (SI)|
|Filtration Area||0.19 m²||0.46 m²|
|Maximum Differential Pressure, bar (psid)||3.5 bar (50 psid) @ 25 °C|
|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|
|Bacterial Endotoxins||Aqueous extraction contains ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test||Aqueous extraction contains ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|1.0 µm||The extractables level was equal to or less than 105 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 255 mg per capsule after a 5 L flush and 24 hours in water at controlled room temperature.|
|2.0 µm||The extractables level was equal to or less than 93 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 225 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 ≥2 L||Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L|
|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.|
|Sterilization||3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable|
|Good Manufacturing Practices||These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.|
|Indirect Food Additive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.|