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SeraDine Sterilizing Grade 0.2 Micron PVDF Membrane Filter Cartridge SERENE PVDF pleated cartridge filters are uniquely constructed with polyvinylidene fluoride media. PVDF membranes offer broad chemical compatibility with low extractable levels, high protein binding and high chemical inertness. The pleat technology maximizes the useful surface area of the filter while maintaining proper flow paths between media pleats. These cartridge filters are manufactured with PVDF and polypropylene support media, both materials are chemically inert non-shedding and biologically safe according to FDA, USP and EEC requirements for pharmaceutical and food contact use. Thermoplastic sealing technologies are used in the cartridge construction eliminating the need for potentially contaminating adhesives. The hydrophilic polyvinylidene fluoride (PVDF) membrane filter is available in discs, capsules, high capacity Mega capsule, and cartridges with 0.1 µm, 0.2 µm, 0.4 µm and 0.6 µm absolute ratings. It is optimized for the clarification, prefiltration and sterile filtration of liquids. Manufactured by a state-of-the-art process, the filter provides the highest flow rates of any PVDF filter. Validated PVDF Membrane All Cartridges are 100% integrity tested prior to release – Validation guide available on request. (Click here for Validation Guide) SeraNYL Filters provide microorganism retention based on following validation method • Brevundimonas (Pseudomonas) diminuta liquid bacteria challenge : Complete retention of ≥ 107 organism/cm2 of Brevundimonas (Pseudomonas) diminuta in accordance with the current HIMA challenge methodology (ASTM F838-05) Biological Tests • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics • Meets Cleanliness per USP Particulates in Injectables • Non-Fiber-Releasing per 21 CFR • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL) • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water Design Features • Modified PVDF membrane for inherent water wettability • Highest flow rates of any PVDF membrane filter • Extremely low protein and preservative binding • Compatible with a wide range of solvents, acids and chemicals • Extremely low extractables • Repeatedly steam sterilizable in situ • Meets ASTM bacterial validation standards • Cleanroom manufactured Application • Sterile filtration of parenterals, antibiotics, vaccines, diagnostics, buffers, diluents, reagents, serum, tissue culture media and media additives • Clarification and purification of deionized water, aqueous solvents, acids, bases and plating solutions • Clarification and stabilization of beer, wine and bottled water products • Particulate removal and bioburden reduction in aqueous liquid streams Technical Specification Nominal Dimension Operating Parameter Bacterial Retention • Passed bacterial challenge testing using of Brevundimonas diminuta (ATCC19146) in accordance with the current HIMA challenge methodology (ASTM F838-83) at a minimum challenge concentration of 1 x 107. • Validation Guide available upon request. Toxicity • All polypropylene components meet the specifications for biological safety per USP Class VI –121˚C for plastics Sterilization & Autoclaving Sterilized by autoclaving for up to 50 cycles at 109 °C (228.2 °F) for 30 minutes. The filters can also be sterilized by steam-in-place procedure up to 50 cycles at 109 °C (228.2 °F) for 30 minutes .The filters can also sanitized by hot water or common chemicals that are compatible with filter components. Food Safety Compliance Materials of construction comply with FDA regulations for food and beverage contact use as detailed in the US Code of Federal Regulations, 21CFR. Materials used to produce filter media and hardware are deemed safe for use in contact with foodstuffs in accordance with EU Directives 1935/2004, and/or 10/2011. practices. This assures continued compliance of the system to meet the highest standards of cleanliness and user confidence. Integrity Data Safety Flow Rate Characteristics Test Criteria: single length (254mm) cartridge, water @20°C. "M" Company PVDF 0.22um SERENE PVDF 0.22pm (LHPV) SERENE PES 0.22um Ordering Information
Sterilizing Grade 0.2 Micron PVDF Membrane Filter Cartridge
SERENE PVDF pleated cartridge filters are uniquely constructed with polyvinylidene fluoride media. PVDF membranes offer broad chemical compatibility with low extractable levels, high protein binding and high chemical inertness. The pleat technology maximizes the useful surface area of the filter while maintaining proper flow paths between media pleats. These cartridge filters are manufactured with PVDF and polypropylene support media, both materials are chemically inert non-shedding and biologically safe according to FDA, USP and EEC requirements for pharmaceutical and food contact use. Thermoplastic sealing technologies are used in the cartridge construction eliminating the need for potentially contaminating adhesives. The hydrophilic polyvinylidene fluoride (PVDF) membrane filter is available in discs, capsules, high capacity Mega capsule, and cartridges with 0.1 µm, 0.2 µm, 0.4 µm and 0.6 µm absolute ratings. It is optimized for the clarification, prefiltration and sterile filtration of liquids. Manufactured by a state-of-the-art process, the filter provides the highest flow rates of any PVDF filter.
All Cartridges are 100% integrity tested prior to release – Validation guide available on request. (Click here for Validation Guide) SeraNYL Filters provide microorganism retention based on following validation method • Brevundimonas (Pseudomonas) diminuta liquid bacteria challenge : Complete retention of ≥ 107 organism/cm2 of Brevundimonas (Pseudomonas) diminuta in accordance with the current HIMA challenge methodology (ASTM F838-05)
• Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics • Meets Cleanliness per USP Particulates in Injectables • Non-Fiber-Releasing per 21 CFR • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL) • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
• Modified PVDF membrane for inherent water wettability • Highest flow rates of any PVDF membrane filter • Extremely low protein and preservative binding • Compatible with a wide range of solvents, acids and chemicals • Extremely low extractables • Repeatedly steam sterilizable in situ • Meets ASTM bacterial validation standards • Cleanroom manufactured
• Sterile filtration of parenterals, antibiotics, vaccines, diagnostics, buffers, diluents, reagents, serum, tissue culture media and media additives • Clarification and purification of deionized water, aqueous solvents, acids, bases and plating solutions • Clarification and stabilization of beer, wine and bottled water products • Particulate removal and bioburden reduction in aqueous liquid streams
• Passed bacterial challenge testing using of Brevundimonas diminuta (ATCC19146) in accordance with the current HIMA challenge methodology (ASTM F838-83) at a minimum challenge concentration of 1 x 107. • Validation Guide available upon request.
• All polypropylene components meet the specifications for biological safety per USP Class VI –121˚C for plastics
Sterilized by autoclaving for up to 50 cycles at 109 °C (228.2 °F) for 30 minutes. The filters can also be sterilized by steam-in-place procedure up to 50 cycles at 109 °C (228.2 °F) for 30 minutes .The filters can also sanitized by hot water or common chemicals that are compatible with filter components.
Materials of construction comply with FDA regulations for food and beverage contact use as detailed in the US Code of Federal Regulations, 21CFR. Materials used to produce filter media and hardware are deemed safe for use in contact with foodstuffs in accordance with EU Directives 1935/2004, and/or 10/2011. practices. This assures continued compliance of the system to meet the highest standards of cleanliness and user confidence.
Test Criteria: single length (254mm) cartridge, water @20°C. "M" Company PVDF 0.22um SERENE PVDF 0.22pm (LHPV) SERENE PES 0.22um