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Sterilizing Grade Nylon 0.2 Micron Membrane Filter Cartridge Filters are specially designed for pre-filtration,Bio-burden and final-filtration of pharmaceutical solution.Nylon membrane with positive charged zeta particle is also available .Cartridges are designed to remove contaminants smaller than the rated pore size (including endotoxins) by way of an adsorptive mechanism. Many particles common in water and other liquids have a net negative charge, allowing for enhanced capture by the positively charged nylon membrane in this filter. This charge-based filtration mechanism combined with the traditional particle size exclusion (sieving) mechanism results in an extremely high removal efficiency at and even below the rated pore size. filter cartridges are characterized by hydrophilic Nylon membrane, providing high throughputs, low extractables and good mechanical strength, widely used for sterile filtration in Active Pharmaceutical Ingredients production. Sterilizing-grade filter cartridges are available with ratings from 0.45 µm for LVPs, reagents and viscous fluids, 0.2 µm for sterile products and intermediates, 0.1 µm for sterilization and mycoplasma removal from biologicals, to 0.04 µm for sterilization and virus reduction from biologicals. Validated NYLON 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) Features & Benefilts • Low extractables and high absorption • High throughputs and cost-effective as well as longer service life • Enhanced removal of endotoxins by positive zeta potential • Low Pressure drop & high flow rates • 100% integrity testable prior to release • Cartridges produced in a controlled environment • Manufactured according to ISO9001 certified Quality Management System Materials of Construction Endotoxin Removal Bacterial endotoxin is the pyrogen of greatest concern in the pharmaceutical and medical device industries. BRHNY+ filter elements have demonstrated capability to remove bacterial endotoxin to below a 0.005 EU/milliliter detection limit at all data points in independent testing Biological Tests • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics • Meets Cleanliness per USP Particulatesin Injectables • Non-Fiber-Releasing per 21 CFR • Non-Pyrogenic per USP BacterialEndotoxins (< 0.25 EU/mL) • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water Sterilization & Autoclaving Sterilized by autoclaving for up to 33 cycles at 123 °C (257 °F) for 30 minutes. The filters can also be sterilized by steam-in-place procedure up to 15 cycles at 135 °C (275 °F) for 30 minutes .The filters can also sanitized by hot water or common chemicals that are compatible with filter components Toxicity •All polypropylene components meet the specifications for biological safety per USP Class VI –121˚C for plastics. 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. Nylon Filter Cartridge Ordering Information
Filters are specially designed for pre-filtration,Bio-burden and final-filtration of pharmaceutical solution.Nylon membrane with positive charged zeta particle is also available .Cartridges are designed to remove contaminants smaller than the rated pore size (including endotoxins) by way of an adsorptive mechanism. Many particles common in water and other liquids have a net negative charge, allowing for enhanced capture by the positively charged nylon membrane in this filter. This charge-based filtration mechanism combined with the traditional particle size exclusion (sieving) mechanism results in an extremely high removal efficiency at and even below the rated pore size. filter cartridges are characterized by hydrophilic Nylon membrane, providing high throughputs, low extractables and good mechanical strength, widely used for sterile filtration in Active Pharmaceutical Ingredients production. Sterilizing-grade filter cartridges are available with ratings from 0.45 µm for LVPs, reagents and viscous fluids, 0.2 µm for sterile products and intermediates, 0.1 µm for sterilization and mycoplasma removal from biologicals, to 0.04 µm for sterilization and virus reduction from biologicals.
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)
• Low extractables and high absorption • High throughputs and cost-effective as well as longer service life • Enhanced removal of endotoxins by positive zeta potential • Low Pressure drop & high flow rates • 100% integrity testable prior to release • Cartridges produced in a controlled environment • Manufactured according to ISO9001 certified Quality Management System
Bacterial endotoxin is the pyrogen of greatest concern in the pharmaceutical and medical device industries. BRHNY+ filter elements have demonstrated capability to remove bacterial endotoxin to below a 0.005 EU/milliliter detection limit at all data points in independent testing
• Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics • Meets Cleanliness per USP Particulatesin Injectables • Non-Fiber-Releasing per 21 CFR • Non-Pyrogenic per USP BacterialEndotoxins (< 0.25 EU/mL) • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
Sterilized by autoclaving for up to 33 cycles at 123 °C (257 °F) for 30 minutes. The filters can also be sterilized by steam-in-place procedure up to 15 cycles at 135 °C (275 °F) for 30 minutes .The filters can also sanitized by hot water or common chemicals that are compatible with filter components
•All polypropylene components meet the specifications for biological safety per USP Class VI –121˚C for plastics.
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.
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