Sartorius® Sartopore 2 candle, 0.45 µm, 20, Sartopore 2 candle

Sartopore 2 0.45 µm filter cartridges have been specially developed for bioburden reduction and particle removal from a wide variety of pharmaceutical products. Due to the "built-in" prefiltration by means of a 0.8 µm membrane made of polyethersulfone and the asymmetric pore structure of the membrane, Sartopore 2 filter elements offer exceptionally high flow rates and service lives. Therefore, they are ideal for prefiltration of aqueous solutions and highly viscous, difficult-to-filter pharmaceutical products. The polyethersulfone membrane makes Sartopore 2 filter elements compatible for solutions ranging from pH 1 to pH 14. Sartopore 2 filter cartridges are designed, developed and manufactured in accordance with an ISO 9001 certified quality management system. Each individual filter element is batch tested for integrity using the diffusion and bubble point test. Validation documentation is available in accordance with regulatory requirements. For linear scale-up and high flexibility within the process, Sartopore 2 0.45 µm filter elements are also available as MaxiCaps, Capsules and Minicaps. Defined microbial retention Superior flow rate & service life Broad chemical compatibility Applications: Typical applications include bioburden and particle removal of: Buffers Biological Fluids Opthalmics LVP Solutions Antibiotics Bulk Products Compatibility: Because Sartopore® 2 0.45 µm filter cartridges are made from a unique hydrophilic membrane of polyethersulfone, they are compatible within the pH range of 1-14 and with numerous steam sterilization cycles. Therefore, they are also ideal for filtration of high/low pH solutions and multiple SIP/CIP cycles. Performance: Sartopore® 2 0.45 µm filter cartridges deliver exceptionally high flow rates, making them ideal for filtration systems at economically significant scales. Due to the "built-in pre-filtration" of a 0.8 µm membrane, the Sartopore® 2 0.45 µm cartridge provides exceptional total flux. Wettability: Sartopore® 2 filter cartridges can be easily wetted for integrity testing even after drying at 80°C for 12 hours. Microbiological retention: Sartopore® 2 0.45 µm filter cartridges have been validated for the removal of "Serratiam marcessens" with a LRV (Log Reduction Value) of 7 according to HIMA and ASTM F-838-05 specifications. Ease of use: Each individual element is tested for integrity to meet the highest quality standards. Documentation: Les cartouches de filtration Sartopore® 2 sont conçues, développées et fabriquées en accord avec le système de gestion de la qualité ISO 9001. Un guide de validation et un guide des extractibles sont disponibles pour répondre aux exigences réglementaires.