Sartorius® Sartopore 2 candle, 0.2 µm, 10, Sartopore 2 candle

Sartopore 2 0.2 µm sterile filter cartridges are designed for filtration of a wide range of pharmaceutical products where compliance with cGMP requirements must be met. Sartopore 2 filter elements feature a hydrophilic, double-layer membrane made of polyethersulfone with high chemical compatibility, maximum thermal stability and exceptionally high service life and flow rates. The polyethersulfone membrane is compatible in a pH range of 1 to 14, making Sartopore 2 filter elements ideal for filtration of high/low pH solutions and for SIP/CIP cycles due to multiple steam sterilizability. Sartopore 2 filter elements offer exceptionally long service life due to the "built-in" pre-filtration of the 0.45 µm membrane and the asymmetric pore structure of the membrane. Even after drying (80°C for 12 h), Sartopore 2 filter elements can be easily wetted for integrity testing. 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 0.2 µm filter elements are also available as MaxiCaps, Capsules and Minicaps. Superior flow performance & service life Most economical process solution Broad chemical compatibility Applications: Typical applications include sterile filtration and mycoplasma removal of: Compatibility: Sartopore® 2 polyethersulfone membrane is compatible in the pH range of pH 1 to 14 and unaffected by steam sterilization cycles, making Sartopore® 2 filter cartridges ideal for filtration of high | low pH solutions and SIP | CIP cycles. Performance: Sartopore® 2 filter cartridges ensure extremely high total flow by split filtration using "built-in pre-filtration" through a 0.45 µm membrane. The asymmetric pore structure of the polyethersulfone membrane ensures high flow rates with low pressure drops. 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 0.2 µm filter cartridges are fully validated sterile filter elements according to HIMA and ASTM F-838-05 guidelines. Quality control: Each individual element is integrity tested to meet the highest quality requirements. 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.