Sartorius Sartoclear 29XDL10-FCFFF Manuals

Directions for Use Sartoclear® Depth Filter 0.08 m² Midscale Cassette 1. Introduction The purpose of this document is to outline the appropriate method for installing and using the laboratory scale device of Sartoclear® Depth Filter 0.08 m² midscale cassette. 2. Liability The products described in this document are intended to be used for the clarification of mammalian and microbial cell cultures. Sartorius shall not assume any liability if Sartoclear® Depth Filter products have been subjected to improper use. The use of this product for any other applications or in another manner than described in this manual may result personal injury or malfunction of the product. Please follow the instructions in this user manual to ensure your own safety and to obtain optimal filtration results. In the interest of product development, we reserve the right to make changes. 3. Identification This document pertains to Sartorius Stedim Biotech Sartoclear® Depth Filter 0.08 m² cassette with the following part numbers: - 29XDL10-FCFFF - 29XDL20-FCFFF - 29XDL60-FCFFF - 29XDL75-FCFFF - 29XDL90-FCFFF Connector types: - FF – ¾” Sanitary Flange 4. Wetting of a Sartoclear® Depth Filter 0.08 m² midscale cassette Sartoclear® Depth Filter 0.08 m² midscale cassette must be flushed with WFI in order to remove air and water soluble compounds originating from the raw materials. For detailed extractable profiles please refer to the validation guide: DIR code: 2632689 Fill the cassette with WFI with both vent valves on side left open. Close both vent valves as soon as fluid flows through the vent valves and start the flushing process. Flushing volumes In order to remove all air from the cassette it is recommended to flush the cassette with at least 50 L/m² WFI (4 Liter per cassette). Flushing rates In order to remove all air from the cassette it is recommended to use flow rates of max. 150 l/m²/h. The flow rate during flushing should be 25% faster than the flowrate used for filtration. Prior filtration the remaining flushing liquid inside the filter can be removed by using 0.4 bar pressurized air to avoid dilution of the filtrate (see also Recovery Optimization). Once Sartoclear® Depth Filter 0.08 m² midscale cassette are completely drained, both drain- age valves should be closed. The cassette is now ready for the filtration process. It is recommended to vent again before filtration. 5. Filtration - Start the Sartoclear® Depth Filter 0.08 m² midscale cassette filtration with a flow rate between 80 – 200 L/ m2/h. (For most applications lower flow rates give better throughputs per m²) - Close the vents on the IN- and OUTLET when the housings are filled (fluid will appear in the tube) - Continue filtration until a pressure of maximal 1.5 bar (21.75 psi) is reached. - NOTE: For an optimal recovery of your product it is recommended to stop the filtration at 1.0 bar (14.5 PSI) (see also: Recovery optimization) - The maximum operating pressure during filtration is 1.7 bar (24.7 psi) - The temperature of the fluid must be between 5 – 40° C Mixing Peristaltic pump Sartoclear module Weight control Pressure control 6. Recovery optimization - Connect a container with a suitable buffer for your application to the filtration set up - Start flushing the system with constant flow or constant pressure - Best results were obtained with 20 L per m² depth filter and a maximum pressure of 1.0 bar (14.5 psi) - Alternative Option: In order to avoid product dilution pressurized air (max. 0.4 bar) can be used to empty the filters (see below: B1 Draining of the system)