Sartorius Lab Instruments GmbH & Co. KG Sartopore® 2 MidiCaps® 0.45 µm Liquid Filters 5445306G8--**--A

Sartopore 2 0.45 μm membrane filter MidiCaps are self contained, ready to use filter units for bioburden reduction and particle removal from a broad range of pharmaceutical products. Membrane prefiltration of aqueous solutions and highly viscous pharmaceutical products difficult to filter can effectively be accomplished due to the outstanding total throughput and flow rate performance of Sartopore 2 0.45 μmMidiCaps. Applications: Typical applications include bioburden reduction and particle removal from: – Therapeutics – Injectables – Buffers – Biological Fluids – Tissue Culture Media – Acetic and basic solutions. Compatibility: The polyethersulfone membrane is compatible with a pH-range from pH 1 to pH 14 making Sartopore 2 MidiCaps ideal forfiltration of solutions with high |low pH. Easy to use: Sartopore 2 MidiCaps are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartopore 2 0.45 μm MidiCaps are available with various filtration areas from 500 cm² | 0.5 ft² up to 0.45 m² | 4.5 ft² and various connector styles for easy adoption to any filtration process independent from the batch size. Scalability: Consistent and predictable scale-up and down trials can reliably be performed as allSartopore 2 filter elements are produced with the same type of membrane and materials and identical construction. Cost Saving: The use of the disposalbe capsule design concept avoids investments into stainless steel filter housings and eliminates additionalcosts for cleaning of housings and cleaning validation. Microbiological Retention: Sartopore 2 filter MidiCaps 0.45 μm rated are fully validated with a Log Reduction Value (LRV) of 7 for Serratia Marcescens according to HIMA and ASTM F-838 05 procedures. Quality Control: Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability. Documentation: Sartopore 2 MidiCaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements. Applications: Typical applications include bioburden reduction and particle removal from: Therapeutics Injectables Buffers Biological Fluids Tissue Culture Media Acidic and basic solutions Compatibility: The polyethersulfone membrane is compatible with a pH range from pH 1 to pH 14 making Sartopore® 2 MidiCaps ideal for filtration of solutions with high | low pH. Easy to Use: Sartopore 2 MidiCaps are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartopore 2 0.45 μm MidiCaps are available with various filtration areas from 500 cm² | 0.5 ft² up to 0.45 m² | 5 ft² and various connector styles for easy adoption to any filtration process independent from the batch size. Scalability: Consistent and predictable scale-up and down trials can reliably be performed as all Sartobran P filter elements are produced with the same type of membrane and identical materials of construction. Cost Saving: The use of the disposalbe capsule design concept avoids investments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation. Microbiological Retention: Sartopore 2 MidiCaps 0.45 μm rated are fully validated with a Log Reduction Value (LRV) of 7 for Serratia Marcescens according to HIMA and ASTM F-838 05 procedures. Quality Control: Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability. Documentation: Sartopore 2 MidiCaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.