MaxiCaps is a unique new housing design concept from Sartorius that brings the benefits of single use filter elements to process scale. The incorporation of Sartopore 2 0.45 µm standard filter cartridges into self contained, high quality polypropylene housings makes it possible to operate large scale filter installations without the need for filter housings. So additional costs for cleaning of housings and cleaning validation can be eliminated. By relying on established process validation data for Sartopore 2 standard cartridge elements, MaxiCaps can easily be implemented into current filtration processes. MaxiCaps are available in 10”, 20” and 30” versions allowing flexibility in process design. Sartopore 2 0.45 µm rated Maxicaps are designed for bioburden reduction and particle removal from a broad range of pharmaceutical products. Due to the “built-in prefiltration” by a 0.8 µm membrane, Sartopore 2 0.45 µm Maxicaps offer extremely high flow rates and total throughputs and are therefore ideally suited for membrane prefiltration of aqueous solutions and highly viscous, difficult to filter pharmaceutical products. Featuring a unique hydrophilic polyethersulfone membrane, Sartopore 2 Maxicaps are compatible with solutions from pH 1 to pH 14. Sartopore 2 Maxicaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. Each individual element is tested for integrity by Diffusion- and Bubble-Point-Test prior to be released assuring absolute reliability and a Validation Guide is available for compliance with regulatory requirements.
Applications:
Typical applications include bioburden reduction and particle removal from:
Flexibility:
Sartopore 2 0.45 μm MaxiCaps are available with various filtration areas from 0.6 m² | 6 ft² up to 1.8 m² | 18 ft² and various connector styles for easy adoption to any filtration process independent from the batch size.
Cost Saving:
The use of the capsule design concept avoids investment in stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation.
Microbiological Retention:
Sartopore 2 filter capsules 0.45 μm rated are fully validated with a Log Reduction Value (LRV) of 7 for Serratia marcessens according to HIMA and ASTM F-838-05 guidelines.
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 MaxiCaps 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.
| Sartorius Lab Instruments GmbH & Co. KG | |
|---|---|
| Product Category | Filter Elements |
| Product Number | 5441306G1--** |
| Product Name | Sartopore® 2 MaxiCaps® 0.45 µm Liquid Filters |
| Configuration | In-line |
| Application / Industry | Biopharmaceutical |
| Filtration Product | Water; Liquids |
| Filter Medium Material | Polyethersulfone |