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 0.2 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 0.2 µm rated sterilizing grade Maxicaps are designed for filtration of a broad range of pharmaceutical products where compliance with cGMP requirements has to be fulfilled. Sartopore 2 Maxicaps feature a unique hydrophilic heterogeneous double layer Polyethersulfone membrane with broad chemical compatibility and very high throughput and flow-rate. The polyethersulfone membrane is compatible with a pH range from pH 1 to pH 14. Sartopore 2 0.2 µm Maxicaps provide an exceptionally high total throughput by fractionated filtration due to the "built-in prefiltration" of the 0.45 µm membrane and its asymmetric pore structure provides high flow rates at low pressure drops. 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 sterilizing grade filtration of: – Therapeutics – Biological Fluids – Injectables – Media – Buffers – Chemicals – Cleaning and sanitizing agents.
Compatibility:
The polyethersulfone membrane is compatible with a pH-range from pH 1 to pH 14 making Sartopore 2 MaxiCaps ideal for filtration of solutions with high | low pH.
Easy to Use:
Sartopore 2 MaxiCaps are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated.
Flexibility:
Sartopore 2 0.2 µm MaxiCaps are available with various filtration areas from 0.6 m² | 6 ft² up to 1.8 m² | 18 ft² 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 Sartopore 2 MaxiCaps are produced with the same type of membrane and materials and identical construction.
Cost Saving:
The use of the disposable 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 0.2 µm rated MaxiCaps are fully validated as sterilizing grade filters 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 | 5441307H1--** |
| Product Name | Sartopore® 2 MaxiCaps® 0.2 µm Liquid Filter Cartridges |
| Configuration | In-line |
| Application / Industry | Biopharmaceutical |
| Filtration Product | Water; Liquids |
| Filter Medium Material | Polyethersulfone |
