Sartorius Lab Instruments GmbH & Co. KG Sartopore® 2 MaxiCaps® 0.1 µm Liquid Filters 5441358K2--**

Description
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 0.1 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 0.1 µm rated Maxicaps are especially developed for validated sterile filtration and reliable Mycoplasma removal from any media originating from animal sources thus likely contain this contamination. In addition these elements are ideally suited for removal of unusually small microorganisms that could possibly pass a 0.2 µm rated sterilizing grade filter. Featuring a unique hydrophilic Polyethersulfone membrane, Sartopore 2 0.1 µm Maxicaps are compatible from pH 1 to pH 14 and therefore ideally suited for filtration of solutions with high|low pH. Sartopore 2 0.1 µm Maxicaps provide exceptional high flow rates, resulting in economical sizing of filtration systems. Due to the “build-in” prefiltration by a 0.2 µm prefilter, Sartopore 2 0.1 µm Maxicaps achieve outstanding total throughputs. 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-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 and Mycoplasma removal from: Animal Sera Cell Culture Media Media Components Bioprocessed Pharmaceuticals Biological Fluids Any other application requiring sub 0.2 μm filtration for enhanced sterility assurance 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 capsules are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartopore® 2 0.1 μm MaxiCaps are available with various filtration areas from 0.6m² | 6 ft² up to 1.8 m² |18 ft² for easy use in 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 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 0.1 μm MaxiCaps are validated as sterilizing grade filters according to ASTM F 838-05 standard and for Mycoplasma removal with a Log Reduction Value (LRV) of 7 for Acholeplasma laidlawii. Quality Control: Each individual element is tested for integrity by 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.
Datasheet

Suppliers

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Product
Description
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Göttingen, Germany
Sartopore® 2 MaxiCaps® 0.1 µm Liquid Filters
5441358K2--**
Sartopore® 2 MaxiCaps® 0.1 µm Liquid Filters 5441358K2--**
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 0.1 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 0.1 µm rated Maxicaps are especially developed for validated sterile filtration and reliable Mycoplasma removal from any media originating from animal sources thus likely contain this contamination. In addition these elements are ideally suited for removal of unusually small microorganisms that could possibly pass a 0.2 µm rated sterilizing grade filter. Featuring a unique hydrophilic Polyethersulfone membrane, Sartopore 2 0.1 µm Maxicaps are compatible from pH 1 to pH 14 and therefore ideally suited for filtration of solutions with high|low pH. Sartopore 2 0.1 µm Maxicaps provide exceptional high flow rates, resulting in economical sizing of filtration systems. Due to the “build-in” prefiltration by a 0.2 µm prefilter, Sartopore 2 0.1 µm Maxicaps achieve outstanding total throughputs. 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-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 and Mycoplasma removal from: Animal Sera Cell Culture Media Media Components Bioprocessed Pharmaceuticals Biological Fluids Any other application requiring sub 0.2 μm filtration for enhanced sterility assurance 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 capsules are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartopore® 2 0.1 μm MaxiCaps are available with various filtration areas from 0.6m² | 6 ft² up to 1.8 m² |18 ft² for easy use in 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 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 0.1 μm MaxiCaps are validated as sterilizing grade filters according to ASTM F 838-05 standard and for Mycoplasma removal with a Log Reduction Value (LRV) of 7 for Acholeplasma laidlawii. Quality Control: Each individual element is tested for integrity by 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.

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 0.1 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 0.1 µm rated Maxicaps are especially developed for validated sterile filtration and reliable Mycoplasma removal from any media originating from animal sources thus likely contain this contamination. In addition these elements are ideally suited for removal of unusually small microorganisms that could possibly pass a 0.2 µm rated sterilizing grade filter. Featuring a unique hydrophilic Polyethersulfone membrane, Sartopore 2 0.1 µm Maxicaps are compatible from pH 1 to pH 14 and therefore ideally suited for filtration of solutions with high|low pH. Sartopore 2 0.1 µm Maxicaps provide exceptional high flow rates, resulting in economical sizing of filtration systems. Due to the “build-in” prefiltration by a 0.2 µm prefilter, Sartopore 2 0.1 µm Maxicaps achieve outstanding total throughputs. 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-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 and Mycoplasma removal from:

  • Animal Sera
  • Cell Culture Media
  • Media Components
  • Bioprocessed Pharmaceuticals
  • Biological Fluids
  • Any other application requiring sub 0.2 μm filtration for enhanced sterility assurance

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 capsules are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated.

Flexibility:

Sartopore® 2 0.1 μm MaxiCaps are available with various filtration areas from 0.6m² | 6 ft² up to 1.8 m² |18 ft² for easy use in 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 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 0.1 μm MaxiCaps are validated as sterilizing grade filters according to ASTM F 838-05 standard and for Mycoplasma removal with a Log Reduction Value (LRV) of 7 for Acholeplasma laidlawii.

Quality Control:

Each individual element is tested for integrity by 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.

Supplier's Site Datasheet

Technical Specifications

  Sartorius Lab Instruments GmbH & Co. KG
Product Category Filter Elements
Product Number 5441358K2--**
Product Name Sartopore® 2 MaxiCaps® 0.1 µm Liquid Filters
Configuration In-line
Application / Industry Biopharmaceutical
Filtration Product Water; Liquids
Filter Medium Material Polyethersulfone
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