Zetapor ® SP Sterilizing Grade Cartridge and Capsule Membrane Filters

CUNO pioneered the development of charge modified Nylon 6,6 filters for the pharmaceutical industry. Zetapor sterilising grade filters and capsules are validated for absolute bacteria retention and provide reliable sterile filtration performance. In addition to a fixed bacteria retentive pore structure, Zetapore membrane is charge modified to provide enhanced removal of negatively charged biological contaminants such as endotoxin, virus and nucleic acid fragments. The combination of a validated bacteria retentive membrane, together with enhanced removal of negatively charged biological contaminants, make Zetapore membrane an ideal choice for pharmaceutical and biopharmaceutical sterilizing applications.

Each Zetapore cartridge and capsule filter is supplied with a Certificate of Quality. A Validation Guide 
is available for ease of compliance with regulatory requirements. The Quality Management System is approved by an internationally recognized accrediting body to an ISO 9001 Quality Systems Standard.

FEATURES 

Proprietary charge-modified Nylon 6,6 filter medium.
High area, pleated membrane design.
Reliable 0.2µm validated performance.
Robust cartridge construction.
Cartridges 100% integrity tested
ISO 9001-registered Quality System.
Tested and optimized for pharmaceutical and biological processing.
Low extractable levels, no surfactants or adhesives used in manufacturing.

BENEFITS

Retention of negatively-charged biological and particulate contaminants including endotoxins.
Inherently hydrophilic membrane for easy wet-out.
High flow rates, low pressure drop.
Smaller filter systems, longer service life for reduced filtration costs.
Meets FDA definition of 0.2 µm sterilizing grade filter.(10⁷CFU / cm² B.diminuta retention).
Integrity test correlated with sterile filtration performance data and supported by Validation Guide.
Cartridges withstand mechanical and thermal stress including SIP operations.
Ensures consistent performance to specifications, integrity testable pre-and post-use.
Quality Management System approved by an accrediting body to an ISO 9001 Quality 
     Systems Standard.
Materials of construction tested for biological safety (USP Class VI) and listed in Drug 
     Master File (DMF) at FDA).
Minimal effect on filtrate quality and purity.

APPLICATIONS

Zeptor 0.2µm cartridge filters are designed for the sterile filtration of liquid solutions such as :- 
Large and small volume parenterals.
Biologicals
Bioprocess-derived protein solutions
Vaccines. 
Diagnostics
Purified water systems
Solvents
Opthalmics
Blood and serum fractions
Reagents & buffers
Pharmaceutical bulk chemical solutions