SPS Filters

Validation

SPS filters are validated using test procedures that comply with ASTM F 838-15(ae1) protocols for the determination of bacterial retention in filters used for liquid filtration. The challenge level is a minimum of 10⁷ organisms per cm² of filter media. CPF filters have > 7-log removal when challenged with the organisms listed below (0.03μm, 0.10μm and 0.22μm meet the FDA definition of sterilizing grade filters). Validation Guides are available upon request.

• 0.03μm: Acholeplasma laidlawii 
• 0.10μm: Brevundimonas diminuta
• 0.22μm: Brevundimonas diminuta
• 0.45μm: Serratia marcescens
• 0.65μm: Saccharomyces cerevisiae

Quality Assurance

SPS filters are 100% integrity tested. CPF filters are developed and manufactured under an ISO 9001:2015 certified Quality Management System and designed to be used in cGMP-compliant processes. 

SPS Cartridges 

Available from 5-40 inches in length with several end connections and O-ring options. SPS/HT Cartridges can be used in processes up to 203°F.

SPS Capsules

These filters are SPS cartridges encapsulated in a polypropylene shell to minimize exposure to process fluids. A popular choice for single-use applications and can be disposed of easily. Sizes range from 2-30 inches in length. SPS Capsules are available pre-sterilized.

SPS Mini-Capsule

Mini-capsules are designed for lab scale testing, process development and small batch production with a filtration area of 500 cm². SPS Mini-Capsules are available pre-sterilized.