SPC Filters

SPC cartridge and capsule filters consist of a single layer, positively charged Polyethersulfone (PES) membrane. Available in 0.03, 0.10, 0.22 and 0.45 µm, SPC filters are validated for absolute bacteria retention to provide reliable sterile filtration performance with a high flow rate. The positive charge removes negatively charged biological contaminants such as endotoxin, virus and other cell fragments. Depending on level of contaminant and flow rate, SPC filters will typically exhibit > 3-log removal of endotoxin. This combination of functionality makes the SPC filter an excellent choice for pharmaceutical and biopharmaceutical applications.

Applications

• Process Water
• Water for Injection (WFI)
  
  

Features and Benefits

SPC is a family of single layer, positively charged pharmaceutical grade Polyethersulfone (PES) sterilizing filters. 

• Removes negatively charged biological contaminants
• Typically exhibits >3-log removal of endotoxin
• Single layer configuration allows for reliable sterile filtration performance with a high flow rate (for high levels of bacteria/endotoxin in the feed consider the PPC filter)
• Available in 0.03, 0.10, 0.22 and 0.45 µm

Filtration Area

Endotoxins

The levels of bacterial endotoxins in aqueous extracts from SPC filters are below current USP limits as specified for water injection.

View Data Sheet for further product information:

• Integrity test specifications
• Materials of construction
• Operating parameters
• Sanitization and sterilization
• Regulation & compliance

SPC 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).

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

Quality Assurance

SPC 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. 

SPC Cartridges 

Available from 5-40 inches in length with several end connections and O-ring options.  

SPC Capsules

These filters are SPC 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. SPC Capsules are available pre-sterilized.