SPC Filters

For absolute bacteria and endotoxin retention.

Applications
  • Process Water
  • Water for Injection (WFI)

Features and Benefits

PES AsymmetricSPC 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
spc 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
 
Validation

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 cartridge        Critical Process Filtration black and white capsule with etched logo 

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.

spc capsule        Critical process black and white capsule with cutout to show cartridge etched logo 

Why Choose Critical Process Filters?
Quality & Performance
  • Over 20 years of engineering and manufacturing the finest filters for critical applications. 
  • Compliance with industry standards required for your operation
  • Product optimization to meet your performance goals
  • ISO 9001:2015 certified Quality Management System
  • Appropriately rated clean room environment
  • Proven success in pharmaceutical and bioprocessing applications
Price Advantage

It's simple. Our products are very competitively priced. Learn more

Services & Support
  • Presales evaluations/recommendations by highly experienced Application Engineers 
  • Post sales support and trouble shooting
  • Testing & Analysis services (our site or yours)
  • Validation Services

Made in USA 800   90012015Large-(1)

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