For absolute bacteria and endotoxin retention.
PPC cartridge and capsule filters consist of a double-layered, positively charged Polyethersulfone (PES) membrane. Available in 0.03, 0.10, 0.22 and 0.45 µm, PPC filters are validated for absolute bacteria retention to provide reliable sterile filtration performance. The positive charge removes negatively charged biological contaminants such as endotoxin, virus and other cell fragments. Depending on level of contaminant and flow rate, PPC filters will typically exhibit > 3-log removal of endotoxin. This combination of functionality makes the PPC filter an excellent choice for pharmaceutical and biopharmaceutical applications.
Applications
- Water for Injection (WFI)
- Process Water
Features and Benefits
PPC is a family of pharmaceutical-grade, positively charged Polyethersulfone (PES) sterilizing filters.
- Removes negatively charged biological contaminants
- Highest available charge capacity
- Typically exhibits >3-log removal of endotoxin
- Double-layer configuration provides higher overall capacity and greater assurance of bacteria and endotoxin removal than the single-layer SPC Filter
Filtration Area
View Data Sheet for further product information:
- Integrity test specifications
- Materials of construction
- Operating parameters
- Sanitization and sterilization
- Regulation & compliance
Validation
PPC 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
Quality Assurance
PPC 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.
PPC Cartridges
Available from 5-40 inches in length with several end connections and O-ring options.
PPC Capsules
These filters are PPC 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. PPC Capsules are available pre-sterilized.