PPS grade Polyethersulfone cartridges are designed to be used as sterilizing grade cartridges for the pharmaceutical industry. The PPS membrane utilized in these cartridges is optimized for retention and are double layered for extra security. Polyethersulfone cartridges see broad service in sterile fill applications in SVPs and biological products. Polyethersulfone is particularly suited for the filtration of products whose constituents, such as preservatives, can adsorb to the media. The lower binding characteristics of Polyethersulfone make it a good choice for filtration of valuable protein solutions such as vaccines and other biologicals. PPS grade cartridges are 100% integrity tested.
Chemical Sanitization
Industry standard concentrations of hydrogen peroxide, peracetic acid, sodium hypochlorite and other selected chemicals. Sanitization protocols designed to extend the useful life of PPS cartridges are available from Critical Process Filtration, Inc.
USP Biosafety
The materials used to construct Pharmaceutical Grade filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and USP24 Plastic Class V1 121°C Test.
FDA Compliance
The materials used to construct Pharmaceutical Grade filters meet the requirements listed by the FDA as appropriate for use in articles intended for repeated food contact as specified in Title 21 CFR sections 174.5, 177.1500, 177.1520, 177.1630, 177.2440 and 177.2600 as appropriate. PPS filters comply with Title 21 CFR sections 210.3 (b)(6) and 211.72, for non-fiber releasing filters.
Applications
Final Filtration of:
- Diagnostics
- LVPs & SVPs
- WFI Water
- Vaccines
- Biologicals
- Medications
Validation
PPS grade cartridges are validated using modified HIMA protocols at a challenge level of 107 organisms per cm2 of filter media. (0.22 µm challenged with Brevundimonas diminuta) (0.45 µm challenged with Serratia marcescens) (0.65 µm challenged with Saccharomyces cerevisiae). Validation Guide is available for 0.22 micron to meet regulatory requirements.
Extractables
The levels of bacterial endotoxins in aqueous extracts from Pharmaceutical Grade Filters are below the USP24 limits defined in Water for Injection (≤0.5 EU/ml). Pharmaceutical Grade Filters typically exhibit low levels of non-volatile residues.
Flow Rate
See the Flow Rate table in more image which represents typical water flow at a one psi (69 mbar) pressure differential across a single 10-inch cartridge element. The test fluid is water at ambient temperature. Extrapolation for housings with multiple elements and higher pressure drops is acceptable, but as flows increase the pressure drop of the housing becomes more apparent.
Quality Assurance
Pharmaceutical Grade Filters are manufactured using current Good Manufacturing Practices under a quality management system that has met ISO 9001 standards. Each Pharmaceutical Grade Filter is assigned a lot code to ensure traceability of the data and materials used in the manufacturing process. Our goal is to ensure our customers the greatest possible value for their filtration dollar. We achieve both low cost manufacture and high quality by employing state of the art manufacturing equipment. This computer controlled equipment is highly automated, reducing hand operations that compromise quality. Each operation including assembly, testing, cleaning, drying and packaging is done in appropriately rated clean rooms. Critical Process Filtration produces validated products to rigorous standards. Manufacturing is controlled using sophisticated MRP software that is networked to work stations in manufacturing centers and inspection points. During the manufacturing and inspection processes, data is collected “real time” from machinery and measuring instruments. This allows variable and attribute data to be quickly and easily analyzed to facilitate constant improvements in both quality and cost.
Total Performance
Critical Process Filtration, Inc. is a vertically integrated supplier of filtration products and services to industries in which filtration is considered to be a critical part of the manufacturing process. We manufacture a complete line of products to help you achieve all your filtration requirements from a single source.