PPS*40S00002

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.

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.

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.

Final Filtration of:

• Diagnostics
• LVPs & SVPs
• WFI Water
• Vaccines
• Biologicals
• Medications

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.

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.

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.

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.

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.