Soluciones de filtración para la industria farmacéutica

The main types of filters used in the pharmaceutical industry include pleated polypropylene (PP) filter cartridges for prefiltration, membrane filter cartridges (PES, PTFE, PVDF, Nylon) for sterilizing-grade and bioburden reduction filtration, depth filters for clarification, stainless steel filter cartridges for high-temperature and solvent applications, and activated carbon filters for decolorization. The filter type selected depends on the application, fluid characteristics, required retention rating, and regulatory requirements.

Filtration in pharmaceutical manufacturing serves to remove particles, bacteria, endotoxins, and other contaminants from drug products, process water, and gases. It is essential for ensuring product sterility, patient safety, and compliance with FDA, EMA, and GMP regulations. Filtration is applied at multiple stages — from raw material processing and API purification to final sterilizing filtration of injectable drugs and ophthalmic solutions.

Sterilizing-grade filters have a validated 0.2µm (or 0.1µm) pore size rating and are designed to remove bacteria from pharmaceutical liquids through a single pass. They are used in final filtration of injectable drugs and sterile solutions. Prefiltration filters typically have larger pore sizes (1–10µm) and are placed upstream of the sterilizing filter to remove larger particles and extend the service life of the final sterilizing filter. Using both in combination is standard practice in pharmaceutical filtration systems.

Selecting the right pharmaceutical filter cartridge depends on several factors: the fluid being filtered (aqueous, solvent, gas), the required micron rating, operating temperature and pressure, chemical compatibility of the filter media, flow rate requirements, and regulatory standards that must be met (FDA, GMP, USP). Pullner offers free application support to help customers select the optimal filter element and housing configuration for their specific pharmaceutical process.

A pharmaceutical filtration manufacturer should hold ISO 9001 quality management certification and operate in compliance with FDA regulations and cGMP (current Good Manufacturing Practice) standards. Additional certifications may include ISO 13485 (for medical device-related filtration), CE marking, and specific material compliance documentation such as FDA 21 CFR, USP Class VI, and EU Regulation 1935/2004 for food/pharma contact materials. Pullner is ISO 9001 certified and FDA registered.

Pharmaceutical water filtration refers to the filtration of Water for Injection (WFI), Purified Water (PW), and other process water used in drug manufacturing. It is critical because water is the most widely used raw material in pharmaceutical production — used in formulation, cleaning, and sterilization. Water filtration systems must meet USP and EP pharmacopoeia standards to prevent microbial contamination, particulate contamination, and endotoxin levels from exceeding acceptable limits.