Entegris Pharmsteri™ series filters are precision filters designed for the field of life sciences, especially widely used in the pharmaceutical industry. The following is a detailed introduction:
Excellent filtration performance: It can provide filtration with a variety of precisions, such as 0.22μm and 0.45μm, etc. It can effectively remove impurities such as particles and bacteria in the liquid, achieve sterilization and clarification, and ensure that the filtrate meets the high purity requirements and meets the purity standards of raw materials, intermediates and finished products in the pharmaceutical process.
Safe and reliable materials: The filter membrane is made of hydrophilic nylon, mixed cellulose esters, hydrophobic PTFE/PVDF and other materials. Hydrophilic nylon and mixed cellulose esters are suitable for sterilization filtration of aqueous solutions, with fast flow rate and low protein adsorption; hydrophobic PTFE/PVDF can be used to filter organic solvents, strong acids and alkalis. The filter housing and other parts are mostly made of polypropylene, which has good chemical stability and meets the relevant regulations on food and drug contact materials.
Strong compliance: Gamma irradiation sterilization is usually used, and sterile independent packaging is provided with a sterilization certificate, which meets the requirements of aseptic process. At the same time, it can provide document support that complies with relevant requirements such as USP Class VI biocompatibility testing, FDA 21 CFR 177 food contact material regulations, ISO 13485 medical device quality management system, etc., to meet the strict regulatory compliance standards of the pharmaceutical industry.
Obvious flow rate advantage: By optimizing the filter membrane structure and support layer design, a higher liquid flow rate can be achieved while ensuring filtration accuracy. This helps to improve filtration efficiency, reduce filtration time costs during large-scale production, and improve production efficiency.
Reasonable structural design: It has omnidirectional pressure resistance characteristics, high sealing interface strength, can withstand system forward and reverse flushing pressure shocks, frequent pressure fluctuations and high working pressure, and can ensure that the filter element has no bypass leakage during the entire use cycle, ensuring the stability and consistency of the filtration effect.