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Sterilising Grade Point Of Use Filtration
T-Safe Point of Use Filtration devices utilise sophisticated hollow fibre ultra-filtration membrane technology that has a pore size of 0.1 µm, providing effective and reliable filtration of harmful waterborne pathogens including Legionella. T-Safe Point of Use Filtration efficacy has been tested and validated as a sterile grade filter in accordance with The American Standard Test Method ‘ASTM F838-15a ‘Determining bacteria retention of membrane filters utilised for liquid filtration.
The ASTM F838-15a standard requires that a sterilising grade filter should demonstrate a guaranteed retention of 7 log steps of Brevundimonas diminuta per cm^2 of the filter area. Independent testing of T-Safe Point of Use Filters was conducted by the ISO 17025 accredited test laboratories against the following test organisms; Brevundimonas diminuta, Legionella pneumophila, Pseudomonas aeruginosa, and Aspergillus brasilensis.
T-Safe filters are manufactured in a controlled production environment that is certified in accordance with EN ISO 13485 standards. ISO 13485 provides the guarantee that as a medical device manufacturer Tandrup have detailed and externally audited processes in place to ensure the quality, safety and effectiveness of our medical devices. This includes randomised batch testing and lot numbering that ensures consistent quality and full tractability throughout the production process.
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