Approvals & Validation

 

Point-of-use filters provide a physical barrier to the release of harmful opportunistic waterborne pathogens, playing a crucial role in infection prevention in healthcare settings. They are relied upon as a critical control measure to protect the most vulnerable of end users that may be immunocompromised and susceptible to infection. It is therefore imperative that filters demonstrate that they are effective over the entirety of their usable life cycle, supported by appropriate validation data and certification. This is of paramount importance in high-risk environments, where any lapse or failure of control could have catastrophic consequences for patient safety.

T-safe offers the highest level of protection against exposure to harmful waterborne pathogens through sterilizing grade membrane filtration. All filters are thoroughly tested and validated in accordance with several standards. Read on to find out more about each approval and how T-safe filters meet and exceed these requirements.

  • T-safe water filters are proven to meet the requirements for sterilizing grade membrane filtration for the control of pathogenic microorganisms in healthcare settings.

    The microbial retention efficacy of T-safe water filters has been subject to exhaustive independent testing and certification through a series of laboratory challenge tests, laboratory life cycle challenge tests, and field evaluations undertaken in major acute UK hospitals.

    • Laboratory ASTM F838 Testing
      T-safe water filters demonstrated total retention efficacy when challenged with >107 CFU per cm2 filtration area of Brevundimonas diminuta in independent laboratory tests undertaken in accordance with ASTM F838.
    • Laboratory Life cycle Testing ASTM F838 Testing
      T-safe water filters demonstrated total retention efficacy when challenged with >107 CFU per cm2 filtration area of Brevundimonas diminuta, Legionella pneumophila, Pseudomonas aeruginosa, Mycobacterium smegmatis (representing NTMs), and Ralstonia picketti in independent laboratory tests undertaken over the entire filter life cycle of 31 and 92 days.
    • Field Studies Evaluation
      T-safe water filters demonstrated total retention efficacy of both Legionella spp. and Pseudomonas aeruginosa during independent field evaluation studies conducted in significantly contaminated water systems at major acute UK hospitals.
  • T-safe water filters are compatible with common surface disinfectants and cleaning agents. This has been validated after 276 exposures (simulating 3 daily exposures for 92 days) under frequent intermittent use of the following disinfectants:

    • ca. 70% ethanol solution
    • 1% chlorine solution
    • ca. 2% chlorine dioxide solution
    • ca. 7.5% hydrogen peroxide solution
    • ca. 15% quaternary ammonium solution
  • The T-safe water filters are compatible with common water system disinfectants. This has been validated by integrity testing the filters after exposure to the following disinfectants at the concentrations and contact time listed.

    • 30 ppm chlorine dioxide combined with 200 mg/L suspended solids in continuous operation throughout the life cycle
    • 30 ppm hydrogen peroxide in continuous operation throughout the life cycle
    • 15 ppm free chlorine in continuous operation throughout the life cycle
    • 10 ppm ozone in continuous operation throughout the life cycle
    • 10 ppm chloramine in continuous operation throughout the life cycle
    • 1000 ppm free chlorine through a 1-hour shock treatment
    • 1000 ppm hydrogen peroxide through a 1-hour shock treatment
    • An aqueous solution with pH 12 through a 1-hour shock treatment
    • 1000 ppm peracetic acid at 60° C through a 2-hour shock treatment
  • T-safe Medical Water Filters contain a bacteriostatic additive in their housing material, that provides protection from surface bacteria growth that may be caused by environmental retrograde contamination.

    Independent testing in accordance with ISO 22196 T-safe filters demonstrated surface bacteria growth reduction of >99.9% after 24 hours against Pseudomonas aeruginosa, Escherichia coli, and Methicillin-resistant Staphylococcus aureus (MRSA).

  • The materials of construction used in T-safe filter products have been independently proven to meet the requirements for extractable leaching and microbial growth tests in accordance with BS 6920:2014. T-safe filter products hold individual WRAS-approved product certification which is fully traceable by product item number and can be viewed via the WRAS Product Directory.

  • Raw materials of the T-safe Medical Water Filtration range have been independently tested by various accredited laboratories and passed microbial growth tests in accordance with DVGW (Deutscher Verein des Gas- und Wasserfaches; German Technical and Scientific Association for Gas and Water) W 270. Therefore, raw materials have been validated not to promote the growth of microorganisms.

  • The materials of construction used in T-safe water filters are compliant with EU Food Regulation 10/2011, respectively regulation 1935/2004 and in compliance with Drinking Water Directive 2020/2184. This provides assurance that the materials are safe to use for contact with food and drinking water.

Do you have any questions regarding our Approvals & Validation?