Validation and Verification Criteria
Point-of-Use Water Filters are typically:
· validated in both the laboratory and under field/in-use conditions for specific installation time periods,
· contain sterilizing grade 0.2 micron membranes (validated according to ASTM 838-15a with HIMA and PDA/FDA rules applied11-14),
· tested and certified to meet appropriate national approvals (e.g. BS 6920),
· have evidence to support material compatibility and non-leaching (e.g. food contact certification EU10/2011). View our declarations of compliance.
CE Marked medical devices should be used if Point-of-Use filters are to be installed for the purposes of patient protection and infection prevention.
Sterilizing grade 0.2 micron filters can be tested according to ASTM 838-15a which applies a challenge of ≥ 107 Brevundimonas diminuta per cm2 of effective filtration area⁷ (B. diminuta is recognized as the industry standard for qualifying sterilizing grade filters because of its small size). If the filters are capable of completely retaining ≥ 1 x 107 B. diminuta organisms per square centimeter of effective membrane surface8 and have experimentally demonstrated to have these capabilities under representative “in-use” processing conditions9-10, then the product should be considered to deliver “Sterilizing Grade Filtration”.
In addition to ASTM 838-15a validation, supporting validation evidence may also be available for specific waterborne pathogens of concern (e.g. Legionella pneumophila, Pseudomonas aeruginosa, Aspergillus spp,).
7. American Society for Testing and Materials (ASTM), Standard F838-15a — Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, 2015. https://www.astm.org/Standards/F838.htm
8. HIMA — Microbial Evaluation of Filters for Sterilizing Liquids, Document No 3, Vol 4, 1982
9. PDA/FDA Special Scientific Forum, Bethesda, MD, Validation of Microbial Retention of Sterilizing Filters, July 12 – 13, 1995
10. FDA, “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice”, September 2004. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070342.pdf