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,).
References:
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
