CSA Z23500-3-2020 pdf free download

CSA Z23500-3-2020 pdf free download.Preparation and quality management of fluids for haemodialysis and related therapies Part 3: Water for haemodialysis and related therapies (ISO 23500-3:20 19, MOD).
Samples should be analysed as soon as possible after collection to avoid unpredictable changes in the microbial population. If samples cannot be analysed within 4 h of collection, they should he stored at <10 °C without freezing until ready to transport to the laboratory for analysis. Sample storage for more than 24 h should be avoided, and sample shipping should be in accordance with the laboratory’s instructions.
Total viable counts (standard plate counts) shall be obtained using conventional microbiological assay procedures (pour plate, spread plate, membrane filter techniques). Membrane filtration is the preferred method for this test. Other methods may be used, provided that such methods have been appropriately validated and are comparable to the cited methods. The use of the calibrated loop technique is not acceptable.
5.2 Microbial contaminant test methods
Methodology to establish microbial contaminant levels is given in Table 3. Such methods provide only a relative indication of the bacterial bioburden rather than an absolute measure.
Recommended methods and cultivation conditions can also be found In ISO 23500-4 and ISO 23500-5 as well as this document (Ta121e). The methodology detailed uses Tryptone Glucose Extract Agar (TGEA) and Reasoner’s Agar No. 2 (R2A) incubated at 17 °C to 23 °C for a period of 7 days and Tryptic Soy Agar (TSA) at an incubation temperature of 35 °C to 37 °C and an incubation time of 48 hiUl, The background for the inclusion of TSA for standard water and standard dialysis fluid used for standard dialysis is explained in detail in &4.
Different media types and incubation periods can result in varying colony concentrations and types of microorganisms recoveredlUll9lli.flJ. The use of Reasoner’s 2A agar (R2A) has been shown in previous studies to result in higher colony counts than tryptic soy agar (TSA) for water and dialysis fluids samplesU-lllillLlZi. In a more recent publication, in 2016, the authors indicated that there were no significant differences for comparisons of bacterial burden of standard dialysis water and standard dialysis fluid yielding colony counts 50 CFU/ml when assayed using R2A and TSA at the conditions stated in the preceding paragraph of this subclause (UI.
historic studies with tryptone glucose extract agar (TGEA) incubated at 17 °C to 23 °C for a period of 7 days also yielded higher colony counts than TSA.[L31 Maltais et al.LUJ in their comparison of this medium with TSA showed that the proportion of standard dialysis water samples yielding colony counts 50 CFU/ml was significantly different from that found using TSA at an incubation temperature of 35 °C to 37 °C and an incubation time of 48 hours (p = 0,001). The proportions of dialysis fluid samples in which microbial burden was 50 CFU/ml were not significantly different on the two media and incubation conditions.
The culture medium and incubation times selected should be based on the type of fluid to be analysed e.g. standard dialysis fluid, water used in the preparation of standard dialysis fluid, ultrapure dialysis fluid, water used for the preparation of ultrapure dialysis fluid or fluid used for online therapies such as haemodlafiltration. The method selected, should be based on the analysis of the advantages, disadvantages and sensitivity, of each of the methods detailed above.CSA Z23500-3-2020 pdf free download.