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12 | 04.10.2021 | Page 28
9.4 Microbiological Inspection
Necessary Values
1
Pathogens < 100 CFU/ml no traces of Pseud. aeruginosa and E. coli
Endotoxins < 0,25 EU/ml
Inspection Interval
2
Inspection of permeate every 3-6 months.
Inspection method
2
Pathogen count determination:
Nutrient medium: TGEA (OXID Nr.CM 127), R2A
Incubation temperature: 22°C ± 2°C
Endotoxins determination:
Method: GEL-Clot; Cromogen; Turbid metric
_________________________
1
According to the European Pharmacopoeia
² Recommendations according to the guideline for the practice of applied hygiene in treatment units for dialysis
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