5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use
Inhalation use (special requirements apply to liquid preparations for nebulisation)
TAMC = total aerobic microbial count = Gesamtzahl aerober Mikroorganismen
CFU (KbE = koloniebildende Einheit)/g or CFU (KbE = koloniebildende Einheit)/mL 102 ≙ 200
TYMC = total combined yeasts/ moulds count = Gesamtzahl an Hefen und Schimmelpilzen
CFU (KbE = koloniebildende Einheit)/g or CFU (KbE = koloniebildende Einheit)/mL 101 ≙ 20
When an acceptance criterion for microbiological quality is prescribed it is interpreted as follows:
- 101 CFU: maximum acceptable count = 20;
- 102 CFU: maximum acceptable count = 200;
- 103 CFU: maximum acceptable count = 2000, and so forth.
5.1.8. Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation
A. Herbal medicinal products containing herbal drugs, with or without excipients, intended for the preparation of infusions and decoctions using boiling water (for example herbal teas, with or without added flavourings)
TAMC = total aerobic microbial count = Gesamtzahl aerober Mikroorganismen
CFU (KbE = koloniebildende Einheit)/g or CFU (KbE = koloniebildende Einheit)/mL 107 ≙ 50.000.000
TYMC = total combined yeasts/ moulds count = Gesamtzahl an Hefen und Schimmelpilzen
CFU (KbE = koloniebildende Einheit)/g or CFU (KbE = koloniebildende Einheit)/mL 105 ≙ 500.000
B. Herbal medicinal products containing, for example, extracts and/or herbal drugs, with or without excipients, where the method of processing (for example, extraction) or, where appropriate, in the case of herbal drugs, of pre-treatment reduces the levels of organisms to below those stated for this category
TAMC = total aerobic microbial count = Gesamtzahl aerober Mikroorganismen
CFU (KbE = koloniebildende Einheit)/g or CFU (KbE = koloniebildende Einheit)/mL 104 ≙ 50.000
TYMC = total combined yeasts/ moulds count = Gesamtzahl an Hefen und Schimmelpilzen
CFU (KbE = koloniebildende Einheit)/g or CFU (KbE = koloniebildende Einheit)/mL 102 ≙ 500
C. Herbal medicinal products containing, for example, extracts and/or herbal drugs, with or without excipients, where it can be demonstrated that the method of processing (for example, extraction with low-strength ethanol or water that is not boiling, or low-temperature concentration) or, in the case of herbal drugs, of pre-treatment, would not reduce the level of organisms sufficiently to reach the criteria required under B
TAMC = total aerobic microbial count = Gesamtzahl aerober Mikroorganismen
CFU (KbE = koloniebildende Einheit)/g or CFU (KbE = koloniebildende Einheit)/mL 105 ≙ 500.000
TYMC = total combined yeasts/ moulds count = Gesamtzahl an Hefen und Schimmelpilzen
CFU (KbE = koloniebildende Einheit)/g or CFU (KbE = koloniebildende Einheit)/mL 104 ≙ 50.000