Microbiological purity

Samples are analysed for the presence of microorganisms in general and specific pathogenic microorganisms.

Samples from non-sterile production is analysed according to the following pharmacopoeia:

  • Ph. Eur. 5.1.4. Microbiological Quality of Non-sterile Pharmaceutical Preparations and Substances for Pharmaceutical Use
  • Ph. Eur. 2.6.12/USP<61> Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests
  • Ph. Eur. 2.6.13/USP<62> Microbiological Examination of Non-sterile Products: Test for Specified Micro-organisms.

Samples from production of herbal medicine is analysed according to the following pharmacopoeia:

  • Ph. Eur. 5.1.8. Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation
  • Ph. Eur. 2.6.31. Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation

 

Examples of microbiological purity tests:

  • Total aerobic microbial count (TAMC)
  • Total combined yeast/molds count (TYMC)
  • Bile-tolerant gram-negative bacteria
  • Escherichia coli
  • Salmonella sp
  • Staphylococcus aureus
  • Psedomonas aeruginosa
  • Candida albicans
  • Clostridia

For verification methods, see validation.

Contact

Mie Hanghøj Grundt Christiansen

Mie Hanghøj Grundt Christiansen

Microbiological analyses, Quality assurance

MSc in biochemistry and molecular biology

mie@dblab.dk