Microbiological examination of pharmaceutical products according Ph. Eur.



Our laboratory provides you with several different mikrobiological examinations of pharmaceutical products. Below, you can find a list of tests that we can perform for our customers. 


If you would like to contact us for a non-binding quotation, simply contact us:





 Water for pharmaceutical purposes in compliance with Ph. Eur. 2.6.12 (filtration on R2A-Agar)


  • Aqua purificata (purified water)
  • Aqua valde purificata (high purified water)
  • Aqua ad iniectabilia (water for injection purposes - WFI)



 Microbiological contamination of non-sterile products according Ph. Eur. 2.6.12


  • Total Aerobic Microbial Count (TAMC)
  • Total Combined Yeast and Mould Count (TYMC)



 Microbiological contamination of non-sterile products according Ph. Eur. 2.6.13
  • detection of specific microorganisms

    • Escherichia coli
    • Pseudomonas aeruginosa
    • Staphylococcus aureus
    • Salmonella
    • Clostridia
    • Candida albicans


  • Combined examination of non-sterile products 

    • Oralia
    • Rectalia
    • Preparations for topical use
    • Preparations for vaginale use
    • Herbal medicinal products


Nachweis spezifizierter Mikroorganismen 



 Validation: Effectiveness evaluation of the applied method in the presence of the product


  • Applicability of the total viable count method in the present of the product (Ph. Eur.2.6.12)
  • Suitability testing of method for specific microorganisms (Ph. Eur. 2.6.13)



 Efficacy of antimicrobial preservation (Ph. Eur. 5.1.3)


  • Parenteralia
  • Ophthalmica
  • Topical preparations
  • Oral preparations



 Test on bacterial endotoxines (LAL-Test, Ph. Eur. 2.6.14)


  • Limit test (Gel-Clot-Method)
  • Validation of the method for Determination of the Total Viable Count



 Analysis of hygienic-samples


  • Contact plates 
  • Sedimentation plates
  • Active air samples



 Qualification of culture media 


  • Examination of Nutritivity and Selectivity according Ph. Eur.