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:

 

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 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.
 

 

    

     

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