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Microbiological Testing

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
  • Clostridien
  • Candida albicans

Combined examination of non-sterile products

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

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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