Reserved Area

Microbiological analysis

  • Microbiology testing on raw materials and finished products: total bacterial/fungal counts according to European Pharmacopoeia/USP , Colipa and ISO (21149 e 16212) methods;
  • Detection of specific bacteria according to European Pharmacopoeia/USP, Colipa and ISO (21150, 22717,22718, 18416) methods;
  • Preservative Effectiveness Test: challenge test according to FDA, USP, Colipa, PCPC, and European Pharmacopoeia,  ISO 11930) methods;
  • Usage test and RDV evaluation to determine the PAO (Period After Opening);
  • Validation of microbiological analysis protocols on specific matrices according to European Pharmacopoeia/USP/ISO;
  • Determination of antimicrobial activity on dermatologically relevant strands, such as Propionibacterium acnes, Staphylococcus aureus and epidermidis, Pseudomonas aeruginosa, Candida albicans, dermatophytes;
  • Evaluation of Minimal Inhibiting Concentration (MIC) through turbidimetry and contact inhibition;

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