Preservatine Efficacy Test PET, Antimicrobial Effectiveness testing for pharmaceuticals, Pharmaceutical Challenge testing

At QACS, The Challenge Test Laboratory, we conduct pharmaceutical challenge testing to substantiate preservation adequacy against microbial contamination which may occur under reasonably foreseeable conditions of storage and use. The Lab is GMP certified for microbiological testing (non-sterility) of human and veterinary medicinal products in various dosage forms by the Greek National Organization for Medicines (EOF).

Preservative properties are adequate when there is a significant drop or no increase of micro-organisms in the inoculated preparation at prescribed temperatures and time specific conditions.

EP reference standard

According to the European Pharmacopoeia (EP) reference standard, wherever possible, we challenge the preparation in its final container. We use a prescribed inoculum of suitable micro-organisms, (Pseudomonas aeruginosaStaphylococcus aureusE. coliCandida albicansAspergilus brasiliensis). Screening is performed by:

  • Storing the inoculated preparation at a prescribed temperature
  • Withdrawing samples from the container at specified intervals of time
  • Counting the organisms in the withdrawn samples

Minimum sample quantity 100 g. Results available within 35 days. Preliminary real-time reports on intermediate readings throughout the screening process. If you are based in the EU, we offer 24-hour courier service

For GMP accredited pharmaceutical Challenge testing contact us –  info@qacs.gr – 30 210 29 34745