Sterility assurance

Our services cover among others the following parameters:

  • Sterility testing according to Eur Ph, chap 2.6.1, USP <71> and NF EN ISO 11737-2

  • BacTAlert 3D for sterility testing in 7 days according to Eur, chap 5.1.6/2.6.27 and USP <71>

  • Container Closure Integrity Test (CCIT)

  • Particulate contamination sub-visible particules according to Eur Ph chap 2.9.19 (CEBIPHAR)

  • Sterility and Fertilty of Media Fill Test (MFT) & Media Process Test (MPT)