Sterility Assurance Level

ACM Pharma provide the following testing and analyses to ensure your sterile products comply with the Pharmacopoeial standards.:

  • Sterility testing according to Eur Ph, chap 2.6.1, USP <71> and NF EN ISO 11737-2 (We use two isolators specifically designed for consistent and reliable sterility testing)

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

  • Container Closure Integrity Test for single-use systems (CCIT)  & Dye test (methylene blue) according to PDA Journal / USP <1207>

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

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