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