ACM PHARMA

Sterility Test Services

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Equipped with two isolators (H2O2 sterilisation and acetic acid) and a clean room (class A in B), qualified and dedicated to sterility testing, ACM Pharma proposes an analysis of the sterility of your products in complete security.

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The sterility tests are conducted in accordance to the reference standards in force :

  • Eur Ph, chap 2.6.1
  • USP
  • NF EN ISO 11737-2
  • Audit of dose with validation and validation of the SIP (Sample Item Portion)
  • BacTAlert 3D for sterility testing in 7 days cell culture media

ACM Pharma takes care of reading your Media Fill Test (MFT), enumeration of biological indicators (BI) andtest of inactivation of BI (growth/non growth).