For our Ready to Use vials / Sterinity, these include :

  • EP 2.6.12 on Microbiological examination of non-sterile products : Microbial enumeration tests
  • EP 2.6.14 on Biological tests - Bacterial endotoxins
  • EP 2.6.1 on Biological tests - Sterility

For our full packaging solution dropper assembly / Ensiemo, these additionally include :

  • The package obtained the Certification of Conformity after a formal test procedure according US 16 CFR § 1700.20 and ISO 8317.2015.