ABMI

Preface


  • The document is supplied as a guideline only, not as a guarantee in itself.
  • The aim of this protocol is to find an optimum balance between product safety and commercial effort in order to achieve commercial sterility.
  • A common aseptic validation protocol defines what can be expected from an aseptic line.
  • All the basic definitions this document refers to are explained in the appendix.

mime file icon Common Aseptic Validation Protocol (250 KB)