Spring Intro 2023

28/03/2023

Sterility and manufacture

Sterility: A critical quality attribute for a parenteral product Preferred choice is terminal sterilisation (autoclaving) for up to 15 minutes at a minimum of 121ºC ● not all active ingredients will withstand this Aseptic processing – components are separately pre-sterilised (or prepared with controlled bio-burden) before being assembled together in a in a sterile environment Key step is filtration, using 0.2 micron filters Aseptic processing carries higher risk than autoclaving – the aseptic processing choice must be supported by data Validation data to show how the sterile envelope is maintained needs to be included in the MAA/NDA, and evaluated on inspection

The Organisation for Professionals in Regulatory Affairs

37

Parenterals manufacture

Vial filling

Lyophilisation

Bulk solution compounding

The Organisation for Professionals in Regulatory Affairs

38