PDA Aseptic Manufacturing Conference – Berlin

Dr. Aidan Harrington presented at the recent PDA Aseptic Manufacturing Conference with a presentation entitled ‘Achieving Meticulous Aseptic Standards and Control in a Filling Isolator – Lessons for Design’.

The presentation examined three aspects if current practices with respect to isolator technology – classification of room background, the requirement to sterilize isolator components prior to VHP and glove integrity.

The presentation evaluates these practices, and highlights in the case of the need to sterilize a stopper bowl,  the regulatory perceptions regarding the limitations of current VHP processes. The validity of these limitations is challenged. The risks of pinholes in gloves is presented, and highlights that the primary use of gloves in isolators is for environmental monitoring. That glove integrity failure investigations rely to a great extent on EM data, the presentation asks if the industry is taking full advantage of isolator technology.

Achieving Meticulous Aseptic Standards & Control in a Filling Isolator – Lessons for Design