Assurance of Sterility for container closure in-direct product contact surfaces in Aseptic process filing.
Role of vaporised hydrogen peroxide bio-decontamination in a contamination control strategy combining Sterilisation + Bio-burden control + VHP/vH202

Ensuring sterility of indirect product contacting surfaces

This article is the fist in a series of PHSS guidance notes prepared by industry subject matter experts and sterile product manufacturing specialists to facilitate understanding and interpretation of aspects of GMP guidelines for aseptic manufacturing of sterile medicinal products. The initial focus of this guidance is on the assurance of sterility of surfaces that contact product contacting parts e.g. product container closures/ stoppers, associated
vibratory feeder bowls, hoppers and chute/ trackway surfaces.

Guidance Notes -Click here

Full details of this guidance is available - Click here