Creating a GIC A3P Barrier Technology
Appendix 1 under review should strongly recommend the absence of direct human intervention in the critical area during the aseptic manufacture of sterile therapeutic products and therefore the use of barrier technology. It is likely that this will be the first step towards the prohibition of direct human presence for new aseptic manufacturing units in the next revision of Annex 1 unless strongly justified exception.
The absence of direct human presence during aseptic processes Barrier Technology makes it possible to justify controls environments and simulations of specific aseptic processes, different from those used in class A / B with human presence.
The recent publication of the draft Annex 17 opens the possibility of applying an approach to "Real Time Release Testing" (RTRT) manufacturing, in which the control of critical parameters and attributes Relevant qualities can be used in place of liberating checks on the final stage of the drugs. Aseptic barrier production technology makes it possible to RTRT approach to manufacturing steps using this technology.
The complexity and diversity of aseptic processes involve Barrier Technology solutions for each of them. The development of new therapeutic alternatives, especially in the area of Innovative Therapy Drugs, makes it essential to find solutions for essentially manual processes requiring great dexterity.
The sub-working groups established for priority topics are to work :
1 - definitions barrier technology: speed, flow, class, leak rate, disposable ...
2 - control of transfers, cleaning and bio-decontamination, management and other exposed surfaces unplanned interventions
3 - Campaign Mode: definition, validation, simulation of aseptic processes, environmental control, ..
4 - gloves management Insulators / RABS, robotics
5 - ITN production
6 - RTRT for aseptic processes
GIC Technology Barriere