There is a rapid shift in processing philosophy for Pharma / Bio Pharma organisations producing sterile and aseptically prepared product. Because there is not a completely sterile/aseptic solution, contamination is primarily managed through 'environment control'. Transfer systems and processes are contained and controlled within large 'Grade A' clean rooms, Restricted Access Barrier Systems (RABs) or isolation units. These 'aseptic environment control' solutions cause significant capital outlays, ongoing operational costs and large manufacturing footprints.With over 80% of product recalls down to sterility assurance issues and most of these attributed to operators contamination, separating the operator from the process is key to improving sterility insurance. The AseptiSafe project will develop a transfer solution able to provide a genuinely sterile valve environment**,** removing the need for environment control**,** allowing for multiple transfers and increased transfer capacity, and removing the need for post-transfer sterilisation.