Microbial control of combo devices

摘要

With recent developments in advanced drug delivery systems manufacturers and contract sterilisation providers are now required to work more closely together than ever before to find a satisfactory sterilisation option for these devices. This new generation of combination devices offer a unique challenge to all parties as the regulatory environment requires that they conform to both pharmaceutical and medical device standards for sterility assurance. The contract sterilisation industry has been able, in most cases, to adapt its processes to handle current requirements through the use of microbiological control and new sterilisation techniques, such as Electron Beam. However, going forward regulatory changes are being looked at to make the process more adaptive.