A CLEAN BREAK FOR ASEPTIC HANDLING

摘要

As market demand for advanced biopharmaceuticals continues to grow so do the demands placed upon modern aseptic processing, and primarily that of parenterals such as vaccines. Quality of the final product remains of utmost importance, putting the techniques involved in ensuring sterility during manufacture under the spotlight. The current techniques adopted to ensure this fundamental requirement is met consist primarily of high classification cleanroom areas and barrier/isolator technology, coupled with validated sterilisation or decontamination processes to ensure both product and components within the critical areas can be maintained at the required sterility assurance level (SAL).