Sartorius have issued a white paper entitled “Enhanced Sterility Assurance in Stopper processing: A Unique System to Unload Stoppers from a Stopper Processing System”.
The abstract to the paper reads:
“Stoppers for pharmaceutical primary packaging must preserve the safety and efficacy of injectable drugs. Thus, before their intended use, these stoppers undergo multiple processing steps, including washing, rinsing, siliconization, steam sterilization and drying. Each step is critical to ensure the physical and mechanical properties of the stoppers by reducing particles, adding the appropriate silicon volume, sterilizing and avoiding re-contamination due to residual moisture. An additional critical step after the stopper processing is maintenance of closure integrity until filling in aseptic conditions. This paper discusses the validation of the transfer of stoppers from a stopper processing system, using a new aseptic transfer technology. It demonstrates that this technology maintains the sterility of the stoppers after their transfer into sterile single-use bags in an ISO Class 7 or 8 environment.”
Posted by Tim Sandle