Enhanced Sterility Assurance in Stopper Processing

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, siliconisation, steam sterilisation and drying. Each step is critical to ensure the physical and mechanical properties of the stoppers by reducing particles, adding the appropriate silicon volume, sterilising 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.

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