Parametric release can be invaluable to companies by accelerating their sterile product’s release-to-market. But how can it be achieved?
Parametric release is based upon a documented review of processing records rather than the testing of biological indicators (BIs) or process challenge devices (PCDs).
This technical presentation and industry Q&A will define parametric release, review the advantages that merit its consideration, and provide a practical way to implement the process. It will provide you with a better understanding of the approach, which is widely accepted in the industry and recognized within ANSI/AAMI/ISO 11135:2014, and its potential to address urgent demand and market fluctuations.