Proposed 2020 revisions to EU Annex 1 around aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on the need for clear best practices for the process simulation of the lyophilization unit operation.
To address these expectations, BioPhorum has written an article called A better approach to aseptic process simulation for lyophilized products, which presents a risk-based, holistic best practice approach for these drug products.
Published by Outsourced Pharma, the article describes a seven-step, best practice method for media fill simulation of the lyophilization unit operation. While previous literature presented a regulatory perspective for aseptic media fill qualification that evaluated vial size and fill-volume parameters, the method described in this paper will ensure a clear worst-case APS based on sound scientific rationale.
It also provides a comprehensive understanding of how the process limitations needed to avoid damaging the media inherently alter the APS.
This method offers a clear operational advantage because, by eliminating the ‘chamber dwell’ during APS, the operational capacity of the lyophilizer (typically the capacity-limiting factor in the manufacture of lyophilized products) is improved.