Technical Report No. 22 (Revised 2025): Process Simulation for Aseptically Filled Products

Technical Report No. 22 (Revised 2025): Process Simulation for Aseptically Filled Products replaces the previous revision of PDA Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products published in 2011. The intent of the current effort is to update that document to reflect the changes in aseptic processing that have occurred within the global industry and the regulatory landscape and, specifically, to support a site's holistic contamination control strategy (CCS). The authors have attempted to address the subject as fully as possible, recognizing the notable contributions made by other organizations, regulators, compendia, and individuals who have worked in this area. In addition, the report provides guidance on and supports sound risk-based approaches in the design and execution of aseptic process simulation (APS). TR-22 (Revised 2025) represents a significant update of the content of the report, replacing the 2011 version. As such, readers and users should fully review this edition as PDA no longer supports or considers the 2011 version valid.

Insights from the discussion between industry experts and regulatory agencies on the latest revision of the European Union (EU) GMP Annex 1: Manufacture of Sterile Medicinal Products (issued August 25, 2022) and concerning APS have been considered in this document to include the current thinking and guidance on this topic.

This TR addresses process capability assessment for aseptic processing. Such assessments consist of one or more APS during pharmaceutical and biopharmaceutical aseptic formulation and filling activities of products for human and veterinary use. Aseptic operations required in the preparation of sterile bulk materials and biotechnology inoculums and feed materials are not a part of this document.

While the focus of this document is on aseptic processing in the pharmaceutical and biopharmaceutical industry, application of the concepts and principles to the preparation of sterile medical devices and diagnostics may be appropriate. Readers are encouraged to review PDA's Points to Consider No 1: Aseptic Processing (Revised 2023) for a more detailed discussion on aseptic processing related topics, that could have an impact on the APS exercise.