Connexo and Novatek shared an exhibition booth at the PDA Aseptic Processing of Biopharmaceuticals Conference on November 4–5, 2025, at the Sheraton Grand Incheon Hotel in South Korea. The team presented Novatek’s stability management, cleaning validation, and environmental monitoring software.
Visitors included quality assurance, quality control, validation, and aseptic manufacturing professionals. Although overall booth traffic was moderate, discussions were specific, with visitors describing the records, schedules, and system connections they wanted to improve.
Questions from quality and validation teams
Stability management discussions focused on study planning, chamber monitoring and alarms, and replacing Excel-based workflows. Visitors also asked about electronic records and the controls needed to support Part 11 and Annex 11 requirements.
For cleaning validation, questions covered total organic carbon verification, retest planning, and the management of residue limits, procedures, and equipment-specific criteria. Visitors wanted a clearer way to track validation work over its full lifecycle.
Environmental monitoring discussions centred on automated trending, alarms, mapping, and links to deviation and CAPA processes. Another recurring topic was how environmental monitoring performance qualification data compares with conditions during routine manufacturing.
Topics from the conference program
The conference addressed Annex 1 implementation, contamination control strategies, automated visual inspection, smoke studies, and data integrity. Sessions also considered robotics and machine learning, validation for mRNA and antibody-drug conjugates, ready-to-use packaging, electron-beam processing, and filling technologies.
Supply and cold chain sessions examined geopolitical risks and the transport needs of biologics and cell therapy products. Across the booth discussions, the common concern was how to connect quality information and reduce reliance on separate paper records and spreadsheets.
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