Aseptic Expertise and Delivery of Services

PROJECT OVERVIEW

CAI assisted a leading pharma industry services company in Italy to address a contamination issue detected during routine requalification of their aseptic simulation process. The project, initiated in February 2024, involved comprehensive observations, feedback and implementation of operational excellence strategies to restart manufacturing activities and prevent drug shortages. CAI’s team provided expertise in aseptic practices, conducted value stream mapping and utilized statistical tools to analyze and improve processes. Through their interventions, CAI helped retrain operators, implement new procedures and successfully requalify the sterile filling line, allowing the resumption of commercial production.

Topics covered

• Aseptic process simulation (APS) failure investigation
• Operational excellence implementation in sterile manufacturing
• Value stream mapping and process flow optimization
• Cleanroom observation and improvement recommendations
• Aseptic technique training and behavior modification
• Compliance with EU GMP Annex 1 and FDA guidance
• Continuous improvement tracking in sterile environments