Aseptic Expertise And Delivery Of Services

In 2024, a pharmaceutical services company engaged CAI for help after a routine requalification of their aseptic simulation process revealed a contaminated unit, leading to a two-month halt in commercial production. The contamination was traced to Staphyococcus cohnii, a bacterium typically found on human skin. CAI leveraged its expertise to evaluate the site's practices, identify potential root causes, and implement strategies to resume operations and prevent future contamination. Key measures included documenting process and equipment observations, providing feedback, and retraining operators on new procedures. The project was successfully completed on time and within budget, with improvements made to the sterile filling line and the aseptic simulation process passing. CAI continues to provide oversight to support commercial production, ensuring quality, compliance, and regulatory standards are met in end-to-end development and manufacturing.