NEWTOWN, PA — A new industry report shows a stark divide between digital ambitions and on-the-ground reality in the life sciences sector, with nearly two-thirds of pharmaceutical, medical device, and contract development companies still relying on manual, paper-based processes for critical production line changeovers.
Catalyx, an automation and vision system integration firm serving highly regulated industries, released its 2025 Life Sciences Line Clearance Benchmark Report revealing that 63% of organizations continue to use traditional methods for line clearance — the essential process ensuring equipment is properly cleaned and configured between product runs to prevent cross-contamination.
Mario L. Rocci, Jr., CEO of Catalyx, said the findings highlight an industry under intense pressure to meet regulatory, safety, and performance demands. He said digital and AI-driven systems could transform line clearance from an operational bottleneck into a driver of efficiency, but adoption remains slow.
The report shows that line clearance failures remain widespread. Seventy percent of organizations experienced at least one failure in the past year, and 30% reported six or more — numbers unchanged since 2023, suggesting limited progress despite heightened attention to modernization.
Even as many companies test new tools, scaling digital solutions has proven difficult. Nearly half of respondents piloted emerging line clearance technologies in 2023, yet only 11% have digitized key components. Another 26% use hybrid models that blend manual checklists with basic digital tools, but paper documentation remains the dominant industry standard.
The operational toll is considerable. Survey respondents said routine production changeovers take from 30 minutes to two hours, while more complex transitions often stretch beyond four hours. Human error, equipment setup mistakes, and missed inspection items were cited as the top contributors to production delays.
Regulatory expectations are also shifting. Global authorities are working toward a framework governing AI-based technologies in manufacturing, a development that could accelerate change. Dave Taylor, product manager and line clearance expert at Catalyx, said digitalization will soon become a regulatory necessity rather than an operational option, with future requirements centered on transparency, data integrity, and explainable outcomes.
Catalyx’s 2025 benchmark survey, its second industry-wide study, drew on input from more than 20,000 professionals worldwide. The full report provides what the company describes as the most comprehensive look at line clearance practices across life sciences manufacturing.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.