Challenge
Aseptic fill-and-finish operations are among the most critical stages of pharmaceutical manufacturing, requiring precise process control, consistent product quality and reliable production performance. For a global pharmaceutical manufacturer, variability across its filling operations was affecting first-pass yield, increasing process deviations and slowing batch release.
Key operating parameters, including fill volume, stopper force, line speed and environmental conditions, influenced process stability and product quality. Inconsistent fill volumes and stopper-related rejects contributed to product loss, while variations in equipment performance made it difficult to maintain consistent operating conditions.
Without a unified view of process behaviour, engineers struggled to identify the root causes of variability. Traditional manual experimentation and limited visibility into operating parameters made it time-consuming to optimise production settings, prevent deviations and maintain reliable performance across manufacturing sites.
Solution
The manufacturer implemented an integrated continuous improvement approach using Takt Kaizen, Takt Insight and Takt Optima to transform process variability into actionable operational intelligence.
Identifying process variability with Takt Kaizen
The engineering team used Takt Kaizen to map the end-to-end aseptic fill-and-finish process, identifying sources of variability across critical operating parameters, including fill volume, stopper force and environmental conditions.
Process mapping highlighted the interaction between fill volume and stopper force as a key driver of deviations and product loss. This enabled the team to prioritise improvement opportunities and focus on the parameters most responsible for inconsistent production performance.
Connecting process data with Takt Insight
Takt Insight was deployed to capture real-time operational data from existing filling machines and sensors.
The platform brought together fill volume, stopper force, line speed, temperature and humidity data, providing engineers with a unified view of equipment performance and process behaviour.
This improved visibility allowed the team to correlate operating conditions with process variations, identify emerging issues before they developed into deviations and make more informed production decisions.
Optimising operating conditions with Takt Optima
Using Takt Optima, the engineering team conducted AI-powered design of experiments to identify the optimal combination of fill volume, stopper force, line speed and environmental conditions.
By analysing interactions between these variables, the team identified a robust operating window designed to maximise first-pass yield while minimising process deviations.
Experiments that previously required extensive manual effort were completed in a fraction of the time. The optimal operating conditions were validated on the live production line, enabling the manufacturer to establish more consistent and repeatable manufacturing processes.
Results
By combining structured process improvement, real-time operational intelligence and AI-driven optimisation, the manufacturer achieved measurable improvements in aseptic fill-and-finish performance.
18% Improvement in First-Pass Yield
Improved process control and optimised operating conditions increased first-pass yield by 18%, helping the manufacturer produce more high-quality medicines with fewer rejects and less product loss.
60% Reduction in Process Deviations
Better understanding of process variability and the identification of robust operating parameters contributed to a 60% reduction in deviations, improving process stability and manufacturing reliability.
30% Faster Batch Release
More consistent production performance and fewer process deviations accelerated batch release by 30%, supporting greater operational efficiency and a more reliable supply of medicines.
Improved Process Control and Operational Scalability
The manufacturer established a more structured, data-driven approach to continuous improvement, enabling engineers to monitor process performance, identify optimisation opportunities and maintain consistent operating conditions.
Takt Insight and Takt Optima are now used as part of the manufacturer’s standard process for ongoing improvement and technology transfer across manufacturing sites.
Beyond the measurable improvements, the organisation achieved a more stable, efficient and scalable manufacturing operation, helping deliver high-quality medicines more reliably and reach more patients worldwide.