Optimizing Sterile Pharmaceutical Capacity: Leveraging Operational...
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Optimizing Sterile Pharmaceutical Capacity: Leveraging Operational Excellence and Process Improvement

Pharma Tech Outlook | Friday, June 02, 2023

It is crucial to optimize existing processes and leverage operational excellence to meet the increasing demand for sterile pharmaceuticals.

FREMONT, CA: Installing a new sterile line in the pharmaceutical industry has traditionally taken many years. The current global supply crisis has extended these installation times significantly. Furthermore, the need for more skilled sterile-manufacturing talent further hampers the ramp-up of new lines, making it unviable to increase sterile capacity in the short term through additional production line installations. This article explores alternative strategies for boosting capacity by partnering with contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs). It highlights the significance of operational excellence in optimizing existing processes to meet growing demand.

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Given the time and resource-intensive nature of installing new production lines, short-term capacity expansion through this method is not feasible. The current global supply crisis exacerbates the challenges associated with installation timelines. Additionally, partnering with CMOs or CDMOs to boost capacity in the short term presents complexities related to technology transfer, especially in filling operations that require extensive process validations.

Effective leadership at all levels is crucial in supporting and inspiring efforts to free up capacity. Setting clear goals and establishing structured transformation governance, aligned with site leaders, can foster buy-in and commitment to change. Communicating the change story to frontline workers conveys the urgency and attainability of the targets. Pilot programs are often implemented at strategic sites within a network to inform subsequent rollouts.

Operational excellence principles emphasize relentless process improvement, freeing up critical bottlenecks along the value chain to unlock value. Through site diagnostics, bottlenecks can be identified and addressed, leading to rapid results through standardization and lean practices. By maximizing existing assets and optimizing processes, superior outcomes can be achieved.

While digital tools and analytics offer the potential for unlocking additional capacity, optimizing key processes and making them lean is essential. Standardizing processes and improving performance management can significantly enhance efficiency. Designing a meeting cascade to ensure clear information flows, training key production roles, and implementing digital performance management tools enable real-time information sharing and streamlined decision-making.

Closing identified performance gaps and managing deviations could benefit from selected key steps before applying analytics-driven prediction and reporting. Initiatives such as redesigning incident triage processes, enhancing investigator training and certification, prioritizing rework in the investigation process, and linking deviation and performance management to promote collaboration can boost effectiveness. Standardizing root-cause problem-solving meetings and review boards further enhances efficiency.

Well-designed pilot programs enhance agility, accelerate learning, and facilitate cultural acceptance of operational excellence. As improvement levers are implemented at the pilot site, knowledge and capabilities can be codified and centrally managed. Replicable and scalable levers expedite rollout, leveraging digital, analytics, and traditional lean practices. Utilizing tools such as KPI dashboards, advanced analytics code blocks, and work instruction templates across different sites optimizes efficiency.

In sterile production lines, downtime often arises from precautions to ensure sterility. Efforts to increase efficiency while maintaining patient safety should focus on optimizing selected operational parameters. For instance, the clean-in-place/sterilize-in-place cycle, which consumes a significant portion of change over time, can be modified by reprogramming filling machines. On-site capabilities in microbiology validation, change control, quality assurance, and engineering ensure that built-in cleaning and sterilizing cycles meet sterility requirements efficiently.

Short-term capacity expansion by installing new production lines faces challenges due to lengthy timelines and talent shortages. Manufacturers can unlock untapped potential, address bottlenecks, and enhance efficiency by partnering with CMOs or CDMOs and implementing operational excellence principles. Sequentially optimizing processes before leveraging digital tools and analytics, managing deviations effectively, and implementing well-designed pilot programs contribute to successfully enhancing sterile pharmaceutical capacity.

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