- Denny Kettwig, Principal Advisory Consultant, Smart Manufacturing NNIT.
A fully integrated Manufacturing Execution System (MES) is essential for attaining a high level of automation in pharmaceutical manufacturing. This includes not just the IT landscape, but also automated vehicles, manufacturing equipment, documentation, and staff training.
In recent years, numerous advances in technology have made automation a key factor in modern life sciences manufacturing.
While the goal of a fully automated 'lights out' facility that operates 24/7 with minimal human intervention has yet to be realized, automation provides significant benefits in terms of efficiency, compliance, and quality.
Examples of automation benefits include increased production speed, reduced risk of contamination, and real-time warnings in case of deviations from critical process parameters. In addition, the trend towards personalized drug development with smaller batch sizes and treatments based on individual patient data is only feasible with automated and digitized manufacturing processes, says Denny Kettwig, Principal Advisory Consultant, Smart Manufacturing Europe at NNIT.
MES is essential to increase automation
Despite the clear advantages, the path to increased automation is far from easy. There are numerous challenges, from adhering to strict regulatory requirements to managing the complexity of multiple equipment vendors and data formats. This requires expertise that no life sciences organization currently has in-house.
An essential step on the automation journey is implementing a Manufacturing Execution System (MES). Acting as the central nervous system of the production facility, the MES plays a key role in orchestrating and managing the many different elements of the manufacturing process.
As anyone in the trenches of life sciences manufacturing know, adopting MES is more than a technological upgrade; it's a strategic move towards enhancing operational efficiency, ensuring quality, and staying competitive in a fast-evolving industry, says Denny Kettwig.
Implementing or upgrading an MES can be a daunting task. Regardless of whether it is a brownfield or greenfield project, the risk of delays and budget overruns is high. Fortunately, much of the risk can be mitigated by using an experienced implementation partner and a proven methodology.
As a veteran digitalization partner with decades of experience working with the life sciences sector, NNIT has gained valuable insights about the optimal way to integrate MES with the entire manufacturing landscape.
Ensure non-biased advisory and project management
One of the key factors for success is to clearly define the intended business objectives that the MES is going to contribute to. In this case, having a partner that can provide a non-biased opinion on every phase of the project, from advisory to go-live and hyper care, is invaluable.
Breaking down each process and focusing on the desired outcomes allows you to determine the necessary requirements and implementation strategies. Additionally, understanding how the individual manufacturing facility fits into the overall supply chain, including relationships with external stakeholders such as logistics partners and health authorities is crucial.
Integration experts with experience from the life sciences industry are needed to bridge the gap between business, vendors and other partners involved, ensuring that the technical aspects align with business processes and regulatory requirements.
Right from the beginning, you want to establish a project organization that allows for close cooperation between the MES vendor, internal subject matter experts and the MES implementation partner. Ideally, you want ensure strong transparency for process discussions, changes in the design approaches and status updates, including resource availability and the strengths and weaknesses of each solution, says Denny Kettwig.
Utilize a proven implementation methodology
An effective way to significantly speed up the implementation of an MES is by adopting a methodology rooted in recognized industry standards, such as NNIT’s Accelerated Implementation Methodology. This approach utilizes established models like MESA, ISA-95, and TOGAF to guide the process.
– The industry models used in NNIT’s Accelerated Implementation Methodology offer a solid framework for designing IT/OT architecture and structuring the implementation process, eliminating the need for creating custom approaches. By leveraging a standardized methodology, businesses can greatly expedite the integration of their systems, , Denny Kettwig explains.
The combination of a proven implementation methodology and domain-specific knowledge about the manufacturing process enables the team to spot critical issues, such as regulatory constraints or ensuring compatibility of the production equipment.
Highly automated systems increase complexity and the need for deep domain knowledge and close coordination with different equipment vendors. When working as an MES implementation partner, NNIT often facilitates contact between equipment suppliers and the client organization to orchestrate the entire setup.
Don’t neglect training and change management
A common mistake is setting aside insufficient time and resources to training and organizational change management. For the production staff, working in a highly automated setting can be a very different experience compared to traditional manufacturing, as tasks such as equipment monitoring, and documentation may now be done automatically via the MES. Proper onboarding is needed to understand how this impacts their job functions.
Overall, there are many crucial factors involved when implementing both MES and increased automation into a life sciences manufacturing setting. But with the aid of a knowledgeable and experienced implementation partner, it can lay the foundation for greatly improved business efficiency, quality, and profitability.