Pharma - Case Histories

Process and Product Optimization case Histories in Pharma

Case Study: Dry Powder Inhaler Scale-up



  • Scale-up the productivity of the molding and assembly manufacturing processes
  • Scale-up the productivity of the drug product formulation process
  • Keep Quality Costs within budget
  • Complete the project in a timely and cost effective manner

  • Project Risk Management
  • Design for Manufacturing
  • Project and Quality Risk Management
  • Design of Experiment


A leading global pharmaceutical company wanted to scale-up the moulding, assembly, productivity and manufacturing process of a Multidose Dry
Powder Inhaler for the treatment of asthma and COPD from industrialization to commercialization.
This device was the next generation in a line of successful Multidose Dry Powder Inhalers which was one of the company’s flagship products.
Maintaining a high level of quality was paramount to the company’s commitment to patient care. In addition to a high level of quality and productivity,
the client also wanted to complete this project in a timely and cost effective manner.



PTM Consulting established a continuous product and project risk management process in order to foresee potential project criticalities and mitigate them upfront.
The project was conducted keeping in mind that the device quality per se was linked with the formulation performances.

The realization of the scale-up was conducted integrating the overarching structure depicted by the 21 CFR 820.30 Design Control for medical devices which allowed to maintain continuous monitoring, traceability and control of the device development progress from both the design and the manufacturing perspective. This was also done while respecting the drug product formulation development program and milestones.

First, PTM Consulting implemented a device Design for Manufacturing [DfM] approach in order to ensure that the design solution proposed satisfied moulding, assembly and filling processes.


Secondly, in order to enhance processes reliability throughout the development, a continuous quality risk management process (QRM) was implemented to identify all the potential risks that might have jeopardized the product and processes, from plastic manufacturing and assembly through filling and final packaging. All the critical process parameters were identified and scientific based tests, by means of a Design of Experiment (DoE) approach, were implemented in order to support a data driven decision- making process to achieve a specific quality level.


The project met all project milestones, budget and workforce constraints. By analyzing and mitigating criticalities in the beginning of the risk management process, the Client was able to re-allocate resources to other higher-ranked, critical activities. The manufacturing line met all productivity goals and exceeded quality standards.

By implementing a project risk management process, the Client was able to reduce the risk of project delays by 10% from the original forecasted time which did not originally include a project risk management process.

Also a reduction of the economic exposure was realized due to continuous monitoring, traceability and control of the design development progress introduced by design control. Development cost was reduced by 5% than what was originally budgeted.

The approach established by PTM Consulting allowed the Client to achieve the intended process and product the first time.

Finally, the documentation provided successfully passed FDA and EMA review.