Narrowing the DDCU Window for HFA pMDIs: In-Line Testing on Two Stage pMDI Filling Lines
Sullivan PP.
RDD Europe 2009. Volume 1, 2009: 83-94.
Abstract:
Manufacture of pressurized metered dose inhalers (pMDIs) faces an ever increasing drive for improved quality and process control. Over recent years the advent of Quality by Design (QbD) and the Process Analytical Technology (PAT) initiatives have raised the standards even further and have presented manufacturing companies with the opportunity to review their current processes and make improvements to guarantee the quality of each pMDI produced. One such quality improvement can be made in the production of two-stage filled pMDI products. This article describes the development of a 100% in-line fill weight checking system implemented during pMDI manufacture to ensure that every can produced contains the correct drug-concentrate and propellant mixture. Verification at each stage of the filling process should result in improved product quality. This development process involved the integration of four factors: (1) an accurate checkweighing system, (2) a can handling solution to present the cans to the checkweigher in a controlled manner, (3) a solution to reduce noise and vibration on the filling machine, and (4) a control system to track the cans and process the information.
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