An approach to Process Development of pMDI’s using Cold Fill and Pressure Fill Technology

Steve Haswell

This paper discusses the manufacturing and process development approach taken from an early development stage through scale up and tech transfer to commercial manufacture. It gives background to both cold fill and pressure fill technology. Both methods are effective and have their specific advantages. It also sites comparisons and points to consider when assessing and selecting cold fill or pressure fill for the manufacture of pMDI’s.
Projects, ideally are quick and inexpensive to develop, meet customer preferences without impact on the expectation of a single cycle review, are easy to routinely manufacture and batch release and tick all of the boxes that allow a product to be well marketed and available to patients at a competitive price to the health care provider.
At 3M, we continue to exercise our prior knowledge and experience, existing and new customer needs and embrace modern business models that advance the way in which we approach our development projects.
In order to realise these aims, it is important that the product development scientist and process development scientist work synergistically to develop a thorough understanding of what is required to ‘realize’ a successful commercial product. Holistic technical and indeed business decisions throughout the development cycle facilitate a smooth transition through product and process development, scale up, commercial manufacture and launch.

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