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Pharmaceutical Manufacturing and Packing Sourcer

Developments and Considerations in Terminal Sterilisation

A crucial element for actualising the safety and efficacy of many pharmaceutical products is to render and keep them sterile through point of use. This is especially true of parenteral products that enter tissues directly and, therefore, bypass the body’s defence mechanisms. Sterilisation is a technology with a very long history, yet continuous innovation. Our industry works to develop new products and classes of products to market, while upholding or even improving the safety and quality standards. This story of long-established practices quietly, yet continuously, amended by innovation is especially significant for new sterile pharmaceuticals.

The manufacture of sterile pharmaceutical products is fundamentally divided between two categories of outcomes: those products that are terminally sterilised, and those that are aseptically prepared in their final primary packaging. This distinction does not reflect a choice for the manufacturer, but rather a distinct hierarchy of options: those products that can be sterilised terminally (that is, sterilised in their final primary packaging) must be, and those that cannot shall be rendered sterile upstream, and complete manufacturing aseptically. Aseptic preparation is to be a last resort because it cannot provide true assurance of sterility (short of destructively testing millions of units) in the same way that validated sterilisation processes can.

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Shaun Devitt is a product development engineer with nearly a decade experience in developing drug delivery devices and related processes. He has worked on the product and process development of novel parenteral packaging, including reconstitution systems and wearable injectors. This work has extended to a focus on sterilisation process development, especially for new forms of products and packages where traditional approaches were not feasible. He has innovated across the range of sterilisation modes (irradiation, heat, and gas) for several clients with multiple patents pending. He and his team have also worked within, and innovated in, the critical related fields of container closure integrity and terminally sterilised package integrity testing. He is a Founder and VP of Neuma LLC, where he has worked with a skilled team of mechanical, electrical, and container science experts to transform innovative technologies into viable drug delivery solutions since 2017.

shaun.devitt@neuma-eng.com
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