Applying Continuous-Flow Pasteurization and Sterilization Processes - Pharmaceutical Technology

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Applying Continuous-Flow Pasteurization and Sterilization Processes
High-temperature, short-time (HTST) pasteurization and ultra-high temperature (UHT) sterilization have potential use for continuous manufacturing of bio/pharmaceuticals.


Pharmaceutical Technology
Volume 37, Issue 5, pp. s28-s31

The learning curve in bio/pharmaceuticals

The technologies of HTST pasteurization and UHT sterilization have been refined for many years in other industries. Details of validation, maintenance of proper safety assurance, and documentation have also been well defined. The tools to generate thermal-destruction kinetics, test products, and optimize operating conditions simplify the adoption of these technologies for bio/pharmaceutical manufacture.

These technologies have been developing for many years, and their adoption involves the use of the existing tools to optimize them for each application. It also requires specific efforts to implement them properly. As continuous-flow processes that are new to a manufacturing environment, they require training and a different outlook to support this transition. It is a cultural change, which extends from manufacturing through maintenance, quality assurance, engineering, and management. Experience in other industries has shown that thorough initial testing of products is important. Screening to determine the suitability of materials and selecting processing conditions are significant initial steps. Test-processing products thoroughly is essential to obtain data supporting optimization of these conditions. It is equally essential that testing demonstrates the performance of the product with down-line unit operations, especially in continuous manufacturing.

Industry participants are finding that HTST pasteurization and UHT sterilization provide another tool for the manufacture of bio/pharmaceuticals. They have found products for which theses processes are strikingly successful and those for which they are not suitable. More importantly, perhaps the most interesting benefit is the ability to facilitate the development of entirely new products.

References

1. K. Weintraub, “Biotech Firms Race For Manufacturing Breakthrough,” MIT Technology Review Business Report, Jan. 30, 2013, www.technologyreview.com/news/509336/biotech-firms-in-race-for-manufacturing-breakthrough.

2. A. Jungbauer, Biotechnol. J. 6 (12), 1431–1434 (2011).


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