Keith Shuttleworth

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Keith Shuttleworth served as an Engineering Officer in the Merchant Navy where he was involved in both the theoretical and practical aspects of steam production, distribution, and usage in a number of applications such as propulsion, power generation turbines, pumps, heating, and distillation. He worked as an Engineering Manager in the UK’s National Health Service and the pharmaceutical industry, where he has been responsible for both plant and clean steam generation/distribution. For the past 27 years, Keith has worked as a consultant providing advice and training on steam sterilization and steam quality, while developing and selling equipment for the testing of steam quality. He has been a member of two PDA Task Forces for the generation of PDA Technical Report Nos. 1 and 61 and has presented at PDA and ISPE venues on a number of topics. Keith worked as a Registered Authorising Engineer (Decontamination) from 1994 to 2019.

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Figure 1: Thermal energy capacity: steam versus electricity.
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Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to grow in process industries around the world. However, there is very little written about the commissioning and qualification of pharmaceutical pure steam systems in GMP regulations or regulatory guidance. This article provides the background and science behind the steam quality tests and proposes a...