Gradical Podcast - The Podcast about Plastics in Medical Technology

How Do You Choose The Right Sterilization Method For Your Device? with Manuel Grandy

Lucas Pianegonda

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0:00 | 43:22

If you are building or scaling a medical device, sterilization problems will catch up with you. Usually later in the process than you want.

In this episode, I speak with Manuel Grandy, Consultant and Managing Partner at SteriComp GmbH, about what sterilization actually means in practice and why so many teams underestimate it until regulators start asking uncomfortable questions.

We talk about ETO gas, gamma radiation, and why there is no universally “correct” sterilization method. The right choice depends on materials, device design, supply chain constraints, and how well you understand the science behind the standards.

Manuel explains why sterile does not mean clean, why following a standard word-for-word is sometimes not enough, and how small decisions like where you place a biological indicator can delay approval by months.

If you work in MedTech development, quality, regulatory, or manufacturing, this episode will help you avoid painful surprises and make better decisions much earlier.


Connect with Manuel Grandy:
LinkedIn: https://www.linkedin.com/in/sterilisation/

Connect with us:
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📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch


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