Cleaning Validation
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In this episode of the AI Pill for Pharma, our esteemed guest is Mr. Thomas Altmann, Global Technical Manager at Ecolab.
Mr. Altmann has 20+ years of experience in pharmaceutical, biotechnology and personal care cleaning process optimization and validation
In this episode, Altmann pinpoints incorrect limit setting as the paramount mistake in the industry, emphasizing that the misunderstanding of health-based exposure limit calculations leads to inefficiencies and potential safety risks. He critiques the reliance on outdated methods like the 10 PPM criteria and LD 50-based calculations, advocating for a risk-based approach that ensures safety without stifling innovation. He underscores the importance of setting operational limits well below health-based exposure limits to allow room for action and ensure absolute safety.
… and more. Tune in!
Top FDA observations Cleaning Validation in Pharma Industry
Build understanding on the recent FDA observations in cleaning validation.
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