Hardware Podcasts

131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer

Let's Combinate · 10 Apr 2024 · 42m

What this episode covers

Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting, explains the regulatory framework for sterilizing drug-device combination products, focusing on the EMA's decision tree which prioritizes terminal sterilization over aseptic filling. She details novel methods such as liquid phase sterilization, ionization, and high-pressure techniques, noting that pharmaceutical companies are often reluctant to adopt them due to perceived regulatory risk despite their availability. Moldenhauer argues that traditional methods (steam, dry heat, radiation, gas, aseptic) are sufficient for nearly all products, but novel approaches like liquid phase sterilization are critical for complex items like 3D-printed artificial organs.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Excellent Pharma Consulting, Sterigenics
Also
EMA, FDA, USP 1229, MAPP 504.01, PDA

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