112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer

Let's Combinate · 29 Nov 2023 · 47m

What this episode covers

Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting, explains the technical nuances of steam and dry heat sterilization for pharmaceutical and combination products. She details the selection of biological indicators like Geobacillus stearothermophilus and Bacillus smithi, noting how solution chemistry and surface contact alter their heat resistance. The discussion covers the distinction between overkill and product-specific cycles, the calculation of F0 values, and the historical shift toward parametric release to accelerate product availability.

Most relevant to

established companies

Topics

Mentioned

Companies: Excellent Pharma Consulting, Parenteral Drug Association, Baxter, FDA
Also: Geobacillus stearothermophilus, Bacillus smithi, Burkholderia cepacia, USP, EP

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Medical & health devices Quality & yield
10 chapters

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