Hardware Podcasts

114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer

Let's Combinate · 13 Dec 2023 · 43m

What this episode covers

Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting, explains the technical and regulatory nuances of irradiation sterilization for combination products, comparing gamma, e-beam, and x-ray modalities. She details how product density, material degradation (such as free radical formation), and bioburden levels dictate cycle development and dose selection. The discussion covers the shift toward terminal sterilization of finished auto-injectors and pre-filled syringes, highlighting the validation timelines and the critical role of dosimeters in ensuring sterility assurance levels (SAL).

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Excellent Pharma Consulting, Baxter
Also
Jeanne Moldenhauer, Subi Sedate, Parenteral Drug Association, FDA

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