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Annex 1 and your isolator!

10th Jul, 2024

Annex 1 Compliance and Hydrogen Peroxide Isolators: Ensuring Sterility in Pharmaceutical Manufacturing

In the industry, maintaining stringent sterility standardise is paramount to ensuring patient safety and product efficacy. The Annex 1 guidelines provide a comprehensive framework for the manufacturing of sterile medicinal products and hydrogen peroxide isolators play a crucial role in achieving compliance with these guidelines.

Brian McBride, a QA pharmacist at Altnagelvin Hospital in Ireland, published his disinfection validation work in the peer-reviewed journal EJPPS in January 2023. He also presented his work at the QA Symposium in Newport Sept 2023. 

Hydrogen peroxide is crucial in aseptic manufacturing. With the Phileas centrifugation technology , there is no need to revamp expensive and complicated isolators. Phileas® Genius + O2SAFE® is the perfect solution for safe and reliable 6 log10 disinfection.

In this article, Brian McBride explains how he validated the disinfection method: qualifying performance with 3 successive cycles, with biological indicators (Geobacillus stearothermophilus ). Brian now uses several Phileas® Genius for the different isolators in the hospital.





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