January / February 2021

Technical

Online water bioburden analyzers (OWBAs) are analytical instruments providing real-time or near real-time measurement of bioburden in purified water systems.1

  • 1Cundell, A., O. Gordon, N. Haycocks, et al. “Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and Business Benefits for Microbiological Risk Reduction. American Pharmaceutical Review 16,...
Technical

The process life-cycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation.1

  • 1US Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” January 2011.
Insights

My parents always told me when I was growing up that I could be anything I wanted to be. They strongly steered me in the direction of engineering at North Carolina State University, so that I would be able to earn a degree that would ensure my future was my own. When I was eight years old, I was introduced to a pharma company my dad worked for and you could say my love of this industry has...

Insights

I think everyone will join me in celebrating the start of 2021! With all the challenges brought by 2020, last year also demonstrated the resilience and innovative thinking of ISPE members. With collaboration and perseverance in mind, I was delighted to begin my tenure as ISPE International Emerging Leaders Chair at the virtual