Read my latest thoughts & opinions on contamination control, ultrapure water, as well as periodic reflections on business and life
Opinions are mine alone and I reserve the right to change them at any time
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Options to Reduce CapEx for a Pharmaceutical Water System
The reasons to spend lavishly on a high-end pharmaceutical water system are plentiful, with the most important being risk mitigation. Upscale systems generally provide more…
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Nitrosamine Testing Requirements for Pharmaceutical Waters
While the topic of nitrosamines in drug products continues to be a widely discussed topic, there is still no guidance or mandated maximum allowable levels…
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Nitrosamines in Pharmaceutical Waters: Origins, Risk Mitigation, and Testing Requirements
Nitrosamines are organic compounds, long known to be probable carcinogens, yet are found in low level concentrations in air, water, soil, and food. Both FDA…
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When to Consider Use-Point Sampling of Pharmaceutical Waters for Conductivity and TOC
Inline conductivity and online* Total Organic Carbon (TOC) monitoring in pharmaceutical water distribution systems has been used for final product quality verification for decades. One…
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