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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Pretreatment Considerations for Pharmaceutical Water Treatment Systems
Pretreatment and Its Purpose It is common to value-engineer the pretreatment stage of a high-purity water treatment system, often with detrimental long-term consequences for operation…
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Feed Water Challenges for Pharmaceutical Vapor Compression Stills
Background Vapor Compression (VC) Distillation has been utilized for decades in producing Water for Injection (WFI), particularly for high-capacity needs. Also, while reverse osmosis and…
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Added Substances in Pharmaceutical Waters
Added Substances It may be necessary to supplement certain pharmaceutical preparations to preserve, increase the stability, or improve the efficacy of the active ingredient(s). Except…
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NEW FDA GUIDANCE ON NITROSAMINE TESTING IN PHARMACEUTICAL WATERS
In September 2024, the FDA released Revision 2 of their guidance document titled “Control of Nitrosamine Impurities in Human Drugs Guidance for Industry.” This updated…
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