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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What Do We Really Know?
At a Pentagon press briefing in 2002, then U.S. Secretary of Defense Donald Rumsfeld was asked about reports suggesting there might not be evidence of…
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Review of a Recent FDA Warning Letter Regarding Pharmaceutical Water
It is not uncommon for FDA Warning Letters to cite concerns regarding pharmaceutical water systems, although such citations seem to have become more frequent recently.…
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Foreign Substances & Impurities in USP Waters: The Effect of Proposed Changes on Testing and Monitoring
Background Earlier this year (2024), the USP published Pharmacopeial Forum 50(2), which introduced proposed changes to the General Notices section of the USP for public…
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Is Integrity Testing of Vent Filters on Compendial Water System Tanks a cGMP Requirement?
The short answer is yes for WFI applications and possibly for Purified Water tanks, but confusion still surrounds the topic. If you were to ask…
IonClear 