High Purity Water Systems: FDA Inspection Guide Explained
What the FDA high purity water inspection guide covers, and what current USP, Ph. Eur., EMA and WHO texts expect from Purified Water and WFI systems today.
Microbiology
Sterility Test: Meaning, Methods, Media and Limits (USP <71>)
What a sterility test is, how membrane filtration and direct inoculation work, media (FTM, SCDM), 14-day incubation and why it cannot prove sterility (USP <71>, Ph. Eur. 2.6.1).