林旭-清洁验证培训稿.ppt

Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 2 Mar 1, 2008By: A. Hamid Mollah, PhDBioPharm InternationalVolume 21, Issue 3  ? Previous 1234 Next ? VALIDATION SAMPLING Sampling depends on the characteristics of soiling and cleaning agents. At Genentech, swabbing and visual inspection are used to inspect product-contact surfaces directly for assessment of surface cleanliness. Visual inspection and surface Fourier transform infrared spectroscopy (FTIR) are sometimes called real direct surface sampling. Rinsate sample testing for pH, conductivity, total orga