The United States Pharmacopeia (USP) and others, such as EP, JP, and ChP, have developed test techniques to ensure that particle counts are kept to a minimum in intravenous injections (parenteral ...
The following article talks about a new machine condition measurement system which integrates particle count data and elemental analysis information in two closely interlinked measurement phases. This ...
This article outlines guidelines for the testing of high pressure gases utilized in cleanrooms according to the cleanliness limits stated in the FDA cGMP guidelines, the ISO 14644-1 cleanroom ...
Tomographic Particle Image Velocimetry (Tomo-PIV) is a 3D particle image velocimetry technology combined with computed tomography (CT), which can realize full-field quantitative measurement of spatial ...
The latest instruments could be provided by a new vendor or the existing manufacturer. It is common for new models to be sourced due to product obsolescence or enhanced specifications, even when the ...
This article outlines improvements and changes to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which during aseptic processing, is a regulatory ...
Modern manufacturing techniques frequently require clean environments designed, constructed, and maintained to facilitate the highest production yields possible while also meeting predictable ...
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