In aseptic Good Manufacturing Practice (GMP) facilities, compliance with USP <790> and EU GMP Annex 1 is critical to ensure the safety and quality of parenteral products. These regulations demand rigorous control of visible particulates, focusing on identifying...
The Challenge: Caked-Up Residues and Cleaning Risks In pharmaceutical Good Manufacturing Practice (GMP) facilities, tablet coating machines, such as pan coaters and fluid-bed coaters, accumulate hardened residues like hydroxypropyl methylcellulose (HPMC), polyvinyl...
Controlling fiber and particle contamination in cleanrooms used for producing and assembling single-use bio production systems is crucial for ensuring the quality and safety of the final product. Particulate matter, such as mobile substances and extraneous materials,...
