One of the main goals of pharmaceutical regulatory rules is to keep environmental contamination at a minimum. According to the EU GMP Annex 1 regulatory standard for sterile drug products, a ...
Biotech and pharmaceutical products must be manufactured in compliance with the current Good Manufacturing Practice (cGMP) regulations. Monitoring these areas meets the requirement for environmental ...
This article addresses a common misunderstanding among some users regarding non-volumetric particle counters. Some users believe that dividing particle counts by the counting efficiency (CE) at the ...