One of the quality characteristics defined in the European and USA pharmacopeias for pharmaceutical waters is Total Organic Carbon (TOC) 1. Contemporary water treatment systems are able to provide ...
The FDA emphasizes the importance of corrective and preventive action (CAPA) for any deviations potentially impacting product quality In their 21CFR guidance. Regulatory authorities expect ...
What changes do you see in pharmaceutical water regulations in the near future? Improvements in water treatment system design and technologies has lead the European Directorate for the Quality of ...
All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this purity, microorganisms ...
The International Society for Pharmaceutical Engineering (ISPE) now offers five professional development certificate programs: Biopharmaceutical Essentials, GAMP® Essentials, Good Engineering ...
This month’s B2B focuses on a new cooling tower to serve a pharmaceutical facility’s new process water system. This tower will be a closed-loop, evaporative condenser to operate 24/7/365. The tower ...