Online water bioburden analyzers (OWBAs) are analytical instruments providing real-time or near-real-time measurement of bioburden in purified water systems.Cundell, A., O. Gordon, N. Haycocks, et al. “Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and Business...
The unavailability of a backup pharmaceutical water system has been a severe limitation for pharmaceutical manufacturers. Until recently, qualification concepts that adhered to current Good Manufacturing Practice (GMP) guidelines hindered the rapid setup of a water system. A new, tailor-made...
This article presents current research on the problem of rouge in clean steam generators and their distribution systems, as well as possible deleterious effects on capital equipment and final drug products.
Why is water so crucial to the pharmaceutical industry?
Water is required for production of all pharmaceutical products and can be the most expensive ingredient in some applications due to the large volumes required for production and cleaning. Water...
The ISPE Good Practice Guide on Sampling for Pharmaceutical Water, Steam, and Process Gases was created for users of water, steam, compressed air or process gases and impacts facilities, production, and quality control personnel within a facility.
This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with....
This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to....