Water

Figure 1: Example of OWBA installation in a WFI system.
Technical
GMP Implementation of Online Water Bioburden Analyzers

Online water bioburden analyzers (OWBAs) are analytical instruments providing real-time or near real-time measurement of bioburden in purified water systems.1

  • 1Cundell, A., O. Gordon, N. Haycocks, et al. “Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and Business Benefits for Microbiological Risk Reduction. American Pharmaceutical Review 16,...
Conductivity Measurement and Its Calibration
Knowledge

Conductivity Measurement and Its Calibration

This presentation from the Critical Utilities Community of Practice was given in February of 2017. Conductivity – What is it ? How and why it is...
Mobile water treatment in an ISO container
Technical
A New Qualification Approach for Mobile Purified Water Systems

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 qualification concept for mobile water treatment has been developed to align with guidance from various...

Article
Technical
Corrosion Investigation of Pharma Clean Steam Systems

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.

Guidance Docs

Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases

Good Practice Guides
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.
Training
Training

Pharmaceutical Water Systems

This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of....
Training
Training

Storage, Delivery, and Qualification Pharma Water Training Course

This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE....