Critical Utilities

Critical Utilities (Crit Util) like water and HVAC (Heating, Ventilation, and Air Conditioning) systems form the backbone of the manufacturing process. As a result, these are treated, as products that must satisfy FDA regulatory requirements and pharmaceutical manufacturing standards, just like raw materials and other equipment used in the industry.
Guidance Documents
Guidance Documents
Guidance Documents
Guidance Documents
Guidance Documents
Simplifying Biowaste Inactivation by Combining Systems
Online TOC Comparison: Sensors and Analyzers
Case Study: Enhance Microbial Monitoring with At-Line Analysis
New GPG Explores Membrane-Based WFI Systems
Figure 1: Thermal energy capacity: steam versus electricity.
 |  PE Articles
Introduction to Steam Quality and Testing
Is a Membrane-Based Water for Injection System Right for Your Facility?

Related Guidance Documents

Commissioning & Qualification (1)

Critical Utilities (8)

Microbiological & Viral Contamination Control (6)

Quality Control (1)

Regulatory (2)

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Pharmaceutical Engineering Magazine Articles

New GPG Explores Membrane-Based WFI Systems
ISPE Briefs: New GPG Explores Membrane-Based WFI Systems
For nearly a century, production of water for injection (WFI) was universally accepted to be…
Figure 1: Thermal energy capacity: steam versus electricity.
Introduction to Steam Quality and Testing
Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to…
Figure 3: AUC used as the metric evaluator for models 1 to 5 (2020 data) and model 1 (2018 data, bottom right).
Case Study: Water for Injection Plant AI-based Maintenance
This article presents the results of applying artificial intelligence (AI), such as machine learning…
Figure 1: Example of OWBA installation in a WFI system.
GMP Implementation of Online Water Bioburden Analyzers
Online water bioburden analyzers (OWBAs) are analytical instruments providing real-time or near real…
New ISPE Good Practice Guide on Critical Utilities
New ISPE Good Practice Guide on Critical Utilities
ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant…
Chlorine dioxide gas sample readings (mg/L) charted over time
Chlorine Dioxide Gas Decontamination vs. Liquid Disinfection
Manual decontamination procedures are laborious processes and can be costly, requiring significant…
Company A energy audit summary (annual carbon savings by utility category).
Two Real-World Experiences in Global Sustainability
The article appraises the real-world experiences of two pharmaceutical companies approaching the…