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.
Product
Good Practice Guide: Membrane-Based WFI Systems
The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on…
Product
Good Practice Guide: Critical Utilities GMP Compliance
The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant…
PE Articles
ISPE Briefs: New GPG Explores Membrane-Based WFI Systems
For nearly a century, production of water for injection (WFI) was universally accepted to be…
PE Articles
Introduction to Steam Quality and Testing
Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to…
iSpeak Blog
Is a Membrane-Based Water for Injection System Right for Your Facility?
For nearly a century, production of Water for Injection (WFI) was universally accepted to be…
Video
Design, Install & Maintain a Pharmaceutical Compressed Air System
Design, Install & Maintain a Pharmaceutical Compressed Air System Complimentary Learning Level…
PE Articles
Electrochemical Techniques for Onsite Surface Qualification
Pharmaceutical critical utilities are typically built of 316L stainless steel; nevertheless, surface…
PE Articles
Cold Systems as a Solution to Decarbonize Water Purification
The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions…
Product
Good Practice Guide: Process Gases 2nd Edition
The ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction…
Product
Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design…
Product
Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition
Published: July 2014 Pages: 120 Table of Contents Special Pricing for Emerging Economies Water and…
Product
Good Practice Guide: Ozone Sanitization of Pharma Water Systems
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides important…
Product
Good Practice Guide: Membrane-Based WFI Systems
The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on…
Product
Good Practice Guide: Critical Utilities GMP Compliance
The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant…
PE Articles
ISPE Briefs: New GPG Explores Membrane-Based WFI Systems
For nearly a century, production of water for injection (WFI) was universally accepted to be…
PE Articles
Introduction to Steam Quality and Testing
Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to…
iSpeak Blog
Is a Membrane-Based Water for Injection System Right for Your Facility?
For nearly a century, production of Water for Injection (WFI) was universally accepted to be…
Video
Design, Install & Maintain a Pharmaceutical Compressed Air System
Design, Install & Maintain a Pharmaceutical Compressed Air System Complimentary Learning Level…
PE Articles
Electrochemical Techniques for Onsite Surface Qualification
Pharmaceutical critical utilities are typically built of 316L stainless steel; nevertheless, surface…
PE Articles
Cold Systems as a Solution to Decarbonize Water Purification
The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions…
Product
Good Practice Guide: Process Gases 2nd Edition
The ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction…
Product
Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design…
Guidance Documents
Commissioning & Qualification (1)
+Critical Utilities (8)
+Microbiological & Viral Contamination Control (6)
+Quality Control (1)
+Regulatory (2)
+Pharmaceutical Engineering Magazine Articles
Case Study: Water for Injection Plant AI-based Maintenance
This article presents the results of applying artificial intelligence (AI), such as machine learning…
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
ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant…
Chlorine Dioxide Gas Decontamination vs. Liquid Disinfection
Manual decontamination procedures are laborious processes and can be costly, requiring significant…
Two Real-World Experiences in Global Sustainability
The article appraises the real-world experiences of two pharmaceutical companies approaching the…
Electrochemical Techniques for Onsite Surface Qualification
Pharmaceutical critical utilities are typically built of 316L stainless steel; nevertheless, surface…
Cold Systems as a Solution to Decarbonize Water Purification
The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions…
ISPE Briefs: New GPG Explores Membrane-Based WFI Systems
For nearly a century, production of water for injection (WFI) was universally accepted to be…
Introduction to Steam Quality and Testing
Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to…
Case Study: Water for Injection Plant AI-based Maintenance
This article presents the results of applying artificial intelligence (AI), such as machine learning…
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
ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant…
Chlorine Dioxide Gas Decontamination vs. Liquid Disinfection
Manual decontamination procedures are laborious processes and can be costly, requiring significant…
Two Real-World Experiences in Global Sustainability
The article appraises the real-world experiences of two pharmaceutical companies approaching the…
Electrochemical Techniques for Onsite Surface Qualification
Pharmaceutical critical utilities are typically built of 316L stainless steel; nevertheless, surface…
Cold Systems as a Solution to Decarbonize Water Purification
The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions…
ISPE Briefs: New GPG Explores Membrane-Based WFI Systems
For nearly a century, production of water for injection (WFI) was universally accepted to be…
Introduction to Steam Quality and Testing
Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to…
Case Study: Water for Injection Plant AI-based Maintenance
This article presents the results of applying artificial intelligence (AI), such as machine learning…
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