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.
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…
Guidance Documents
Commissioning & Qualification (1)
Critical Utilities (8)
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition
- Good Practice Guide: Ozone Sanitization of Pharma Water Systems
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Critical Utilities GMP Compliance
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Microbiological & Viral Contamination Control (6)
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: Ozone Sanitization of Pharma Water Systems
- Good Practice Guide: Membrane-Based WFI Systems
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Quality Control (1)
Pharmaceutical Engineering Magazine Articles
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…
Webinars
iSpeak Blog Posts
Professional Development Training
Critical Utility GMP Compliance
This course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics. The content is primarily based on the new ISPE Good Practice Guide “Critical Utilities GMP Compliance”.
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 Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.
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 water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered.
Pharma Water Generation USP WFI & Purified Water Training Course
This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.
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