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.
iSpeak Blog
Validation of an Autoclave Cycle
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
Video
Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory
Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory…
PE Articles
New Edition of Ozone Sanitization Good Practice Guide
The second edition of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water…
Video
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume Complimentary Learning…
PE Articles
Setting Net-Zero Targets: Tangible Benefits of Sustainability
Many organizations are on the right path to sustainability, but more can still be done— especially…
PE Articles
Decarbonizing Pharmaceutical Manufacturing Facilities
Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This…
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…
Guidance Documents
Commissioning & Qualification (1)
Critical Utilities (7)
- 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: 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 (5)
Quality Control (1)
Pharmaceutical Engineering Magazine Articles
New Edition of Ozone Sanitization Good Practice Guide
The second edition of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water…
Setting Net-Zero Targets: Tangible Benefits of Sustainability
Many organizations are on the right path to sustainability, but more can still be done— especially…
Decarbonizing Pharmaceutical Manufacturing Facilities
Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This…
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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