Critical Utilities COP E-Letters

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E-Letters

E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs). The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.

*COPs are now an ISPE Member-only benefit, therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing all E-Letter content and other valuable resources that will assist you in being more effective at your job.

April 2013

Dissolved Ozone in Pharmaceutical Water Systems 101
Dissolved ozone is gaining in popularity with pharmaceutical companies. Unfamiliar with this unique ambient water loop sanitizer? Nissan Cohen provides the basics. More. ( 179 KB)

Advances in Vapor Compression Technology for the Production of USP Purified Water and Water For Injection
An article by George V. Gsell, Chet Nunez, and Michael Smith-Palmer in the March/April 2013 issue of Pharmaceutical Engineering presents the advancements in vapor compression technology and how these advancements affect the efficiency and reliability of the equipment. More.

ISPE Critical Utilities Sampling Guide – Call for Contributors
Have you ever had challenges with sampling? Inconsistent results? More variability than expected? Excursions that mysteriously disappeared? Trouble identifying the root cause?  Regardless of whether sampling closed systems such as pharmaceutical water, steam, or process gas streams, or open systems such as controlled environment systems, the extraction of truly representative samples poses unique challenges in the industry. The ISPE Critical Utilities Steering Committee is forming a team to address sampling issues, and produce a comprehensive Good Practice Guide focused on best practices covering all aspects of sampling. If you have sampling expertise and would like to participate, we welcome your input and encourage you to get involved with this important Good Practice Guide. Please contact the GPG leader Brian Hagopian at brian@clear-water-consulting.com.

2013 ISPE Critical Utilities Training
ISPE will offer training courses on Pharmaceutical Water Generation and Storage Delivery and Qualification of Pharmaceutical Waters both in May in St. Louis, Missouri, USA, in September in Burlingame, California, USA, and in December in Tampa, Florida, USA.

Newly Revised COP Operations Handbook Now Available
The Community of Practice (COP) Operations Handbook has been recently revised to provide guidance on governance, organizational structure, and operational procedures for COPs. The Operations Handbook is intended to serve as a resource for COP Steering Committee Members and local COP leaders, as well as all Volunteer groups or individuals who interact with ISPE COPs. Visit the Volunteer Resources section of the ISPE website to download a copy of the newly revised COP Operations Handbook.

January 2013

Spray Devices in Pharma Water Tanks/Vessels – Are They Needed?
Spray devices are among the most misapplied and misunderstood components considered for application within pharmaceutical water systems, according to an article by Joe Manfredi. Rethinking the use of spray balls in pharmaceutical water tanks is appropriate in a risk-based environment and may be one part of an overall system improvement approach. More. ( 223 KB)

Proposed Changes to USP <645> Water Conductivity
In 1996, the United States Pharmacopoeia (USP) adopted historic changes to the Purified Water and Water for Injection monographs by deleting the chemical tests of pH, chloride, sulfate, calcium, ammonia, and carbon dioxide, and replacing these with a single test of conductivity. This is expressed in USP general chapter <645> Water Conductivity which has been the model for other pharmacopeia to adopt. This general chapter has remained virtually untouched since its inception, with the exception of adding specific methods and test limits for Sterile Waters. In Pharmacopeial Forum 38(6) Nov/Dec 2012 edition, an update to <645> Water Conductivity has been proposed. The revision proposal is dedicated to providing consistent and modern terminology and clarity in the calibration requirements. It is clearly noted that there are no changes to the test methodologies, test limits, calibration requirements, or the types of waters to be tested. Public comment to this proposal is accepted until February 2013. An article by Anthony Bevilacqua provides an overview of the changes. More. ( 29 KB)

Sampling and Analysis
How many times have you heard the question "what is the proper way to store water samples for QC testing?" or "where should I collect samples for microbial testing?" or "how long do I flush the hose" or "can I use on-line chemical testing for water release?" If you are Dr. Teri (T.C.) Soli, the answer is most likely "it depends." It depends on many factors such as the purpose of the testing, how the water is used in production, the design of the water system, etc. With more water system designers and owners moving to (or at least considering) on-line testing, there is more emphasis and questions about proper sampling locations and validation. For more traditional off-line sampling, the questions are equally challenging. Is the data for process control or quality control? How often to sample? What are good and not-so-good practices? What are regulatory authorities looking for?

A presentation by Dr. T.C. Soli answers many of these questions. This presentation does not represent the views of ISPE, USP, or other individuals. It does represent Dr. Soli's view about the strategies and tactics to employ in the development of a realistic sampling plan. More. ( 330 KB)

ISPE Critical Utilities Sampling Guide – Call for Contributors
Have you ever had challenges with sampling? Inconsistent results? More variability than expected? Excursions that mysteriously disappeared? Trouble identifying the root cause?  Regardless of whether sampling closed systems such as pharmaceutical water, steam, or process gas streams, or open systems such as controlled environment systems, the extraction of truly representative samples poses unique challenges in the industry. The ISPE Critical Utilities Steering Committee is forming a team to address sampling issues, and produce a comprehensive Good Practice Guide focused on best practices covering all aspects of sampling. If you have sampling expertise and would like to participate, we welcome your input and encourage you to get involved with this important Good Practice Guide. Please contact the GPG leader Brian Hagopian at brian@clear-water-consulting.com.

ISPE Critical Utilities Conferences
ISPE will hold two conferences in 2013 focused on Critical Utilities. “Cost Optimization Alternatives for Critical Utilities” will be held 25 – 26 February in Tampa, Florida, USA. “The Challenges of Physical States – Gases, Water and Steam” will be held 12 – 13 March in Copenhagen, Denmark.

October 2012

Calculating the Cost of Purified Water or WFI by the Gallon, Liter, or Metric Ton
Every water system is different as a result of different components, operating times, labor costs, sanitization and maintenance schedules, replacement component costs, instrumentation costs, utility costs, etc. However, you can determine the total cost of ownership by following these calculations and suggestions. More. ( 16 KB)

Proposed Changes to Test Limits for USP Sterile Water Monographs
The United States Pharmacopoeia (USP) has proposed changes to the monograph for Sterile Water for Injection and potential changes to other Sterile Water monographs and related test chapters <645> Water Conductivity and <643> Total Organic Carbon. Here are the details on these changes and their potential impact to your work. More. ( 53 KB)

New Guide Provides Holistic View of Ozone Sanitization Systems
The use of ozone to sanitize pharmaceutical water storage and distribution systems has increased as manufacturers of drug components and substances strive for innovative methods to reduce capital and operating costs. But, there is no regulatory or detailed industry standard or guidance on the topic. The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Systems provides a comprehensive overview of the requirements, advantages, and disadvantages to consider when choosing ozone over other sanitization solutions.

Updated Water and Steam Guide Addresses Decade of Changes in Regulations and Industry Practices
The ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition) has been completely revised to address changes in industry practices and global regulations over the past decade. More.

Guide Defines Current Best Practices for Process Gas Systems in Pharmaceutical Manufacturing
The ISPE Good Practice Guide: Process Gases aims to define current best practices that come into direct contact with the biopharmaceutical and pharmaceutical process streams, such as nitrogen, oxygen, argon, and compressed air. More.

July 2012

What Do You Know About Ozone?
The use of ozone to sanitize pharmaceutical water storage and distribution systems has increased as manufacturers of drug components and substances strive for innovative methods to reduce capital and operating costs. But, there is no regulatory or detailed industry standard or guidance on the topic. ISPE will release next month the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Systems, which provides a comprehensive overview of the requirements, advantages, and disadvantages to consider when choosing ozone for sanitization over heat and chemical solutions. More.

Behind-the-Scenes Primer for the ISPE Good Practice Guide: Process Gases
Lead authors of the ISPE Good Practice Guide: Process Gases share the reason why ISPE developed the guide and what you should focus on as a reader. More. ( 45 KB)

Updated Water and Steam Guide Addresses Decade of Changes in Regulations and Industry Practices
ISPE released the long-awaited ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition). Reviewed by the US FDA, the Guide has been completely revised to address changes in industry practices and global regulations over the past decade. More.

April 2012

Potential Savings Using the Updated ISPE Water and Steam Guide
A presentation by an author of the newly released ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition) provides an overview of why the original guide was revised, the revisions (including new content), and potential water/energy/cost savings that may be realized through modern industry practices discussed in the Guide. More. ( 2 MB)

Overview of Upcoming Guide on Ozone Sanitization of Pharmaceutical Systems
A presentation provides an overview of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Systems, which is expected to be published in second quarter 2012. Ozone usage for sanitization of pharmaceutical water storage and distribution systems has increased over the last few years as manufacturers and drug components and substances strive for innovative methods to reduce capital and operating costs. Although its use has increased, there is no regulatory or detailed industry standard or guidance on the topic. More. ( 268 KB)

Overview of the ISPE Good Practice Guide: Process Gases
A presentation provides an overview of the ISPE Good Practice Guide: Process Gases. Published in July 2011, the Guide aims to define current best practices within pharmaceutical manufacturing applications in regards to gases that come into direct contact with the biopharmaceutical and pharmaceutical process streams, such as nitrogen, oxygen, argon, and compressed air. More. ( 187 KB)

USP/ISPE Survey of Pharmaceutical Water System Users on the Use of Non-Distillation Systems for the Production of WFI
An article in the November/December 2011 issue of Pharmaceutical Engineering presents the results of a jointly sponsored USP/ISPE survey of the pharmaceutical industry and analyzes the potential to use alternative methods of production (other than distillation) as the final purification in the preparation of Water for Injection (WFI). More.

Online Rouge Monitoring:  A Science-Based Technology to Measure Rouge Rates
An article in the November/December 2011 issue of Pharmaceutical Engineering presents the implementation and installation of an online rouge monitor which measures in near real-time the rouge rate and accumulation (metal loss) over time helping to determine derouging and passivation frequency based on empirical data. More.

New ISPE Training Course on Pharmaceutical Water Generation
Pharmaceutical water is perhaps the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for generating USP Purified Water and USP Water for Injection. The course has been substantially updated to feature the guiding principles of the newly released ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition) with particular emphasis on new chapters on microbial control and laboratory water, as well as key design philosophies. The course, to be held 23-24 April in Atlanta, Georgia, USA, includes a pre-recorded Webinar on basic concepts to be provided before the training event. More.

New ISPE Training Course on Storage, Delivery, and Qualification of Pharmaceutical Waters
This course explores 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 newly released ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition) with particular emphasis on new chapters on microbial control, laboratory water, and rouging. The course will be held 25-26 April in Atlanta, Georgia, USA and 30 May-1 June in Brussels, Belgium. More.

January 2012

Updated Water and Steam Guide Addresses Decade of Changes in Regulations and Industry Practices
ISPE released the long-awaited ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition). Reviewed by the US FDA, the Guide has been completely revised to address changes in industry practices and global regulations over the past decade. More.

Pharmaceutical Engineering Issue Focuses on Utilities
The November/December 2011 issue of Pharmaceutical Engineering includes articles on predictive maintenance techniques, online rouge monitoring, weld discoloration, in-situ testing of ePTFE HEPA filters, and the USP/ISPE Water Survey results. More.

New Critical Utilities Training Courses for 2012
ISPE 2012 Training will feature two new Critical Utilities courses, both to be held 21-22 March at its San Diego, California training event and 25-26 April at its Atlanta, Georgia training event:

Available Now – ISPE Good Practice Guide: Process Gases
The ISPE Good Practice Guide: Process Gases aims to define current best practices within the pharmaceutical manufacturing applications in regards to gases that come into direct contact with the biopharmaceutical and pharmaceutical process streams, such as nitrogen, oxygen, argon, and compressed air. More.

Guide on Ozone Sanitization of Pharmaceutical Systems Closer to Publication
Draft 2 of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Systems is undergoing final edit in preparation for publication. Ozone usage for sanitization of pharmaceutical water storage and distribution systems has increased over the last few years as manufacturers and drug components and substances strive for innovative methods to reduce capital and operating costs. Although its use has increased, there is no regulatory or detailed industry standard or guidance on the topic. More.

October 2011

The ISPE Good Practice Guide: Process Gases – What Were They Thinking?
A lead author of the recently published ISPE Good Practice Guide: Process Gases shares some behind-the-scenes thinking on the making of the document and what you should focus on as a reader. More. ( 45 KB)

Under Construction – Guide on Ozone Sanitization of Pharmaceutical Water Systems
While conceptually, ozone use in water systems is understood, when it comes to the specification of system user requirements, design details operational issues, there are many different considerations. Enter, the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems. Currently undergoing final edit in preparation for ISPE’s Guidance Documents Executive Committee (GDEC) review, the Guide’s objective is to provide detailed guidance related to design, operation, and verification of water storage and distribution systems using ozone for sanitization. More.

Critical Utilities Education at ISPE 2011 Annual Meeting
The quality of water, steam, and gases must be verified where the utility is delivered. The “Critical Utilities” session will address risk-based sampling programs, GMP sampling techniques, sources of error, and corrective action. Case studies will be presented for on-line release and supplementary analytical techniques. Design challenges with use-point design and acquiring representative samples will be discussed. This includes the frequency of use-point monitoring for critical utilities and elimination of use-point testing altogether. This session will serve as a springboard for the proposed ISPE Good Practice Guide on Sampling for Critical Utilities. More.


July 2011

Forum Features 268 Discussion Threads on Critical Utilities
Need an answer to your Critical Utilities question? Check out an archive of 268 discussion threads compiled by the CU COP. In addition to being a useful FAQ tool, this alphabetical listing shows the diversity of topics and frequency of discussion on Critical Utilities. More ( 104 KB) .

Scope, Background, and Procedure for Validating a Pharmaceutical Water System using Process Analytical Technology
The pharmaceutical water system as designed is a perfect candidate for the application of PAT, according to an article by Nissan Cohen More ( 91 KB) .

ISPE 2011 Classroom Training to Feature Courses on Pharmaceutical Water
Indianapolis Training in Indianapolis, Indiana, USA, will include courses on:

Norwood Training in Norwood, Massachusetts, USA, will include a course on:


April 2011

Dissolved Ozone in Pharmaceutical Water Systems: Why Use and Measure Dissolved Ozone
Charles W. Eliot was quoted as saying that “all business proceeds on beliefs or judgments of probabilities; and not on certainties.” This is also largely true of what we call science today. The analysis of dissolved ozone in USP or general pharmaceutical waters is no exception. There are risks and rewards for using the ambient sanitizer. A paper by Nissan Cohen seeks to establish a fundamental understanding of dissolved ozone and its use in a pharmaceutical water plant. More ( 82 KB) .

Development and Mission of the Critical Utilities Community of Practice (CU COP)
A summary provides a brief history of the formation and the current mission of the CU COP. More.

CU COP Membership Has Its Professional Benefits
Developing best practices in utilities is just one of many benefits offered by the CU COP. More.


October 2010

Improving Water System Performance: A Continuous TOC Measurement Technology to Enhance Real-Time Process Control
An article in Pharmaceutical Engineering magazine discusses real time TOC tracking in the water purification process and the importance of rapid, continuous, and reliable TOC monitoring for real time critical water release. Read More ( 780 KB) .

Process Gases and Distribution Systems in Pharmaceutical Production
This article in Pharmaceutical Engineering magazine discusses the use of process gases in the pharmaceutical industry. Read More ( 204 KB) .

Design of Pure Steam Generation and Distribution Systems
An article in Pharmaceutical Engineering magazine presents an overview of design requirements of pharmaceutical pure steam generation and distribution systems with particular emphasis on recommended terminology (clean vs. pure steam) and feed water quality requirements. Read More ( 4 MB) .

Methods of Producing Water for Injection
This article in Pharmaceutical Engineering magazine presents the advantages and disadvantages of distillation-based and membrane-based methods for producing WFI, outlines international WFI regulatory requirements, discusses historical market penetration and performance of distillation and membrane-based WFI systems, and includes a membrane case study. Read More ( 2 MB) .

What the Critical Utilities Community is Discussing Right Now
Pressure testing for water systems and SOPs for critical utilities maintenance are a sampling of several hot topics being discussed at the Critical Utilities Community of Practice site. Read More.


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