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
Electric Motor Asset Management for Energy Efficiency
Motors consume a large portion of a pharmaceutical facility’s electrical energy. A
Pharmaceutical Engineering Knowledge Brief by Ian Wilson discusses the importance of motor
efficiency and how speed control can deliver large savings. More.
Is Sustainability Becoming a Baseline?
What was green yesterday is normal today, says Peter Garforth in his article in Plant Services. He
calls for entire industry sectors to explore what it will take to shift green energy and other aspects of
sustainability from being an optional extra to an embedded part of the baseline design, manufacturing, and
delivery of products. More.
Variable Frequency Drives for Centrifugal Pumps
An article by Joseph T. Ramey in Chemical Engineering provides a method to estimate the economics of
using variable frequency drives. More.
Facilities of the Future
Success for today’s pharmaceutical manufacturing facility depends on speed, and addressing all
potential risks and regulatory questions from the earliest design stages, according to Agnes Shanley in her
article in PharmaManufacturing. More.
2013 ISPE Training on HVAC for Pharmaceutical Facilities
The ISPE Training Course on HVAC for Pharmaceutical Facilities will take place 13-15 May in
Indianapolis, Indiana, USA, 27-29 August in Durham, North Carolina, USA, 9-11 September in Burlingame,
California, USA, and 9-11 December in Tampa, Florida, USA. More.
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
ISPE Critical Utilities Conference Features Track on HVAC
HVAC and Process Gases: Strategies for Minimizing Cost will be a featured track at the ISPE Critical
Utilities Conference “Cost Optimization Alternatives for Critical Utilities” 25 – 26 February 2013 in Tampa,
Florida, USA. Case studies and interactive sessions will illustrate alternative strategies for
cost-effective, risk-based approaches to design, construction, and maintenance. More.
Report on the HVAC and Sustainability Joint Presentation at ISPE Annual Meeting
The HVAC and Sustainability communities presented together at the 2012 ISPE Annual Meeting last
November in San Francisco, California, USA. The education session “Quality Doesn’t Have to Cost the Earth”
focused on regulatory requirements for classified areas, current expectations, and the history behind those
expectations. Nick Haycocks provides a report. More. (
40 KB) 
Environmental Monitoring Equipment
Environmental monitoring of cleanrooms and isolators has been subject to a significant rise in
regulatory requirements recently, as contaminations can harm product, slow the product’s time to market, and
even result in recalls, according to an article in the October issue of Contract Pharma. More.
Training on HVAC for Pharmaceutical Facilities
This ISPE Training course will provide a detailed description of HVAC system fundamentals, including
a discussion of primary system components such as fans, coils, humidifiers, and filters. Participants will
receive an overview of critical parameters for products and processes that can be affected by HVAC, and
explore the basic concepts of controlling these parameters using properly designed HVAC control systems. The
course will take place 8 – 11 April in Newton, Massachusetts, USA. More.
HVAC Systems for Quality Laboratories
The new ISPE Good Practice Guide: Quality Laboratory Facilities includes a chapter
dedicated to the criteria related to cost effective and efficient design of HVAC systems serving quality
laboratories, such as, HVAC systems reliability, diversity, and segregation, classification of areas,
assessment of appropriate risks (HVAC equipment redundancy, emergency power, critical room HVAC parameters),
and commissioning and qualification. More.
What’s New on the HVAC COP Discussion Page?
There is much discussion on various topics on the HVAC discussion page. Mel Crichton provides a
summary of what’s on the minds of the HVAC community. More. (
72 KB) 
October 2012
Quality Doesn’t Have to Cost the Earth
Join the HVAC and Sustainability communities at the 2012 ISPE Annual Meeting next month in San
Francisco, California, USA, to discuss regulatory requirements for classified areas, current expectations,
and the history behind those expectations. Presentations on recent innovations and experiments will show how
current operations costs can be reduced while maintaining a compliant manufacturing area. More.
HVAC Systems for Quality Laboratories
The new ISPE Good Practice Guide: Quality Laboratory Facilities includes a chapter
dedicated to the criteria related to cost effective and efficient design of HVAC systems serving quality
laboratories, such as, HVAC systems reliability, diversity, and segregation, classification of areas,
assessment of appropriate risks (HVAC equipment redundancy, emergency power, critical room HVAC parameters),
and commissioning and qualification. More.
Using Statistical Probability to Make Energy-Related Decisions
An article in Plant Services makes the case for why statistical probabilities around climate change
are helpful guides to making energy-related investment decisions. More.
Biopharma’s Flexible Imperative
An article in Pharmaceutical Manufacturing by Robert Dream, leader of the upcoming ISPE Guide:
Biopharmaceutical Process Development and Manufacturing, discusses how business forces, bioterror, and
pandemic risks demand new approaches to manufacturing. More.
July 2012
Training on HVAC for Pharmaceutical Facilities
This ISPE Training course will provide a detailed description of HVAC system fundamentals, including
a discussion of primary system components such as fans, coils, humidifiers, and filters. Participants will
receive an overview of critical parameters for products and processes that can be affected by HVAC, and
explore the basic concepts of controlling these parameters using properly designed HVAC control systems. The
course will take place 24 - 26 September in Chicago, Illinois, USA. More.
Technology, Budget and Sustainability Challenges
The 2012 Lab Trends and Profiles supplement by Laboratory Equipment magazine focuses on the
challenges involved in operating the modern research lab, including technology, budget and sustainability
challenges. More.
Volunteer Opportunity – HVAC Energy Reduction in Life Science Facilities
The Energy and Environment Task Team is a collaborative effort between the HVAC and Sustainable
Facilities COPs to address HVAC energy reduction opportunities in life science facilities. The team plans to
develop content addressing the problem statement: Actual and perceived internal and external compliance
barriers prevent significant reduction of energy consumption in life science facilities. If you are
interested in getting involved, contact Nigel
Lenegan or Nick Haycocks.
April 2012
Task Team to Address HVAC Energy Reduction in Life Science Facilities
ISPE’s HVAC and Sustainable Facilities communities have formed the Energy and Environment Task Team
to address HVAC energy reduction opportunities in life science facilities. The team plans to develop content
addressing the problem statement: Actual and perceived internal and external compliance barriers prevent
significant reduction of energy consumption in life science facilities. For more information and to support
this task team, visit the HVAC COP and Sustainable
Facilities COP websites.
ISPE Training Course on HVAC for Pharmaceutical Facilities
This course will provide a detailed description of HVAC system fundamentals, including a discussion
of primary system components such as fans, coils, humidifiers, and filters. Participants will receive an
overview of critical parameters for products and processes that can be affected by HVAC, and explore the
basic concepts of controlling these parameters using properly designed HVAC control systems. The course will
take place 23-25 April in Atlanta, Georgia, USA and 30 May-1 June in Brussels, Belgium. More.
Chiesi Farmaceutici S.p.A. Wins 2012 Facility of the Year Award for Sustainability
Chiesi Farmaceutici received the award for its Chiesi Farmaceutici Research and Development Centre
facility in Parma, Italy. The center was designed and constructed to incorporate sustainable systems and
processes into the building with particular attention to energy saving and reduction of the structure’s
environmental impact. Look for an in depth case study on the center in the Facility of the Year Award Special
Edition, a supplement to the upcoming Pharmaceutical Engineering May/June 2012 issue. More.
Alternative Test Methodology for In-Situ Testing of ePTFE HEPA Filters for Pharmaceutical
Applications
An article in the November/December 2011 issue of Pharmaceutical Engineering presents the
study results of using an ultra low poly-alpha-olefin challenge and a particle counter to preform leak sizing
on an expanded polytetrafluoroethylene (ePTFE) filter. More.
Particle Counting Resource
The website www.particle.com features particle counting news
and product information and life science compliance updates to ISO standards, applications, and technical
specifications.
October 2011
HVAC Community Weighs in on “Challenging the Cleanroom Paradigm”
The ISPE HVAC Community of Practice (COP) was asked to comment on the August 2011 BioPharm
International article, “Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug
Substances.” The authors of the article re-examine environmental controls in the context of technical
advances in manufacturing. More.
Alternative Methods for HEPA Filter Leak Detection
An article in the March/April 2011 issue of Pharmaceutical Engineering discusses HEPA
filter leak detection methods that provide robust alternatives to current filter testing practices. More.
Making Sustainability Pay: Lessons Learned and Best Practices
An ISPE 2011 Annual Meeting session will focus on case studies and lessons learned from the 2011
Facility of the Year Award Category Winner in Sustainability and the “Green HVAC” group. More.

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