As another year draws to a close, it’s time to take a look back at the articles and topics that have been of the most interest to the readers of Controlled Environments throughout 2017.
The most popular article of the year was “HVAC
Design for Cleanrooms,” which discussed how the
HVAC system is the “heart” of a facility. There
are distinct differences between conventional and
cleanroom HVAC setups, as well as between an
HVAC system and an HVAC unit. The information
in this article is intended to “[simplify] simplifying
the cleanroom HVAC concept to facilitate conversations with your cleanroom supplier for your next
Alarms are needed in cleanrooms to monitor equipment and product, and can prevent lost revenue and
product. “Setting Appropriate Alarm Limits in Sterile
Manufacturing Processes” cautions against the misinterpretation of cGMP guidelines as well as uninformed
use of environmental monitoring systems, which can
doom a cleanroom’s mission before it even begins.
The pharmaceutical industry can sometimes
be slow to change. Current cleaning agents may be
preferable to older methods, and may overcome the
weaknesses that cleanroom facility managers faced
in the past. “Changing the Paradigm of Cleaning and
Disinfection of Cleanrooms” talks about how to obtain
the greatest assurance of contamination control …
while noting that the most effective method remains
preventing the contamination in the first place. https://
Ultrasonic cleaning is used in a wide range of
professions. Correct cleaning solution formulations,
in addition to applicable pre- and post-cleaning procedures, are a vital part of compliance with QC and
QA standards. “Guidelines for Ultrasonic Cleaning
Solution Selection” helps cleanroom professionals
understand the basics: the specific types of contamination that need to be removed, the product composition, post-cleaning steps, and the very definition of the
word “clean.” https://www.cemag.us/article/2017/02/
The Cleanroom Tips section of Controlled
Environments features “do’s and don’ts” sent in by
our readers. Our most popular tip of 2017 was
“Minimizing Human Contamination,” contributed by
Michael Rodd of M+W Products, which explained
that human contamination is the foremost concern
when dealing with cleanrooms. https://www.cemag.
As cleanrooms come in all shapes and sizes, there’s
no one-size-fits-all answer for determining their classification levels. “Understanding What Cleanroom
Classifications Mean” discusses how best to tailor your
practices, apparel, products, and equipment to meet
specific needs. For this article we spoke to Patrick
McGee, Cleanroom Division Manager at PortaFab
Corp., for details about how to properly accommodate different levels of cleanroom classifications.
Cleanroom facility managers often want to
know about best practices in regards to the frequency of particulate and viable aseptic monitoring.
Recommendations are provided by WHO and USP
<1116>. Monitoring frequency should be made in
accordance with the manufacturer’s risk assessment.
“Microbial Air Sampling in Pharmaceutical Aseptic
Monitoring” discusses this issue in depth.
Our “Regulatory Forum” columnist, Bikash
Chatterjee, wrote “Understanding Annex 16 Changes
for Qualified Persons and Batch Release,” which
detailed recent changes in the European Union concerning responsibilities related to drug quality. https://
There are many different types of cleanrooms,
built around all sorts of needs. “The Costs of Building
a Cleanroom” described various kinds of facilities,
as well as what must be considered when designing
and constructing them, as well as the hidden costs.
Rounding out our top 10 articles of the year was our
annual Cleanroom Trends and Salary Survey, where
we sent a questionnaire to our readers to analyze cleanroom facility-related purchasing decisions, as well as
their salary and benefits packages and job satisfaction.
We used these results to analyze the latest trends —
check out the article to compare your cleanroom and
overall compensation package with those of your peers,
and to see what could be in store for the cleanroom
industry in the future. https://www.cemag.us/arti-
Controlled Environments will continue to track
these topics, as well as others related to cleanrooms
and contamination control, as we bring you fresh new
content in 2018. Thanks for reading!