Controlled Environments January/February 2018 Vol. 21 • No. 1
TABLE OF CONTENTS January/February 2018 • www.cemag.us 2
4 How Classification Impacts the Design of a Cleanroom
Cleanroom design elements are impacted by cleanroom classifications.
7 Controlling Ventilation Rates at University Research
The laboratory ventilation system makes up the majority of electricity demand.
13 FDA Updates Guidance on Electronic Records, Signatures
What to expect from the FDA’s Updated Guidance on Use of Electronic Records &
Electronic Signatures in Clinical Investigations under Part 11.
14 Cleanroom Products Showcase
10 Avoiding the “Killer Defect”
Even when safeguards are taken, contamination in a cleanroom still occurs.
3 From the Editor
15 How It Works
16 Trending on the Web
17 Cleanroom Tip and Index
Cover image: Shutterstock