Controlled Environments MARCH 2014 Vol. 17 • No. 3
TABLE OF CONTENTS March 2014 • www.cemag.us 4
8 2020 Pharma
A conversation with industry experts on the future of cleaning and validation.
12 Understanding Cleanroom Classifications
When using a classification system, be cognizant of the implications.
18 Container Closure Integrity Testing
CCI testing is a viable alternative to sterility testing for vials and prefillable syringes,
and may include a variety of test methods.
22 Practical Application of Rapid Microbiological Methods to
the USP <1116> Contamination Recovery Rate Approach
The past year has seen a change in the way pharmaceutical manufacturers monitor their
26 The Building Commissioning Maze, Part 1
Understanding the various types of commissioning and the
role each plays in today’s built environments.
30 Document Management
ISO 9001:2008 Clause 4.2. Documentation Requirements defines
all documentation as a tool for information transmission and
communication. The type and extent of the documentation
depends on several factors.
32 Interphex 2014 Product Showcase
6 From the Editor
21 Trending on the Web
54 Cleanroom Tip
2014 Buyer’s Guide
The most comprehensive resource
of contamination control
vendors, products, and